(88 days)
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No
The description mentions microprocessor control for parameters and alarms, which is standard automation, not AI/ML. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development.
No
The device is an incubator designed to store, preserve, and grow biological samples (gametes/embryos), not to treat or diagnose a disease or condition in a patient. It provides a controlled environment, which is a supportive function, not a direct therapeutic one.
No
The device is an incubator designed to store, preserve, and grow gametes and/or embryos by controlling environmental conditions. It does not perform any diagnostic functions or analyze medical conditions.
No
The device description clearly states it is a physical incubator unit with controlled parameters and alarm functions, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "store, preserve and grow gametes and/or embryos" and "provide an environment... for the development of ova or embryos." This describes a device used to maintain biological samples outside of the body for development or storage, not for diagnostic testing performed in vitro on samples taken from the body.
- Device Description: The description focuses on controlling environmental parameters (temperature, CO2, humidity, O2) to support biological growth. This aligns with the function of an incubator for cell or tissue culture, not a diagnostic device that analyzes samples.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on the samples within the incubator.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This incubator's function is to provide a suitable environment for biological development, which is a different purpose.
N/A
Intended Use / Indications for 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.
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.
Product codes
85 MQG
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Forma Scientific Universal Water-Jacketed Incubators were subjected to electrical safety, electromagnetic compatibility acceptability and operating performance. The incubators passed all these tests.
Key Metrics
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Predicate Device(s)
63 FR 48428, September 10, 1998
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
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 Incubator |
| 21 CFR 884.6120 | |
| Predicate Device: | 63 FR 48428, September 10, 1998 |
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).
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.
1
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.