(166 days)
Not Found
No
The description focuses on a biological indicator and a reader that uses a fluorescence algorithm to determine results. There is no mention of AI or ML.
No
The device is a biological indicator and reader intended for monitoring sterilization systems, not for directly treating a patient's condition.
No.
The device is intended for monitoring STERRAD Sterilization Systems to ensure they are functioning effectively, not for diagnosing a medical condition in a patient. It assesses the sterility of processed medical instruments by detecting the survival of bacterial spores after a sterilization cycle.
No
The device description clearly outlines both a physical biological indicator (BI) and a physical reader device. While the reader utilizes software for its fluorescence algorithm and user interface, it is fundamentally a hardware device with integrated software, not a standalone software-only medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of sterilization cycles in STERRAD Sterilization Systems. This is a quality control measure for a sterilization process, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device uses a biological indicator (spores) and a reader to determine if the sterilization process was successful in killing those spores. While it involves biological material (spores and growth medium), it's not analyzing a human biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention analyzing patient samples (blood, urine, tissue, etc.), diagnosing diseases, or providing information about a patient's health status.
Therefore, the STERRAD VELOCITY Biological Indicator and Reader system falls under the category of a sterilization process indicator/monitor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring of the following STERRAD Sterilization Systems:
- STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without . ALLClear™ Technology
- STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
- STERRAD® 100S ●
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device, 3M Attest™ Rapid Readout Biological Indicator 1295. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (a-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of α-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.
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)
Non-Clinical Data:
STERRAD VELOCITY BIOLOGICAL INDICATOR:
Performance testing was conducted to satisfy the requirements for the STERRAD VELOCITY BI, as outlined in the Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions Document issued on: October 4, 2007, and ISO 11138-1:2006, Sterilization of health care products – Biological indicators - Part 1: General requirements. All testing yielded passing results.
Summary of Performance Testing:
- Spore Population Determination: Verification of performance characteristics for spore population. Pass.
- D-value Determination: Verification of D-values using Holcomb-Spearman-Karber Procedure (HSKP) and Survivor Curve method. Pass.
- Test Organism Characterization: Verification of Geobacillus stearothermophilus (ATCC 7953). Pass.
- Reduced Incubation Time (RIT) Study: Verification of reduced incubation time: 30 minutes for fluorescence results and 5 to 7 days for spore growth results. Pass.
- Growth Inhibition Study: Verification that carrier and primary packaging materials do not have bacteriostatic effects that inhibit the growth of the indicator microorganism, Geobacillus stearothermophilus. Pass.
- Holding Time Assessment: Verification that labeled holding time does not have adverse effects on the resistance characteristics for the BI growth results or the fluorescence response characteristics for the fluorescence results. Pass.
- Chemical Indicator Functionality Study: Verification of functionality of the chemical indicator (CI) as a Type 1 process indicator. Pass.
- BI Performance Study in STERRAD 100NX: Verification of performance in monitoring STERRAD 100NX STANDARD, FLEX, EXPRESS, and DUO Cycles. Pass.
- BI Performance Study in STERRAD NX: Verification of performance in monitoring STERRAD NX STANDARD and ADVANCED Cycles. Pass.
- BI Performance Study in STERRAD 100S: Verification of performance in monitoring STERRAD 100S Cycle. Pass.
- Impact of Load Conditioning (ALLClear Technology) Feature on STERRAD VELOCITY BI: Verification that the load conditioning feature of the STERRAD 100NX and NX with ALLClear Technology has no statistically significant impact on the STERRAD VELOCITY BI. Pass.
- Shelf Life Study (Real Time): Verification that the STERRAD VELOCITY BI meets its end of shelf life requirements. Pass.
STERRAD VELOCITY READER:
Electrical Safety testing was conducted to verify compliance to IEC/EN 61010-1:2010, IEC/EN 61010-2-010:2014, UL 61010-1:2012, UL 61010-2-010:2015, CAN/CSA-C22.2 No. 61010-1-12 (2012), and CAN/CSA-22.2 No. 61010-2-010:15 (2015).
