(109 days)
No
The device description and performance studies focus on traditional biological and chemical indicators for steam sterilization, with no mention of AI or ML.
No.
This device is a process challenge device used to monitor the effectiveness of steam sterilizers, not to treat a medical condition or disease.
No
Explanation: This device is used for monitoring the effectiveness of steam sterilizers, not for diagnosing medical conditions in patients. It assesses the performance of a sterilization process.
No
The device description clearly outlines physical components (plastic tray, foil cover, biological indicator, chemical integrator) and its function is tied to a physical sterilization process, not purely software processing or analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring the effectiveness of steam sterilization cycles, not for diagnosing a disease or condition in a patient using a sample from the human body.
- Device Description: The device contains a biological indicator and a chemical integrator to assess the sterilization process, not to analyze biological samples.
- Anatomical Site/Patient Information: The device is not applied to or used with a patient.
- Performance Studies: The performance studies focus on the device's ability to challenge a sterilization process and its equivalence to a standard test pack, not on diagnostic accuracy metrics like sensitivity or specificity in relation to a disease.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is entirely related to monitoring a sterilization process.
N/A
Intended Use / Indications for Use
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- · 250°F (121°C) 30-minute gravity
- · 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The VERIFY"" Assert" STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.
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)
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3-3. Simulated use testing was done side-by-side with the predicate device and all other testing demonstrates the PCD meets the criteria of the FDA guidances for CI and BI as they pertain to PCD.
- Simulated Use: Performance of the BI in the PCD is equivalent to the performance of the BI in the AAMI reference pack in their respective sterilization processes. Performance of the chemical integrator in the PCD is equivalent to the performance of the chemical integrator in AAMI reference pack in their respective processes. PCD provides an equivalent or greater challenge than the AAMI standardized test pack. Conclusion: PASS.
- BI in pack vs BI outside of pack: PCD provides a greater challenge to the process than the BI itself. Conclusion: PASS.
- CI in pack vs CI outside of pack: PCD provides a greater challenge to the process than the integrator by itself. Conclusion: PASS.
- Chemical Integrator: Chemical integrator does not reach endpoint before BI is inactivated. Conclusion: PASS.
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 at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.2800, Product code FRC).
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.
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
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
STERIS Corporation Mr. Anthony Piotrkowski Senior Manager, Regulatory Affairs 5960 Heisley Rd. Mentor, Ohio 44060
Re: K170070
Trade/Device Name: VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles Regulation Number: 21 CFR 880.2800 (b) Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 28, 2017 Received: March 29, 2017
Dear Mr. Anthony 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -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) K170070
Device Name
VERIFY Assert STEAM Process Challenge Device for Gravity Cycles
Indications for Use (Describe)
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- · 250°F (121°C) 30-minute gravity
- · 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
| 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 STERIS logo. The word "STERIS" is in large, bold, black letters at the top of the image, with a small registered trademark symbol to the right of the word. Below the word is a graphic of several horizontal blue lines that are slightly curved, resembling waves.
510(k) Summary For VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles
Sponsor Facility
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Manufacturing Facility
STERIS Corporation 9325 Pinecone Drive Mentor, OH 44060 Phone: (440) 392-7800 Fax No: (440) 392-7896
Contact: Tony Piotrkowski
Telephone: (440) 392-7437 Fax No: e-mail: tony_piotrkowski.@steris.com
April 28, 2017 Submission Date:
Premarket Notification Number: K170070
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert " STEAM Process Challenge Device for Gravity Cycles
Device Name 1.
| Trade Name: | VERIFYTM AssertTM STEAM Process Challenge Device
for Gravity Cycles |
|------------------------|------------------------------------------------------------------------|
| Common/usual Name: | Biological Indicator Pack (PCD) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
(21 CFR 880.2800, FRC) |
2. Predicate Device
3M Attest Super Rapid 5 Steam-Plus Challenge Pack K121593
3. Description of Device
The VERIFY"" Assert" |STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.
4. Intended Use/ Indications for Use
The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.
