(234 days)
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
The ULTRA SYSTEM is a reusable sterilization container system.
I am sorry, but based on the provided text, there is no information available about acceptance criteria, device performance results, or any study details.
The document is a 510(k) clearance letter from the FDA for a device called "ULTRA SYSTEM," which is a sterilization container system. The letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities. It also includes the "Indications for Use" for the device, listing its purpose and various container sizes.
However, it does not contain any of the following requested information:
- A table of acceptance criteria and the reported device performance: This document explicitly states that the 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." It simply allows the device to be marketed based on its equivalence to a predicate, not necessarily on performance against specific acceptance criteria presented in this letter.
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Therefore, I cannot fulfill your request for this information based on the provided text.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized wing or feather shapes.
MAR 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. Richard Bloom Vice President Promedica, Incorporated 114 Douglas Road East Oldsmar, Florida 34677
Re: K032445
Trade/Device Name: Ultra System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: I Product Code: KCT Dated: March 1, 2004 Received: March 2, 2004
Dear Mr. Bloom:
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.
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Page 2 - Mr. Bloom
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.
This letter will allow you to begin marketing your device as described in your Section 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 (301) 594-5618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K032445
Device Name: ULTRA SYSTEM
Indications for Use:
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
| Ultra System Container Sizes (in inches) | ||||
|---|---|---|---|---|
| 13 x 8.5 x 4 | 13 x 8.5 x 5 | 13 x 8.5 x 6 | 13 x 8.5 x 8 | |
| 13 x 13 x 4 | 13 x 13 x 5 | 13 x 13 x 6 | 13 x 13 x 8 | |
| 18 x 13 x 4 | 18 x 13 x 5 | 18 x 13 x 6 | 18 x 13 x 8 | 18 x 13 x 9 |
| 22 x 8.5 x 4 | 22 x 8.5 x 5 | 22 x 8.5 x 6 | 22 x 8.5 x 8 | |
| 24 x 13 x 4 | 24 x 13 x 5 | 24 x 13 x 6 | 24 x 13 x 8 |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Ques
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K032445
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).