The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 50, STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined loads containing devices that do not exceed claims of the cycle.

Device Description

The STERRAD® 50/100S/200 Test Pack consists of a pouch which holds a closed vial containing a STERRAD® CYCLESURE® 24 Biological Indicator (BI) and silicon mats. The vial and its corresponding cap have defined orifices.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the STERRAD® 50/100S/200 Test Pack:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "at least as resistant" performance compared to a biological model, and the chemical indicator functioning "appropriately." The study focuses on proving substantial equivalence to predicate devices, rather than meeting specific numerical performance thresholds in a typical diagnostic sense.

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biological Indicator Resistance: Test Pack must be at least as resistant to the sterilization process as the biological model (based on survival curves).	Passed: Survivor curves for Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) exposed to varying hydrogen peroxide doses in STERRAD® 100S, 50, or 200 Cycles were compared to the biological model's curves. The data showed the Test Pack was at least as resistant as the biological model.
Biological Indicator Resistance: Test Pack must be at least as resistant to the sterilization process as the biological model (based on fraction negative data).	Passed: Fraction negative data collected using Test Packs (from three lots of CYCLESURE® 24 BI) exposed to increasing volumes of hydrogen peroxide in STERRAD® 100S, 50, or 200 Cycles indicated the Test Pack configuration was at least as resistant as the biological model.
Chemical Indicator Functionality: Chemical indicator in the Test Pack configuration must be appropriate.	Passed: Indicative functionality of the chemical indicator in a STERRAD® 50/100S/200 Test Pack configuration was evaluated using half-cycle parameters of the STERRAD® 100S, STERRAD®50, and STERRAD® 200 Cycles and was determined to be appropriate.
Overall Performance: Device functions as intended in the specified sterilizers.	Passed: Design Evaluation and Performance Qualification studies were performed for the STERRAD® 50/100S/200 Test Pack in the STERRAD® 50, STERRAD® 100S, and STERRAD® 200 Sterilizers, and all passed. Functional Compatibility Testing of STERRAD® Test Pack Reusable Components also passed.

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

Sample Size: "Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI)" were used for both survival curve and fraction negative data collection. The exact number of test packs within each batch or for each exposure condition is not specified.
Data Provenance: The data appears to be prospective as it involves controlled experimental exposures of the test packs to sterilizers to evaluate their resistance. The country of origin of the data is not explicitly stated but is implicitly associated with the manufacturer (Advanced Sterilization Products, Irvine, CA, USA).

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

This type of device (biological indicator/test pack for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging AI might. The "ground truth" here is the scientifically established biological model for the sterilization resistance and the physical/chemical properties of the indicator. Therefore, the concept of "experts establishing ground truth" in the traditional sense is not directly applicable.

Instead of human experts, the standard for comparison (ground truth) is the "biological model developed for their respective cycles." This model represents the scientifically validated susceptibility of microorganisms to the sterilization process.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on a "biological model" and scientific measurement, not on human consensus or adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a scientific and engineering performance study rather than a clinical multi-reader study. The device is a sterilization indicator, not a diagnostic tool requiring human interpretation comparison.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is essentially a standalone performance study. The device's performance (resistance to sterilization, chemical indicator change) is evaluated directly against established scientific models and performance criteria without human intervention in the primary measurement of its function. The "algorithm" here is the physical and chemical design of the indicator responding to the sterilization process.

7. Type of Ground Truth Used

The ground truth used is a scientifically established biological model representing the resistance of microorganisms to the sterilization process, combined with physical-chemical properties for the chemical indicator. This is based on validated scientific principles of sterilization efficacy.

8. Sample Size for the Training Set

Not applicable. This device is a passive indicator/test pack, not an AI/ML algorithm that requires a "training set" in the conventional sense. Its performance is inherent in its design and manufacturing.

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

Not applicable, as there is no "training set" for this type of device.

