(88 days)
Not Found
No
The device description details a biological indicator (spore test strip) and growth media for manual interpretation of sterilization effectiveness. There is no mention of any computational analysis, algorithms, or learning processes.
No
The device is a spore test strip used to assess the effectiveness of a sterilization process, not to treat or diagnose a medical condition.
No.
The device is used to assess the effectiveness of a chemical sterilization process, not to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components (filter paper strip, glassine envelope, media vials, transfer clip) and a biological component (Geobacillus stearothermophilus spores). It is a physical test strip and associated materials, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to assess the effectiveness of a sterilization process (killing spores on the test strip) within a specific processing system. It does not diagnose a disease, condition, or state of health in a human or animal.
- Device Description: The device is a biological indicator used to monitor a sterilization process. It involves incubating the strip in media and observing for growth, which is a measure of the sterilization process's efficacy, not a diagnostic test on a biological sample from a patient.
- Lack of Patient Information: There is no mention of patient samples, anatomical sites, or patient age ranges, which are typical characteristics of IVDs.
- Focus on Process Monitoring: The entire description revolves around evaluating the performance of a sterilization system, not analyzing a biological sample for diagnostic purposes.
While the device involves biological material (spores) and a laboratory-like process (incubation and observation), its purpose is to validate a sterilization process, not to provide diagnostic information about a patient.
N/A
Intended Use / Indications for Use
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
Product codes
OVY
Device Description
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60℃ for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
There are no changes to the strip itself for this submission: only the indications for use and consequently, labeling are changing to include the Spore Test Strip's use in the STERIS enspire CLCSPS, which uses S40 Sterilant Concentrate.
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: Performance Testing
Sample Size: Not specified
Key Results:
- Population Wash Off Stability: Evaluate the population of the spores remaining on the STS after processing without sterilant. Conclusion: PASS
- Simulated Use: Demonstrate the STS functions appropriately in the enspire CLSPS. Conclusion: PASS
- Bacteriostasis: Ensure no inhibitory effects on the outgrowth of a low number of spores. Conclusion: PASS
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6887 Spore test strip.
(a)
Identification. The spore test strip consists of a carrier or strip with a known number of spores, at least 5 log10 per strip, of known resistance to a particular liquid chemical sterilant in a liquid chemical sterilant processing system. A “no growth” result from the spore test strip after the specified predetermined incubation period indicates that the liquid chemical sterilization process achieved the conditions necessary to kill the specified minimum number of viable spores on the test strip which is 5 log10 spores/strip; it does not confirm the expected full performance of the liquid chemical sterilant processing cycle because full performance is a 6 log10 spore kill in a full liquid chemical sterilization cycle.(b)
Classification. Class II (special controls). The special controls for this device are:(1)
Spore strip characterization. (i) Population of viable spores on strip shall be a minimum of 5 log10 after physical wash off of spores from the strip by exposure to liquid chemical sterilant in the liquid chemical sterilant processing system, which should be validated over the claimed shelf life.(ii) The resistance characteristics of the viable spores on the strip should be defined and be validated over the claimed shelf life.
(iii) The spore strip description should address the carrier material, how the spores are placed on the carrier, and whether there is any feature that minimizes spore wash off. Bacteriostasis of the spore strip materials should be evaluated.
(iv) Incubation time for viable spores on the strip should be validated under the specified incubation conditions over the claimed shelf life.
(2)
Simulated Use Testing. Simulated use testing should demonstrate performance of spore test strip in liquid chemical sterilant/high level disinfectant under worst case in use conditions over the claimed shelf life.(3)
Labeling. Labeling should specify appropriate instructions, warnings, cautions, limitations, and information relating to viable spore population, resistance characteristics, and interpretation of a “no growth” result.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 11, 2023
Steris Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Rd Mentor, Ohio 44060
Re: K231746
Trade/Device Name: VERIFY Spore Test Strip for S40 Sterilant Concentrate Regulation Number: 21 CFR 880.6887 Regulation Name: Spore Test Strip Regulatory Class: Class II Product Code: OVY Dated: June 15, 2023 Received: June 15, 2023
Dear Gregory Land:
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.
