The COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes.

Device Description

The COOK Test Tube Heater is an electronically controlled heating unit that holds collection test tubes and their contents during oocyte recovery. The unit is designed to accept up to six Falcon® 2001 Series 10 mL test tubes.

AI/ML Overview

Due to the nature of the device being a test tube heater and the provided documents focusing on its regulatory approval rather than clinical studies, much of the requested information (especially points 2, 3, 4, 5, 6, 7, 8, and 9 related to human subject studies or complex AI algorithms) is not applicable. The documentation primarily describes substantial equivalence to a predicate device and basic performance testing.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maintain the temperature of egg (oocyte) collection tubes at or near body temperature.	"The COOK Test Tube Heater was subjected to testing to assure satisfactory operating performance. The COOK Test Tube Heater passed the requirements of all tests." (Specific temperature ranges or tolerances are not provided in the submitted documents.)

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

Not applicable. The provided document describes technical performance testing of a device (a test tube heater), not a study involving human subjects, images, or biological samples with associated data provenance.

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

Not applicable. Ground truth, in the context of expert review, is not relevant for a test tube heater's performance evaluation as described. Performance is measured against engineering specifications.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used in studies involving subjective interpretations (e.g., image analysis by multiple readers) to resolve discrepancies. This is not relevant for a device like a test tube heater.

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 not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a hardware component; it does not involve algorithms or AI.

7. The type of ground truth used

For the performance of the test tube heater, the "ground truth" would be established engineering specifications and measurement standards (e.g., calibrated thermometers). The document states the device "passed the requirements of all tests," indicating it met these pre-defined technical specifications.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI algorithms that require a training set.

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

Not applicable. There is no training set for this type of device.

Summary

{0}------------------------------------------------

K983609 9 · 510(K) SUMMARY

Submitted By:

Brenda Davis Regulatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer. Indiana, 47460.

October 13, 1998

Names of Device:

COOK Test Tube Heater Trade Name: Common/Usual Name: IVF Test Tube Heater Assisted reproduction accessory - Collection tube Proposed Classification Name: warmer 21 CFR §884.6120

Predicate Device: 63 FR 48428. September 10, 1998

Device Description:

Intended Use:

The COOK Test Tube Heater is intended to be used to maintain the temperature of egg (oocvte) collection tubes at or near body temperature.

Substantial Equivalence:

The COOK Test Tube Heater is comparable with respect to intended use to the FDA published predicate device description and meets the requirements for 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The COOK Test Tube Heater was subjected to testing to assure satisfactory operating performance. The COOK Test Tube Heater passed the requirements of all tests.

Conclusions Drawn from Tests:

This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract shapes that resemble human figures or birds in flight. The shapes are arranged in a diagonal line, with the top shape being the largest and the bottom shape being the smallest.

DEC I 6 1998

Ms. Brenda Davis Regulatory Affairs Cook Ob/Gyn® 1100 West Morgan Street Spencer, IN 47460

Dear Ms. Davis:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983609 Cook Test Tube Heater Dated: October 13, 1998 Received: October 14, 1998 Regulatory Class: II 21 CFR 884.6120/Procode: 85 MQG

We have reviewed vour 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 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) 594-4613. 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

{2}------------------------------------------------

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ COOK Test Tube Heater

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. Segeen

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

Prescription Use_ V (Per 21 CFR 801.109)

Over-The-Counter Use___ (Optional Format 1-2-96)

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.