BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

K031647 · Getinge USA, Inc. · JOJ · Jul 29, 2003 · General Hospital

Device Facts

• Record ID: K031647
• Device Name: BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
• Applicant: Getinge USA, Inc.
• Product Code: JOJ · General Hospital
• Decision Date: Jul 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome.

Device Story

Test pack for monitoring 132°C pre-vacuum steam sterilizers; contains self-contained Geobacillus stearothermophilus biological indicator (10^6 spores/strip) and steam integrator card; simulates ANSI/AAMI ST46-1993 16-towel test pack. Integrator card provides immediate visual feedback (purple to green color change) upon exposure to sterilization parameters; biological indicator provides definitive assurance via post-incubation growth media color change (red = no growth). Used in clinical settings by sterilization personnel. Integrator card predicts biological outcome; biological indicator confirms sterilization success. Benefits include dual-layer verification of sterilizer performance.

Clinical Evidence

Bench testing only. Samples from 3 lots tested in validated BIER unit and Getinge straightline sterilizer at 132°C pre-vacuum cycles. Compared against Biosign EZ-VU and SteriTec Biological Test Pack. No clinical data.

Technological Characteristics

Constructed of porous and non-porous materials simulating 16-towel test pack. Contains Geobacillus stearothermophilus biological indicator and chemical integrator card. Integrator uses purple-to-green indicator ink. Shelf life 18 months. Standalone device.

Indications for Use

Indicated for biological testing of pre-vacuum steam sterilizers operating at 132°C. Used by operators to monitor sterilization cycles; provides immediate chemical indicator verification (purple to green) and biological indicator confirmation (no growth) of sterilization parameters.

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

• Castle Biosign EZ-VU Biological Test Pack (K922212)
• SteriTec Biological Test Pack with Instant Readout Integrator (K001444)

Submission Summary (Full Text)

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Biosign SSI Test Pack with Instant Readout Integrator Card 510(K) Summary

JUL 2 9 2003

K031647
Page 1 of 2

# 510(K) SUMMARY

# Prepared on May 2, 2003

| Submitter: | Getinge USA, Inc.<br>1777 East Henrietta Road<br>Rochester, NY 14623 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karla Byrne, Operations Director Consumable Products Division<br>Telephone: [phone] Fax: [phone] |
| Common Name: | Biological Sterilization Test Pack |
| Proprietary Name: | Biosign SSI Test Pack with Instant Readout Integrator |
| Classification: | Indicator, Biological Sterilization Process – Class II, 80 FRC |
| Predicate Device: | Castle Biosign EZ-VU Biological Test Pack (K922212)<br>SteriTec Biological Test Pack with Instant Readout Integrator (K001444) |

## Device Description:

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a test pack designed specifically for biological testing of steam 132°C pre-vacuum sterilization cycles. When used to monitor steam 132°C pre-vacuum cycles, the product is intended to give the user an instant reassurance based on a result from a steam integrator card, and after biological indicator incubation, even greater assurance that the sterilizer operated at proper sterilization parameters.

The Biosign SSI Test Pack with Instant Readout Integrator is constructed using a self-contained Geobacillus stearothermophilus biological indicator (10"spores/strip), placed inside a small package of porous and nonporous materials, and includes a steam integrator card. The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993. The instant readout integrator card provides immediate verification that the test pack was exposed to sterilization parameters, when the word "PASS" imprinted with a purple indicator ink, changes to green. The biological indicator gives an even greater assurance that sterilization occurred, when the incubated spores display no growth, as indicated by no color change (red) in the growth media.

The shelflife of the new Biosign SSI Test Pack with Instant Readout Integrator is the same as the predicate Biosign EZ-VU Test pack (18 months). The biological indicator is the generally limiting factor and the shelflife of the product can never go beyond the shelflife of the biological indicator, or the shelflife of the integrator card, whichever is shortest.

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is the same size as, utilizes the same materials and is constructed the same as the Biosign EZ-VU Test pack, only with the addition of the instant readout indicator card printed with the integrator ink utilized in the SteriTec Biological Test Pack with Instant Readout Integrator. Since the integrator card was designed to function inside a test pack, its placement in the biological test pack offers no difference in functional environment. The same Biosign biological indicator with Geobacillus stearothermophilus is utilized in the Biosign SSI Test Pack with Instant Readout Integrator, as is used in the Biosign EZ-VU Test pack.

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#### Intended Use:

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome.

## Comparison to Predicate Device:

The Getinge Biosign SSI Test Pack with Instant Readout Integrator's functional parameters. manufacturing materials, and storage conditions are the Getinge Biosign EZ-VU Test Pack with the addition of the Instant Readout Indicator card. The Instant Readout Integrator Card's functional parameters and manufacturing materials are the Instant Readout Integrator Card in the SteriTec Biological Test Pack with Instant Readout Integrator.

## Description of Testing:

Samples from 3 different lots of Biosign SSI Test Pack with Instant Readout Integrator were run at steam 132° pre-vacuum for various exposure times. For comparison, different lots of Biosign EZ-VU Test Pack and SteriTec Biological Test Pack with Instant Readout Integrator were also run at steam 132°C pre-vacuum. Testing was conducted in a validated BIER unit and in a Getinge straightline sterilizer.

# Conclusion:

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is substantially equivalent to the Castle Biosign EZ-VU Biological Test Pack and the SteriTec Biological Test Pack with Instant Readout Integrator for monitoring pre-vacuum steam sterilizers operating at 132°C.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 2003

Ms. Karla Byrne Consunabie Products Operations Director Getinge USE, Incorporated 1777 East Henrietta Road Rochester, New York 14623-3133

Re: K031647

Trade/Device Name: Biosign SSI Biological Test Pack with Instant Readout Integrator Regulation Number: 880. 2800 Regulation Name: Sterilzation Process indicator Regulatory Class: II Product Code: JOJ Dated: May 13, 2003 Received: May 28, 2003

Dear Ms. Byrne:

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 such 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. Byrne

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-firee number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Patricia Curenit/ker

Susan Runner, DDS, MA Interim 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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Getinge USA, Inc. Biosign SSI Test Pack with Instant Readout Integrator

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# Indications for Use

510(k) Number: _ K 03 1647

Device Name: Biological Test Pack with Instant Readout Integrator

#### Indications For Use:

The Getinge Biosign SSI Test Pack with Instant Readout Integrator is a sleam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132°C. The instant readout integrator card gives the operator a prediction of the biological test outcome. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.

SPB Hor Chiu Lin

General Hospital. nesthesk Infection Control. Denta

510(k) Number: K031647

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Concurrence of CDRH, Office of Device Evaluation (ODE)