(29 days)
Not Found
No
The device description details a biological indicator system that relies on spore growth and a color change in media for interpretation, with no mention of computational analysis, algorithms, or learning processes.
No.
The device is a spore test strip used to assess the effectiveness of a sterilant, not to treat a disease or condition in a patient.
No
This device, a spore test strip, is used to assess the effectiveness of a sterilization process by determining if spores have been killed. It does not diagnose a disease or 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 (spores), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assess the effectiveness of a sterilization process (spore kill by S40 Sterilant) in specific processing systems. It does not involve testing a sample taken from the human body to diagnose a disease or condition.
- Device Description: The device is a biological indicator (spore test strip) used to monitor a sterilization process. It does not analyze biological samples from a patient.
- Lack of Patient Interaction: The device is used within a sterilization system and interacts with the sterilant, not directly with a patient or a patient sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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 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.
Product codes
OVY
Device Description
The Spore Test Strip for S40 Sterilant Concentrate (STS) consists of a 1 ¼ in. x 1¼ 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°C 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.
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
Table 2. Summary of verification activities.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Population Wash Off Testing | The modification does not affect the performance of the device. | Pass |
| Bacteriostasis Testing | The modification does not affect the performance of the device. | Pass |
| New testing was performed to evaluate the modified device. The results indicate that the modification does not affect the performance of the device for Population Wash Off Testing and Bacteriostasis Testing. |
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.
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December 15, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K233682
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: November 16, 2023 Received: November 16, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
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 liguid chemical sterilization cvcle.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary For K233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 (440) 354-2600
Gregory Land Contact Lead Regulatory Affairs Specialist (440) 392-7424
Summary Date December 13, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
Trade Name:
Device Classification: Common Name: Classification Name: Classification Panel: Classification Number: Product Code
VERIFY Spore Test Strip for S40 Sterilant Concentrate II Spore Test Strip Liquid Chemical Processing System General Hospital and Personal Use Devices Panel 21 CFR 880.6887 OVY
2. Predicate Device
VERIFY Spore Test Strip for S40 Sterilant - K231746
Device Description 3.
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°C 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 an expansion to the exposure time to the chemical sterilant.
4. Intended 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 105 viable spores (5 logs) on
6
the spore test strip (STS). It does not confirm the expected full performance of the liquid chemical sterilization cycle.
ട. Technological Characteristic Comparison Table
The modified device and its predicate are physically identical. The only difference is the modified device has an expanded contact time with the liquid chemical sterilant. Table 1 summarizes the predicate and subject device comparison in tabular format.
| Table 1. Device Comparison Table | |||
|---|---|---|---|
| Feature | Modified | ||
| VERIFY Spore Test Strip for | |||
| S40 Sterilant Concentrate | Predicate K231746 | ||
| VERIFY Spore Test Strip for | |||
| S40 Sterilant Concentrate | Comparison | ||
| Intended | |||
| 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. | 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. | Identical | ||
| 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 |
Table 1. Device Comparison Table
7
STERIS SPECIAL 510(k) PREMARKET NOTIFICATION VERIFY® SPORE TEST STRIP FOR S40 STERILANT
| Feature | Modified
VERIFY Spore Test Strip for
S40 Sterilant Concentrate | Predicate K231746
VERIFY Spore Test Strip for
S40 Sterilant Concentrate | Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------|
| 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 (+ up to 9 minute and
30 second Warm/Mix Phase)
• 45.5 - 60°C | • >1820 mg/L PAA
• 6 minutes
• 45.5-60°C | Similar |
| 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 |
6. Summary of Non-Clinical Testing
Shown in Table 2 is the new testing which was performed to evaluate the modified device.
Table 2. Summary of verification activities.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Population Wash Off | ||
| Testing | The modification does not affect the | |
| performance of the device. | Pass | |
| Bacteriostasis Testing | The modification does not affect the | |
| performance of the device. | Pass |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K231746), Class II (21 CFR 880.6887), product code OVY.