(444 days)
Gemini Sterilization Wrap is 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 such content for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- . Pre-vacuum steam cycles
- 0 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
- Gravity steam cycles ●
- 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time ಂ
- STERRAD® Sterilization ●
- STERRAD® 100NX, Flex cycle o
- STERRAD® 100NX, Standard cycle 0
- STERRAD® 100NX, Express cycle O
- STERRAD® 100S, Standard cycle O
- STERRAD®NX, Advanced cycle O
- STERRAD® NX, Standard cycle O
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Gemini Sterilization Wrap." It approves the device for marketing and outlines its intended use. There is no information provided in this document regarding acceptance criteria, device performance, or any studies conducted on the device. Therefore, I am unable to answer most of your questions based on the provided text.
The document only states the following:
1. Acceptance Criteria and Device Performance:
- No acceptance criteria or reported device performance for Gemini Sterilization Wrap are mentioned in this document. The FDA letter grants substantial equivalence based on the provided indications for use and classification, but it does not detail specific performance metrics or studies.
The following information is NOT available in the provided document:
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on the regulatory approval of the "Gemini Sterilization Wrap" after reviewing its 510(k) submission, confirming its substantial equivalence to a predicate device, and listing its intended uses and applicable sterilization methods.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries, Incorporated One Medline Place MUNDELEIN IL 60060-4486
Re: K113353
Trade/Device Name: Gemini Sterilization Wrap Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: January 17, 2013 Received: January 22, 2013
Dear Mr. Clausen:
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. Clausen
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 of medical devicerelated 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/CDRH0ffices/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,
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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known): K113353
Device Name:
Gemini Sterilization Wrap
Indications For Use:
Gemini Sterilization Wrap is 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 such content for 180 days following sterilization. Gemini Sterilization Wrap is validated for use in steam or STERRAD® sterilization processes in the following sterilization modes and cycles.
- . Pre-vacuum steam cycles
- 0 4 Minutes Exposure at 270°F/132°C with minimum 20 minutes dry time
- Gravity steam cycles ●
- 30 Minutes Exposure at 250°F/121°C with minimum 20 minutes dry time ಂ
- STERRAD® Sterilization ●
- STERRAD® 100NX, Flex cycle o
- STERRAD® 100NX, Standard cycle 0
- STERRAD® 100NX, Express cycle O
- STERRAD® 100S, Standard cycle O
- STERRAD®NX, Advanced cycle O
- STERRAD® NX, Standard cycle O
Prescription Use (Part 21 CFR 801 Subpart D) OR
. Over-the-Counter Use X (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)
Ramesh C. Panguluri -S 2013.01.29 15:10:58 -05'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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).