The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.

Device Description

The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes. It consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle. The subject device replaces the biological indicator in the predicate device with the SporView® 10 Steam Self Contained Biological Indicator.

AI/ML Overview

The document describes substantiation for a 510(k) submission for a medical device called "SporView® Plus BI Test Pack." This device is a biological sterilization process indicator. The submission is not for a new device, but for a modification to an existing one (K051173), specifically replacing the biological indicator within the test pack.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Steam Sterilization Effectiveness: The SporView® Plus BI Test Pack must assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes. This implies the device accurately indicates whether sterilization parameters (temperature and time) have been met, leading to spore inactivation.	Validation was accomplished with performance testing in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C. "All results from testing meet the predetermined acceptance criteria." The device provides a defined challenge to the sterilization process that is equal to or greater than the challenge posed by the AAMI reference PCD. The internal monitoring components and chemical indicator function as expected.
Equivalence to AAMI Reference PCD: The device's performance must be equivalent to that of the AAMI reference Process Challenge Device (PCD).	"The performance of the SporView® Plus BI Test Pack has been demonstrated to be equivalent to that of the AAMI reference PCD."
Functionality in Pass, Fail, and Partial Cycles: The device must reliably indicate successful (pass), unsuccessful (fail), and partially successful (partial) sterilization cycles.	Testing consisted of running test packs and control packs (predicate) within the same cycles for pass, fail, and partial cycles at the end of the product's shelf life (18 months). "We have demonstrated with testing that the SporView® Plus Steam BI Test Pack performs consistently when run in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C for pass, fail and partial cycles."
Reliable Indication of Exposure (External Process Indicator): The external process indicator must alert users if a pack has been exposed to the sterilization process.	"The external process indicator alerts users when a pack has seen the sterilization process."
Biological Indicator Culture Conditions: The included biological indicator (Geobacillus Stearothermophilus ATCC 7953) must function correctly under specified culture conditions.	Culture Conditions: 55-60°C. (Implied to be met as part of overall performance.)
Spore Population: The viable spore population must be $10^5$ or greater.	Viable spore population: $10^5$ or greater. (Implied to be met as part of overall performance.)
Resistance Characteristics: The resistance characteristics must be equivalent to the predicate, calculated per USP.	Resistance characteristics: Equivalent, calculated per USP. (Implied to be met as part of overall performance.)
Shelf Life: The device must maintain its performance characteristics for its specified shelf life.	Shelf Life: Eighteen (18) months. (Testing was conducted at the end of this shelf life, indicating successful adherence.)

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a precise numerical sample size for the test set. It mentions "running test packs and control packs (predicate) within the same cycles" for various conditions (pass, fail, partial).
- Data Provenance: The testing was non-clinical, conducted by SPSmedical Supply Corp. in Rush, NY, USA. The study followed the FDA Guidance document for Industry and FDA Staff entitled, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical study involving a biological indicator device. The "ground truth" is established by the known conditions of the steam sterilization cycles (e.g., specific temperature and time exposures designed to cause a "pass" or "fail" condition), and the subsequent growth or non-growth of the bacterial spores. There are no human "experts" establishing ground truth in the context of interpreting images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable to this type of non-clinical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of data (e.g., medical images) requires consensus among multiple readers.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case comparative effectiveness study was not conducted. This device is a biological indicator for sterilization processes, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is effectively a standalone device performance study. The "algorithm" here is the biological and chemical reaction of the indicator to sterilization conditions. Its performance is evaluated independently of human interpretation, although humans observe the results (e.g., color change, bacterial growth).
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth is based on pre-defined physical and biological parameters of steam sterilization cycles. The cycles are intentionally set up as "pass" (full sterilization conditions), "fail" (insufficient sterilization conditions), or "partial" (borderline conditions) based on established scientific principles for sterility assurance and industry standards (e.g., AAMI). The "truth" of whether the spores should be inactivated is determined by these controlled cycle parameters, and then the BI's ability to reflect this is assessed.
The sample size for the training set:
- This is not an AI/machine learning device, so there is no training set in the conventional sense. The "training" or development of such a biological indicator involves extensive research into microbial resistance, material science, and sterilization physics, but not data-driven machine learning.
How the ground truth for the training set was established:
- As stated above, there is no training set for this type of device. The ground truth for biological indicators is established through fundamental microbiology and sterilization science principles.