The validated steam sterilization cycles include:
- · 250°F (121°C) 30-minute gravity
- · 270°F (132°C) 15-minute gravity
The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.
5
K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles
Summary of Technical Characteristics ട.
| Feature | Assert Gravity PCD | Attest 41482V | Comparison |
|---|---|---|---|
| (proposed) | (K121593) Predicate | ||
| Intended | |||
| Use | The VERIFY™ | ||
| Assert™ STEAM | |||
| Process Challenge | |||
| Device (PCD) is used | |||
| for qualification, routine | |||
| microbial monitoring, | |||
| and load monitoring of | |||
| steam sterilizers. | |||
| 270F (132°C), 15- | |||
| minute gravity; | |||
| 250F (121°C), 30- | |||
| minute gravity | |||
| When used in | |||
| conjunction with the | |||
| VERIFY Incubator for | |||
| Assert Self Contained | |||
| Biological Indicators, | |||
| the VERIFY Assert | |||
| Self-Contained | |||
| Indicator within the | |||
| Process challenge | |||
| device provides a | |||
| fluorescent result within | |||
| 40 minutes | Use 3M Attest Super | ||
| Rapid 5 Steam-Plus | |||
| Challenge Pack in | |||
| conjunction with the 3M | |||
| Attest Auto-reader 490 | |||
| to qualify or monitor | |||
| dynamic air removal | |||
| (prevacuum) steam | |||
| sterilization cycles of 4 | |||
| minutes at 270 F (132 | |||
| C) and 3 minutes at 275 | |||
| F (135 C). | |||
| The 3M Attest Super | |||
| Rapid Readout | |||
| Biological Indicator | |||
| contained within the | |||
| challenge pack provides | |||
| a final fluorescent result | |||
| in 1 hour. An optional | |||
| visual pH color change | |||
| result is observed in 48 | |||
| hours. | Both are intended for | ||
| monitoring steam | |||
| sterilization cycles. | |||
| Testing to demonstrate | |||
| performance in the | |||
| claimed cycles has been | |||
| completed. | |||
| General | |||
| Design | Indicators are sealed in | ||
| plastic tray with channel | |||
| to limit steam | |||
| penetration/air removal. | Layers of medical index | ||
| cards, some of which | |||
| are die-cut to contain | |||
| indicators, overwrapped | |||
| and secured with a | |||
| label. | Both the devices are | ||
| contained in a steam | |||
| barrier. Testing to | |||
| demonstrate equivalence | |||
| has been completed. | |||
| Biological | |||
| Indicator | Verify Assert Self | ||
| Contained Biological | |||
| Indicator (40-minute | |||
| fluorescent result) | Attest 1492V Biological | ||
| Indicator (1-hour | |||
| fluorescent result) | Both contain 510(k)- | ||
| cleared Biological | |||
| Indicators with rapid | |||
| fluorescent results. | |||
| Chemical | |||
| Integrator | Non-commercial | ||
| Chemical Integrator | SteriGage Chemical | ||
| Integrator | Both contain chemical | ||
| integrators | |||
| Means to | |||
| distinguish | |||
| processed | |||
| PCD from | |||
| unprocessed | Proposed device's | ||
| internal integrator is | |||
| visible through the | |||
| pack. | External process | ||
| indicator. Yellow to | |||
| brown color change | |||
| when exposed to steam | Both have a means to | ||
| distinguish processed | |||
| PCD from unprocessed | |||
| Feature | Assert SCBI | ||
| (K162701) | Attest 1492V | ||
| (K121484) | Comparison | ||
| Indicator | |||
| organism | > 90% similarity to ATCC | ||
| 7953 Geobacillus | |||
| stearothermophilus | > 90% similarity to ATCC | ||
| 7953 Geobacillus | |||
| stearothermophilus | Same criteria | ||
| Mechanism | |||
| of action | An enzyme, which is | ||
| produced by the organism, | |||
| reacts with a fluorogenic | |||
| substrate within the | |||
| defined nutrient media to | |||
| produce a fluorescent | |||
| moiety | An enzyme, which is | ||
| produced by the organism, | |||
| reacts with a fluorogenic | |||
| substrate within the | |||
| defined nutrient media to | |||
| produce a fluorescent | |||
| moiety | Same mechanism | ||
