VERIFY Assert VH2O2 Self-Contained Biological Indicator

K171504 · STERIS Corporation · FRC · Aug 22, 2017 · General Hospital

Device Facts

• Record ID: K171504
• Device Name: VERIFY Assert VH2O2 Self-Contained Biological Indicator
• Applicant: STERIS Corporation
• Product Code: FRC · General Hospital
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

Intended Use

The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities. When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

Device Story

Device is a self-contained biological indicator (SCBI) for monitoring vaporized hydrogen peroxide (VH2O2) sterilization cycles. Input: Geobacillus stearothermophilus spores and fluorogenic substrate within a plastic vial. Operation: After sterilization, the SCBI is placed in a proprietary incubator/reader. A reporter enzyme produced by surviving spores reacts with the substrate to produce a fluorescent moiety. The reader detects this fluorescence within 20 minutes. Output: Fluorescent signal indicating sterilization failure (spore survival) or absence of signal indicating success. Used in healthcare facilities by clinical staff. Results inform the healthcare provider whether the sterilization cycle was effective, ensuring the safety of instruments for patient use.

Clinical Evidence

Bench testing only. Studies included Reduced Incubation Time (RIT) testing (>97% alignment with 7-day conventional incubation), viable spore population counts (1.0–4.0 x 10^6/SCBI), resistance testing (D-value >3 sec, survival time ≥4 sec, kill time ≤6 min), carrier growth inhibition, hold time, and simulated use testing in worst-case cycles. All tests passed.

Technological Characteristics

SCBI containing Geobacillus stearothermophilus spores and fluorogenic substrate in a plastic vial. Sensing principle: enzymatic reaction producing fluorescence. Energy source: external incubator/reader. Connectivity: standalone incubator/reader. Sterilization: VH2O2 process. Complies with ISO 11138-1 for biological indicators.

Indications for Use

Indicated for routine monitoring and qualification of Non Lumen, Flexible, and Lumen cycles of V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• VERIFY V24 Self-Contained Biological Indicator (K140499)

Reference Devices

• 3M Attest Rapid Readout Biological Indicator 1295 (K160546)
• VERIFY V-PRO Chemical Indicator (K140515)
• VERIFY V-PRO Chemical Indicator (K091174)

Submission Summary (Full Text)

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

August 22, 2017

STERIS Corporation Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heislev Rd Mentor, Ohio 44060

Re: K171504

Trade/Device Name: VERIFY Assert VH2O2 Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: July 31, 2017 Received: August 1, 2017

Dear Mr. Piotrkowski:

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 (reporting of medical device

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Tara A. Ryan -S

for

Lori Wiggins Acting 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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## Indications for Use

510(k) Number (if known) K171504

Device Name

VERIFY Assert VH2O2 Self-Contained Biological Indicator

Indications for Use (Describe)

The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(k) Summary For VERIFY Assert VH2O2 Self-Contained Biological Indicator

### Sponsor Facility

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: [phone] Fax No: [phone]

### Manufacturing Facility

STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: [phone] Fax No: [phone]

Tony Piotrkowski Contact: Senior Manager, Regulatory Affairs

Telephone: [phone] Fax No: [phone] e-mail: [e-mail]

Submission Date: August 21, 2017

Premarket Notification Number: K171504

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### Device Name 1.

| Trade Name: | VERIFY Assert VH2O2 Self-Contained Biological Indicator |
|------------------------|-----------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>(21 CFR 880.2800, FRC) |

#### 2. Predicate Device

VERIFY® V24 Self-Contained Biological Indicator, K140499

### Reference Devices

3M Attest™ Rapid Readout Biological Indicator 1295, K160546

#### 3. Description of Device

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert VH2O2 Self-Contained Biological Indicator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

#### Intended Use/ Indications for Use 4.

The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.

