(317 days)
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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device named "Water for Tissue Culture, Model 1500" or "Water for Assisted Reproduction Procedures". This document clears the device for market but does not contain the specific acceptance criteria or details of a study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a detailed clinical study in the way a PMA (Pre-Market Approval) submission would.
Therefore,Based on the provided text, the following information about acceptance criteria and a detailed study is not available:
- A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) clearance letter or the Indications for Use statement.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Irrelevant as the device is "Water for Assisted Reproduction Procedures," not an AI diagnostic device.
- The type of ground truth used: Not provided, as the nature of the device (water) doesn't typically require 'ground truth' in the same way a diagnostic imaging device would. The focus is on purity and sterility.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what the document does provide:
- Device Name: Water for Tissue Culture, Model 1500 (also referred to as Water for Assisted Reproduction Procedures)
- Intended Use: For use in assisted reproduction procedures; specifically for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos in IVF or other assisted reproduction procedures, and as a final rinse for labware or other assisted reproduction devices that will contact gametes or embryos.
- Regulatory Class: Class II
- Procode: 85 MTW
- Regulatory Mechanism: 510(k) clearance, indicating substantial equivalence to a predicate device.
To obtain the detailed acceptance criteria and study data, one would typically need to review the full 510(k) summary and submission documents which are usually publicly available on the FDA website, but are not part of the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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)
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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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§ 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).