| Accessories | Automated incubator / | ||
| reader (K1635870) | |||
| • 40 minute incubation | |||
| time | |||
| • Holds temperature | |||
| range throughout | |||
| incubation time. | Automated incubator / | ||
| reader | |||
| • 60 minute incubation | |||
| time | |||
| • Holds temperature | |||
| range throughout | |||
| incubation time. | RIT testing performed with | ||
| the proposed | |||
| incubator/reader cleared | |||
| uner K163587. Inubator | |||
| readers meet criterion of | |||
| FDA BI 510(k) guidance. | |||
| Viable spore | |||
| population | 1.0 - 4.0 x 106 spore/SCBI | ≥ 1.0 x 106 spore/SCBI | Both proposed and predicate |
| meet criteria of ISO 11138-3 | |||
| and FDA guidance | |||
| Resistance | D121 ≥ 1.5 min | ||
| D132 ≥ 10 s | |||
| D135 ≥ 8 s | D132 ≥ 10 s | ||
| D135 ≥ 8 s | |||
| Culture | |||
| Conditions | 55- 59 °C, media included | ||
| in SCBI, 40 minute | |||
| incubation time. | 55- 59 °C, media included | ||
| in SCBI, 60 minute | |||
| incubation time. | RIT Testing and ISO 11138 | ||
| media testing verifies | |||
| performance | |||
| Primary | |||
| Packaging | Direct inoculum on plastic | ||
| vial, cap with recovery | |||
| media. | Inoculated paper in plastic | ||
| vial with cap and glass | |||
| ampoule with recovery | |||
| media in capped vial. | Similar configuration. | ||
| Component testing per ISO | |||
| 11138-1 Annex B | |||
| demonstrates packaging is | |||
| compatible with indicator | |||
| and sterilization process |
A comparison of technical characteristics of the PCD are in Table 3-1. Table 3-1 Summary of PCD Physical Description and Technological Properties
6
K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert™ STEAM Process Challenge Device for Gravity Cycles
A comparison of technical characteristics BI components of the PCD are in Table 3-2.
Table 5-2 Summary of SCBI Components of the PCD Physical Description and Technological Properties
Any differences between the predicate and proposed device as noted above are addressed through testing summarized below or submitted as part of the cleared 510(k): K162701 for the BI component and K163587 for the incubator.
6. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 3-3 below. Simulated use testing was done side-by-side with the predicate device and all other testing demonstrates the PCD meets the criteria of the FDA guidances for CI and BI as they pertain to PCD.
7
K170070/S001 STERIS TRADITIONAL 510(k) PREMARKET NOTIFICATION VERIFY" Assert™ |STEAM Process Challenge Device for Gravity Cycles
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Simulated Use | Performance of the BI in the PCD is equivalent to the | |
| performance of the BI in the AAMI reference pack in | ||
| their respective sterilization processes Performance of the chemical integrator in the PCD is | ||
| equivalent to the performance of the chemical integrator | ||
| in AAMI reference pack in their respective processes PCD provides an equivalent or greater challenge than | ||
| the AAMI standardized test pack | PASS | |
| BI in pack vs BI | ||
| outside of pack | PCD provides a greater challenge to the process than | |
| the BI itself. | PASS | |
| CI in pack vs CI | ||
| outside of pack | PCD provides a greater challenge to the process than | |
| the integrator by itself. | PASS | |
| Chemical Integrator | Chemical integrator does not reach endpoint before BI | |
| is inactivated. | PASS |
Table 3-3. Summary of Non-clinical Testing vs Predicate
"PASS" indicates that acceptance criteria were met and that the proposed pack performed at least as effectively as the predicate device.
7. Conclusion
The VERIFY Assert |STEAM Process Challenge Device for Gravity Cycles 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 at least as safely and effectively as the legally marketed predicate device, Class II (21 CFR 880.2800, Product code FRC).