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#### 5. Summary of Technical Characteristics

A comparison of technical characteristics versus the predicate is summarized in Table 5-1 and versus the reference device in Table 5-2.

| Feature | Assert VH202 SCBI | VERIFY V24 SCBI | Comparison |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (proposed) | Predicate (K140499) | |
| Intended Use | The VERIFY Assert<br>VH2O2 Self-Contained<br>Biological Indicator is<br>used for routine<br>monitoring, and<br>qualification of Non<br>Lumen, Flexible and<br>Lumen Cycles of the V-<br>PRO 1, 1 Plus, maX, and<br>60 Low Temperature<br>Sterilizers in healthcare<br>facilities. | The VERIFY® V24 Self-<br>Contained Biological<br>Indicator is intended for<br>routine monitoring of the<br>Lumen, Non Lumen and<br>Flexible cycles of V-PRO®<br>Low Temperature<br>Sterilization Systems. | Intended cycles are the same<br>for both predicate and<br>proposed. The proposed<br>indications for use include<br>information about the<br>incubator/reader and read<br>time that are supported<br>through testing in<br>accordance with FDA<br>guidance for BI 510(k). |
| | When used in conjunction<br>with the VERIFY<br>Incubator for Assert<br>VH2O2 SCBI, the<br>VERIFY Assert Self-<br>Contained Indicator<br>provides a fluorescent<br>result within 20 minutes. | | |
| Indicator | Geobacillus | Geobacillus | Same |
| organism | stearothermophilus | stearothermophilus | |
| Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety. | Visual detection of growth<br>based on media color<br>change in the presence of<br>surviving indicator<br>organisms. | Both devices indicate<br>survival of indicator<br>organisms after sterilization.<br>The mechanism of the<br>proposed device is more<br>similar to the reference<br>device (see table 5-2).<br>Resistance testing and<br>simulated use testing<br>demonstrate appropriate<br>monitoring of indicated<br>sterilization cycles. |
| Accessories | Automated incubator /<br>reader | None | This accessory is more<br>similar to the reference<br>device (see table 5-2) than to<br>the predicate device. RIT<br>testing and simulated use<br>testing demonstrate<br>appropriate monitoring of<br>indicated sterilization<br>cycles. |
| Feature | Assert VH2O2 SCBI<br>(proposed) | VERIFY V24 SCBI<br>Predicate (K140499) | Comparison |
| Viable spore<br>population | $1.0 – 4.0 \times 10^6$ spore/BI | $2.0 – 3.4 \times 10^6$ spore/BI | Both contain greater than<br>$10^6$ spores/BI. |
| Resistance<br>characteristics | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 3 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Resistance @ 2.7 mg/L<br>H2O2:<br>• D-value 4.0 – 8.0 sec<br>• Survival Time 4 - 30 sec<br>• Kill Time ≤ 16 min | Resistance testing for<br>proposed device at a higher<br>H2O2 concentration.<br>Simulated use testing<br>verifies suitability for use in<br>claimed cycles. |
| Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 55- 59 °C, media included<br>in SCBI, 24h incubation<br>time. | RIT Testing and ISO 11138–1<br>media testing verifies<br>performance |
| Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Direct inoculum on plastic<br>vial, glass ampule with<br>recovery media. | Similar configuration.<br>Component testing per ISO<br>11138-1 Annex B<br>demonstrates packaging is<br>compatible with indicator<br>and sterilization process. |
| Process<br>indicator | VERIFY V-PRO<br>Chemical Indicator<br>(K140515); magenta to<br>yellow color change. | VERIFY V-PRO<br>Chemical Indicator<br>(K140515); magenta to<br>yellow color change. | Same |
| Shelf-life | Currently 3 months<br>Target of 13 months | 18 months | Real-time testing ongoing |

### Table 5-1 SCBI Physical Description and Technological Properties vs the Predicate Device

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### Table 5-2 SCBI Physical Description and Technological Properties vs the Reference Device

