Who is the manufacturer of VERIFY Incubator for Assert Self Contained Biological Indicators?

STERIS Corporation filed the 510(k) submission for VERIFY Incubator for Assert Self Contained Biological Indicators (K163587).

What is the FDA product code for VERIFY Incubator for Assert Self Contained Biological Indicators?

OWP. It is classified under 21 CFR 880.2805 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for VERIFY Incubator for Assert Self Contained Biological Indicators?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VERIFY Incubator for Assert Self Contained Biological Indicators?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VERIFY Incubator for Assert Self Contained Biological Indicators

Q: What are the predicate devices for VERIFY Incubator for Assert Self Contained Biological Indicators?

VERIFY CRONOS SCBI (K102469/DEN110006).

K163587 · STERIS Corporation · OWP · Mar 24, 2017 · General Hospital

Device Facts

Record ID	K163587
Device Name	VERIFY Incubator for Assert Self Contained Biological Indicators
Applicant	STERIS Corporation
Product Code	OWP · General Hospital
Decision Date	Mar 24, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2805
Device Class	Class 2

Intended Use

Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.

Device Story

The VERIFY Incubator is an accessory device used to monitor sterilization processes by incubating and reading VERIFY Assert Self-Contained Biological Indicators (SCBI). The device maintains a constant temperature (55-60 °C) to facilitate the outgrowth of Geobacillus stearothermophilus spores. As the spores grow, they produce an enzyme that cleaves a fluorogenic substrate within the SCBI media, generating a fluorescent signal. The incubator uses a photodiode to detect this increasing fluorescence. When an SCBI is inserted and the 'ACTION' button is pressed, the device monitors the signal over a 40-minute period. A positive result (indicating potential sterilization failure) triggers an audible alarm, a red LED light, and an LCD text display. A negative result is indicated by a green LED and LCD text. The device is intended for use in clinical settings by healthcare personnel to verify the efficacy of sterilization cycles.

Clinical Evidence

Bench testing only. Performance testing demonstrated >97% alignment between the 40-minute fluorescent read and 7-day growth results, consistent with FDA guidance on reduced incubation time. Testing confirmed proper function of alarms, LEDs, and print outputs, as well as correct identification of positive/negative results following full and abbreviated sterilization cycle exposures.

Technological Characteristics

Incubator/reader with 8-well capacity; operates at 55-60 °C; photodiode-based fluorescence detection; 90-264 VAC input with 12 VDC conversion; factory-calibrated. Complies with IEC 61010-1 (2010) and IEC 61010-2-010 (2013) for electrical safety and EMC standards (FCC Part 15, EN 55011, EN 61000 series).

Indications for Use

Indicated for use by healthcare providers to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators (SCBI) at 57 °C to monitor sterilization processes.

Regulatory Classification

Identification

A Recombinant-DNA plasmid biological indicator is intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization.

Predicate Devices

VERIFY CRONOS SCBI (K102469/DEN110006)

Reference Devices

3M Attest 390 Auto-reader (K123546)