Summary

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Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 7, 2014

Crosstex International Mr. Michael Nolan Research and Development Coordinator 6789 West Henrietta Road Rush, NY 14543

Re: K140620

Trade/Device Name: SporView® Plus BI Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC July 9, 2014 Dated: Dated: Received: July 11, 2014

Dear Mr. Nolan:

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 - Mr. Nolan

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 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/ReportaProblem/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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K140620

SporView® Plus Steam BI Test Pack Device Trade Name:

INDICATIONS FOR USE:

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

Sreekanth Sigland Signaly Signed by Sieckanth Gutala -

Digitally signed by Sreekanth ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000 540490, cn=Sreekanth Gutala -S Date: 2014.08.06 11:54:54 -04'00'

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510(k) Summary

SUBMITTER INFORMATION:

SPSmedical Supply Corp.	Contact:	Michael G. Nolan
a division of Crosstex International		Research and Development Coordinator
6789 West Henrietta Road	Phone:	(800) 722-1529
Rush, NY 14543 U.S.A.	Fax:	(585) 359-0167
Date of Summary:August 5, 2014

DEVICE INFORMATION:

Device Trade Name:	SporView® Plus Steam BI Test Pack
Common Name:	Biological Test Pack
Classification Name:	Biological Sterilization Process Indicator 21 CFR § 880.2800(a)
Review Panel:	General Hospital
Product Code:	FRC
Device Class:	II

PREDICATE DEVICE:

The SPSmedical SporView® Plus BI Test Pack cleared under K051173.

DEVICE DESCRIPTION:

Description of change to the legally marketed predicate device—The SporView® Plus BI Test Pack cleared under K051173 contained a biological which required 24 hours of incubation time. This submission aims to replace that biological with the Spor View® 10 Steam Self Contained Biological Indicator within the SporView® Plus BI Test Pack.

Functionality-The SporView® Plus BI Test Pack is a single use device designed to assess the effective performance of both gravity displacement and pre-vacuum steam sterilization processes.

Scientific Concepts—The SporView® Plus BI Test Pack provides a defined challenge to the sterilization process that is equal to or greater than the challenge posed by the AAMI reference PCD.

Physical Characteristics-The SporView® Plus BI Test Pack consists of layers of paper with a biological indicator and a load record card with chemical integrator placed in the center and all placed within an exterior containment box. A process indicator label placed on the containment box alerts users if a pack has been exposed to the sterilization process. The approximate dimensions of the pack are 4-5/8" x 7/8" x 6-1/4". The load record card is used to record all the detailed information from the sterilization cycle.

Performance Characteristics-The performance of the SporView® Plus BI Test Pack has been demonstrated to be equivalent to that of the AAMI reference PCD.

INTENDED USE:

NOTE: The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.

The SPSmedical SporView® Plus Steam BI Test Pack is designed to monitor sterilization cycles in both gravity displacement and pre-vacuum steam sterilizers. It is to be used for routine monitoring and qualification testing of steam sterilizers.

TECHNICAL CHARACTERISTICS:

The outer box and layers of paper within the SporView® Plus BI Test Pack provide a significant challenge to air removal and subsequent steam penetration of prevacuum and gravity steam The Load Record Card with STEAMPlus™ Steam Integrator allow for an immediate sterilizers. observation of cycle performance with 10 hour incubation results of the SporView® 10 Steam Self Contained Biological Indicator offers complete assurance of cycle performance. The external process indicator alerts users when a pack has seen the sterilization process.

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RECOMMENDED STORAGE CONDITIONS:

Store in a cool, dry place (15-30°C).

NON-CLINICAL TESTING:

Validation of the SporView® Plus BI Test Pack was accomplished with performance testing in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C. All results from testing meet the predetermined acceptance criteria. All testing followed the FDA Guidance document for Industry and FDA Staff entitled, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," issued on October 4, 2007. Testing consisted of running test packs and control packs (predicate) within the same cycles for pass, fail and partial cycles at the end of the product's shelf life of eighteen (18) months.

COMPONENTS:

The Spor View® Plus BI Test Pack Components are equivalent to its original filing with the exception of the Spor View® Steam Self Contained Biological Indicator.