Electromagnetic Compatibility testing was completed to verify compliance of Radiated and Conducted Emissions per US Code of Federal Regulations (CFR), Title 47, Part 15, Subpart B (Class A), ICES-003, and ANSI C63.4:2014. Test results met the requirements and standards (Compliant).
Software Verification and Validation Testing was conducted and documentation was provided as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. Unit, Integration, and System level testing were successfully completed.
Clinical Data:
No clinical data was generated in support of this Premarket Notification.
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.
Not Found
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 consists of a stylized eagle or bird-like figure with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2017
Advanced Sterilization Products (asp) Sun Choi Senior Regulatory Affairs Program Lead 33 Technology Drive Irvine, California 92618
Re: K170039
Trade/Device Name: STERRAD VELOCITY™ Biological Indicator and Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 19, 2017 Received: May 22, 2017
Dear Sun Choi:
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,
Lori A. Wiggins -S6
Lori A. Wiggins, MPT, CLT 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) K170039
Device Name
STERRAD VELOCITY™ Biological Indicator and Reader
Indications for Use (Describe)
The STERRAD VELOCITY™ Biological Indicator, in conjunction with the STERRAD VELOCITY™ Reader, is intended to be used as a standard method for frequent monitoring STERRAD Sterilization Systems: · STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without ALLClear™ Technology
• STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
· STERRAD® 100S
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Registration Use (Part 81 CFR 801 Subpart D) On-The-Spot Use (81 CFR 801 Subpart G) |
__ 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 a logo with the letters "ASP" in a stylized font. The letters are white and are set against a rounded, light blue background. There is a registered trademark symbol in the upper right corner of the logo.
510(k) Summary
Advanced Sterilization Products STERRAD VELOCITY™ Biological Indicator and Reader
General Information
| Submitter Name: | Advanced Sterilization Products
Division of Ethicon, Inc., a Johnson & Johnson company |
|-----------------|--------------------------------------------------------------------------------------------------------|
| Address: | 33 Technology Drive
Irvine, CA 92618 |
| Contact Person: | Sun Choi
Senior Regulatory Affairs Program Lead
Phone: 949-453-6378
Email: sjchoi@its.jnj.com |
| Date Prepared: | June 8, 2017 |
| 510(k) Number: | K170039 |
Device Name
| Proprietary Name: | STERRAD VELOCITY™ Biological Indicator and Reader |
|---|---|
| Common Name: | Biological Indicator |
| Classification Name: | Biological Sterilization Process Indicator |
| Device Class: | Class II |
| Product Code: | FRC |
| CFR Section: | 21 CFR 880.2800 |
Predicate Devices
- Primary Predicate: ● STERRAD® CYCLESURE® 24 Biological Indicator, K151971 cleared October 29, 2015
- 3M Attest™ Rapid Readout Biological Indicator 1295 and 3M Attest™ Auto-Reader 490H, K140392 cleared August 13, 2014, and K152060 cleared December 1, 2015
Device Description
STERRAD VELOCITY BIOLOGICAL INDICATOR
The STERRAD VELOCITY Biological Indicator is a self-contained biological indicator (BI), used in conjunction with the STERRAD VELOCITY Reader, that is intended for frequent monitoring of the STERRD Sterilization Cycles, using rapid readout technology that provides a final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃.
4
Image /page/4/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a blue-green background. The logo is enclosed in a rounded rectangle shape, and there is a small registered trademark symbol in the upper right corner.
The STERRAD VELOCITY BI can also be determined as growth-positive or growth-negative via an optional visual pH-based color change result (using bromocresol purple). When using this method, the biological indicator must be cultured in an incubator at 55-60°C for 5 to 7 days to get a final visual result.
The STERRAD VELOCITY BI consists of a glass fiber disc containing a minimum of 1 x 10° Geobacillus stearothermophilus (ATCC 7953) spores and a glass ampoule containing nutrient growth medium and non-fluorescent substrate, as well as a vial, cap, cap label, insert, and chemical indicator. The spore disc, growth media ampoule, and insert are contained in a clear plastic vial with a vented cap. The cap is designed with sterilant ingress openings which allow for penetration of hydrogen peroxide vapor into the vial during the sterilization process. The chemical indicator (CI), placed on the top of the cap, is a Type 1 process indicator that changes color from red/pink to yellow with some red/orange/brown dots when exposed to hydrogen peroxide.
