The CooperSurgical Trial Transfer catheters are single-use sterile, disposable, flexible catheters with a round smooth distal end. The tip has a blind/closed end. The device has an overall length of either 18cm or 23cm including a polypropylene Luer Lock Adaptor that is affixed at its proximal end. The inner catheter is a clear tube with a 1.8mm outer diameter and a 0.8mm inner catheter is surrounded by an outer sheath with a 2.3mm outer diameter. This inner catheter has a series of graduated markings that are placed 1cm apart at the proximal end to provide reference to the degree of inner catherer insertion to the uters during embryo placement. The distal 0.1cm length of the outer sheath possesses a gradual taper and is shorter than the inner catheter leaving the distal 5cm of the inner catheter exposed. The proximal circumferences of the outer sheath and inner catheter are molded directly into the distal end of the Luer Lock Adaptor. Five black (ink) graduation markings are located on the distal portion of the outer sheath at 1cm increments to indicate the degree of advanced into the cervix. This facilitates catheter positioning and placement during embryo replacement with an assisted reproduction catheter.

AI/ML Overview

This document describes the 510(k) premarket notification for the CooperSurgical Trial Transfer Catheter. However, it does not contain specific acceptance criteria, a study proving device performance against those criteria, or details regarding diagnostic accuracy, sensitivity, or specificity.

The document indicates that the device has undergone biocompatibility testing and complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements. It also states that the device is substantially equivalent to a predicate device (Wallace Trial Transfer Catheter K990348) based on having the same indications for use, material composition, sterilization method, and working dimensions, with minor differences in luer size and packaging.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in the format you've outlined, as that information is not present in the provided text. The submission focuses on substantial equivalence to an existing predicate device rather than presenting a performance study with defined acceptance criteria for diagnostic accuracy or similar metrics.

Here's what I can extract based on the provided text, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for Performance / Diagnostic Accuracy)	Reported Device Performance (Summary from text)
Biocompatibility: Meet ISO 10993-1 requirements	The subject device has been subject to biocompatibility testing for its materials, which is equivalent to ISO 10993-1 Biocompatibility requirements.
Luer Taper: Comply with ISO 594-1 1986	The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.
Functional Equivalence: Same indications for use as predicate	The subject devices have the same indications for use as the predicate (Wallace Trial Transfer Catheter K990348). Intended use: "The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus."
Material Equivalence: Same material composition as predicate	The subject device is composed of the same materials as the predicate. (Detailed material list provided for inner catheter, outer sheath, and luers).
Sterilization Method Equivalence: Same sterilization method as predicate	The subject device is sterilized using the same method as the predicate.
Dimensional & Working Equivalence: Similar working dimensions as predicate	The subject device has similar working dimensions as the predicate. (Minor difference noted: "The luers of the subject device are slightly larger (both in diameter and length) than the predicate device.")
Packaging: Different but acceptable packaging	The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film. (Considered a minor difference).
Safety and Effectiveness: As safe and effective as predicate	The submission concludes that "the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices," based on the substantial equivalence argument and compliance with biocompatibility and luer standards. No specific performance metrics for assessing "advancement through the cervical canal and positioning of the uterus" are provided.

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. The submission focuses on substantial equivalence based on design, materials, and existing standards, rather than a clinical performance study with a distinct "test set" in the context of diagnostic accuracy.
The biocompatibility testing and luer taper compliance would have involved laboratory testing of samples, but the specific sample sizes for these tests are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. This type of information is relevant for studies assessing diagnostic or clinical performance against a "ground truth" established by experts (e.g., radiologists, pathologists). This submission is for a medical device (catheter) based on substantial equivalence, and not a diagnostic tool requiring expert ground truth for a test set.

4. Adjudication method for the test set:

Not applicable / Not provided. See point 3.

5. 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:

No. This is a submission for a physical medical device (catheter), not an AI/software device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not performed.

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

No. This is a physical medical device, not an algorithm or AI.

