(14 days)
Ronclave® packaging is indicated for use by health care facilities for the packaging, sterilization (by steam, chemical vapor or dry heat) and maintenance of sterility during storage of various medical items. The chemical indicator imprint is intended to allow the user to distinguish packages that have been processed from those that have not by changing its color from green to blue-gray.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding a sterilization wrap, not a device that would typically have acceptance criteria and a study to prove performance in the way machine learning or diagnostic devices do.
The content mainly focuses on the regulatory approval process (510(k)) and states that the device is "substantially equivalent" to legally marketed predicate devices. It does not contain information about specific performance acceptance criteria, a standalone study evaluating the device's diagnostic or predictive capabilities, or details like sample sizes, expert qualifications, or ground truth establishment for such a study.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Reported Performance: The document does not specify quantitative acceptance criteria for device performance nor does it report performance metrics (e.g., sensitivity, specificity, accuracy) that would be derived from a clinical or technical study. The approval is based on "substantial equivalence" to existing predicate devices for its intended use (sterilization wrap for packaging, sterilization, and maintaining sterility).
- No Clinical/Performance Study Details: The document does not describe a study design, sample sizes, data provenance, expert involvement, or ground truth establishment. This type of information is typically found in submissions for diagnostic or AI-powered devices, not for a sterilization wrap where the primary concern is its physical properties and ability to maintain sterility.
- No AI Component: The Ronclave® is a sterilization wrap, a physical product, and does not involve AI, machine learning, or software with human-in-the-loop performance measurement. Therefore, questions about MRMC studies, standalone algorithm performance, or human reader improvement with AI assistance are not applicable.
- Ground Truth for Manufacturing: While there would undoubtedly be quality control and testing for the physical properties of the wrap (e.g., microbial barrier, tear strength), the document does not detail these, nor does it refer to a "ground truth" in the diagnostic sense (e.g., pathology vs. AI interpretation). The ground truth for a sterilization wrap would be its ability to maintain sterility through physical and chemical testing, which is assumed to be part of the manufacturing process and regulatory submission, but not detailed here.
In summary, the provided text is a regulatory clearance letter for a medical device (sterilization wrap) based on substantial equivalence, not a technical report detailing the performance of a diagnostic or AI-powered device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Ronpak, Incorporated Dr. Thomas A. Augurt 4301 New Brunswick Avenue P.O. Box 1005 South Plainfield, New Jersey 07080
Re: K031022 Trade/Device Name: Ronclave® Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: March 25, 2003 Received: March 31, 2003
Dear Mr. Augurt:
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. Augurt
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) 594-4618. 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,
Susan Runne
Susan Runner, DDS, MA Interim 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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Attachment 2
Indications for Use Statement
510(K) Number (if known)
K 031022
Ronclave® Device Name
Ronclave® packaging is indicated for use by health care facilities for Indications the packaging, sterilization (by steam, chemical vapor or dry heat) and for Use maintenance of sterility during storage of various medical items. The chemical indicator imprint is intended to allow the user to distinguish packages that have been processed from those that have not by changing its color from green to blue-gray.
Qian S. Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K031022
§ 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).