(41 days)
HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "HTF Plus - HTF with non-essential amino acids," indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.
The letter explicitly states: "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...". This means the submission primarily focused on demonstrating equivalence to an existing device, rather than providing detailed acceptance criteria or a specific study proving performance against such criteria.
The document includes:
- Trade/Device Name: HTF Plus - HTF with non-essential amino acids
- Regulation Number/Name: 21 CFR 884.6180, Reproductive media and supplements
- Regulatory Class: II
- Product Code: 85 MQL
- Indications for Use: HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.
- 510(k) Number: K022334
- Date of Clearance: August 28, 2002
It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Information about standalone algorithm performance studies.
- Details on the type of ground truth used.
- Sample size or ground truth establishment for a training set.
Therefore, I cannot fulfill your request based on the provided text.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 8 2002
Mr. Michael D. Cecchi President international, Inc. 393 Soundview Rd. GUILFORD CT 06437
Re: K022334 Trade/Device Name: HTF Plus- HTF with non-essential amino acids Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: July 17, 2002 Received: July 18, 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.
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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) K022334
Device Names: HTF Plus -HTF with non-essential amino acids
Indication for Use:
HTF Plus (HTF with non-essential amino acids) is used as a holding media and a supplement for human gametes and embryos for assisted reproduction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √ or Over-the Counter Use _
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022334
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.