Related Devices

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K190297 — Celerity HP Incubator · STERIS Corporation · May 14, 2019
K250061 — Celerity Incubator · STERIS Corporation · Feb 6, 2025
K233681 — ConFirm 20 Minute Incubator · STERIS Corporation · Dec 15, 2023
K123546 — 3M ATTEST(TM) AUTO-READER · 3M Company · Mar 18, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 24, 2017 Steris Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5976 Heisley Rd Mentor, Ohio 44060 Re: K163587 Trade/Device Name: Verify Incubator For Assert Self Contained Biological Indicators Regulation Number: 21 CFR 880.2805 Regulation Name: Recombinant Biological Indicator Regulatory Class: Class II Product Code: OWP Dated: February 17, 2017 Received: February 21, 2017 Dear 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 devicerelated 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. {1}------------------------------------------------ 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/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 (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) K163587 #### Device Name VERIFY® Incubator for Assert™ Self Contained Biological Indicators Indications for Use (Describe) Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all caps and in a serif font. Below the word STERIS is a graphic of several horizontal wavy lines that are blue. # 510(k) Summary For K163587 VERIFY® Incubator for Assert™ Self-Contained Biological Indicators #### 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: Anthony Piotrkowski Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tony piotrkowski(@steris.com Submission Date: March 22, 2017 510(k) Number: K163587 STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | VERIFY® Incubator for Assert™ Self Contained Biological Indicators | |------------------------|-----------------------------------------------------------------------| | Common/usual Name: | Incubator/Reader (accessory to Biological Indicator) | | Device Classification: | Class II | | Classification Name: | Recombinant Biological Indicator (21 CFR 880.2805, OWP) | #### 2. Predicate Device VERIFY CRONOS SCBI K102469/DEN110006 Reference Device: 3M Attest 390 Auto-reader K123546 #### 3. Description of Device The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms. #### 4. Intended Use/ Indications for Use Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes. #### 5. Summary of Technical Characteristics A comparison of technical characteristics are summarized in Tables 1 and 2. {5}------------------------------------------------ | Feature | VERIFY Incubator for Assert SCBI (proposed) | VERIFY CRONOS SCBI (K102469/DEN110006) Predicate | Comparison | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self- Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes. | The Verify Cronos Self- Contained Biological Indicator for Steam Sterilization Processes is intended for use by health care providers as a standard method to monitor steam sterilization processes. The Verify Cronos is validated to be used in the following steam sterilization cycles: 1.) Standard Prevac 270°F/132°C for 4 minutes 2.) Standard Prevac 275°F/135°C for 3 minutes 3.) Standard Gravity 250°F/121°C for 30 minutes 4.) Standard Gravity 270°F/132°C for 15 minutes 5.) Standard Gravity 275°F/135°C for 10 minutes 6.) Standard SFPP 270°F/132°C for 4 minutes | The predicate incubator was an accessory to the Biological Indicator and did not have its own intended use or indications for use. The proposed device is an accessory to the VERIFY Attest SCBI. | | Basis of Readout | Photodiode detects fluorescence produced by enzymatic activity that results from growing biological indicator organisms | Photodiode detects fluorescence produced by enzymatic activity that results from growing biological indicator organisms | Same | | Incubation Temperature Range | 55 - 60 °C | 55 - 60 °C | Same | | Voltage Range | 90 to 264 VAC with 12 VDC conversion. | 90 to 264 VAC with 12 VDC conversion. | Same | | Test capacity | 8 wells | 8 wells | Same | | Calibration | Factory calibration - no calibration by customer | Factory calibration - no calibration by customer | Same | | Incubation Time | 40 minutes | 40 minutes | Same | | Feature | VERIFY Incubator for Assert SCBI (proposed) | VERIFY CRONOS SCBI (K102469/DEN110006) Predicate | Comparison | | Fluorescence Detection | Active enzyme from the spores cleaves the fluorogenic substrate contained within the SCBI's media to produce a fluorescent molecule. | Active enzyme from the spores cleaves the fluorogenic substrate contained within the SCBI's media to produce a fluorescent molecule. | Same | | Indication of Results | Positive - audible alarm, visual LED lights and screen Negative - no alarm, visual indication with LED lights and LCD screen User must acknowledge results | Positive - audible alarm, visual LED lights and screen Negative - no alarm, visual indication with LED lights and LCD screen User must acknowledge results | Same | | Compliance | Electrical Safety and EMC Testing • IEC 61010-1 (2010) Third Ed • IEC 61010-2-010 (2013) Third Ed Electromagnetic compatibility • USA Title 47, Code of Federal Regulations (2007) for: • Radiated Emissions (FCC Part 15, Subpart B, Class A) • Conducted Emissions (FCC Part 15, Subpart B, Class A) • IEC 61326:2013 - • EN 55011:2009, Inc. A1:2010 • EN 