(146 days)
The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse plasticware intended for preparing, manipulating or transferring gametes and embryos in group of the many of the in vitro fertilization techniques, and cell culture
Not Found
Based on the provided text, this document is a 510(k) clearance letter for the Nunc IVF Multidish 4 wells Nunclon. It's a regulatory approval document and does not contain the acceptance criteria or a study description of the type requested for an AI/CADe device.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA's review for such devices generally focuses on manufacturing, labeling, and other general controls, not on a detailed performance study as would be required for a novel AI/CADe system.
Therefore, I cannot provide the requested information from this document. It does not include:
- A table of acceptance criteria and reported device performance: This document doesn't define performance criteria or report on device performance based on a study.
- Sample size, data provenance: Not applicable to this type of regulatory submission.
- Number/qualifications of experts, adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not conducted for this type of device.
- Standalone performance study: Not conducted.
- Type of ground truth used: Not applicable.
- Sample size for training set, how training ground truth was established: Not applicable, as this is not an AI/ML device.
The "Indications for use" states that the device is "a sterile non-pyrogenic, Embryotoxicity tested single-use plasticware interface for preparing, handling, manipulating or transferring gametes or embryos in vitro in conjunction with many of the in vitro fertilization techniques, and cell culture." This describes the intended function of the laboratory dish itself, not the performance of an analytical or AI algorithm.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2004
Mr. Henrik Kvistgaard OA & RA Manager Nunc A/S Kamstrupvej 90 P.O. Box 280, DK-4000 Roskilde DENMARK
Re: K040717
Trade/Device Name: Nunc IVF Multidish 4 wells Nunclon Model Number 144444 Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: 85 MQK Dated: August 2, 2004 Received: August 4, 2004
Dear Mr. Kvistgaard:
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 such 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 tor 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 Section 510(k) I his letter will anow you to ought haves of substantial equivalence of your-device to a legally premaired predication. The PDF intally sification 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 If you desire aposition at one of the following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the please note the regulation entitled, "Misbranding Other or Othphanes as (21CFR Part 807.97) you may obtain. Other general by recented to premarred nontions on er the Act may be obtained from the Division of Small Intermation on your responsional 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. Brydon
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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510(k) number K040717
Device name: Nunc IVF Multidish 4 Wells nunclon
Indications for use:
The plate is a sterile non-pyrogenic, Embryotoxicity tested singleuse The place is a sectio not pyrogency, manipulating or transferring plasticware interraca for proparing, but in group of the many of the in vitro fertilization techniques, and cell culture
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segram
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Device 510(k) Number
Page 1 of __
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.