GIFT CATHETER SET/S by COOK OB/GYN

The GIFT Catheter Set/s are used to transfer gametes directly into the fallopian tube. The materials used in this device are stainless steel, silicone, polyethylene and TFE. These materials are widely used in the medical field and biocompatibility testing is assured.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GIFT Catheter Set/s by Cook OB/GYN, submitted in 1996 and approved in 1998. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document. The 510(k) process for this type of device at that time typically relied on demonstrating similarity to already legally marketed devices, rather than conducting new clinical trials to establish performance against pre-defined metrics.

Here's a breakdown of what can be extracted from the document in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The document explicitly states: "Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness." It then claims substantial equivalence based on "indications for use, design, construction and materials equivalence" to these predicate devices. There are no specific acceptance criteria or quantitative performance metrics reported for the GIFT Catheter Set/s itself within this document. The focus is on demonstrating that it is "substantially equivalent" to existing devices.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable. No test set or associated data provenance is mentioned. The submission is based on comparison to predicate devices, not a new performance study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. No test set requiring expert ground truth is mentioned.

4. Adjudication Method for the Test Set

Not Applicable. No test set requiring adjudication is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, Effect Size of AI vs. without AI assistance

Not Applicable. This is a medical device (catheter) submission from 1996/1998, long before AI in medical imaging or diagnostics was a primary consideration for device approval in this context. No MRMC study or AI component is mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not Applicable. There is no performance study or ground truth established for this device within this document. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not Applicable. There is no training set mentioned, as this is not a machine learning or algorithm-based device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As no training set is mentioned, there is no ground truth established for one.

Summary of Device and Approval Process from the Document:

Device: GIFT Catheter Set/s
Indication for Use: To transfer gametes directly into the fallopian tube. Sterile and intended for one-time use.
Predicate Devices: Lingard Laparoscopic GIFT Catheter Introducer Set and Cook Molloy Catheter (both manufactured by Cook Australia).
Basis for Approval: Substantial Equivalence to predicate devices in terms of indications for use, design, construction, and materials.
Materials: Stainless steel, silicone, polyethylene, and TFE (materials widely used in the medical field, with biocompatibility assured).
Regulatory Focus: Compliance with general controls provisions of the Medical Device Amendments and current Good Manufacturing Practice (GMP) requirements.

This document serves as an example of a 510(k) submission where regulatory clearance is achieved primarily through demonstrating equivalence to existing safe and effective devices, rather than through de novo studies with specific performance criteria and ground truth validation.

Summary

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510(k) Premarket Notification GIFT Catheter Set/s Cook OB/GYN

DEC 2 1 1996

K983590

】. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted By:

Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 October 13, 1998

Device

Trade Name: Proposed Classification Name: GIFT Catheter Set/s Assisted Reproduction Catheters Class II 85 MQF

Predicate Devices:

Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used Cook Australia products as our predicate to illustrate safety and effectiveness. The GIFT Catheter Set/s are substantially equivalent to other GIFT catheters in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Lingard Laparoscopic GIFT Catheter Introducer Set and Cook Molloy Catheter manufactured by Cook Australia.

Device Description:

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 1998

Ms. Brenda Davis Regulatory Affairs Technical Writer Cook Ob/Gyn® 1100 West Morgan Street Spencer, Indiana 47460

Re: K983590 Laparoscopic GIFT Catheter Set Dated: October 13, 1998 Received: October 13, 1998 Regulatory Class: II 21 CFR 884.6110/Procode: 85 MQF

Dear Ms. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compilance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,


Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Not yet assigned K 983590

Device Name: GIFT Catheter Set/s

Indications for Use: The GIFT Catheter Set/s are used to transfer gametes directly into the fallopian tube. These sets are sterile and intended for one-time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use________

David A. Segner

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 884.6110 Assisted reproduction catheters.

(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).