Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.
Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.

Device Description

Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.
Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.

AI/ML Overview

The provided text describes a medical device called "Water for Assisted Reproductive Technologies (A.R.T.) Use." It is a water product intended for use in A.R.T. laboratory procedures. The document is a 510(k) submission, seeking substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Non-pyrogenic high purity grade of water	Water for A.R.T. Use is USP WFI grade.
Supports embryonic growth as shown by mouse embryo assay	Assayed by mouse embryo assay prior to release to market, assurance that it will support embryonic growth.
No toxic components present as shown by mouse embryo assay	Assayed by mouse embryo assay prior to release to market, assurance that no toxic components are present.
Suitable for intended use in A.R.T. laboratory procedures	Conclusion from performance testing and historical information in professional literature shows suitability for intended use.
Meets criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335	Found to meet these criteria.
Substantial equivalence to other 510(k) cleared Irvine Scientific products	Found to be substantially equivalent.
USP 24 testing prior to release	USP 24 testing will be performed as a condition of release.

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

The document does not specify a distinct "test set" with a particular sample size in the context of a clinical study or a separate validation study. Instead, it mentions that the product is "assayed by mouse embryo assay prior to its release to market." This suggests that the mouse embryo assay is a routine quality control measure applied to batches of the product, rather than a one-time test set for regulatory submission.

Sample Size: Not explicitly stated as a fixed sample size for a "test set." It refers to ongoing "mouse embryo assay" and "USP 24 testing" for each lot.
Data Provenance: The document states that the "equivalent of Water for Assisted Reproductive Technologies (A.R.T.) Use has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium." This implies historical clinical use data, but the specific origins (e.g., country) are not provided. The mouse embryo assay and USP 24 testing are internal to the manufacturer prior to market release.

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

Not applicable. The "ground truth" for this device appears to be defined by adherence to established quality standards (USP WFI grade, non-pyrogenicity, support for embryonic growth, absence of toxic components) determined through laboratory assays (mouse embryo assay, USP 24 testing). There is no indication of human expert consensus being used to establish ground truth for a "test set" in the way it might be for an AI diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of an adjudication method, as the tests are laboratory assays with clear pass/fail criteria rather than assessments requiring human interpretation and consensus.

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

Not applicable. This device is a water product for laboratory use, not an AI diagnostic device that would involve human readers.

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

This question is not directly applicable in the context of the device described. The "performance" of the water is assessed through laboratory assays (mouse embryo assay, USP 24 testing) which can be considered "standalone" without human-in-the-loop interpretation in the sense of a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used is primarily based on:

Laboratory Assay Results: Mouse embryo assay for embryonic growth support and absence of toxic components.
Pharmacopoeial Standards: USP WFI (Water for Injection) grade and USP 24 testing for purity and quality.
Historical Clinical Usage: The past performance of equivalent products in clinical settings.

8. The sample size for the training set

Not applicable. This device is a laboratory reagent, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply.

Summary

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JUN 1 3 2001

K011598
May 9, 2001
Page 1 of 2

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: Wendell Lee, Pharm. D.

Water for Assisted Reproductive Technologies

Date Submitted: May 9, 2001

Device Identification:

Trade Name:

(A.R.T.) Use

Common Name:

(A.R.T.) Use

Classification Name:Reproductive Media (21 CFR 884.6180)

Predicate Device:

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

Description:

Water for Assisted Reproductive Technologies (A.R.T.) Use is a water intended for use in A.R.T. laboratory procedures requiring a non-pyrogenic high purity grade of water.

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Mav 9. 2001

K011598
page 2 of 2

Intended Use:

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in A.R.T. laboratory procedures.

Technological Characteristics:

Water for Assisted Reproductive Technologies (A.R.T.) Use is highly purified water of USP WFI grade.

Performance Data:

Water for Assisted Reproductive Technologies (A.R.T.) Use is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. The equivalent of Water for Assisted Reproductive Technologies (A.R.T.) Use has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for the fertilization and growth of human gametes and embryos.

Additional Information:

Mouse embryo, and USP 24 testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis.

Conclusion:

The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Water for Assisted Reproductive Technologies (A.R.T.) Use is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N 0335 in addition to showing substantial equivalence to other 510(k) cleared Irvine Scientific products.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2001

Wendell Lee, Pharm. D. Vice President Quality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588

Re: K011598

Water for Assisted Reproductive Technologies (A.R.T.) Use Dated: May 9, 2001 Received: May 24, 2001 Regulatory Class: II 21 CFR §884.6170/Procode: 85 MTW

Dear Dr. Lee:

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 (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 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) 594-4639. 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" (21CFR 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/dsmadsmamain.html".

Sincerely yours.

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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Irvine Scientific

INDICATIONS FOR USE STATEMENT (page 1 of 1)

510(K) Number: KO11598

Device Name: Water For Assisted Reproductive Technologies (A.R.T.) Use

Water for Assisted Reproductive Technologies (A.R.T.) Use is intended for use in assisted reproductive technology procedures.

(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)

David L. Hynson

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

Regulation Number and Section

§ 884.6170 Assisted reproduction water and water purification systems.

(a)
Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).