| Feature | Assert VH2O2 SCBI<br>(proposed) | Attest 1295<br>Reference (K160546) | Comparison |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The VERIFY Assert<br>VH2O2 Self-Contained<br>Biological Indicator is<br>used for routine<br>monitoring, and<br>qualification of Non<br>Lumen, Flexible and<br>Lumen Cycles of the V-<br>PRO 1, 1 Plus, maX, and<br>60 Low Temperature<br>Sterilizers in healthcare<br>facilities.<br><br>When used in conjunction<br>with the VERIFY<br>Incubator for Assert<br>VH2O2 SCBI, the<br>VERIFY Assert Self-<br>Contained Indicator<br>provides a fluorescent<br>result within 20 minutes. | Use the 3MTM AttestTM<br>Rapid Readout Biological<br>Indicator 1295 in<br>conjunction with the 3M<br>AttestTM Auto reader 490H<br>as a standard method of<br>routine monitoring of<br>vaporized hydrogen<br>peroxide sterilization<br>processes in the Amsco®<br>V-PRO® maX Low<br>Temperature Sterilization<br>System (Lumen, Non<br>Lumen, and Flexible<br>cycles), and in<br>STERRAD® 100S,<br>STERRAD® NX<br>(Standard and Advanced<br>cycles) and 100NX<br>(Standard, Flex, Express<br>and Duo cycles) systems. | Intended cycles for both<br>reference and proposed<br>devices include V-PRO<br>sterilizer cycles.<br><br>Both require an automated<br>incubator/reader for results. |
| Indicator<br>organism | <i>Geobacillus<br/>stearothermophilus</i> | <i>Geobacillus<br/>stearothermophilus</i> | Same |

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| Feature | Assert VH2O2 SCBI<br>(proposed) | Attest 1295<br>Reference (K160546) | Comparison |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mechanism<br>of action | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety. | An enzyme, which is<br>produced by the organism,<br>reacts with a fluorogenic<br>substrate within the<br>defined nutrient media to<br>produce a fluorescent<br>moiety. | Same mechanism of action |
| Accessories | Automated incubator /<br>reader | Automated incubator /<br>reader | This accessory is similar to<br>the reference. RIT testing<br>and simulated use testing<br>demonstrate appropriate<br>monitoring of indicated<br>sterilization cycles. |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/BI | ≥ 1.0 x 106 spore/BI | Both contain greater than<br>106 spores/BI. |
| Resistance<br>characteristics | Resistance @ 9.1 mg/L<br>H2O2:<br>• D-value > 3 sec<br>• Survival Time ≥ 4 sec<br>• Kill Time ≤ 6 min | Resistance @ 10 mg/L<br>H2O2:<br>• D-value > 1 sec<br>• Survival Time ≥ 5 sec<br>• Kill Time = 7 min | Resistance values are similar<br>for both devices. Simulated<br>use testing verifies<br>suitability for use in claimed<br>cycles. |
| Culture<br>Conditions | 55- 59 °C, media included<br>in SCBI, 20-minute<br>incubation time. | 60 +/- 2 °C; media<br>included in SCBI, 4-hour<br>incubation time. | RIT Testing and ISO 11138-1<br>media testing verifies<br>performance |
| Primary<br>Packaging | Direct inoculum on plastic<br>vial, cap with recovery<br>media. | Inoculation on plastic disc<br>within vial, ampoule of<br>recovery medium. | Similar configuration.<br>Component testing per ISO<br>11138-1 Annex B<br>demonstrates packaging is<br>compatible with indicator<br>organism and sterilization<br>process. |
| Process<br>indicator | VERIFY V-PRO<br>Chemical Indicator<br>(K091174); magenta to<br>yellow color change. | H2O2 sensitive ink;<br>appears blue until<br>processed, then appears<br>pink | Both contain a VH2O2 CI to<br>distinguish processed SCBI<br>from unprocessed SCBI. |
| Shelf-life | Currently 3 months<br>Target of 13 months | 18 months | Real-time testing ongoing |

#### Summary of Nonclinical Tests 6.

Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.

| Test | Acceptance Criteria | Conclusion |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------|
| Reduced Incubation<br>Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the<br>20-minute results with the conventional incubation<br>time of 7 days | PASS |
| Viable spore<br>population | 1.0 - 4.0 x 106 spore/SCBI | PASS |

Table 5-3. Summary of Non-clinical Testing

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| Test | Acceptance Criteria | Conclusion |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------|
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time ≥ 4 sec | PASS |
| Kill Time | Kill Time ≤ 6 min | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use | Demonstrate no growth when exposed to worst-case cycles | PASS |

#### 7. Conclusion

The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as the legally marketed predicate device, K140499, Class II (21 CFR 880.2800, Product code FRC).