PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.

Device Description

PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Irvine Scientific PVP-Polyvinylpyrrolidone device.

Acceptance Criteria and Device Performance

The provided document describes the device, its intended use, and its technological characteristics. However, it does not explicitly list specific numerical acceptance criteria for performance. Instead, it relies on a historical review and the established use of the product.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicit)	Reported Device Performance
N/A (See note below)	Has been used in a variety of clinical settings for its intended use for a number of years.
N/A (See note below)	Has become one of the standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures.
N/A (See note below)	Suitable for its intended use.
N/A (See note below)	Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

Note on Acceptance Criteria: The document references a "Notice of Final Rule" and "criteria outlined" within it, but these specific criteria are not detailed in the provided text. The submission primarily argues substantial equivalence based on the device's history of use and the fact it is considered a "standard" in the field.

Study Information:

The submission does not describe a specific clinical study with a test set, ground truth, or statistical analysis in the way a typical medical device study would. Instead, it relies on historical and widespread clinical adoption.

1. Sample sizes used for the test set and data provenance:
* Test Set Sample Size: Not applicable. No dedicated "test set" in the conventional sense is described.
* Data Provenance: The device's performance is supported by its "use in a variety of clinical settings" and its status as "one of the standard media" in the field over "a number of years." This implies broad, retrospective, and multi-country provenance, though specific countries or retrospective/prospective distinctions are not provided.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
* Not applicable. No explicit "ground truth" establishment process for a test set is described. The "ground truth" seems to be established by consensus in the professional literature over time, reflecting widespread clinical acceptance and efficacy.

3. Adjudication method for the test set:
* Not applicable. No formal adjudication method is mentioned as there's no specific test set undergoing expert review.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:
* Not applicable. This is not an AI-assisted device, and no MRMC study or comparison of human reader performance with/without AI is mentioned.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm. Its performance is inherent in its chemical properties and how it aids human procedures (ICSI).

6. The type of ground truth used:
* The primary "ground truth" appears to be expert consensus and widespread clinical use/outcomes over time, as evidenced by the statement: "The conclusion from a review of the historical information contained in professional literature shows that PVP is suitable for its intended use..." and that it "has become one of standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures." This implies that successful clinical outcomes historically have validated its efficacy.

7. The sample size for the training set:
* Not applicable. This device is a chemical medium, not a machine learning algorithm requiring a training set.

8. How the ground truth for the training set was established:
* Not applicable. There is no training set mentioned.

Summary of Approach:

Irvine Scientific's 510(k) submission for PVP-Polyvinylpyrrolidone relies heavily on its historical use and established position as a standard product in the field of intracytoplasmic sperm injection (ICSI). The regulatory filing is for a device that has already gained significant clinical acceptance and is presenting this historical performance as evidence of its safety and effectiveness, rather than reporting on a new, specific clinical trial. This approach is common for devices seeking substantial equivalence where a strong predicate device or an extensive history of safe and effective use already exists. The "study" proving it meets acceptance criteria is effectively the accumulated body of professional literature and clinical experience over "a number of years."

Summary

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Irvine Scientific

Image /page/0/Picture/2 description: The image shows the date JUL 14 1999 and the number K991343 at the top. Below this text is a black and white logo. The logo is a stylized design, possibly representing initials or a company symbol. The letters 'TM' are located at the bottom right of the logo.

1999

IRVINE SCIENTIFIC

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by:

Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

Telephone: (800) 437-5706 Facsimile: (949) 261-6522

Contact: Roberta L. Johnson

Date Submitted: April 16, 1999

Device Identification:

Trade Name:	PVP-Polyvinylpyrrolidone
Common Name:	Sperm Immobilization Medium
Classification Name:	Reproductive Media (21 CFR, 886.6180)

Predicate Device:

Notice of Final Rule, 63 FR 48428, Docket number 97N-0335

Description:

PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.

Intended Use:

PVP is intended for use as an aid in the immobilization and isolation of sperm prior to intracytoplasmic sperm injection (ICSI) procedures.

PVP (Polyvinylpyrrolidone)

Page 23 of 27

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Technological Characteristics:

Intracytoplasmic sperm injection (ICSI) procedures are typically performed in those instances where infertility is either caused by severe male factor (i.e. poor quality or insufficient number of sperm) or is of unknown cause, and where traditional in vitro fertilization procedures have not resulted in pregnancy. In ICSI, viable sperm cells are concentrated and purified, and then isolated in a culture dish, where a single cell is aspirated into a pipette or syringe, and injected into an ovum. PVP is used to assist in the isolation and immobilization of sperm, prior to ICSI procedures.

Performance Data:

PVP has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become one of standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures.

Additional Information:

Endotoxin, hamster sperm penetration assay performance and sterility tests will be performed as a condition of release for this product. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.

Conclusion:

The conclusion from a review of the historical information contained in professional literature shows that PVP is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 14 1999

Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K991343 Polyviny Dated: April 16, 1999 Received: April 19, 1999 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Ms. Johnson:

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, 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requirin regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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 regulations.

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 vitro 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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INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: KGQ 1343

Device Name:_PVP (Polyvinylpyrrolidone)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-C. Pally
(Division Sign-On)

Division of Re- Muctive, Abdominal, ENT, and Radiologi . . 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.