ISolate® is a density gradient medium designed to separate the motile fraction of sperm from seminal fluid. As a two-layer gradient system, it effectively reduces cellular contaminants such as dead sperm, white blood cells and miscellaneous debris. The resulting sample contains predominantly motile sperm. It is intended for use as a human sperm separation medium, to concentrate and purify viable sperm, prior to in vitro fertilization, and related assisted reproductive technology, procedures.

Device Description

The products are a colloidal suspension of silica particles that have been covalently modified with hydrophilic silane. The colloid is formulated in a buffered physiological solution, compatible with human sperm. They are identical to the predicate device, in formulation and differ only in the intended use.

ISolate Concentrate and ISolate Stock Solution differ only from each other, and from the predicate, in the concentration of the colloidal silica in the formulation. ISolate Stock Solution, is, in fact, identical to the "lower layer" component of the two layer kits. They are provided for those laboratories that wish to use either a two-layer gradient with densities of their own choice, or a single gradient procedure. ISolate Concentrate is designed for further dilution by the user, into an appropriate density gradient. ISolate Stock Solution may be used as supplied, for those laboratories who choose to use a single density procedure, or may be diluted to densities of the laboratory's choice.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

The document describes the submission of ISolate® Concentrate and ISolate® Stock Solution for an expanded intended use to include sperm processing procedures prior to in vitro fertilization. The primary method of demonstrating substantial equivalence is by comparing these new products to a predicate device, ISolate 2-layer kits (cleared under K971809).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (ISolate Concentrate vs. Predicate)	Basis of Comparison
Sperm survival	Performed comparably	Clinical comparison
Forward progression	Performed comparably	Clinical comparison
Percent recovery of motile sperm	Performed comparably	Clinical comparison

Note: The document explicitly states: "ISolate Concentrate has been compared clinically to ISolate 2-layer kits, and has been found to perform comparably in sperm survival, forward progression and percent recovery of motile sperm." The "acceptance criteria" here are implied to be "comparable performance" to the predicate device in these specific metrics. For ISolate Stock Solution, the acceptance criterion is being "identical" to the "Lower Layer" component of the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample size used for the clinical comparison.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is simply referred to as a "clinical comparison."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The document describes a "clinical comparison" but does not detail the methodology for assessing sperm parameters or the experts involved in establishing ground truth for the comparison.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (sperm separation media), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

No, a standalone (algorithm only) performance study was not done. This document describes a medical device (sperm separation media), not a standalone algorithm. Its performance is evaluated based on its ability to separate sperm, which is a chemical/physical process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical comparison appears to be based on direct measurements of sperm parameters: "sperm survival, forward progression and percent recovery of motile sperm." These measurements would typically be performed by laboratory technicians or embryologists using established laboratory protocols, rather than expert consensus on images or pathology.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical medium, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As stated above, this is not an AI/machine learning device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized letter "I" and "S" inside of a square. The words "IRVINE SCIENTIFIC" are printed below the square.

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

1991341

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

Contact: Roberta L. Johnson

Date Submitted: April 13, 1999

Device Identification:

ISolate® Trade Name: ISolate® Concentrate ISolate® Stock Solution Sperm Separation Medium Common Name: Cervical Cap (21 CFR, 844.5250) Classification Name:

Predicate Device:

ISolate® 2-layer kit K971809

Description:

ISolate® ISolate® Concentrate ISolate® Stock Solution Page 36 of 44

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Irvine Scientific

April 13, 1999

Intended Use:

The product is intended for use in the preparation, concentration and purification of human sperm prior to assisted reproductive technology procedures, included in vitro fertilization.

Technological Characteristics:

Sperm separation media are commonly used to separate motile sperm from the other constituents of semen (such as non-viable sperm, other cell types, soluble biochemicals and proteins). The resulting concentrated and purified sperm contains more active, viable cells which may then be used in a variety of insemination procedures.

The predicate device, ISolate 2-layer kits, is a two density gradient system designed to assist in the separation of human sperm from seminal fluid. Seminal fluid is layered over the step gradient, briefly centrifuged, and the suspended pellet extracted. Due to the higher density of the motile sperm, they penetrate the density gradient to form the pellet under centrifugation, while cellular debris, and other constituents of semen, are trapped in the upper layer of the gradient. The supernatant is then remove, the pellet resuspended in an appropriate medium, and the pellet washed twice by additional centrifugation.

The intent of this submission is to expand the intended use of these devices to include sperm processing procedures prior to in vitro fertilization.

ISolate® ISolate® Concentrate ISolate® Stock Solution

Page 37 of 44

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Performance Data:

ISolate Concentrate has been compared clinically to ISolate 2-layer kits, and has been found to perform comparably in sperm survival, forward progression and percent recovery of motile sperm. ISolate 2-layer kits were cleared for marketing under K971809. ISolate Stock Solution is identical to the "Lower Layer" component of the 2-layer kits.

Additional Information:

The shelf-life and biocompatibility of both ISolate Concentrate and ISolate Stock Solution are identical to the predicate device, ISolate 2-layer kits. Mouse embryo testing will not be performed on the device, but sperm survival tests are performed as a condition of release. Endotoxin and sterility tests are also performed and documented on the labeling and certificate of analysis.

Conclusion:

The conclusion from performance testing, as well as an examination of the formulations of ISolate Concentrate and ISolate Stock Solution, when compared to the predicate, ISolate 2-layer kits, shows that the devices are substantially equivalent for the preparation and concentration of human sperm prior to use in insemination procedures in assisted reproductive technology, including in vitro fertilization.

Solate® ISolate® Concentrate ISolate® Stock Solution Page 38 of 44

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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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that resembles an abstract bird with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 1999

Ms. Roberta L. Johnson Manager, Requiatory Affairs Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705

Re: K991341

Solated: ISolated Concentrate; ISolated Stock Solution Dated: April 16, 1999 Received: April 19, 1999 Regulatory Class: II 21 CFR 5884.6180/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, itsting of devices, good manufacturing practice, labeling, and prohibilions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or dass 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 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 requirement 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 predication 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)

991341 510(K) Number:

Device Name: ISolate®; ISolate® Concentrate; ISolate® Stock Solution

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991341

ISolate® ISolate® Concentrate ISolate® Stock Solution Page 2 of 42

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.