(317 days)
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No
The summary describes a water product for assisted reproduction and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is water used for assisted reproduction procedures, not a therapeutic device. It is used for reconstitution of media, rinsing labware, and other aspects of the procedure, but it does not directly treat a disease or condition.
No
The device is water used in assisted reproduction procedures for reconstitution of media, aspiration, incubation, transfer, or storage of gametes or embryos, or as a final rinse. It does not diagnose any condition but rather facilitates fertility procedures.
No
The 510(k) summary describes "Water for Assisted Reproduction Procedures," which is a physical substance, not software. The description of its use in reconstitution of media and rinsing labware further confirms it is a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "assisted reproduction procedures" and involves reconstitution of media, rinsing labware, and contact with gametes or embryos. This is a direct interaction with biological materials outside of the body, but it's for the purpose of facilitating a medical procedure (assisted reproduction), not for diagnosing a condition or disease.
- Lack of Diagnostic Purpose: The description does not mention any intent to diagnose, monitor, or screen for any disease or condition. IVDs are specifically designed to provide information about a patient's health status.
- Typical IVD Activities: IVDs typically involve analyzing samples (blood, urine, tissue, etc.) to detect markers, measure substances, or identify pathogens. This device's function is purely procedural support.
While the device interacts with biological materials, its purpose is to support a medical procedure, not to provide diagnostic information. Therefore, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures.
It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.
Product codes
85 MTW
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.6170 Assisted reproduction water and water purification systems.
(a)
Identification. Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, water quality testing, design specifications, labeling requirements, biocompatibility testing, and clinical testing).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The image is in black and white.
2 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Conception Technologies c/o Greg Holland Regulatory Consultant Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K993140
Water for Tissue Culture, Model 1500 Dated: March 27,2000 Received: May 11, 2000 Regulatory Class: II 21CFR 884.6170/Procode: 85 MTW
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have devices We have reviewed your Section 510(k) hourcelion of market the enclosmed to feet it market bredicate devices
device is substantially equivalent (for the indications for use a device is substantially equivalent (for the natural not be of the Medical Device Andreinendments, or to evices that market in interstate commerce pror to May 26, 1976, the ender someth someth on the may therefore,
have been reclassified in accordance with the provisions of the Peders on th have been reclassified in accordance with the provisions of the Act. The general of the Act includes of the Act include matket the device, subject to the general controls of the Act. "The general control of the nown of the nown of the broading and adulteration.
If your device is classified (see above) into either class III (Fremated Approval). It may be subject to lf your device is classified (see above) into emericas) of class in in the Code of Federal Regulations, Title 21,
such additional controls. Existing major regulations artic such additional controls. Existing major tegulations and be Touth to Current God Manufacting Pradice
Parts 800 to 895. A substantially equivalent determination (AC) for Ce Parts 800 to 895. A substantaliy equivalent delection (GS) for Medical Devices: Cerech negulation (21 CFR Pat 820) and requirements, as set forth in the Quality (QS) in Reducer Colour roganding. Forlue to onnply with that, through periodic OS inspections, the Food and Internet of the rannoncements concerning your device in
the GMP regulation may result in regulator, In addition, EDA not m the GMP regulation may result in regulation in the position indicsion submission on affect any might of you might
the Federal Register. Please note this response of sinceres the Federal Register. Please note inis response to your premation a do work of the order of the order Federal laws or regulations.
This letter will allow you to begin marketing your device as described in the FDA finding of This letter will allow you to begin marketed predicale 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 Pat 801 and additionally for questions on the progri If you desire specific advice for your device of Or I at documly for ender matrially, for ensultion and the promotion and diagnostic devices), please contact the Office of Conplice at (301) 594-459. Also, please note the regulation entiled
advertising of your device, please contact the of Conpl advertising of your device, please contact to Childer (2017). Other general information on our respibilities under the "Misbranding by reference to premaker noticalidation in Arian Manufactor of John Manaton on Jose Cop 1 or (301) 443-5597
Act may be obtained from the Division of Small Manufa / to they be obtainouses "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
David S. Gold, M.D.
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
1
Page
510(k) Number (if known):_ K993140
Device Name:Water for Assisted Reproduction Procedures
Indications For Use:
Water for Assisted Reproduction Procedures is to be used for in assisted reproduction procedures.
It may be used for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for IVF or other assisted reproduction procedures. It may also be used as the final rinse for labware or other assisted reproduction devices which will contact the gametes or embryos.
(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, ENT,
and Radiological Devices
| 510(k) Number | K993140 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
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