61000-3-2:2006, Inc. A1:2009 and A2:2009 EN 61000-3-3-2013 | Electrical Safety and EMC Testing • IEC 61010-1 second Ed • IEC 61010-2-010 Second Ed Electromagnetic compatibility • USA Title 47, Code of Federal Regulations (2007) for: • Radiated Emissions (FCC Part 15, Subpart B, Class A) • Conducted Emissions (FCC Part 15, Subpart B, Class A) • IEC 61326: • EN 55011: • EN 61000-3-2:2006, Inc. A1:2009 and A2:2009 EN 61000-3-3 | Both meet applicable electrical safety standards | | Feature | VERIFY Incubator for Assert SCBI (proposed) | VERIFY CRONOS SCBI (K102469/DEN110006) Predicate | Comparison | | System Operation | The reader/incubator wells are arranged in 2 banks of 4 wells and preset to 57°C. The measurement of fluorescence is initiated by placement of a VERIFY Assert SCBI into any of the incubation wells and pressing the adjacent "ACTION" button. When an SCBI is placed into a well, the auto-reader detects its presence. Upon pressing the button associated with that well, a blinking yellowish light indicates that incubation is in process and the read initiated. A "positive" reading is interpreted as an indication of a potential sterilization cycle failure. A "positive" finding is indicated to the user by red light on the front panel adjacent to the well, by an audible alarm, and by text displayed on the LCD screen. The alarm must be muted by the operator when a positive result is obtained. The LCD screen provides instructions for the user to turn off the alarm for that specific SCBI. Should another BI become "positive", the alarm will sound again and the above actions are repeated. If the result is not positive at the end of the incubation time, the result is negative. Negative results are identified by a green light on the front panel adjacent to the well with the "negative" BI and by text on the LCD. | The reader/incubator wells are arranged in 2 banks of 4 wells and preset to 57°C. The measurement of fluorescence is initiated by placement of a VERIFY Assert SCBI into any of the incubation wells and pressing the adjacent "ACTION" button. When an SCBI is placed into a well, the auto-reader detects its presence. Upon pressing the button associated with that well, a blinking yellowish light indicates that incubation is in process and the read initiated. A "positive" reading is interpreted as an indication of a potential sterilization cycle failure. A "positive" finding is indicated to the user by red light on the front panel adjacent to the well, by an audible alarm, and by text displayed on the LCD screen. The alarm must be muted by the operator when a positive result is obtained. The LCD screen provides instructions for the user to turn off the alarm for that specific SCBI. Should another BI become "positive", the alarm will sound again and the above actions are repeated. If the result is not positive at the end of the incubation time, the result is negative. Negative results are identified by a green light on the front panel adjacent to the well with the "negative" BI and by text on the LCD. | Same | ## Table 1 Summary of Incubator Physical Description and Technological Properties vs Predicate {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## Table 2 Summary of Incubator Physical Description and Technological Properties vs Reference Device | Feature | VERIFY Incubator for Assert SCBI (proposed) | Attest 390 (K123546) Reference | Comparison | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self- Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes. | The 3M Attest 390 Auto- reader is designed to incubate and automatically read the 3M Attest Rapid readout Biological indicators for Steam 1291, 1292, at 60 °C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292. | Both are intended for incubation and automatic reading of specific self- contained biological indicators. | | Basis of Readout | Photodiode detects fluorescence produced by enzymatic activity that results from growing biological indicator organisms | Photodiode detects fluorescence produced by enzymatic activity that results from growing biological indicator organisms | Same | | Incubation Temperature Range | 55 - 60 °C | 60 ± 2 °C | Both operate within the growth temperature range of Geobacillus stearothermophilus | | Voltage Range | 90 to 264 VAC with 12 VDC conversion. | 100-240 VAC with 12 VDC conversion. | Similar range and same operating voltage. Electrical safety testing demonstrates suitability. | | Test capacity | 8 wells | 10 wells | Both can accommodate multiple samples | | Calibration | Factory calibration - no calibration by customer | Factory calibration - no calibration by customer | Same | | Incubation Time | 40 minutes | 1 hour (1291), 3 hours (1292) | Reduced incubation time testing in accordance with FDA guidance is provided in this submission | | Fluorescence Detection | Active enzyme from the spores cleaves the fluorogenic substrate contained within the SCBI's media to produce a fluorescent molecule. | UV LEDs are used to excite the fluorescent molecule produced by enzyme cleavage of the fluorogenic substrate contained in the SCBI's media. The emitted light is detected by a photodiode.…

VERIFY Incubator for Assert Self Contained Biological Indicators

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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Device Story

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