(106 days)
The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers are provided nonsterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (prevacuum, 270°F, 4 minutes with 40 minutes drying time).
Lac-Mac Ltd. 84E Series Single Ply Wrapper
This document is a 510(k) clearance letter from the FDA for a medical device called "Lac-Mac Ltd. 84E Series Single Ply Wrapper." It does not contain any information regarding the acceptance criteria or a study proving the device meets that criteria in the context of an AI/ML powered device.
The document grants clearance for a physical product (sterilization wrap) and primarily addresses its substantial equivalence to previously marketed predicate devices under the 510(k) pathway. This regulatory pathway is for conventional medical devices and does not involve AI/ML performance evaluation as would be required for a software-as-a-medical-device (SaMD) or an AI-enabled device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or how ground truth was established for an AI/ML model.
This document is entirely irrelevant to the query about AI/ML device evaluation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Lac Mac, Limited C/O Mr. Jeffrey O. Stull International Personnel Protection, Incorporated 7809 Adelaide Drive Austin, Texas 78739
JAN 1 4 2011
Re: K102864
Trade/Device Name: Lac-Mac Ltd. 84E Series Single Ply Wrapper Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: December 31. 2010 Received: January 4, 2011
Dear Mr. Stull:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Mr. Stull
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A. 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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510(k) Number (if known):
Device Name: Lac-Mac Ltd. 84E Series Single Ply Wrapper
Indications for Use:
The Lac-Mac Ltd. 84E Series Single Ply Wrappers are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider. They are intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed medical device for at least 30 days. The Lac-Mac Ltd. 84E Series Single Ply Wrappers are provided nonsterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (prevacuum, 270°F, 4 minutes with 40 minutes drying time).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth F. Clunie-Will
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology | |
| General Hospital | |
| Format 1-2-96) | |
| Division of Anesthesiology | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K102864 |
§ 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).