Permanent pacing lead, Model Petite™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for a medical device submitted to the FDA and primarily assesses substantial equivalence to a predicate device, rather than providing a detailed study on specific acceptance criteria and performance metrics of the new device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC study effect sizes is not explicitly present within the provided text.

The document focuses on:

Safety and effectiveness problems associated with permanent pacing leads in general (not specific to the Model Petite™ lead). This section defines potential complications and issues that could lead to device malfunction or patient harm.
FDA's determination of substantial equivalence of the Model Petite™ lead to a legally marketed predicate device.
Indications for Use for the Model Petite™ lead.

Without a detailed performance study report, which is typically a much more extensive document than what is provided here, it's impossible to fill in the requested table and answer the study-specific questions.

However, based on the provided text, we can infer the general categories of concerns that would likely be addressed in such a study, even if the specific metrics are absent.

Here's a breakdown of why this information is missing and what would typically be expected:

A table of acceptance criteria and the reported device performance: This would be found in a performance study report, which is not included here. The Summary and Certification section only lists general problems associated with pacing leads, not specific acceptance criteria for the Model Petite™.
Sample size used for the test set and the data provenance: Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
Adjudication method for the test set: Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a pacing lead, not an AI-assisted diagnostic tool, so an MRMC study related to human readers and AI would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Again, this is a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory approval letter for a medical device (a pacing lead) based on substantial equivalence. It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical for diagnostic devices or AI-driven systems.

Summary

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MAR 2 8 2002

OSCOR INC. SUMMARY AND CERTIFICATION

STATEMENT REGARDING SAFETY AND EFFECTIVENESS INFORMATION

Safety and effectiveness information will be available to interested persons upon request.

CERTIFICATION AND SUMMARY

I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for iridium coated tip permanent pacing leads. I further certify that I am aware of the types of problems and possible complications to which permanent pacemaker leads are susceptible, and that the following summary of the types and causes of safety and/or effectiveness problems about permanent pacing leads is complete and accurate:

Types and Causes of Safety and/or Effectiveness Problems

Intermittent or continuous loss of pacing or sensing caused by such factors as:

RELATED TO LEAD FUNCTION

Complete or partial dislodgment of the electrode. Lead may require surgical repositioning or removal. 1.
Breakage of the conductor or its insulation. Lead may require surgical removal and/or repair. 2.
An increase in thresholds. 3.
Poor electrical connection to the pulse generator র্ব

RELATED TO CARDIOVASCULAR/PATIENT

Inadvertent engagement of the lead tip with intracardiac structures, such as the tricuspid valve or 1. chordae tendineae.
Inadvertent cardiac perforation can cause: 2. Phrenic nerve stimulation or diaphragmatic muscle stimulation Cardiac tamponade
Myocardial irritability may occur at implant (PVC's, ventricular tachycardia, and fibrillation). 3.
Air embolism, pneumothorax, arterial puncture, and hematoma at insertion point can occur with 4. transvenous introduction of a lead.
Infection. As with the introduction of any foreign object into the body, infection can result from the 5. use of endocardial leads. Surgical removal of the lead may be required.
When removing an implanted endocardial lead, if the connector is cut off, the lead's insulation 6. tubing, under sufficient traction, may separate from the lead conductor and slide off, leaving an exposed conductor coil in the heart and vein.

These complications can occur during implantation, explantation, or at any time postoperatively, and may require noninvasive or invasive management techniques.

Attached is a bibliography of the materials upon which the summary is based on.

510(K) Submitter: Signature of Submitter: Title of Submitter: Name of Company: Date:

Mila Doskocil

Director of RA/QA

Oscor Inc.

February 27, 2002

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure with three flowing lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

MAR 2 8 2002

Ms. Mila Doskocil Director of RA/QA Oscor, Inc. 3816 DeSoto Boulevard Palm Harbor, FL 34683

Re: K020669

Trade Name: Permanent Pacing Lead, Model Petite™ Regulation Number: 21 CFR 870.3680 Regulation Name: Permanent Pacemaker Electrode Regulatory Class: Class III (three) Product Code: DTB Dated: February 27, 2002 Received: March 1, 2002

Dear Ms. Doskocil:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Mila Doskocil

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dalla Tilla

-Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510k Number (if known) -

Device Name: Permanent Pacing Lead, Model Petite™

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrenceof CDRH, Office of Device Evaluation (ODE)

Prescription Use ે (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use

Dale Tiller

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Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.