(108 days)
Not Found
Not Found
No
The description focuses on standard incubator technology with microprocessor control for temperature and CO2, and there is no mention of AI or ML.
No.
The device is used for storage and preservation of gametes and embryos, not for treating a disease or condition in a patient.
No
The device is described as an incubator for storing and preserving gametes and embryos, not for diagnosing any condition.
No
The device description explicitly states it is a "small microprocessor-controlled, carbon dioxide (CO2) incubator" and provides "controlled temperature and CO2 gas flow," indicating it is a hardware device with embedded software for control.
Based on the provided information, the COOK Mini-Incubator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "store and preserve gametes and/or embryos at or near body temperature." This is a function related to maintaining biological samples, not performing a diagnostic test on them.
- Device Description: The description details a controlled environment for incubation (temperature, CO2, humidity). This is a support function for biological processes, not a diagnostic measurement or analysis.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting markers, or providing information for diagnosis, treatment, or prevention of disease.
- Predicate Device: The predicate device reference (63 FR 48428) likely refers to a regulation or guidance document related to devices used in assisted reproductive technology (ART) or similar fields, not specifically IVDs.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. The COOK Mini-Incubator's function is to provide a suitable environment for biological samples, which is a different category of medical device.
N/A
Intended Use / 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.
Product codes
MQG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The COOK Mini-Incubator was subjected to testing to assure satisfactory operating performance. The COOK Mini-Incubator passed the requirements of all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
63 FR 48428, September 10, 1998
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1 1999 FEB
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:
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.
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.
1
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
2
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)
مد
Reproductive, Abdominal, BNT 100k) Number
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