Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a test pack for monitoring sterilization cycles, consisting of physical components like biological indicators and chemical indicators. There is no mention of software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the resistance of the test pack to the sterilization process, not on the performance of any AI/ML model.

Therapeutic

No.
The device is used for monitoring and testing sterilizers, not for treating diseases or conditions.

Diagnostic

No.
The device is described as a routine monitoring and periodic testing tool for sterilizers, not for diagnosing patient conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components such as a pouch, vial, biological indicator, silicon mats, and a chemical indicator. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for monitoring and testing the performance of STERRAD® sterilizers. This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample to determine a medical condition.
Device Description: The components are related to biological and chemical indicators used to assess the effectiveness of sterilization, not to analyze biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens for diagnostic purposes.

The device is clearly intended for use in a hospital setting to ensure the proper functioning of sterilization equipment, which is a critical aspect of infection control, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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) .

Product codes (comma separated list FDA assigned to the subject device)

FRC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051643, K071537

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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) .

1

3. INDICATIONS FOR USE

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.

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

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.

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

2

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 or
STERRAD® 200 cycle	For use in STERRAD®
50, STERRAD® 100S or
STERRAD® 200 cycle	For use in STERRAD®
100NX® Standard or
Flex cycle
Biological
Indicator	STERRAD®
CYCLESURE® 24
Biological Indicator	STERRAD®
CYCLESURE® 24
Biological Indicator	STERRAD®
CYCLESURE® 24
Biological 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 with
an opening (1.40 to
1.55 mm) in the
center of the bottom;
17 mm x 52 mm
• High density
polyethylene
(HDPE)	• Test Vial has an
opening (1.3 ± 0.20
mm diameter) in the
center of the bottom;
27 mm x 61 mm
• High density
polyethylene
(HDPE)	• Test Pack Vial, with
no opening in the
bottom; 17 mm x 52
mm
• High density
polyethylene
(HDPE)

Table 1: Comparison of Similarities and Differences hetween Devices

3

| | Subject Device | Predicate Device
(K051643) | Predicate Device
(K071537) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Test Vial Cap | • Test Vial Cap with
an opening (1.40 to
1.55 mm) in its
center; diameter of
18 mm
• High density
polyethylene
(HDPE) | • Cap has an opening
( $1.3 ± 0.20$ mm
diameter) in the
center; diameter of
22 mm
• High density
polyethylene
(HDPE) | • Test Vial Cap with
an opening (1.40 to
1.55 mm) in its
center; diameter of
18 mm
• High density
polyethylene
(HDPE) |
| STERRAD®
Sterilization
Mat | 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/200
Test Pack	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.
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)
Predicate
Device
(K051643)	STERRAD®
CycleSure® Test
Pack	The STERRAD® Sterilizer CycleSure® 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.

4

Device	Name	Indications for Use Statement
Predicate
Device
(K071537)	STERRAD®
100NX® Test
Pack	The STERRAD® 100NX® Test Pack is used for routine
monitoring of the STERRAD® 100NX® sterilization
cycle and is also used for the periodic testing of a
STERRAD® 100NX® system using hospital-defined
loads.

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.

5

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.

6

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

7

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)

." ( )( )"