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231746
Device Name VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
Indications for Use (Describe)
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
| 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)
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3
Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word "STERIS" is written in a bold, sans-serif font at the top of the image, with a registered trademark symbol to the right of the word. Below the word is an image of several horizontal, wavy lines that are blue in color.
510(k) Summary For VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE K231746
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Gregory Land Lead Regulatory Affairs Specialist (440) 392-7424 Telephone: Email: greg land@steris.com
Submission Date: June 15, 2023
Submission Number: K231746
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT
Device Name 1.
| Trade Name: | VERIFY Spore Test Strip for S40 Sterilant Concentrate |
|---|---|
| Models: | N/A |
| Common Name: | Spore Test Strip |
| Classification Name: | Liquid Chemical Processing System |
| Classification | 21 CFR 880.6887 |
| Product Code | OVY |
2. Predicate Device
VERIFY Spore Test Strip for S40 Sterilant - K180553
3. Device Description
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 % in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The STS are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. The transfer clip is used to remove the STS from the glassine envelope and serves to hold the strip in a fixed location in either the enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (enspire CLCSPS) or the SYSTEM 1E or SYSTEM 1 endo Liquid Chemical Sterilant Processing system. After the cycle concludes, the transfer clip is used to aseptically transfer the STS from the processor into the growth media for incubation at 55-60℃ for a minimum of 24 hours but may be incubated for up to 7 days. If the media remains red and non-turbid, the user interprets the results as a pass. If the media color turns yellow or is turbid, the user interprets the result as a fail. The shelf life is 12 months when stored at 2-24°C and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
There are no changes to the strip itself for this submission: only the indications for use and consequently, labeling are changing to include the Spore Test Strip's use in the STERIS enspire CLCSPS, which uses S40 Sterilant Concentrate.
4. Intended Use/Indications for Use:
The VERIFY Spore Test Strip for S40 Sterilant Concentrate is intended to provide users with a means to assess spore kill by S40 Sterilant Concentrate use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems and enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System). A "no growth" result from the VERIFY Spore Test Strip for S40 Sterilant Concentrate after 24 hours of incubation indicates that the liquid chemical sterilization process
5
achieved the conditions necessary to kill at least 1 x 105 viable spores (5 logs) on the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
ട്. Description of Technological Similarities and Differences
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical. Table 1 summarizes the predicate and subject device comparison in tabular format.
The revised indications for use statement will enable use of the VERIFY Spore Test Strip for S40 Sterilant Concentrate in the enspire CLCSPS which uses S40 Sterilant Concentrate with critical parameters identical to those in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System, previously cleared for use with the STS.
| Feature | Proposed
VERIFY Spore Test Strip for S40
Sterilant Concentrate | Predicate K180553
VERIFY Spore Test Strip for S40 | Comparison |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
use/
Indications
for Use | The VERIFY Spore Test Strip for S40
Sterilant Concentrate is intended to
provide users with a means to assess
spore kill by S40 Sterilant Concentrate
use dilution in the STERIS automated
Liquid Chemical Sterilant Processing
Systems (SYSTEM 1E and SYSTEM
1®endo Liquid Chemical Sterilant
Processing Systems and enspire 3000
Series Cleaning and Liquid Chemical
Sterilant Processing System). A “no
growth” result from the VERIFY Spore
Test Strip for S40 Sterilant Concentrate
after 24 hours of incubation indicates that
the liquid chemical sterilization process
achieved the conditions necessary to kill
at least 1 x $10^5$ viable spores (5 logs) on
the spore test strip (STS). It does not
confirm the expected full performance of
the liquid chemical sterilization cycle. | The VERIFY® Spore Test Strip for
S40 Sterilant is intended to provide
users with a means to assess spore kill
by S40 sterilant use dilution in the
STERIS automated Liquid Chemical
Sterilant Processing Systems
(SYSTEM 1E Liquid Chemical
Sterilant Processing System and
SYSTEM 1 endo Liquid Chemical
Sterilant Processing System). A "no
growth" result from the VERIFY
Spore Test Strip for S40 Sterilant after
24 hours of incubation indicates that
the liquid chemical sterilization
process achieved the conditions
necessary to kill at least 1 x 10E5
viable spores (5 logs) on the test strip.
It does not confirm the expected full
performance of the liquid chemical
sterilization cycle. | The proposed
Indications for
use are expanded
to include the
enspire
CLCSPS. The
Indications have
been altered to
include the
enspire
processor as well
as the previously
cleared
processors. The
words
"Concentrate"
and "spore" are
inserted into the
proposed
Indications to
ensure precision
in
communication. |
| Organism | Geobacillus stearothermophilus 7953
spores | Geobacillus stearothermophilus 7953
spores | Identical |
Table 1. Device Comparison Table
6
| STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION |
|---|
| VERIFY® SPORE TEST STRIP FOR S40 STERILANT |
| Feature | Proposed
VERIFY Spore Test Strip for S40
Sterilant Concentrate | Predicate K180553
VERIFY Spore Test Strip for S40 | Comparison |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------|
| Viable
Spore
Population | At manufacture: ≥1.5 x 105 CFU
Post-Builders: ≥ 1.0 x 105 CFU | At manufacture: ≥1.5 x 105 CFU
Post-Builders: ≥ 1.0 x 105 CFU | Identical |
| Resistance
characterist
ics | At 1635 ppm PAA:
• D-value 12 – 26 seconds
• Survival Time ≥ 38 seconds
• Kill Time ≥ 239 seconds | At 1635 ppm PAA:
• D-value 12 – 26 seconds
• Survival Time ≥ 38 seconds
• Kill Time ≥ 239 seconds | Identical |
| LCSPS
cycle
parameters | • >1820 mg/L PAA
• 6 minutes
• 45.5 – 60°C | • >1820 mg/L PAA
• 6 minutes
• 45.5 - 60°C | Identical |
| Culture
Conditions | • Trypticase Soy Broth Based Media
• Incubation Temp.: 55-60°C
• Incubation Time: 24 hours minimum;
up to 7 days | • Trypticase Soy Broth Based Media
• Incubation Temp: 55-60°C
• Incubation Time: 24 hours
minimum; up to 7 days | Identical |
| Carrier
Material | Filter paper | Filter paper | Identical |
| Primary
Packaging | • 20 BIs in Glassine
• 20 Media Vials | • 20 BIs in Glassine
• 20 Media Vials | Identical |
| Shelf Life | 12 months | 12 months | Identical |
Description of Safety and Substantial Equivalence 6.
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored by the strip are identical.
This submission revises the product's indications for use and consequently, labeling, expanding its indications for use to include the enspire CLCSPS that provides identical S40 Sterilant Concentrate exposure conditions in a unique flow pattern.
7. Performance Testing
While the sterilant exposure conditions in the enspire are identical to the sterilant exposure conditions in the previously cleared processors, the flow rates the STS are exposed to are different. Testing, described in this submission, was undertaken to ensure safety and efficacy in the enspire CLCSPS. Refer to Table 2.
7
| Testing | Summary | Conclusion |
|---|---|---|
| Population Wash Off | ||
| Stability | Evaluate the population of the spores | |
| remaining on the STS after processing | ||
| without sterilant. | PASS | |
| Simulated Use | Demonstrate the STS functions appropriately | |
| in the enspire CLSPS. | PASS | |
| Bacteriostasis | Ensure no inhibitory effects on the outgrowth | |
| of a low number of spores. | PASS |
Table 2. Performance Testing on Subject Device
Conclusion 8.
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs at least as well as the legally marketed predicate device (K180553), Class II (CFR 880.6887), product code OVY.