The COOK Mini-Incubator is a small microprocessor-controlled, carbon dioxide (CO2) incubator that provides two separate humidified incubation chambers, each accepting up to four NUNC® or FALCON® 4-well culture trays. Designed for bench top use, the COOK Mini-Incubator provides controlled temperature and CO2 gas flow.

AI/ML Overview

The provided text describes the COOK Mini-Incubator, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information required to fill out a table of acceptance criteria and a comprehensive study description as requested.

The document states: "The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator passed the requirements of all tests." This is a high-level statement without specific outcomes or methodology.

Therefore, I cannot provide the requested information from the given text.

Here's why and what's missing:

Acceptance Criteria Table: The document doesn't list any specific performance metrics or their acceptable ranges (e.g., temperature stability, CO2 concentration accuracy, humidity levels).
Reported Device Performance: No actual performance data (e.g., "temperature maintained at 37°C +/- 0.5°C") is provided.
Sample Size (Test Set): The document does not mention the number of devices or experimental replicates used in the testing.
Data Provenance: No information about the origin of the data (e.g., country, retrospective/prospective).
Number of Experts/Qualifications (Ground Truth): This type of device (an incubator) typically doesn't involve expert readers for ground truth in the way medical imaging AI devices do. The "ground truth" would be objective measurements from calibrated instruments. The document doesn't describe who conducted the tests or their qualifications (e.g., "engineers with X years of experience in thermal dynamics").
Adjudication Method: Not applicable for this type of device testing as described.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is relevant for AI-assisted image analysis where human readers interpret medical images. It is not applicable to a device like an incubator.
Standalone Performance: While the "algorithm only" concept doesn't apply, the device's standalone performance was assessed (it underwent testing to assure satisfactory operating performance). However, the details of that performance are absent.
Type of Ground Truth: For an incubator, ground truth would be established by calibrated sensors and instruments measuring temperature, CO2, and humidity. This is not explicitly stated, nor are the specific methods.
Sample Size (Training Set): Not applicable for this type of device where performance is validated through physical testing, not a machine learning model.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided FDA 510(k) summary is a high-level regulatory document confirming substantial equivalence, but it does not contain the detailed technical study results or acceptance criteria that would typically be found in a design verification and validation report for the device.

Summary

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1 1999 FEB

K983642

510(K) SUMMARY ு

Submitted By:

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

October 15, 1998

Names of Device:

Trade Name: Common/Usual Name: Classification Name:

COOK Mini-Incubator IVF Incubator Embryo incubator 21 CFR §884.6120

Predicate Device:

63 FR 48428, September 10, 1998

Device Description:

Intended Use:

The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

Substantial Equivalence:

The COOK Mini-Incubator is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.

Discussion of Tests and Test Results:

The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EEB 1 1999

Brenda Davis Regulatory Affairs Cook Ob/Gyn 1100 West Morgan Street Spencer, Indiana 47460

Re: K983642 Cook Mini Incubator Dated: January 7, 1999 Received: January 11, 1999 Regulatory Class: II 21 CFR 884.6120/Procode: 85 MQG

Dear Ms. Davis:

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 (Special Controls) or 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 regult 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 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

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ COOK Mini-Incubator

Indications For Use:

The COOK Mini-Incubator is intended to be used to store and preserve gametes and/or embryos at or near body temperature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Reproductive, Abdominal, BNT 100k) Number

Image /page/2/Picture/9 description: The image shows the words "Prescription Use" and "(Per 21 CFR 801.109)". There is a line going through the words "Use" and "(Per 21 CFR 801.109)". The text is in black and the background is white.

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.