The STERRAD VELOCITY BI has the same α-glucosidase enzyme system for the fundamental scientific technology as the predicate device, 3M Attest™ Rapid Readout Biological Indicator 1295. The a-glucosidase enzyme, which is generated naturally during growth of G. stearothermophilus and released during spore germination, hydrolyzes the bond between the glucose and 4methylumbelliferyl (4-MU) moieties of 4-methylumbelliferyl a-D-glucopyranoside (a-MUG). In the combined state, α-MUG is not fluorescent. Once the bond between the glucose and 4-MU is hydrolyzed, the 4-MU component becomes fluorescent when excited with UV light. Therefore, the a-glucosidase enzyme in its active state can be detected by measuring the fluorescence produced by the enzymatic hydrolysis of α-MUG.
The resultant fluorescent by-product (4-MU), is detected by the Reader and the fluorescent signal is used to determine the positive or negative result of the biological indicator. The measured enzyme activity is reduced upon exposure to hydrogen peroxide. As the enzyme activity is directly correlated with the spore outgrowth, the reduction of the enzyme activity below a certain level indicates that all spores have been inactivated. The level of the fluorescence response is determined using the algorithm developed for the STERRAD VELOCITY BI and is used to distinguish between the positive and negative responses.
STERRAD VELOCITY READER
The STERRAD VELOCITY Reader is designed to automatically read the STERRAD VELOCITY BI to obtain the final fluorescence result in 30 minutes at the incubation temperature of 57 ± 2℃. The STERRAD VELOCITY Reader utilizes the fluorometric enzymatic assay method to detect the enzyme activity from the BI and the fluorescence emitted from the BI is converted into a voltage. This voltage reading is then used by the fluorescence algorithm in the Reader to determine the final fluorescence result.
There are eight individual BI incubation wells in the STERRAD VELOCITY Reader. Its heater system is designed to maintain the biological indicators at 57 ± 2℃ to promote the outgrowth of the indicator organisms. Each well contains an ultraviolet light source that excites fluorescence in the growth medium, and a photodetector to detect that fluorescence.
The STERRAD VELOCITY Reader features a touch screen for an effective user interface. Directly under each well is a well number illuminated by a well status indicator light. Three colors (white, green, and red) and two states (off and solid line) are used for the indicator light on the touch screen to show the status of the BI processing. The Reader has a thermoplastic exterior which makes it easy to clean and maintain. A built-in barcode scanner coupled with network connectivity makes maintaining sterilization records easy.
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Image /page/5/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and outlined in a thin white line, set against a light blue background. The logo is enclosed in a rounded rectangle shape, and there is a small circled "R" symbol in the upper right corner, indicating a registered trademark.
The STERRAD VELOCITY BI and Reader have intended capability for "ecosystem" connectivity and integration. This system is intended to allow communication among STERRAD Sterilizers with ALLClear™ Technology.
Intended Use/Indications for Use
The STERRAD VELOCITY Biological Indicator, in conjunction with the STERRAD VELOCITY Reader, is intended to be used as a standard method for frequent monitoring of the following STERRAD Sterilization Systems:
- STERRAD® 100NX (STANDARD, FLEX, EXPRESS, and DUO Cycles) with and without . ALLClear™ Technology
- STERRAD NX® (STANDARD and ADVANCED Cycles) with and without ALLClear™ Technology
- STERRAD® 100S ●
The indications for use statement for the STERRAD VELOCITY Biological Indicator and Reader is identical to those of the predicate devices with minor exceptions related to the inclusion of the recently cleared STERRAD ALLClear Technology, and removal of obsoleted STERRAD 50 and 200 Sterilizers.
These exceptions do not affect the safety and effectiveness of the subject device relative to its predicates. Both the subject and predicate devices share intended use for monitoring of hydrogen peroxide gas plasma sterilization processes.
