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. When the chemical integrator "PASS" changes from purple to green, it indicates correct exposure conditions of temperature, time and steam.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Biosign SSI Test Pack with Instant Readout Integrator, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The core acceptance criteria for this device revolve around demonstrating substantial equivalence to its predicate devices in terms of function and performance, specifically for monitoring 132°C pre-vacuum steam sterilization cycles. The performance is assessed for both the instant readout integrator card and the biological indicator.

Acceptance Criteria (Inferred from Comparison)	Reported Device Performance (as described in the document)
Instant Readout Integrator Card:
• Accurately predict biological test outcome.	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. This indicates correct exposure conditions of temperature, time and steam.
• Functions within a test pack.	The integrator card was designed to function inside a test pack, and its placement in the biological test pack offers no difference in functional environment when compared to the predicate device (SteriTec Biological Test Pack with Instant Readout Integrator).
• Comparable performance to predicate.	The Instant Readout Integrator Card's functional parameters and manufacturing materials are the same as the Instant Readout Integrator Card in the SteriTec Biological Test Pack with Instant Readout Integrator. Testing was conducted to compare its performance to predicate devices during various exposure times in 132°C pre-vacuum steam.
Biological Indicator:
• Accurately indicate sterilization.	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. It utilizes Geobacillus stearothermophilus (10^6 spores/strip), consistent with the predicate device.
• Simulates 16-towel test pack.	The package simulates the biological indicator 16-towel test pack as defined by ANSI/AAMI ST46-1993.
• Comparable performance to predicate.	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. Testing was conducted to compare its performance to predicate devices (Biosign EZ-VU Test Pack) during various exposure times in 132°C pre-vacuum steam, in both a validated BIER unit and a Getinge straightline sterilizer. The study concluded it is "substantially equivalent."
Overall Device:
• Shelf-life.	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), with the biological indicator being the limiting factor.
• Substantial Equivalence.	The conclusion states: "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." This implies that the performance characteristics (e.g., thermal resistance characteristics, ability to indicate proper sterilization, ability to indicate failure of sterilization parameters) are comparable to the legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "Samples from 3 different lots of Biosign SSI Test Pack with Instant Readout Integrator" were used. In addition, "different lots of Biosign EZ-VU Test Pack and SteriTec Biological Test Pack with Instant Readout Integrator were also run." While the specific number of packs per lot is not stated, the use of multiple lots for both the new device and predicates suggests a reasonable attempt at demonstrating consistency.
Data Provenance: The testing was conducted internally by Getinge USA, Inc. The nature of the testing (running samples in sterilization equipment) means it's a prospective study of the device's performance under controlled conditions. The country of origin for the data is implicitly the USA, where Getinge USA, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This device is a biological indicator and chemical integrator for sterilization processes. The "ground truth" is not established by human experts interpreting images or complex data. Instead, it's established by the physical and biological processes of sterilization itself. The outcome (sterilization achieved vs. not achieved) is determined by the environmental parameters of the sterilizer (temperature, time, steam presence) and the viability of the biological spores.

4. Adjudication Method for the Test Set

Not Applicable. As the ground truth is not expert-derived, there is no human adjudication process involved in determining the test set's outcome. The "readout" is built into the device: a color change for the integrator, or lack of growth for the biological indicator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. An MRMC study is not relevant for this type of device. MRMC studies are typically used to evaluate diagnostic imaging devices where human readers interpret and make decisions based on complex visual information, and the AI's role is to assist or augment that interpretation. This device's function is a direct, objective chemical/biological response to sterilization parameters.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, effectively. The performance of the instant readout integrator card and the biological indicator can be considered "standalone" in that their function is an objective, automated response to the sterilization cycle.
- The integrator card changes color (purple to green) if sterilization parameters are met, without human interpretation of nuanced data.
- The biological indicator shows no growth if sterilization is achieved, which is an objective biological outcome based on spore viability.
- While humans visually inspect the color change or growth, the "algorithm" (the device's chemical/biological mechanism) itself provides the direct output. The study described tests this standalone performance against predicate devices.

7. The Type of Ground Truth Used

The ground truth is based on the physical and biological conditions of sterilization.
- For the chemical integrator, the ground truth is whether the correct exposure conditions of temperature, time, and steam were met, as designed by the underlying chemical reaction.
- For the biological indicator, the ground truth is whether the biological spores were killed (indicating a successful sterilization cycle), which is then verified by the absence of growth in the incubation media.
- The predicate devices further serve as a reference for establishing "expected" ground truth performance.

8. The Sample Size for the Training Set

Not Applicable / Not Explicitly Stated. This device is a physical/chemical/biological indicator, not an AI software algorithm that "learns" from a training set. Its design and performance are based on established scientific principles of sterilization biology and chemistry, not machine learning. Therefore, the concept of a "training set" as typically understood in AI/ML is not relevant here.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set in the AI/ML sense, this question is not relevant. The device's fundamental function is based on established sterilization principles and material science, not a learned model from labeled data.

Summary

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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.1777 East Henrietta RoadRochester, NY 14623
Contact Person:	Karla Byrne, Operations Director Consumable Products DivisionTelephone: (585) 272-5007 Fax: (585) 272-5271
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)SteriTec Biological Test Pack with Instant Readout Integrator (K001444)

Device Description:

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Intended Use:

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three wavy lines above it.

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

Page 8 of 10

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is 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.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is 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.(2)
Classification. Class II (performance standards).