(12 days)
Not Found
No
The description focuses on a biological indicator and an optical reader detecting a fluorescent signal. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a biological indicator used to monitor the effectiveness of steam sterilization processes, not to treat a medical condition.
No
This device is a biological indicator used to monitor the effectiveness of steam sterilization processes, not to diagnose a medical condition in a patient.
No
The device is a biological indicator consisting of a biological organism and nutrient media, which undergoes an optical change detected by a hardware reader. It is not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of steam sterilization processes for medical devices. It assesses whether the sterilization cycle successfully killed resistant microorganisms.
- Device Description: The device contains a biological organism and nutrient media to indicate the success or failure of a sterilization process. It does not analyze a sample taken from a human body to diagnose a disease or condition.
- Lack of IVD Characteristics: The description does not mention analyzing human specimens (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to validate a sterilization process, not to diagnose or monitor a patient's health.
N/A
Intended Use / Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
Product codes
OWP
Device Description
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
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 5-2 below.
Table 5-2. Summary of Non-clinical Testing
| Test | Acceptance Criteria | Result |
|---|---|---|
| Simulated Use | BI is inactivated when exposed in a worst-case cycle with a worst-case load | No growth of BI |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
June 13, 2018
STERIS Corporation Anthony Piotrkowski Senior Regulatory Affairs Manager 5960 Heisley Road Mentor. Ohio 44060
Re: K181442
Trade/Device Name: VERIFY Assert Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2805 Regulation Name: Recombinant Biological Indicator Regulatory Class: Class II Product Code: OWP Dated: May 30, 2018 Received: June 1, 2018
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Elizabeth F. Claverie -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) K181442
Device Name
VERIFY Assert Self-Contained Biological Indicator
Indications for Use (Describe)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator 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
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510(k) Summary For K181442 VERIFY Assert Self-Contained Biological Indicator
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 Senior Manager, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 357-9198 e-mail: tpiotrko@steris.com
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | VERIFY Assert Self-Contained Biological Indicator |
|---|---|
| Common/usual Name: | Biological Indicator (BI, SCBI) |
| Device Classification: | Class II |
| Classification Name: | Biological Sterilization Process Indicator with |
| Recombinant-DNA Plasmid (21 CFR 880.2805, OWP) |
2. Predicate Device
VERIFY Assert Self-Contained Biological Indicator, K162701
3. Description of Device
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
4. Intended Use/ Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the VERIFY Incubator for Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes.
5
Summary of Technical Characteristics ട.
| Feature | VERIFY Assert SCBI
K181442 | VERIFY Assert SCBI
Predicate (K162701) | Comparison |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The VERIFY Assert Self-
Contained Biological
Indicator (SCBI) is for
routine monitoring,
qualification testing and
product testing of the
following steam
sterilization processes:
270F, 4-minute dynamic
air removal; 275F, 3-
minnute dynamic air
removal; 250 F, 30-
minute gravity; 270, 15-
minutes gravity.
When used in conjunction
with the VERIFY
Incubator for Assert Self-
Contained Biological
Indicator, the VERIFY
Assert Self-Contained
Indicator provides a
fluorescent result within
40 minutes. | The VERIFY Assert Self-
Contained Biological
Indicator (SCBI) is for
routine monitoring,
qualification testing and
product testing of the
following steam
sterilization processes:
270F, 4-minute dynamic
air removal; 275F, 3-
minnute dynamic air
removal; 250 F, 30-
minute gravity; 270, 15-
minutes gravity.
When used in conjunction
with the VERIFY
Incubator for Assert Self-
Contained Biological
Indicator, the VERIFY
Assert Self-Contained
Indicator provides a
fluorescent result within
40 minutes. | Identical |
| Indicator
organism | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | > 90% similarity to ATCC
7953 Geobacillus
stearothermophilus | Identical |
| Mechanism
of action | An enzyme, which is
produced by the indicator
organism, reacts with a
fluorogenic substrate
within the defined nutrient
media to produce a
fluorescent moiety. | An enzyme, which is
produced by the indicator
organism, reacts with a
fluorogenic substrate
within the defined nutrient
media to produce a
fluorescent moiety. | Identical |
| Accessories | Automated incubator /
reader | Automated incubator /
reader | Identical |
| Viable spore
population | 1.0 - 4.0 x 106 spore/BI | 1.0 – 4.0 x 106 spore/BI | Identical |
| Resistance
characteristics | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | Identical |
| Culture
Conditions | 55- 59 °C, media included
in SCBI, 40-minute
incubation time. | 55- 59 °C, media included
in SCBI, 40-minute
incubation time. | Identical |
| Primary
Packaging | Direct inoculum on plastic
vial, cap with recovery
media. | Direct inoculum on plastic
vial, cap with recovery
media. | Identical |
| Process
indicator | STERIS STEAM II
(K113356) | STERIS STEAM II
(K112256) | Identical |
| Feature | VERIFY Assert SCBI
K181442 | VERIFY Assert SCBI
Predicate (K162701) | Comparison |
| Label | Single-ply on cap edge | Two-ply on top of cap | Same adhesive and
substrate, different format
and location |
| Shelf-life | 13 months | 13 months | Identical |
Table 5-1. Summary of SCBI Physical Description and Technological Properties
6
Summary of Nonclinical Tests 6.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
Table 5-2. Summary of Non-clinical Testing
| Test | Acceptance Criteria | Result |
|---|---|---|
| Simulated Use | BI is inactivated when exposed in a worst-case | |
| cycle with a worst-case load | No growth of BI |
7. Conclusion
The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical tests performed demonstrate the subject device is as safe, as effective, and performs as well or better than the legally marketed predicate device, K162701 Class II (21 CFR 880.2805, Product code OWP).