GEMINI STERILZATION WRAP

K113353 · Medline Industries, Inc. · FRG · Jan 31, 2013 · General Hospital

Device Facts

• Record ID: K113353
• Device Name: GEMINI STERILZATION WRAP
• Applicant: Medline Industries, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Jan 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended 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

Device Story

Gemini Sterilization Wrap; flexible barrier material used to wrap medical instruments/devices prior to sterilization; allows penetration of sterilizing agents (steam or STERRAD® hydrogen peroxide gas plasma); maintains sterility of contents for 180 days post-processing; used in clinical/hospital settings; operated by sterile processing technicians; provides physical barrier against contaminants; ensures device readiness for surgical/clinical procedures.

Clinical Evidence

Bench testing only; validation of sterilization efficacy and sterility maintenance for 180 days in specified steam and STERRAD® cycles.

Technological Characteristics

Flexible sterilization wrap material; compatible with pre-vacuum steam, gravity steam, and STERRAD® (100NX, 100S, NX) sterilization cycles; provides microbial barrier; non-active device.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via steam or STERRAD® processes and to maintain sterility of contents for up to 180 days post-sterilization.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a stylized abstract symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

## 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.

{1}------------------------------------------------

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hor

Keth
Harshuid
te

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

{2}------------------------------------------------

## 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: