(89 days)
Not Found
No
The device is a biological indicator that relies on the growth or lack of growth of spores in a culture medium to indicate sterilization effectiveness. The interpretation of the results is based on a simple color change and turbidity, which is a manual observation by the user, not an automated process involving AI/ML.
No
This device is a biological indicator used to assess the efficacy of a sterilization process, not to treat a medical condition or disease.
No
Explanation: The device assesses the efficacy of a sterilization process, not the health status of a patient. It evaluates whether the sterilant achieved the conditions necessary to kill spores, which is a quality control function for a medical device sterilization process.
No
The device description clearly outlines physical components including a filter paper-based strip, glassine envelope, media vials, and a transfer clip. It is a biological indicator, not software.
Based on the provided text, 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 strip) within a specific sterilant processing system. It is not intended to diagnose a disease, condition, or state of health in a human or animal.
- Mechanism: The device works by providing a biological indicator (spores) to challenge the sterilization process. The outcome (growth or no growth) indicates whether the sterilization conditions were met, not the presence or absence of a disease or condition in a biological sample.
- Biological Sample: The device does not analyze a biological sample from a patient (like blood, urine, tissue, etc.) to provide diagnostic information. It is used to test the performance of a medical device (the sterilizer).
Therefore, while it is a medical device used in a healthcare setting, it falls under the category of a sterilization process indicator rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OVY
Device Description
The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends.
For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the Vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. 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 Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.
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)
Summary of Non-Clinical Testing:
Study Type: Simulated Use, Stability of Media Color, Reduced Incubation Time, Shelf Life for 12 months.
Key Results: All tests passed, demonstrating the device met the acceptance criteria for each test.
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.
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
§ 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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2018
Steris Corporation Marcia Benedict Senior Director, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K180553
Trade/Device Name: VERIFY Spore Test Strip for S40 Sterilant Regulation Number: 21 CFR 880.6887 Regulation Name: Spore Test Strip Regulatory Class: Class II Product Code: OVY Dated: February 28, 2018 Received: March 1, 2018
Dear Marcia Benedict:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Geeta K. Pamidimukkala -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
2
Indications for Use
510(k) Number (if known) K180553
Device Name VERIFY® Spore Test Strip for S40® Sterilant
Indications for Use (Describe)
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 "ho 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.
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
STEF
510(k) Summary For VERIFY® SPORE TEST STRIP for S40® STERILANT
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Marcia L. Benedict Senior Director, Regulatory Affairs Telephone: (440) 392-7063 Fax No: (440) 357-9198
Submission Date: May 22, 2018
Premarket Notification Number: K180553
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | VERIFY® Spore Test Strip for S40 Sterilant |
|---|---|
| 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 – DEN110002 (K100049)
3. Device Description
The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 36 in. x 14 in. filter paper-based strip inoculated with Geobacillus stearothermophilus spores and is enclosed in a glassine envelope. The Spore Test Strips are provided with media vials containing a modified tryptic soy broth with phenol red pH indicator, and a transfer clip. Using the clip, the Spore Test Strip is secured on the available post located in the tray of the liquid chemical sterilant processor. The transfer clip thus holds the Spore Test Strip in a fixed location during a processing cycle in the STERIS Liquid Chemical Sterilant Processing System and enables aseptic transfer of the strip from the processor into the growth media vial after the cycle ends.
For use, the Spore Test Strip is removed from the glassine envelope and secured using the transfer clip in the SYSTEM 1E Liquid Chemical Sterilant Processing System or SYSTEM 1 endo Liquid Chemical Sterilant Processing System along with the items to be liquid chemically sterilized. The liquid chemical sterilization cycle is initiated. At the end of the full cycle, the Spore Test Strip is removed and placed into the vial of growth medium for incubation under the specified conditions that will promote spore growth for at least 24 hours. 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 Spore Test Strip is incubated at 55-60°C for a minimum of 24 hours, but may be incubated for up to 7 days. The shelf life is 12 months when stored at 2-24℃ and 30-80% relative humidity (RH) away from sterilizing agents and excessive heat.
The current submission makes no changes to the strip itself; only the indications for use are changing to encompass the VERIFY Spore Test Strip's broader use in more than one STERIS automated liquid chemical sterilant processing system (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid
5
Chemical Sterilant Processing System) that uses S40 Sterilant Concentrate under identical exposure conditions.
4. Intended Use:
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 10° viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.
5. Technological Characteristic Comparison Table
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored are identical.
The revised indication for use statement will enable use of the VERIFY Spore Test Strip for S40 Sterilant in a STERIS automated liquid chemical sterilant processor that uses S40 Sterilant Concentrate in an identical controlled cycle. This will facilitate the indicator's intended use in the SYSTEM 1E Liquid Chemical Sterilant Processing System and the SYSTEM 1 endo Liquid Chemical Sterilant Processing System.
| Feature | K180553
VERIFY Spore Test Strip
for S40 Sterilant | Predicate DEN110002
VERIFY Spore Test Strip
for S40 | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | 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 | The Verify Spore Test Strip for
S40 is intended to provide users
with a means to assess spore kill
by S40 sterilant use dilution in
the SYSTEM 1E Liquid
Chemical Sterilant Processing
System.
A "no growth" result from the
VERIFY Spore Test Strip for
S40 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 test strip. It does not
confirm the expected full
performance of the SYSTEM 1E | The proposed
rewording
describes the
sterilant and
the liquid
chemical
sterilization
cycle the
Spore Test
Strip assesses
rather than
citing one
processor by
name. |
| Feature | K180553
VERIFY Spore Test Strip
for S40 Sterilant | Predicate DEN110002
VERIFY Spore Test Strip
for S40 | Comparison |
| | liquid chemical sterilization
process achieved the conditions
necessary to kill at least 1 x 105
viable spores (5 logs) on the test
strip. It does not confirm the
expected full performance of the
liquid chemical sterilization
cycle. | Liquid Chemical Sterilization
Cycle. | |
| Organism | Geobacillus stearothermophilus
7953 spores | Geobacillus stearothermophilus
7953 spores | Identical |
| 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
characteristic
s | 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 |
Table 1. Device Comparison Table
6
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT
6. Description of Spore Strip Specifications:
The proposed device and its predicate are physically identical. The liquid chemical sterilant exposure conditions monitored by the strip are identical.
7
STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT
Table 1 demonstrates the validated populations, resistance characteristics, and reduced incubation time the predicate Spore Test Strips maintain over the product's labeled use life of 12 months when stored at 2-24°C and 30-80% relative humidity.
| Value | Spore Test Strip for S40 |
|---|---|
| Population | |
| • At manufacture | $\geq$ 1.5 x 105 cfu/strip |
| • After wash-off (end of cycle) | $\geq$ 1.0 x 105 cfu/strip |
| Resistance | |
| • D-value | 12-26 sec at 1635 ppm PAA |
| • Survival Time | $\geq$ 38 seconds |
| • Kill Time | $\leq$ 239 seconds |
| Reduced Incubation Time | 24 hours |
Table 1. Spore Test Strip Specifications *
*cfu = colony forming units, ppm = parts per million, PAA = peracetic acid
7. Summary of Non-Clinical Testing
Table 2 summarizes non-clinical testing performed on the device. Based on the testing results from the simulated use, stability of media color, reduced Incubation Time, and the shelf life testing the device demonstrated it met the acceptance criteria for each test.
Table 2. Performance Testing on Predicate
| Testing | Results |
|---|---|
| Simulated Use | PASS |
| Stability of Media Color | PASS |
| Reduced Incubation Time | PASS |
| Shelf Life for 12 months | PASS |
8. Conclusion
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 (DEN110002), Class II (CFR 880.6887), product code OVY.