K Number

Device Name

SporView Rapid Read Biological Indicator SteamPlus Test Pack

Manufacturer

Crosstex/SPSmedical, A Division of Cantel Medical

Date Cleared

2018-11-14

(166 days)

Product Code

FRC

Regulation Number

880.2800

Intended Use

Device Description

The SporView Rapid Read Biological Indicator SteamPlus Test Pack is intended for routine monitoring and sterilizer qualification testing of dynamic-air-removal (pre-vacuum) steam sterilization cycles at 270°F (132°C) for 4 minutes exposure time. The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle. The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101910

Reference Devices

K140620

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a physical test pack with biological and chemical indicators for monitoring sterilization cycles. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.

Therapeutic

No
This device is a test pack used for monitoring and qualifying steam sterilization cycles, not for treating a condition or disease in a patient.

Diagnostic

This device is a biological indicator test pack used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

The device description clearly states the device consists of physical components like paper cards, a polypropylene vial, spore carrier, media ampoule, and a vented cap. It is a physical test pack, not software.

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 qualifying steam sterilization cycles. This is a quality control process for medical devices or materials, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
Device Description: The description details a test pack containing a biological indicator (spores), chemical indicators, and a record card. These components are used to assess the effectiveness of a sterilization process, not to analyze a patient sample.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing information about a patient's health status
- Being used in a clinical laboratory setting for patient diagnosis or monitoring

The device is clearly designed to evaluate the performance of a sterilization process, which falls under the category of sterilization process indicators, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

FRC

Device Description

The test pack consists of multiple layers of paper cards with a SporView Rapid Read Biological Indicator, chemical process indicators and load record card. The load record card is used to record the detailed information from the sterilization cycle.

The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

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 following testing has been conducted in accordance with the FDA Guidance on Biological Indicators and the FDA Guidance for Industry and FDA Staff – Premarket Notification [510(k)] Submissions for Chemical Indicators and the FDA Guidance for Industry and FDA Staff -Premarket Notification [510(k)] Submissions for Chemical Indicators.
Performance Testing: Test Pack Performance
Details and Acceptance Criteria: All test packs have complete kill in a 270°F (132°C) pre vacuum steam sterilization cycle for an exposure time of 4 minutes.
Results: Pass

Performance Testing: Resistance Performance
Details and Acceptance Criteria: The test pack has resistance greater than or equal to the AAMI Towel Pack.
Results: Pass

Performance Testing: Resistance Performance
Details and Acceptance Criteria: The test pack has resistance greater than the self-contained biological indicator itself.
Results: Pass

Performance Testing: Chemical Indicator Performance
Details and Acceptance Criteria: Testing to confirm process indicators contained in the test pack perform as intended per the FDA Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators.
Results: Pass

Non-Clinical Performance Testing of the Subject:
Performance testing demonstrates that the subject device has more resistance than the self-contained biological indicator itself and the subject device has resistance greater than or equal to the AAMI Towel Pack. There was no growth of the SCBI contained in the subject device after a full sterilization cycle.

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.

3M Attest 41382 Rapid Readout Steam-Plus Process Challenge Device (K101910)

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.

SporView Plus BI Test Pack Process Challenge Device (K140620)

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

November 14, 2018

Crosstex/SPSmedical, A Division of Cantel Medical Megan Skaar Regulatory Affairs Specialist 6789 West Henrietta Road Rush, New York 14543

Re: K181434

Trade/Device Name: SporView Rapid Read Biological Indicator SteamPlus Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: October 11, 2018 Received: October 15, 2018

Dear Megan Skaar:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181434

Device Name

SporView Rapid Read Biological Indicator SteamPlus Test Pack

Indications for Use (Describe)

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

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "CANTEL" in blue font next to a blue circular logo. The logo is a circle with several horizontal lines running through it. The word "CANTEL" is in all capital letters and appears to be a sans-serif font. The image is likely a company logo.

510(k) Summary - K181434

Manufacturer:	Crosstex/SPSmedical, a Cantel Medical Company
Address:	6789 W. Henrietta Road
Rush, NY 14543
(800) 722-1529
Official Contact:	Megan Skaar
Regulatory Affairs Specialist, Cantel Medical
Date:	9 November 2018
Trade Name:	SporView Rapid Read Biological Indicator SteamPlus Test Pack
Common Name:	Sterilization Biological Test Pack
Classification Name:	Sterilization Process Indicator
Product Code:	FRC
Device Class:	II
Regulation No:	Subject Device – SporView Rapid Read Biological Indicator Test Pack,
880.2800
Predicate Device – 3M Attest 3M Attest 41382 Rapid Readout Steam-Plus
Process Challenge Device, 880.2800

1. Device Description

The SporView Rapid Read Biological Indicator, cleared under 510(k) K172432, is composed of a polypropylene vial containing a spore carrier and media ampoule enclosed with a vented cap.

Image /page/4/Picture/0 description: The image shows the logo for Cantel Medical. The logo consists of a blue circle with several horizontal lines running through it on the left, and the word "CANTEL" in blue on the right. The font is sans-serif and the overall design is simple and modern.

