Modified Ham's F-10 with Albumin is intended for assisted reproduction procedures such as the processing or manipulation of human sperm prior to insemination, in vitro fertilization and intracytoplasmic sperm injection (ICSI) procedures.

Device Description

Modified Ham's F-10 with Albumin is synthetic, defined media composed of a mixture of salts and other physiologically compatible substances. Modified Ham's F-10 with Albumin contains 5 mg/mL of human serum albumin.

AI/ML Overview

The provided text describes a medical device, "Modified Ham's F-10 with Albumin," and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device for sperm processing media. The performance data section describes the product's quality control rather than a clinical study evaluating its effectiveness as a diagnostic or AI-powered tool.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly for AI/diagnostic applications, cannot be generated from the given document as it pertains to a reproductive media product, not an AI-powered diagnostic device.

However, I can extract the information related to the quality control and historical use of the product, which serves as its "performance data" in this context.

Here's a breakdown based on the provided text, using the closest applicable interpretations:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from a quality control perspective)	Reported Device Performance
Non-toxic components	Assured by mouse embryo assay (prior to release to market). Satisfactory results allow product release.
Endotoxin levels	Tested (as a condition of release). Results reported on lot-specific certificate of analysis.
Sterility	Tested (as a condition of release). Results reported on lot-specific certificate of analysis.
Suitability for intended use	History of satisfactory use for sperm processing prior to intrauterine insemination. Concluded to be suitable for intended use.
Meet criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335	"Performance testing, as well as a history of satisfactory use... shows that Modified Ham's F-10 with Albumin is suitable for its intended use, and meet the criteria outlined..."

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

Test Set (for quality control): The "test set" in this context refers to batches of the manufactured medium.
- Sample Size: Not explicitly stated as a number of individual tests, but implies each lot/batch of the product is subjected to the specified assays.
- Data Provenance: Not applicable in the traditional sense of clinical data. It's internal quality control data from Irvine Scientific's manufacturing process.

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

Not applicable. This document describes quality control assays (mouse embryo assay, endotoxin, sterility) for a culture medium, not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method for the test set:

Not applicable. The "adjudication method" usually refers to reconciling differences in expert opinions for ground truth. Here, results are from laboratory assays and historical use are evaluated against predefined specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This is not an AI-powered diagnostic device, and thus, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

No. This product is a biological medium used in assisted reproductive procedures, not an algorithm.

7. The type of ground truth used:

For quality control: Laboratory assay results (mouse embryo assay, endotoxin, sterility) and historical satisfactory use in clinical settings.
For the intended effect (purification and concentration of viable sperm): Clinical observation of successful insemination/fertilization outcomes (implied by "history of satisfactory use" and the goal of increasing viable sperm concentration for successful procedures).

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set is involved.

Summary

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JUL - 2 1999

Irvine Scientific

Image /page/0/Picture/2 description: The image shows the logo for Irvine Scientific. The logo features a stylized, white "IS" monogram set against a black square. Below the square, the words "IRVINE SCIENTIFIC" are printed in a simple, sans-serif font.

K991420

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 20, 1999

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:

April 20, 1999

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.. . . . . .

Intended Use:

Modified Ham's F-10 with Albumin is intended for use in assisted reproductive procedures such as sperm washing.

Technological Characteristics:

Modified Ham's F-10 with Albumin is 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 intra-uterine. When performed with a culture medium such as Modified Ham's F-10 with Albumin, 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:

Modified Ham's F-10 with Albumin is assayed by mouse embryo assay prior to its release to market. This assay assures that the product contains no toxic components. Modified Ham's F-10 with Albumin has been used in a variety of clinical settings, for its original, intended use, for a number of years. In that time, the product had become an standard alternative media used for the processing of human sperm prior to assisted reproductive procedures.

Additional Information:

Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays

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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 Modified Ham's F-10 with Albumin is suitable for its 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 1999

Ms. Roberta L. Johnson Manager, Requlatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana. CA 92705-5588

Re: K991420 Modified Ham's F-10 with Albumin Dated: April 22, 1999 Received: April 23, 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 regulation (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 requlation (21 CFR Part 801 and additionally 809,10 for in vitro diagnostic devices), please contact the Office of Compiiance 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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Irvine Scientific

INDICATIONS FOR USE STATEMENT (page 1 of 1)

191420 510(K) Number:_

Device Name:_Modified Ham's F-10 with Albumin

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number

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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.