PVP (POLYVINYLPYRROLIDONE)

K991343 · Irvine Scientific Sales Co., Inc. · MQL · Jul 14, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991343
• Device Name: PVP (POLYVINYLPYRROLIDONE)
• Applicant: Irvine Scientific Sales Co., Inc.
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

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

Device Story

PVP (polyvinylpyrrolidone) is a chemical medium used in assisted reproductive technology (ART) laboratories. It functions by increasing the viscosity of the culture medium, which facilitates the immobilization and isolation of individual sperm cells. During ICSI procedures, a clinician uses the medium to slow down sperm motility, allowing for easier aspiration of a single viable sperm into a pipette for injection into an ovum. The device is used in clinical embryology settings by trained laboratory personnel. By enabling precise sperm handling, it assists in successful fertilization for couples experiencing severe male factor infertility or unexplained infertility.

Clinical Evidence

No clinical data provided. The device relies on historical information and professional literature demonstrating its established use as a standard medium for sperm immobilization in ICSI procedures. Performance is verified through bench testing, including endotoxin, hamster sperm penetration assay, and sterility testing.

Technological Characteristics

Polyvinylpyrrolidone dissolved in ultra-pure water and lyophilized. Reproductive media (21 CFR 884.6180).

Indications for Use

Indicated for use in assisted reproductive technology procedures involving gamete manipulation, specifically for sperm immobilization during intracytoplasmic sperm injection (ICSI) for patients with severe male factor infertility or unknown infertility where traditional IVF failed.

Regulatory Classification

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.).

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] Facsimile: [phone]

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)

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

(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)