2. Indications for Use

3. Technological Characteristics Comparison Table

Table 05.1 below provides a detailed comparison between the subject, predicate and reference devices –

| Technological
Characteristics | Subject Device -
SporView Rapid
Read Biological
Indicator Test
Pack | Predicate Device

3M Attest 41382
Rapid Readout
Steam-Plus
Process
Challenge Device
(K101910) | Reference Device
SporView Plus
BI Test Pack
Process
Challenge Device
(K140620) | Comparison
Summary |
|----------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Intended Use | Monitor 270°F
(132°C)
prevacuum steam
sterilization cycles
for 4 minutes
exposure time. | Monitor 270°F
(132°C)
prevacuum steam
sterilization cycles
with exposure time
of 4 minutes. | Monitor 250°F
(121°C) gravity
displacement
cycles and 270°F
(132°C)
prevacuum steam
sterilization cycles
for 4 minutes
exposure time. | Same |
| Product Code | FRC | FRC | FRC | Same |

Table 05.1 - Predicate Device Comparison Table

Image /page/5/Picture/0 description: The image shows the logo for CANTEL. The logo consists of a blue circular graphic on the left and the word "CANTEL" in blue on the right. The circular graphic has several horizontal lines running through it, giving it a stylized appearance.

| FDA

Regulation	21 CFR 880.2800	21 CFR 880.2800	21 CFR 880.2800	Same
Device Class	II	II	II	Same
Organism	> 90% genetic
similarity to G.
stearothermophilus
ATCC™ strain
7953	> 90% genetic
similarity to G.
stearothermophilus
ATCC™ strain
7953	> 90% genetic
similarity to G.
stearothermophilus
ATCC™ strain
7953	Same
Viable Spore
Population	$1.0 x 10^5$	$1.0 x 10^5$	$1.0 x 10^5$	Same
D-Value of
Biological
Indicator	Steam 132°C:
10.0 Seconds	Steam 132°C:
10.0 Seconds	Steam 132°C:
10.0 Seconds	Same
Includes 510(k)
Cleared Chemical
Indicators?	Yes	Yes	Yes	Same
Paper of Test
Pack	Paper Index Cards	Paper Index Cards	Paper Index Cards	Same
Shelf life	12 Months	24 Months	18 Months	Similar
Storage	Controlled room
temperature	Controlled room
temperature	Controlled room
temperature	Same
Incubation
Temperature	60±2°C	60±2°C	55-60°C	Same as
Predicate
Device
BI Incubation
Duration	3 hours	3 hours	10 hours	Same as
Predicate
Device
Biocompatibility	No direct patient
contact	No direct patient
contact	No direct patient
contact	Same

The subject device – the SporView Rapid Read Biological Indicator SteamPlus Test Pack and its predicate device - 3M Attest 41382 Rapid Readout Steam-Plus Process Challenge Device are similar in that they both have the same intended use, fundamental technology and general performance. Both the subject device and the 3M Attest 41382 Rapid Readout Steam-Plus Process Challenge Device have 510(k) cleared self-contained biological indicators with a spore carrier inoculated with the same organism, G. stearothermophilus. The subject and predicate test packs both provide a significant challenge to the steam sterilization process.

The subject device is very similar to its reference device - the SporView Plus Bl Test Pack cleared under K140620. The 510(k) cleared chemical indicators in the subject device, including the locations, of the subject test pack are identical to the reference device.

Image /page/6/Picture/0 description: The image shows the word "CANTEL" in blue font. To the left of the word is a blue circular logo with several horizontal lines running through it. The logo and the word "CANTEL" are the only elements in the image. The background is white.

4. Summary of Non-Clinical Performance Data

The following testing has been conducted in accordance with the FDA Guidance on Biological Indicators and the FDA Guidance for Industry and FDA Staff – Premarket Notification [510(k)] Submissions for Chemical Indicators and the FDA Guidance for Industry and FDA Staff -Premarket Notification [510(k)] Submissions for Chemical Indicators. Please refer to the table below for a brief description of the subject device testing

Results

Pass

Performance Testing	Details and Acceptance Criteria
Test Pack Performance	All test packs have complete kill in a 270°F (132°C)
pre vacuum steam sterilization cycle for an
exposure time of 4 minutes.
Resistance
Performance	The test pack has resistance greater than or equal to
the AAMI Towel Pack.

contained biological indicator itself.

. Non-Clinical Performance Testing of the Subject:
Performance testing demonstrates that the subject device has more resistance than the self-contained biological indicator itself and the subject device has resistance greater than or equal to the AAMI Towel Pack. There was no growth of the SCBI contained in the subject device after a full sterilization cycle.

The test pack has resistance greater than the self-

Testing to confirm process indicators contained in the

test pack perform as intended per the FDA Guidance

for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Chemical Indicators.

5. Conclusion

Chemical Indicator

Performance

Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as the legally marketed predicate cleared under 510(k) K101910.