7. The type of ground truth used:

For biocompatibility: In vitro and in vivo biological response criteria as defined by ISO 10993-1.
For luer taper conformity: Engineering specifications and measurements against ISO 594-1 standards.
For substantial equivalence: Comparison to the specifications, materials, and intended use of the legally marketed predicate device (Wallace Trial Transfer Catheter K990348).
There is no clinical "ground truth" (e.g., pathology, outcomes data, expert consensus) mentioned for evaluating the catheter's intended use ("assessing advancement through the cervical canal and positioning of the uterus"), as the submission relies on substantial equivalence to a device already on the market.

8. The sample size for the training set:

Not applicable / Not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.

9. How the ground truth for the training set was established:

Not applicable / Not provided. See point 8.

Summary

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510 (k) Summary

K023384

DEC 1 3 2002

Date Prepared [21 CFR 807.92(a)(1)|

October 7, 2002

Submitter's Information [21 CFR 807.92(a)(1)]

Joseph M. Azary C/o CooperSurgical, Inc. P.O. Box 2156 Huntington, CT 06484

Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical, Inc., 95 Corporate Drive, Trumbull, CT 06611. CooperSurgical, Inc. is an FDA-registered medical device under establishment# 1216677.

Trade Name, Common Name, Classification [21 CFR 807.92(2)(2)]

Trade names are: CooperSurgical Trial Transfer Catheter Common Name: Assisted Reproduction Catheter Classification: Class 11, 21 CFR 884.6110, MQF

Predicate Device [21 CFR 807.92(a)(3)]

Wallace Trial Transfer Catheter K990348 .
The subject devices have the same indications for use, material composition, sterilization method, and working dimensions as the predicate. A minor difference lies in the fact that the luers of the subject device are slightly larger (both in diameter and length) than the predicate device. The subject device is packaged in a pouch composed of Tyvek and film, whereas the predicate device is packaged in a pouch composed of paper and film. Additional information regarding the predicate device can be found in Annex 4. A chart comparing the subject device to the predicate device can be found in Annex 7.

Description of the Device [21 CFR 807.92(a)(4){

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FDA 510(k) Premarket Notification CooperSurgical - Trial Transfer Catheter

The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouches will be placed in a carton. Each carton will contain 10 units.

The two versions to be offered are: AR-TT18 (18cm) and AR-TT23 (23cm).

The subject devices are composed of the following materials:

Component	Material	Details
Inner Catheter	Polyurethane	Pellethane 2363-90A R0120 Poly-urethane
Outer Sheath	Teflon	Fluortek FEP-20 White (akaNeoflon NP-20) with 8-10% Bar-ium Sulfate.
Luers	Polypropylene (with colorants).	Montell Profax 6323 Compoundedby Chroma with PMS 240 U Pink.
Luers		Montell Profax 6323 Natural com-pounded by Chroma with FDAwhite colorant.
Tip Protector	Polyethylene	No patient contact

Intended Use [21 CFR 807.92(a)(5)]

The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus.

Technological Characteristics [21 CFR 807.92(a)(6)]

CooperSurgical, Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and is similar dimensionally. The only differences are with the packaging and the outer diameter and length of the Luer.

Performance Data [21 CFR 807.92(b)(1)|

The subject device has been subject to biocompatibility testing (for the materials that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.

Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 image of an eagle with three overlapping wing shapes, suggesting movement or flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 13 2002

CooperSurgical, Inc. % Mr. Joseph M. Azary Azary Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484

Re: K023384 Trade/Device Name: CooperSurgical, Inc.

Trial Transfer Catheter Regulation Number: 21 CFR 884.6110 Regulation Name: Assisted reproduction catheters Regulatory Class: II Product Code: 85 MQF Dated: December 3, 2002 Received: December 4, 2002

Dear Mr. Azary:

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 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.

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 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 vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FDA 510(k) Premarket Notification CooperSurgical - Trial Transfer Catheter

5 10(k) Number (if known): K023384

Device Name: CooperSurgical, Inc. Trial Transfer Catheter

The sterile single-use device is intended to assess advancement through the cervical canal and positioning of the uterus. .

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Dancy C. Broadon

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

2023589
Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)

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).