(122 days)
No
The device description and performance studies focus on biological and optical detection methods, with no mention of AI or ML.
No.
This device is a biological indicator used to monitor the effectiveness of steam sterilization processes and does not provide therapy or treatment to a patient.
No
Explanation: This device is a biological indicator used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient.
No
The device description clearly states the product consists of a biological organism and nutrient media, which are physical components, not software. It also relies on a proprietary reader (hardware) to detect the optical change.
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 and other items. It's a quality control tool for sterilization equipment, not a test performed on a biological sample from a patient to diagnose a condition or monitor their health.
- Device Description: The device contains a biological organism and nutrient media to assess if the sterilization process successfully killed the organism. This is a test of the sterilization process itself, not a test of a patient sample.
- Lack of Patient Interaction: The device does not interact with a patient or analyze any biological material from a patient.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on validating a sterilization process.
N/A
Intended Use / Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring 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 (comma separated list FDA assigned to the subject device)
FRC
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)
Summary of Non-clinical Testing:
Test: Reduced Incubation Time (RIT) Testing
Purpose of the Test: Validate the labeled incubation time of the SCBI
Acceptance Criteria: Meets FDA's requirement of > 97% alignment of the 40-minute results with the conventional incubation time of 7 days*, ‡
Conclusion: PASS
Test: Viable spore population
Purpose of the Test: Enumerate the number of viable spores per SCBI
Acceptance Criteria: 1.0 - 4.0 x 10^6 spore/SCBI**, ‡
Conclusion: 2.7 - 3.7 x 10^6 spore/SCBI
Test: Resistance
Purpose of the Test: Determine the resistance of the SCBI to steam
Acceptance Criteria: D121 ≥ 1.5 min *; D132 ≥ 10 s *; D135 ≥ 8 s *
Conclusion: D121 ≥ 2.13 min; D132 ≥ 42 s; D135 ≥ 31 s
Test: Signal Generation
Purpose of the Test: Validate that the SCBI will produce signal in its reader
Acceptance Criteria: All unexposed SCBI show positive growth signal in reader within 40 minutes of incubation‡
Conclusion: PASS
Test: Hold Time
Purpose of the Test: Demonstrate that performance of the SCBI is not affected by delaying incubation up to 72 hours
Acceptance Criteria: Performance not affected if incubated within 72 hours of exposure to steam sterilization‡
Conclusion: PASS
Test: Simulated Use
Purpose of the Test: Demonstrate SCBI performance in a steam sterilizer with the AAMI reference load (16 towel pack)
Acceptance Criteria: Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle‡
Conclusion: Abbreviated cycle – growth; Full cycle – no growth
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/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 22, 2020
STERIS Corporation Anthony Piotrkowski Regulatory Affairs Director 5960 Heisley Road Mentor, Ohio 44060
Re: K200126
Trade/Device Name: VERIFY Assert Self-Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: April 23, 2020 Received: April 24, 2020
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K200126
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, load monitoring 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
510(k) Summary For 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 Director, 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 |
| (21 CFR 880.2800. FRC) |
2. Predicate Device
Celerity 20 Steam Biological Indicator, K173634, as modified under K181686. (21 CFR 880.2800. FRC)
3. Reference Device
VERIFY Assert Self-Contained Biological Indicator. K162701, as modified under K181422. (21 CFR 880.2805, OWP)
4. 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.
5. Intended Use/ Indications for Use
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring 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 |
5
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.
Summary of Technical Characteristics 6.