Subject of this change SporView® 10 Steam Self Contained Biological Indicator (K122024)
Load Record Card with STEAMPlus™ Steam Integrator (K051173) o
External Process Indicator with lot and expiration information (K051173) ●
o Outer box and paper inserts (K051173)

SUBSTANTIAL EQUIVALENCE DISCUSSION

SPSmedical has identified the SporView® Plus BI Test Pack (K051173) as the (primary) predicate device. We believe the predicate device to be substantially equivalent to the subject device in terms of their intended use and functional characteristics as they are essentially the same device. See a comparison of the subject device to the predicate device (K051173) in Table 1.

PREDICATE I.D .:

Trade Name:	SporView® Plus BI Test Pack
Model No.:	SBT-025 (25 controls) & SBT-255 (5 controls)
Submitter/holder:	SPSmedical Supply Corp.6789 West Henrietta RoadRush, NY 14543 U.S.A.Phone: (585) 359-0130Fax: (585) 359-0167
510(k) No.:	K051173

COMPARISON OF INDICATIONS FOR USE (IFU):

Predicate IFU K051173-The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time or longer and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.

Subject IFU K140620—The SPSmedical SporView® Plus Steam BI Test Pack with STEAMPlus Integrator is indicated for use in routine monitoring and sterilizer qualification testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and for use in pre-vacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time.

Compared to the predicate the subject device has changes for clarity but is otherwise the same.

DESIGN DIFFERENCES PREDICATE VS. SUBJECT DEVICE:

The Predicate Device contains the SporView® Steam Self-Contained Biological Indicator which was cleared under K070595. The Subject Device contains the SporView® 10 Steam Self Contained Biological Indicator which was cleared under K122024.

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FUNCTIONAL CHARACTERISTICS:

The SporView® Plus Steam BI Test Pack is designed to create a significant challenge to air removal and steam penetration. Like the AAMI test pack, the SPSmedical SporView® Plus Steam BI Test Pack provides a significant challenge to the steam sterilization process and is used for routine monitoring and qualification testing of gravity displacement and pre-vacuum steam sterilizers. Both have internal steam monitoring components located within the center of the pack and chemical indicator located on the pack.

DISCUSSION:

SPSmedical is claiming substantial equivalence for its SporView® Plus Steam BI Test Pack to the original SporView® Plus Steam BI Test Pack (K051173) based on test data obtained during validation studies. We have demonstrated with testing that the Spor View® Plus Steam BI Test Pack performs consistently when run in steam gravity and prevacuum cycles operating at 250°F/121°C and 270°F/132°C for pass, fail and partial cycles.

SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

The SporView® Plus Steam BI Test Pack has the same intended use and characteristics as the predicate Spor View® Plus Steam BJ Test Pack. They both provide a significant challenge to the steam sterilization process. Testing data demonstrates the subject device is substantially equivalent to the predicate device.

Element	Subject Device(K140620)	Predicate(K051173)
Intended use: methodof sterilizationprocess parameters	Steam250°F/121°C 30 minutes270°F/132°C 4 minutes	Steam250°F/121°C 30 minutes270°F/132°C 4 minutes
Indications for Use(IFU)	The SPSmedical SporView® Plus Steam BI TestPack with STEAMPlus Integrator is indicatedfor use in routine monitoring and sterilizerqualificationtestingof steamgravitydisplacement cycles at 121°C/250°F for 30minutes exposure time and for use in pre-vacuumsteam sterilization cycles at 132°C/270°F for 4minutes exposure time.	The SPSmedical SporView® Plus Steam BI TestPack with STEAMPlus Integrator is indicatedfor use in routine and challenge testing of steamgravity displacement cycles at 121°C/250°F for30 minutes exposure time or longer and for usein pre-vacuum steam sterilization cycles at132°C/270°F for 4 minutes exposure time orlonger.
Labeling	Equivalent, except for 10 hourincubation time	Equivalent, except for 24 hourincubation time
Organism: sporespecies& strain	Geobacillus StearothermophilusATCC 7953	Geobacillus StearothermophilusATCC 7953
Viable sporepopulation	$10^5$ or greater	$10^5$ or greater
Resistancecharacteristics	Equivalent, calculated per USP	Equivalent, calculated per USP
Culture Conditions	55-60°C	55-60°C
Carrier Materials	Whatman Paper	Whatman Paper
Packaging: primary &secondary	Equivalent	Equivalent
Storage	Equivalent	Equivalent
Shelf Life	Eighteen (18) months	Eighteen (18) months

TABLE 1-COMPARISON OF THE SUBJECT DEVICE TO THE PREDICATE

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).