Sydney IVF™ PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Device Description

Sydney IVE™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP), and is used to reduce the motility of sperm and make it easier to collect them with an ICSI Pipette. Sydney IVF™ PVP is provided in glass vials with FluroTech-coated stoppers available in 200 µL fill volumes.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called Sydney IVF™ PVP, which is a sperm immobilization medium. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies for the device itself against predefined metrics.

Therefore, many of the requested details about acceptance criteria, performance metrics, ground truth, and study design are not explicitly available in the provided text. The document primarily states that the device was "subjected to testing to assure biocompatibility and satisfactory operating performance" and "passed the requirements of all tests," but it does not specify what those tests were, what acceptance criteria were used, or the results.

Here's an attempt to answer your questions based on the limited information provided:

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not include a detailed table of acceptance criteria and reported device performance in the way one would typically find for a diagnostic or AI-powered device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility	"Sydney IVF™ PVP passed the requirements of all tests."
Satisfactory Operating Performance	"Sydney IVF™ PVP passed the requirements of all tests."
Intended Use (Immobilization & Isolation of Sperm)	"This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description."
Substantial Equivalence to Predicate Device	"Sydney IVF™ PVP is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence."

Note: The document states that the device "passed the requirements of all tests." However, explicit numerical or qualitative acceptance criteria and the specific results achieved are not detailed in this summary.

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

This information is not provided in the 510(k) summary. The document does not describe specific clinical or in-vitro test sets with sample sizes or data provenance.

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

This information is not provided in the 510(k) summary. The nature of the device (a sperm immobilization medium) suggests that validation would likely involve laboratory-based assays rather than expert interpretation of medical images or data.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary.

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

This information is not applicable/provided. The device is a "sperm immobilization medium," not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This information is not applicable/provided. The device is a chemical medium, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" for a sperm immobilization medium would likely be established through laboratory-based assays and functional testing to confirm its ability to immobilize sperm and its biocompatibility. However, the specific methodology is not detailed in this summary.

8. The sample size for the training set

This information is not applicable/provided. The device is a chemical medium, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided for the reasons stated in point 8.

Summary

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510(k) Summary as Required by Section 807.92(a)

Submitted By:	COOK OB/GYN TMRegulatory Affairs1100 West Morgan StreetSpencer, Indiana, 47460
Telephone:	812-829-6500
Facsimile:	812-829-2022
Contact:	Brenda Davis
Date Submitted:	April 8, 2003

Names of Device:

Trade Name:	Sydney IVF™ PVP
Common/Usual Name:	Sperm Immobilization Medium
Classification Name:	Reproductive media and supplements21 CFR, 884.6180 (85MQL)
Predicate Device:	63 FR 48428, September 10, 1998

Device Description:

Intended Use:

Sydney IVF™ PVP consists of a sperm medium containing 10% oyunoy in the reserved is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.

Substantial Equivalence:

Sydney IVE™ PVP is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

Discussion of Tests and Test Results:

Sydney IVF™ PVP was subjected to testing to assure biocompatibility and satisfactory operating performance. Sydney IVF™ PVP passed the requirements of all tests.

Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2004

Ms. Brenda Davis Regulatory Affairs/Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460-6500

Re: K031304

Trade/Device Name: Sydney IVF"" PVP Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: December 23, 2003 Received: December 24, 2003

Dear Ms. Davis:

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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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,

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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Indications for Use

510(k) Number (if known): K 031304

Device Name: Sydney IVF™ PVP

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segner

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

Regulation Number and Section

§ 884.6180 Reproductive media and supplements.

(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.