The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature.
The intended use of these incubators is to provide an environment with controlled temperature, CO2 and an elevated humidity, for the development of ova or embryos. Certain models also control O2 at suppressed levels.

Device Description

The Forma Scientific incubators are bench top, or floor standing units. They control carbon dioxide (CO2), temperature and provide elevated humidity. Certain models also control O2 at suppressed levels. Controlled parameters and alarm functions are microprocessor controlled. The volume of each chamber is approximately 6.5 cubic feet (184 liters).

AI/ML Overview

The provided text describes a 510(k) submission for the Forma Scientific Incubator, an embryo incubator. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance metrics in the way a diagnostic device might.

Therefore, much of the requested information (items 1-9) about a study proving the device meets acceptance criteria is not applicable or not present in the provided text. The incubator is a medical device that requires environmental controls, and the "tests and test results" section refers to engineering and safety verifications rather than clinical performance studies with a "ground truth."

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Electrical safety	Passed all tests
Electromagnetic compatibility acceptability	Passed all tests
Operating performance	Passed all tests
Maintain controlled CO2	Controls CO2
Maintain controlled temperature	Controls temperature
Provide elevated humidity	Provides elevated humidity
(Certain models) Control O2 at suppressed levels	(Certain models) Controls O2 at suppressed levels

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable/Not provided. The "tests" mentioned are engineering and safety verifications, not clinical trials with "test sets" or "data provenance" in the typical sense of a diagnostic device.

3. 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)

Not applicable/Not provided. There is no "ground truth" to be established by experts for the operational performance of an incubator in the context of this document. The "tests" are against predefined technical specifications.

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

Not applicable/Not provided.

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 an incubator, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant.

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

Not applicable. This device is an incubator, not an algorithm.

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

Not applicable. The "ground truth" for the performance of an incubator would be its ability to maintain specified environmental parameters (e.g., CO2 concentration, temperature, humidity) within acceptable tolerances. This is measured directly by sensors and calibrated equipment, not by expert consensus or pathology.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/ML model that requires a "training set."

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

Not applicable/Not provided.

Summary

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ma Scientific, Inc.

SECTION 10

SECTION 10

1991408

510(k) SUMMARY

Richard L. Miller Submitted By: Manager -- Regulatory Compliance Forma Scientific, Inc. Mill Creek Road Marietta, Ohio 45750

April 20, 1999

Names of Devices:

Trade Name:	Forma Scientific Incubator
Common/Usual Name:	Embryo Incubator
Classification Name:	Embryo Incubator21 CFR 884.6120
Predicate Device:	63 FR 48428, September 10, 1998

Device Description:

Intended Use:

The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature.

Substantial Equivalence:

In accordance with the Final Rule on reclassification of Medical Devices Used for In Vitro Fertilization, Forma Scientific cites the Final Rule as support for substantial equivalence.

Discussion of Tests and Test Results:

The Forma Scientific Universal Water-Jacketed Incubators were subjected to electrical safety, electromagnetic compatibility acceptability and operating performance. The incubators passed all these tests.

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Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 1999

Mr. Richard L. Miller Manager of Regulatory Compliance Forma Scientific, Inc. Box 649, Mill Creek Road Marietta, OH 45750

Re: K991408 ThermoQuest Universal Water-Jacketed Incubators Dated: April 20, 1999 Received: April 22, 1999 Regulatory Class: Il 21 CFR §884.6120/Procode: 85 MQG

Dear Mr. Miller:

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 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 requilation 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 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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Page 1 of 1

510(k) Number (if known): K991408

Device Name: Embryo Incubator

Indications For Use:

The intended use of these incubators is to provide an environment with controlled temperature, CO2 and an elevated humidity, for the development of ova or embryos. Certain models also control O2 at suppressed levels.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ે હતું (Per 21 CFR 801.109)

(Optional Format 3-10-98)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Rauloiogical Devices 91408 510(k) Number.

Regulation Number and Section

§ 884.6120 Assisted reproduction accessories.

(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.