Summary

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MAR 2 8 2014

K130263

510(k) Summary

Applicant's Name, Address, Telephone, FAX, Contact Person

Advanced Sterilization Products, Division of Ethicon, Inc. a Johnson & Johnson company 33 Technology Drive Irvine, CA 92618

Contact Person

Nancy Chu Manager, Regulatory Affairs Tel: (949) 453-6435 Fax: (949) 789-3900

SUMMARY DATE

February 26, 2014

1. CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Common/Usual Name: Product Classification: Product Code: Panel: Classification Regulation: Proprietary Name:

Biological Sterilization Process Indicator Biological Indicator (Test Pack) Class II FRC General Hospital 21 CFR 880.2800 STERRAD® 50/100S/200 Test Pack

2. PREDICATE DEVICES

STERRAD® CycleSure® Test Pack (K051643, cleared August 19, 2005) .
STERRAD® 100NX® Test Pack (K071537, cleared December 18, 2007) .

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3. INDICATIONS FOR USE

The STERRAD® 50/100S/200 Test Pack consists of the following components:

STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324) .
Test Pack vial with "STERRAD" 50/100S/200" marking and a corresponding cap .
STERRAD® Instrument Mats (REF 99205) .
Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340) .

4. DESCRIPTION OF DEVICE

5. SUMMARY OF NONCLINICAL TESTS

The STERRAD® 50/100S/200 Test Pack has been evaluated for its resistance to the STERRAD® 100S, 50, and 200 Sterilizers.

A comparison of the STERRAD® 50/100S/200 Test Pack to the biological model developed for their respective cycles indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.

STERRAD® 50/100S/200 Test Packs assembled from three lots of CYCLESURE® 24 Biological Indicator (BI) were exposed to several doses of hydrogen peroxide in STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. These survivor curves were compared to the survivor curves for the biological model developed for the respective cycles. The test data showed that the Test Pack configuration was at least as resistant as the biological model.

Additionally, fraction negative data were collected using Test Packs assembled from three lots of CYCLESURE® 24 BI and exposed to increasing volumes of hydrogen peroxide in

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STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. The results indicated that the Test Pack configuration was at least as resistant as the biological model.

Indicative functionality of the chemical indicator in a STERRAD® 50/100S/200 Test Pack configuration was evaluated using half-cycle parameters of the STERRAD® 100S, STERRAD®50, and STERRAD® 200 Cycles and was determined to be appropriate for a chemical indicator.

The subject device and its predicate device have the same intended use which is for routine monitoring of the STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycles. Additionally, they have the same technological characteristics, the same operating principles and are subjected to the same sterilant (hydrogen peroxide) and therefore, the subject device is substantially equivalent to the predicate. A comparison of similarities and differences of design features and materials of construction and Indications for Use of both the subject and two predicate devices are shown in Table 1 and Table 2, respectively.

Table 1: Comparison of Similarities and Differences between Devices
	Subject Device	Predicate Device(K051643)	Predicate Device(K071537)
Name	STERRAD®50/100S/200 Test Pack	STERRAD® CycleSure®Test Pack	STERRAD® 100NX®Test Pack
Cycle	For use in STERRAD®50, STERRAD® 100S orSTERRAD® 200 cycle	For use in STERRAD®50, STERRAD® 100S orSTERRAD® 200 cycle	For use in STERRAD®100NX® Standard orFlex cycle
BiologicalIndicator	STERRAD®CYCLESURE® 24Biological Indicator	STERRAD®CYCLESURE® 24Biological Indicator	STERRAD®CYCLESURE® 24Biological Indicator
Tyvek Pouch	Tyvek Pouch, 8"x16"	• Tyvek Pouch, 3" x 8"• Tyvek Pouch, 6" x 12.5"	Tyvek Pouch, 6" x 12.5"
Test Pack Vial	• Test Pack Vial withan opening (1.40 to1.55 mm) in thecenter of the bottom;17 mm x 52 mm• High densitypolyethylene(HDPE)	• Test Vial has anopening (1.3 ± 0.20mm diameter) in thecenter of the bottom;27 mm x 61 mm• High densitypolyethylene(HDPE)	• Test Pack Vial, withno opening in thebottom; 17 mm x 52mm• High densitypolyethylene(HDPE)

Table 1: Comparison of Similarities and Differences hetween Devices

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	Subject Device	Predicate Device(K051643)	Predicate Device(K071537)
Test Vial Cap	• Test Vial Cap withan opening (1.40 to1.55 mm) in itscenter; diameter of18 mm• High densitypolyethylene(HDPE)	• Cap has an opening( $1.3 ± 0.20$ mmdiameter) in thecenter; diameter of22 mm• High densitypolyethylene(HDPE)	• Test Vial Cap withan opening (1.40 to1.55 mm) in itscenter; diameter of18 mm• High densitypolyethylene(HDPE)
STERRAD®SterilizationMat	Four mats, 2.5" x 6.5"	Two mats, 2.5" x 6.5"	Four mats, 2.5" x 6.5"

