Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.
Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.

Device Description

Sperm Washing Medium and Modified Sperm Washing Medium are synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. The two products differ only in their protein supplementation. Sperm Washing Medium contains 5 mg/mL of human serum albumin, while Modified Sperm Washing Medium contains the same concentration of bovine serum albumin.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for Irvine Scientific's Sperm Washing Medium and Modified Sperm Washing Medium, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it refers to regulatory compliance and historical use as indicators of suitability.

Acceptance Criteria (Implied)	Reported Device Performance
Regulatory Compliance	Meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
Non-Toxicity	Assayed by mouse embryo assay prior to release to market, which "assures that the product contains no toxic components."
Suitability for Intended Use	"Conclusion from performance testing, as well as a history of satisfactory use for sperm processing prior to intrauterine insemination."
Quality Control	Mouse embryo testing, endotoxin, and sterility testing performed as conditions of release. Results reported on a lot-specific certificate of analysis.

Study Information

The provided text describes a submission for a 510(k) premarket notification, which largely relies on demonstrating substantial equivalence to a predicate device and established safety/effectiveness through existing data and product history. It does not detail a formal, prospective clinical study designed to "prove" the device meets specific, novel acceptance criteria in the way a new drug or high-risk device might.

Here's what information can be extracted regarding the "study" aspects:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated as a separate "test set" for a new study. The primary "testing" referenced is:
  - Mouse embryo assay: This is a quality control test for each lot, not a clinical study test set. The number of embryos per assay is not specified.
  - "Variety of clinical settings": The products "have been used in a variety of clinical settings, for their original, intended use, for a number of years." This implies a large, cumulative, retrospective dataset from actual clinical practice. No specific numbers of patients or procedures are given.
- Data Provenance: Not specified, but given Irvine Scientific's US location, it's likely primarily US-based clinical use, though this is an inference. Predominantly retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable in the context of the information provided. The "ground truth" for the performance claims relies on the historical clinical outcomes from using these media and the biological assays (mouse embryo assay, endotoxin, sterility). There isn't a "ground truth" established by human experts reviewing test data in the way a diagnostic imaging study might.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no human adjudication of a novel test set performance. The "adjudication" of the device's suitability fundamentally comes from regulatory bodies (FDA) based on the provided evidence of equivalence and historical safety/effectiveness.
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:
- Not applicable. This device is a biological medium, not an AI-powered diagnostic tool, and no MRMC study was conducted or mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The mouse embryo assay could be considered a "standalone" test of product quality, but it's a product quality control, not a standalone performance study in the AI context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The primary "ground truth" for the device's effectiveness relies on outcomes data (successful insemination/fertilization outcomes from actual clinical use) and biological assay results (absence of toxicity from mouse embryo assay, sterility, endotoxin levels). The success in assisted reproductive procedures when these media were used over "a number of years" serves as strong evidence.
The sample size for the training set:
- Not applicable in the conventional sense. This is not a machine learning or AI device. The term "training set" doesn't apply to the development or validation of these media in the provided context. The general "history of satisfactory use" could be thought of as a vast, non-quantified "experience set" that informed both the current product and its predicate.
How the ground truth for the training set was established:
- Not applicable, as there's no training set in the AI sense. The "ground truth" of the product's quality and suitability for its intended use stems from established biological testing methodologies (mouse embryo assay, endotoxin, sterility) and long-term clinical experience with the product and its predicate, indicating successful outcomes in assisted reproductive procedures.

Summary

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K9835F8

4/26/99

Irvine Scientific

October 9, 1998

Image /page/0/Picture/4 description: The image is a black and white graphic of a logo. The logo is a stylized design with a combination of straight lines and geometric shapes. The logo is enclosed within a square border. The letters 'TM' are visible in the lower right corner of the image.

IRVINE SCIENTIFIC

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

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

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

Contact: Roberta L. Johnson

Date Submitted: October 9, 1998

Device Identification:

Trade Name:	Sperm Washing MediumModified Sperm Washing Medium
Common Name:	Sperm processing media
Classification Name:	Reproductive Media (21 CFR, 886.6180)

Predicate Device:

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

Description:

Sperm Washing Medium

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October 9, 1998

Intended Use:

Sperm Washing Medium and Modified Sperm Washing Medium are intended for sperm processing procedures prior to intrauterine or in vitro fertilization procedures.

Technological Characteristics:

Sperm Washing Medium and Modified Sperm Washing Medium are used to purify and concentrate sperm prior to use in assisted reproductive procedures. The goal of such sperm "washing" procedures is to concentrate and purify viable sperm, and separate them from the non-sperm constituents of seminal fluid, simulating the filtering effect of cervical mucous. A higher concentration of viable sperm increases the chance of successful insemination, either in vitro, or intrauterine. When performed with a culture medium such as Sperm Washing Medium, semen is suspended in the medium, centrifuged to concentrate the viable sperm, and the supernatant, containing seminal debris, is removed. The sperm pellet is then resuspended in fresh medium, and recentrifuged. During this process, viable sperm are concentrated in the medium, and are then aspirated and used for the fertilization procedure.

Performance Data:

Sperm Wash and Modified Sperm Wash are assayed by mouse embryo assay prior to their release to market. This assay assures that the product contains no toxic components. Both Sperm Wash and Modified Sperm Wash have been used in a variety of clinical settings, for their original, intended use, for a number of years. In that time, the products have become the standard media used for the processing of human sperm prior to assisted reproductive procedures.

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Additional Information:

Mouse embryo testing will be performed as a condition of release for these products, as well as endotoxin and sterility testing. 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 performance testing, as well as a history of satisfactory use for sperm processing prior to intrauterine insemination, shows that Sperm Washing Medium and Modified Sperm Washing Medium are suitable for their intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 6 1999

Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K983588

Sperm Washing Medium, Modified Sperm Washing Medium Dated: February 12, 1999 Received: February 16, 1999 Regulatory 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 (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 compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 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 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:_K983588

Device Name: Sperm Washing Medium, Modified Sperm Washing Medium

Indications for Use:

Sperm Washing Medium and Modified Sperm Washing Medium are intended for assisted reproduction procedures that require the processing or manipulation of human sperm prior to insemination or in vitro fertilization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription

David A. Segner

Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number

Sperm Washing Medium
Modified Sperm Washing Medium

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.