(119 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is described as an "accessory item" for assisted reproductive procedures, which suggests it supports the procedure rather than providing a direct therapeutic effect.
No
The provided text states, "The Workbench will be used as an accessory item during assisted reproductive procedures." It does not mention any diagnostic function, only an accessory role in a procedure.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an "accessory item during assisted reproductive procedures." This suggests the device is used in conjunction with or to facilitate a procedure performed on a patient, rather than for testing a sample in vitro (outside the body).
- Lack of IVD Indicators: The description lacks any of the typical characteristics of an IVD:
- No mention of analyzing biological samples (blood, urine, tissue, etc.).
- No mention of detecting or measuring specific analytes.
- No mention of providing diagnostic information about a patient's health status.
- Focus on Procedure Support: The description points towards a role in supporting a clinical procedure (assisted reproduction).
In summary, the information provided strongly indicates that this "Workbench" is a tool or piece of equipment used during a medical procedure, not a device designed for in vitro diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Workbench will be used as an accessory item during assisted reproductive procedures.
Product codes
85 MQG
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850 .
JUN 1 9 2002
Mr. Michael D. Cecchi President International, Inc. 393 Soundview Road GUILFORD CT 06437
Re: K020560
Trade/Device Name: Workbench™ by Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted reproduction accessory Regulatory Class: II Product Code: 85 MQG Dated: May 14, 2002 Received: May 15, 2002
Dear Mr. Cecchi:
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, 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 (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.
1
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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international, inc. 510(K) Submission
INDICATIONS FOR USE
510 (k) Number (if known)_____________________________________________________________________________________________________________________________________________________
Device Names: Workbench ™ By
Indication for Use:
The Workbench will be used as an accessory item during assisted reproductive procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020560 |
Prescription Use $\boxed{\checkmark}$ or
Over-the Counter Use
B