Table 5-1.Comparison of SCBI Physical Description and Technological Properties to Reference
| VERIFY Assert SCBI | VERIFY Assert SCBI | ||
|---|---|---|---|
| Feature | (modified) | Reference (K162701) | Comparison |
| Intended Use | The VERIFY Assert Self- | ||
| Contained Biological | |||
| Indicator (SCBI) is for | |||
| routine monitoring, | |||
| qualification testing, load | |||
| monitoring and product | |||
| testing of the following | |||
| steam sterilization | |||
| processes: | |||
| 270F, 4-minute dynamic | |||
| air removal; 275F, 3- | |||
| minute 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- | |||
| minute 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. | Added load monitoring | ||
| to the indications for | |||
| use | |||
| 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 | ||
| Feature | VERIFY Assert SCBI | ||
| (modified) | VERIFY Assert SCBI | ||
| Predicate (K162701) | Comparison | ||
| 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 Π | ||
| (K112256) | STERIS STEAM Π | ||
| (K112256) | Identical | ||
| Label | Single-ply on cap edge | Two-ply on top of cap | This modification was |
| cleared under K181442 | |||
| Shelf-life | 13 months | 13 months | Identical |
| Exogenous | |||
| DNA | None | plasmid pSTERIS-Q1 | Plasmid has been |
| removed |
6
Table 5-2. Comparison of SCBI Physical Description and Technological Properties to Predicate Device
| Feature | VERIFY Assert SCBI
(modified) | Celerity 20 Steam SCBI
Predicate (K173634) | Comparison |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The VERIFY Assert Self-
Contained Biological Indicator
(SCBI) is for routine monitoring,
qualification testing, load
monitoring and product testing
of the following steam
sterilization processes:
• 270F, 4-minute dynamic air
removal;
• 275F, 3- minute 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 Celerity 20 Steam
Biological Indicator is used for
routine monitoring,
qualification testing, load
monitoring and product testing
of the following steam
sterilization cycles:
• 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 Celerity™ Steam
Incubator, the Incubator
provides a fluorescent result
within 20 minutes. | Predicate includes
an indication for
load monitoring
The only
differences are
product name, read
time and incubator |
| 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/SCBI | Identical |
| Resistance | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | D121 ≥ 1.5 min
D132 ≥ 10 s
D135 ≥ 8 s | Identical |
7
| Feature | VERIFY Assert SCBI
(modified) | Celerity 20 Steam SCBI
Predicate (K173634) | Comparison |
|-----------------------|---------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------|
| Culture
Conditions | 55- 59 °C, media included in
SCBI, 40-minute incubation
time. | 55- 59 °C, media included in
SCBI, 20-minute incubation
time. | Reference device
has a shorter read
time |
| 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 Π (K112256) | STERIS STEAM Π (K112256) | Identical |
| Label | Single-ply on cap edge | Two-ply on top of cap | This modification
was cleared under
K181442 |
| Shelf-life | 13 months | 13 months | Identical |
| Exogenous
DNA | None | None | Identical |
The modifications that have triggered this premarket notification include a change to remove the GMO component (plasmid pSTERIS-Q1) from the biological indicator spore and to revise the indications for use to include load monitoring.
7. Summary of Nonclinical Tests
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-3 below.
Table 5-3. Summary of Non-clinical Testing
| Test | Purpose of the Test | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Reduced | |||
| Incubation | |||
| Time (RIT) | |||
| Testing | Validate the labeled | ||
| incubation time of the | |||
| SCBI | Meets FDA's requirement of > | ||
| 97% alignment of the 40-minute | |||
| results with the conventional | |||
| incubation time of 7 days*, ‡ | PASS | ||
| Viable spore | |||
| population | Enumerate the number | ||
| of viable spores per | |||
| SCBI | $1.0 - 4.0 x 10^6 spore/SCBI**, ‡$ | $2.7 - 3.7 x 10^6$ | |
| spore/SCBI | |||
| Resistance | Determine the | ||
| resistance of the SCBI | |||
| to steam | $D_{121} ≥ 1.5 min *$ | ||
| $D_{132} ≥ 10 s *$ | |||
| $D_{135} ≥ 8 s *$ | $D_{121} ≥ 2.13 min$ | ||
| $D_{132} ≥ 42 s$ | |||
| $D_{135} ≥ 31 s$ | |||
| Signal | |||
| Generation | Validate that the SCBI | ||
| will produce signal in | |||
| its reader | All unexposed SCBI show | ||
| positive growth signal in reader | |||
| within 40 minutes of incubation‡ | PASS | ||
| Hold Time | Demonstrate that | ||
| performance of the | |||
| SCBI is not affected by | |||
| delaying incubation up | |||
| to 72 hours | Performance not affected if | ||
| incubated within 72 hours of | |||
| exposure to steam sterilization‡ | PASS |
8
| Test | Purpose of the Test | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Simulated Use | Demonstrate SCBI performance in a steam sterilizer with the AAMI reference load (16 towel pack) | Demonstrate growth when exposed to abbreviated cycle and all kill in a full cycle‡ | Abbreviated cycle – growth |
| Full cycle – no growth |
*Acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
** Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
- Acceptance criteria based on specifications of the reference device, VERIFY Assert Self-Contained BI
8. Conclusion
The VERIFY Assert Self-Contained Biological Indicator has met the established performance criteria. The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device, K173634 Class II (21 CFR 880.2800, Product code FRC).