ONCE-A-DAY VERTOS TEST PACK

K082620 · Propper Mfg. Co., Inc. · JOJ · Jul 8, 2009 · General Hospital

Device Facts

• Record ID: K082620
• Device Name: ONCE-A-DAY VERTOS TEST PACK
• Applicant: Propper Mfg. Co., Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 8, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An inefficient air removal stage, an air leak, or non-condensable gases in the steam supply are some of the conditions that could cause an incomplete change in the air removal indicator, e.g., uneven color change. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

Device Story

Chemical sterilization process indicator (Bowie & Dick type test pack) for pre-vacuum steam sterilizers. Device placed on lowest shelf over chamber drain in empty sterilizer. Input: steam exposure at 134° C for 3.5 minutes. Principle: chemical indicator ink changes color from blue to pink upon exposure to steam and successful air removal. Output: visual color change pattern; uniform pink indicates acceptable cycle; uneven color indicates air removal failure, air leak, or non-condensable gases. Used by healthcare providers in clinical settings to verify sterilizer performance. Does not confirm sterilization parameters; serves as diagnostic tool for equipment function.

Clinical Evidence

Bench testing only. Device performance validated against AAMI/ANSI/ISO 11140-1:2005 and 11140-5:2007 standards, including test format parameters, performance at 134° C for 3.5 minutes in pass/fail cycles, dry heat test parameters, and ink transfer limitations.

Technological Characteristics

Class 2 chemical indicator; Bowie & Dick type test pack. Complies with AAMI/ANSI/ISO 11140-1:2005 and AAMI/ANSI/ISO 11140-5:2007. Sensing principle: chemical color-change ink (blue to pink). Form factor: standardized test pack for pre-vacuum steam sterilizers.

Indications for Use

Indicated for use by healthcare providers to assess air removal efficiency and steam penetration in pre-vacuum steam sterilizers operating at 134° C for 3.5 minutes. No specific patient population restrictions; intended for use in clinical sterilization processing environments.

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.

Predicate Devices

• Propper's once-a-day® Bowie and Dick Test Pack (K961156)

Submission Summary (Full Text)

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K082620

## 510(k) Summary

Submitted by Propper Manufacturing Company, Inc. 36-04 Skillman Avenue. Address: Long Island City, New York 11101 [phone] or [phone] Telephone: JUL - 8 2009 [phone] Facsimile: Marian M. Schuman, Executive V.P. / General Counsel Contact Name:

Date Submitted: September 8, 2008

Once-A-Day® Vertos™ Test Pack Trade Name: Chemical Sterilization Process Indicator (Bowie & Dick Test Pack) Common Name:

Product Code / Regulation: JOJ / 21 C.F.R. 880.2800

Description: The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.

Intended Use: The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick. Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An inefficient air removal stage, an air leak, or non-condensable gases in the steam supply are some of the conditions that could cause an incomplete change in the air removal indicator, e.g., uneven color change. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

### Substantial Equivalence:

The Once-A-Day® Vertos™ Test Pack is similar in intended use and operating characteristics to Propper's once-a-day® Bowie and Dick Test Pack, K961156. Substantial equivalence to the predicate

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device was evaluated according to the FDA guidance document "Premarket Notification [510(k)] Submissions for Chemical Indicators," issued on December 19, 2003.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a symbol with three abstract shapes, possibly representing human figures or elements of health and well-being. The text is in a sans-serif font and is arranged to follow the curve of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marian M. Schuman Executive Vice President/General Counsel Propper Manufacturing Company, Incorporated 36-04 Skillman Avenue Long Island City, New York 11101

JUL - 8 2009

Re: K082620

Trade/Device Name: Once-A-Day® Vertos™ Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 12, 2009 Received: June 16, 2009

Dear Ms, Schuman:

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 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 - Ms. Schuman

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Anthony D. Watson (or

Susan Runner, D.D.S., M.A. Acting 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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### Indications for Use

## 510(k) Number (if known): K082620

# Device Name: Once-A-Day® Vertos™ Test Pack

#### Intended Use:

The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and por ous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.

Prescription Use (Part 21 CFR 801 Subpart D) AND/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)

Shule A. Murphy, MD

(Division Sign-Off)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082620

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