Signature Approvals
Name
Title
Signature
Date
PMS Report Author(s)
Jeffrey Chou
Regulatory Affairs Specialist
Jeffrey Chou
12/17/2021
PMS Report Reviewers
Farhad Daghighian
Chief Scientist
12/17/2021
Abbreviations/Acronyms/Definitions
Abbreviation/Acronym
CAPA
CER
EU
FDA
FSCA
GHTF
GSPRs
HHE
IMDRF
IFU
IPU
IQS
MAUDE
MDR
MedSun
PCR
PMCF
PMS
OUS
Q1
TGA Australia
TPLC
US
UK
Definition
Corrective Action/Preventive Action
Clinical Evaluation Report
European Union
US Food and Drug Administration
Field Safety Corrective Action
Global Harmonization Task Force
General Safety and Performance Requirements
Health Hazard Evaluation
International Medical Device Regulators Forum
Instructions for Use – User Guide
Incident Per Unit
Initial Quality Study
FDA – Manufacturer and User Facility Device Experience
Medical Device Regulation
FDA – Medical Product Safety Network Reports
Problem Cause Resolution Code
Post Market Clinical Follow-up
Post Market Surveillance
Out of United States
First quarter of year
Therapeutic Goods Administration
FDA – Total Product Life Cycle
United States
United Kingdom
1. Purpose/Objectives of the Post-Market Surveillance (PMS)
Report
This PMS Report summarizes the systematic collection of post-market regulatory
activities and company processes, including metrics, used to continually monitor the
safety and performance of the Node Seeker 2000 and to facilitate a comprehensive
analysis of the clinical outcomes.
The objectives of this PMS Report are as follows:
1. Provide a summary of the collection and review of marketplace experience for
this device.
2. Ensure the utmost public safety and well-being exists for patients in a clinical
environment.
3. Provide for the health and safety of healthcare professional end users of this
device.
4. Summarize collected data and note actions on any necessary preventive or
corrective actions.
As this is the initial PMS Report developed by Intra-Medical Imaging to comply with
the new EU MDR requirements, the data and analysis is from product launch in
December 2017 to November 12, 2021. In the future, scheduled reports will be
generated on an annual basis within Q1 of each calendar year.
2. Scope
The following regulatory, directive, and guidance documents have been reviewed and
utilized in preparing the associated Post Market Surveillance Plan 2020
EU MDR 2017/745, Medical Device Regulation (European Parliament and the Council of 5
April 2017)
MEDDEV 2.7-1 rev. 4, Medical Device Directive (Council Directive 93/42/EEC of 14 June
1993)
MEDDEV 2.12-1 rev. 8, Additional Guidance Regarding the Vigilance Systems as outlined in
MEDDEV 2.12-1 rev.8
MEDDEV 2.12-2 rev.2, Guidelines on Medical Devices Post Market Clinical Follow-up
Studies
EN ISO 13485: 2016, clauses 8.2.1 (Feedback) and 8.2.5 (Monitoring and measurement of
processes)
NBMED 2.12 rec 1, Coordination of Notified Bodies Medical Devices on Council Directives
90/385/ECC,93/42/EEC and 98/79/EC Post-Marketing Surveillance
(PMS) post market/production
3.
3.1
Description of the Product or Product System
Product or Product System:
Node Seeker 2000:
4. Product(s) Instructions for Use (IFUs)
The intended use for Node Seeker 2000
5. Clinical Literature Data Analysis
Content included in the Clinical Literature relevant to safety and performance will be discussed in the
Clinical Evaluation Report.
6. Internal PMS Data Review and Evaluation
The information within this report is being conveyed from manufacturing and engineering systems,
quality management systems, marketing, and sales, as well as patients, healthcare professional users,
distributors, and importers.
6.1
6.2
6.3
7.
CAPA: Corrective and Preventive Action
Feedback
Complaint data inclusive to relevant Service Request Information