Table 2: Comparison of Indications for Use between Devices

Device	Name	Indications for Use Statement
Subject Device	STERRAD®50/100S/200Test Pack	The STERRAD® 50/100S/200 Test Pack is used forroutine monitoring of the STERRAD® 50, STERRAD®100S and STERRAD® 200 Sterilizers and is also usedfor the periodic testing of these sterilizers usinghospital-defined loads containing devices that do notexceed claims of the cycle.The STERRAD® 50/100S/200 Test Pack consists of thefollowing components:• STERRAD® CYCLESURE® 24 BiologicalIndicator (REF 14324)• Test Pack vial with "STERRAD® 50/100S/200"marking and a corresponding cap• STERRAD® Instrument Mats (REF 99205)• Tyvek® Pouch with STERRAD® ChemicalIndicator (REF 12340)
PredicateDevice(K051643)	STERRAD®CycleSure® TestPack	The STERRAD® Sterilizer CycleSure® Test Pack isused for routine monitoring of the STERRAD® 50,STERRAD® 100S and STERRAD® 200 Sterilizers andis also used for the periodic testing of these sterilizersusing hospital-defined loads.

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Device	Name	Indications for Use Statement
PredicateDevice(K071537)	STERRAD®100NX® TestPack	The STERRAD® 100NX® Test Pack is used for routinemonitoring of the STERRAD® 100NX® sterilizationcycle and is also used for the periodic testing of aSTERRAD® 100NX® system using hospital-definedloads.

Table 3 below lists the tests performed to demonstrate that the STERRAD® 50/100S/200 Test Pack functions as intended in the STERRAD® 100S, STERRAD®50, or STERRAD® 200 Cycle.

Table 3: Testing Summary

Studies Performed	Results
Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 50 Sterilizer	Passed
Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 100S Sterilizer	Passed
Design Evaluation and Performance Qualification of STERRAD® 50/100S/200 Test Pack in the STERRAD® 200 Sterilizer	Passed
Functionality Study of the Chemical Indicator Disc of CYCLESURE® 24 BI in Test Pack	Passed
Functional Compatibility Testing of STERRAD® Test Pack Reusable Components	Passed

6. OVERALL PERFORMANCE CONCLUSIONS

The performance data shows that the STERRAD® 50/100S/200 Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing the STERRAD® 100S, STERRAD® 50 and STERRAD® 200 Sterilizer, and it is substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

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

March 28, 2014

Advanced Sterilization Products Ms. Nancy Chu Manager, Regulatory Affairs 33 Technology Drive Irvine, CA 92618

Re: K130263

Trade/Device Name: STERRAD® 50/100s/200 Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Indicator (Test Pack) Regulatory Class: II Product Code: FRC Dated: February 26, 2014 Received: February 27, 2014

Dear Ms. Chu:

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 - Ms. Chu

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Image /page/6/Picture/8 description: The image contains a combination of text and graphic elements. On the right side, the text "Tejashri Purohit-Sheth, M.D." is visible, followed by "Clinical Deputy Director" and "DAGRID". The word "FOR" is at the bottom right. On the left side, there is an abstract graphic element that appears to be a stylized design or logo.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K130263

Device Name STERRAD® 50/100S/200 Test Pack

Indications for Use (Describe)

The STERRAD® 50/100S/200 Test Pack is used for routine monitoring of the STERRAD® 100S and STERRAD® 200 Sterilizers and is also used for the periodic testing of these sterilizers using hospital-defined based that do not exceed claims of the cycle.

The STERRAD® 50/100S/200 Test Pack consists of the following components:

· STERRAD® CYCLESURE® 24 Biological Indicator (REF 14324)
· Test Pack vial with "STERRAD® 50/100S/200" marking and a corresponding cap
· STERRAD® Instrument Mats (REF 99205)
· Tyvek® Pouch with STERRAD® Chemical Indicator (REF 12340)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

[X] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

." ( )( )"

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).