NEV'S INK AUTOCLAVE TAPES

K101580 · Nev'S Ink, Inc. · JOJ · Jul 1, 2010 · General Hospital

Device Facts

• Record ID: K101580
• Device Name: NEV'S INK AUTOCLAVE TAPES
• Applicant: Nev'S Ink, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.

Device Story

Nev's Ink Autoclave Tapes function as both a mechanical fastener for sterilization packs and a chemical process indicator. The tape is applied to packs before steam sterilization. Upon exposure to specific steam sterilization parameters—gravity steam at 121°C for 10 minutes or pre-vacuum steam at 134°C for 2 minutes—the indicator ink undergoes a color change, displaying the word "Autoclaved" in pink. This visual change allows healthcare personnel to distinguish between processed and unprocessed items. The device is intended for use in clinical or hospital settings where steam sterilization is performed.

Clinical Evidence

Bench testing only. The device's performance as a sterilization process indicator was verified through exposure to specified steam sterilization cycles (121°C/10 min and 134°C/2 min) to confirm the visual color change indicator function.

Technological Characteristics

Pressure-sensitive adhesive tape with chemical indicator ink. Operates via chemical reaction triggered by steam sterilization temperature and time parameters. Form factor: adhesive tape rolls. Intended for steam sterilization environments.

Indications for Use

Indicated for use as a sterilization process indicator and packaging fastener in steam sterilizers to identify processed items.

Regulatory Classification

Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Nev's Ink, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

JUL - 1 2010

Re: K101580

Trade/Device Name: Nev's Ink Autoclave Tapes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 23, 2010 Received: June 24, 2010

Dear Mr. Job:

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. Job

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

Sincerely yours,

Susan Moore

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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Nev's Ink, Inc. Autoclave Tapes 510(k) Premarket Notification

## 2. Indications for Use Statement

## Indications for Use

510(k) Number : _ K101580 Device Name: Nev's Ink Autoclave Tapes Product numbers: LFA-5BP, LFA-75BP, LFA-1BP, LFA-50BP, LFA-750BP, LFA-10BP

## Indications for Use:

Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.

Prescription Use (Part 21 CFR 801 Subpart D) Over-the-Counter-Use X (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off)

Division of Anesthesiology, General Hospital nfection Control, Dental Devices

K 101580 510(k) Number:

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June 22, 2010