The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage.

The intended use of these freezers is to freeze gametes and/or embryos. The freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.

Device Description

The CryoMed controlled rate freezers are bench top units. They control temperature and temperature rate through the use of liquid nitrogen (LN2), an electric heater and an air-circulating fan. Freezing parameters and alarm functions are controlled by a microprocessor built into the controlled rate freezer itself. The freezer is supplied with several preloaded freezing profiles as well as allowing the user to define their own profiles. Optional PC resident software, supplied with each unit, allows user defined programs to be written on a personal computer and downloaded to the freezer. The freezer then stores these parameters in its memory and takes over control of the run.

AI/ML Overview

The provided text describes a 510(k) summary for the Thermo Forma CryoMed® IVF Controlled Rate Freezer. It outlines the device, its intended use, and substantial equivalence to a predicate device based on the Final Rule on reclassification of Medical Devices Used for In Vitro Fertilization.

However, the provided document does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets those criteria. The document states that "Thermo Forma's CryoMed ® Controlled Rate Freezers were subjected to electrical safety, electromagnetic compatibility and operating performance tests. The freezers passed all these tests." but does not provide:

A table of specific acceptance criteria values.
Reported device performance against those criteria.
Sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case study results, standalone performance, type of ground truth, or details on the training set.

Therefore, I can only provide a partial answer based on the information present in the document and highlight what is missing.

Acceptance Criteria and Device Performance Study Details:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Electrical Safety	(Not specified in document)	Passed
Electromagnetic Compatibility	(Not specified in document)	Passed
Operating Performance	(Not specified in document)	Passed

Note: The document only states that the freezers "passed all these tests" without detailing the specific criteria for each category or providing quantitative performance metrics.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. It's an engineering test for a physical device, so it would likely be conducted in a laboratory setting by the manufacturer, but the location or whether it was internal testing, an independent lab, etc., is not mentioned.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable/not specified. The tests mentioned (electrical safety, EMC, operating performance) typically rely on engineering standards and measurement equipment rather than expert human interpretation for ground truth.
Adjudication Method for the Test Set:
- Not applicable/not specified.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is a hardware device (controlled rate freezer), not an AI/software diagnostic tool. MRMC studies are not relevant for this type of product.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device. The concept of "standalone performance" for an algorithm is not applicable. The device itself is standalone in terms of its function as a freezer.
The Type of Ground Truth Used:
- Engineering Standards and Specifications: For electrical safety and electromagnetic compatibility, the ground truth would be defined by relevant national and international electrical and EMC standards. For operating performance, it would be based on the device's design specifications for temperature control, cooling rates, and accuracy. The document does not specify which standards or what operating performance specifications were used.
The Sample Size for the Training Set:
- Not applicable. This is a manufactured hardware device. It does not use machine learning or AI models that require a "training set" in the conventional sense.
How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.

Summary of Missing Information:

To fully answer your request, the following specific details would be needed, which are not present in the provided 510(k) summary:

Specific numerical acceptance criteria for electrical safety (e.g., leakage current limits, dielectric strength), electromagnetic compatibility (e.g., emissions limits, immunity levels), and operating performance (e.g., temperature control accuracy, cooling rate precision, uniformity within the chamber).
Quantitative results demonstrating the device's performance against each of those specific criteria.
Details about the test protocols, the number of units tested, and where the testing was performed.

Summary

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K021042

MAY 1 5 2002

Thermo Forma

P.O. Box 649 • 401 Millcreek Road Marietta, OH 45750

740-373-4763 Fax: 740-373-6700 www.thermoforma.com

510(k) SUMMARY

Submitted By:

Richard L. Miller, CQE Manager of Regulatory Compliance Thermo Forma, Inc. 401 Millcreek Road Marietta, Ohio 45750

March 28, 2002

Names of Devices:

Trade Name: Common/Usual Name: Classification Name:

CryoMed ® IVF Controlled Rate Freezer IVF Controlled Rate Freezer IVF Controlled Rate Freezer 21 CFR 884.6120

Predicate Device:

63 FR 48428, September 10, 1998

Device Description:

The CryoMed controlled rate freezers are bench top units. They control temperature and temperature The ce your the use of liquid nitrogen (LN2), an electric heater and an air-circulating fan. Freezing parameters and alarm functions are controlled by a microprocessor built into the controlled rate freezer itself. The freezer is supplied with several preloaded freezing profiles as well as allowing the user to define their own profiles. Optional PC resident software, supplied with each unit, allows user defined programs to be written on a personal computer and downloaded to the freezer. The freezer then stores these parameters in its memory and takes over control of the run.

Intended Use:

The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage.

Substantial Equivalence:

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

Discussion of Tests and Test Results:

Thermo Forma's CryoMed ® Controlled Rate Freezers were subjected to electrical safety, electromagnetic compatibility and operating performance tests. The freezers passed all these tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

MAY 1 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard L. Miller, CQE Manager of Regulatory Compliance Thermo Forma, Inc. P.O. Box 649 401 Millcreek Road MARIETTA OH 45750

Re: K021042

Trade/Device Name: Thermo Forma Controlled Rate Freezers Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: 85 MQG Dated: March 27, 2002 Received: April 1, 2002

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, 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):

Device Name: IVF Controlled Rate Freezer

1021042

Indications For Use:

The intended use of these freezers is to freeze gametes and/or embryos. The I he intendou doo on the freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 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.