Comparison of Technological Characteristics with Predicate Device
The subject and predicate devices have technological characteristics based on their use in the monitoring of hydrogen peroxide gas plasma sterilization processes. The following technological characteristics are the same for both the subject device and predicate devices:
- . BI design: Self-contained biological indicator
- . Test organism: Geobacillus stearothermophilus (ATCC 7953)
- Viable spore population: ≥ 106 CFU/BI ●
- . Rapid readout technology: The a-glucosidase enzyme, generated naturally during growth of Geobacillus stearothermophilus, is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate (α-MUG). The resultant fluorescent byproduct (4-MU) is detected in the reader and the fluorescence signal is used to determine a positive or negative BI result.
- Carrier material for spore disc: Glass fiber ●
- . Materials used for BI components (vial, cap, and insert): Transparent thermoplastic polymer for vial and insert, and opaque thermoplastic polymer for cap
- . Method of fluorescence detection: UV LED, optical filters, with sensing by photodiode
Some technological differences exist between the subject and predicate devices as listed below. However, these differences were successfully assessed through performance testing and do not raise any questions of safety and effectiveness. Therefore, the subject device is as safe and effective as the predicate devices.
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Image /page/6/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The letters are white and are set against a light blue background. The logo is enclosed in a rounded rectangle shape. There is a registered trademark symbol in the upper right corner of the logo.
- . Resistance characteristics: The use of 5 mg/L hydrogen peroxide that is within the range used for the two predicates (2.5 mg/L and 10 mg/L); and the choice of two out of three recommended test methods as specified in ISO 11138-1:2006, Section 6.4.1.
- Incubation temperature: The temperatures used by the subject and predicate devices are within the temperature range of the optimal growth of test organism, Geobacillus stearothermophilus (ATCC 7953).
- . Reduced incubation time (RIT): The RIT of the subject device (30 minutes) has been successfully verified through performance testing.
- Chemical indicator: The chemical indicator for the subject device has been verified to be a . Type 1 process indicator through performance testing.
Refer to the following Table for a comparison of predicate and proposed device characteristics.
| Predicate Devices | Subject device | ||
|---|---|---|---|
| Device Characteristics | 3M Attest™ Rapid Readout | ||
| Biological Indicator 1295 | |||
| (K140392 and K152060) | STERRAD | ||
| CYCLESURE 24 BI | |||
| (K151971) | STERRAD | ||
| VELOCITY BI | |||
| Intended Use | Same as STERRAD | ||
| CYCLESURE 24 BI | Monitoring of hydrogen peroxide | ||
| gas plasma sterilization processes | Same as STERRAD | ||
| CYCLESURE 24 BI | |||
| Indications for Use | Used in conjunction with the 3M | ||
| Attest Auto-Reader 490H as a | |||
| standard method of routine | |||
| monitoring of vaporized hydrogen | |||
| peroxide sterilization processes | |||
| in: | |||
| • STERRAD 100S | |||
| • STERRAD NX | |||
| (STANDARD and | |||
| ADVANCED Cycles) | |||
| • STERRAD 100NX | |||
| (STANDARD, FLEX, | |||
| EXPRESS and DUO Cycles) | Used as a standard method for | ||
| frequent monitoring of the | |||
| following STERRAD | |||
| Sterilization Systems and has | |||
| been validated for use in health | |||
| care facilities: | |||
| • STERRAD 100S | |||
| • STERRAD 50 | |||
| • STERRAD 200 | |||
| • STERRAD NX | |||
| • STERRAD 100NX | |||
| (STANDARD, FLEX and | |||
| EXPRESS Cycles) | Used as a standard method for | ||
| frequent monitoring of the | |||
| following STERRAD | |||
| Sterilization Systems: | |||
| • STERRAD® 100NX | |||
| (STANDARD, FLEX, | |||
| EXPRESS, and DUO Cycles) | |||
| with and without | |||
| ALLClear™ Technology | |||
| • STERRAD NX® | |||
| (STANDARD and | |||
| ADVANCED Cycles) with | |||
| and without ALLClear™ | |||
| Technology | |||
| • STERRAD® 100S | |||
| Organism | |||
| (Spore, Species, Strain) | Geobacillus stearothermophilus | ||
| traceable to ATCC™ 7953 | Same | Same | |
| Viable Spore Population | $≥ 1x106 CFU/BI$ | Same | Same |
| Carrier Material | PET (Polyethylene terephthalate) | Glass Fiber | Same as STERRAD |
| CYCLESURE 24 BI | |||
| Resistance | |||
| Characteristics: | Tested at 10 mg/L vaporized | ||
| hydrogen peroxide | |||
| D-value $10 mg/L ≥ 1 second$ | |||
| Survival Time $≥ 5 seconds$ | |||
| Kill Time: 7 minutes | Tested at 2.5 mg/L hydrogen | ||
| peroxide | |||
| D-value $2.5 mg/L: ≥ ~1 second$ | |||
| Survival Time: calculated based | |||
| on D-value | |||
| Kill Time: 60 seconds | Tested at 5 mg/L hydrogen | ||
| peroxide | |||
| D-value $5mg/L: ≥ 1 second$ , using | |||
| two D-value methods (Survivor | |||
| Curve and Fraction Negative) | |||
| per ISO 11138-1 |
Biological Indicator Substantial Equivalence Comparison Table
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Image /page/7/Picture/0 description: The image shows a logo with the letters "ASP" in a stylized, interconnected design. The letters are white and are set against a rounded, light blue background. A small "R" in a circle, indicating a registered trademark, is visible in the upper right corner of the logo.
| Predicate Devices | Subject device | ||
|---|---|---|---|
| 3M Attest™ Rapid Readout | |||
| Biological Indicator 1295 | |||
| (K140392 and K152060) | STERRAD | ||
| CYCLESURE 24 BI | |||
| (K151971) | STERRAD | ||
| VELOCITY BI | |||
| Device Characteristics | |||
| Rapid Readout | |||
| Technology | The α-glucosidase enzyme system is generated naturally during growth of Geobacillus stearothermophilus. The α-glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the reader. The fluorescence signal is used to determine a positive or negative result. | N/A | Same as 3M predicate |
| Incubation Temperature | 60 +/- 2°C | 55 - 60°C | 57 +/- 2°C |
| Reduced Incubation | |||
| Time | 4-hour fluorescence results read | ||
| on 3M 490H Auto-reader | 24-hour visual pH color change | ||
| results | 30-minute fluorescence results | ||
| read in STERRAD VELOCITY | |||
| Reader and optional visual pH | |||
| color change results at 5 to 7 | |||
| days | |||
| Chemical Indicator | H2O2 sensitive ink; appears blue | ||
| until processed, then appears | |||
| pink | Throughput indicator, changes | ||
| color from red to golden yellow | |||
| or bronze to indicate exposure to | |||
| hydrogen peroxide | Type 1 process indicator | ||
| changes color from red/pink to | |||
| yellow or yellow with some | |||
| red/orange/brown dots to | |||
| indicate exposure to hydrogen | |||
| peroxide | |||
| Shelf Life | 18 months | 12 months | 6 months |
Reader Substantial Equivalence Table
| Predicate Device | Subject device | |
|---|---|---|
| Device Characteristics | 3M Attest™ 490H Auto-Reader (K140392) | STERRAD VELOCITY Reader |
| Intended Use | Used to incubate and automatically read the 3M Attest™ 1295 Rapid Readout Biological Indicator at 60°C for a final fluorescence result at 4 hours. | Used to incubate and automatically read the STERRAD VELOCITY Biological Indicator at 57°C for a final fluorescence result in 30 minutes. |
| Incubation Temperature | 60 +/- 2°C | 57 +/- 2°C |
| Basis of Rapid Readout | Fluorescence of biological indicator medium | Same |
| Use with Biological Indicators | 3M Attest™ Rapid Readout Biological Indicator 1295 | STERRAD VELOCITY BI |
| Method of Fluorescence Detection | UV LED, optical filters, with sensing by photodiode | Same |
| Indicator of Adequate | ||
| Sterilization Cycle | (-) on LCD Display | Same ("Negative" displayed on LCD Display) |
| Indicators of Possible | ||
| Sterilization Cycle Failure | (+) on LCD Display, Audible Alarm | Same ("Positive" displayed on LCD Display, Audible Alarm) |
| Incubation Wells | 10 incubation/reader wells | 8 incubation/reader wells |
| Voltage Range | 100-240 Volts AC (12 Volt DC conversion for internal circuitry) | Same |
| Product Safety | UL/IEC 61010-1 | Same |
| EMC Compliance | FCC Part 15, Subpart B, Class A | Same |
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Non-Clinical Data
STERRAD VELOCITY BIOLOGICAL INDICATOR
Performance testing was conducted to satisfy the requirements for the STERRAD VELOCITY BI that is the subject of this submission, as outlined in the Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions Document issued on: October 4, 2007, and ISO 11138-1:2006, Sterilization of health care products – Biological indicators - Part 1: General requirements. All testing yielded passing results. This testing is summarized in the following Table.
| Performance Testing | Description | Pass/Fail |
|---|---|---|
| Spore Population | ||
| Determination | Verification of performance characteristics for spore population. | Pass |
| D-value Determination | Verification of D-values using Holcomb-Spearman-Karber | |
| Procedure (HSKP) and Survivor Curve method. | Pass | |
| Test Organism | ||
| Characterization | Verification of Geobacillus stearothermophilus (ATCC 7953). | Pass |
| Reduced Incubation Time | ||
| (RIT) Study | Verification of reduced incubation time: 30 minutes for | |
| fluorescence results and 5 to 7 days for spore growth results. | Pass | |
| Growth Inhibition Study | Verification that carrier and primary packaging materials do not | |
| have bacteriostatic effects that inhibit the growth of the indicator | ||
| microorganism, Geobacillus stearothermophilus. | Pass | |
| Holding Time Assessment | Verification that labeled holding time does not have adverse | |
| effects on the resistance characteristics for the BI growth results or | ||
| the fluorescence response characteristics for the fluorescence | ||
| results. | Pass | |
| Chemical Indicator | ||
| Functionality Study | Verification of functionality of the chemical indicator (CI) as a | |
| Type 1 process indicator. | Pass | |
| BI Performance Study in | ||
| STERRAD 100NX | Verification of performance in monitoring STERRAD 100NX | |
| STANDARD, FLEX, EXPRESS, and DUO Cycles. | Pass | |
| BI Performance Study in | ||
| STERRAD NX | Verification of performance in monitoring STERRAD NX | |
| STANDARD and ADVANCED Cycles. | Pass | |
| BI Performance Study in | ||
| STERRAD 100S | Verification of performance in monitoring STERRAD 100S | |
| Cycle. | Pass | |
| Impact of Load Conditioning | ||
| (ALLClear Technology) | ||
| Feature on STERRAD | ||
| VELOCITY BI | Verification that the load conditioning feature of the STERRAD | |
| 100NX and NX with ALLClear Technology has no statistically | ||
| significant impact on the STERRAD VELOCITY BI. | Pass | |
| Shelf Life Study (Real Time) | Verification that the STERRAD VELOCITY BI meets its end of | |
| shelf life requirements. | Pass |
Summary of Performance Testing
STERRAD VELOCITY READER
Electrical Safety testing was conducted to verify compliance to the standards listed below. The testing provides a standardized level of assurance that the system is electrically safe when operated and maintained in accordance with the STERRAD VELOCITY Reader User's Guide.
- . IEC/EN 61010-1:2010; Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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Image /page/9/Picture/0 description: The image shows a logo with the letters ASP in a stylized font. The A is represented by a triangle, and the letters are white against a light blue background. The logo is enclosed in a rounded rectangle, and there is a small registered trademark symbol in the upper right corner.
- . IEC/EN 61010-2-010:2014: Safety requirements for electrical equipment for measurement. control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
- . UL 61010-1:2012; UL Standard for Safety Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements
- UL 61010-2-010:2015; UL Standard for Safety Requirements for Electrical Equipment for . Measurement, Control and Laboratory Use – Part 2-010: Particular Requirements for Laboratory Equipment for the Heating of Materials
- . CAN/CSA-C22.2 No. 61010-1-12 (2012); Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements
- CAN/CSA-22.2 No. 61010-2-010:15 (2015); Safety requirements for electrical equipment for . measurement, control and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials
Electromagnetic Compatibility testing was completed to verify compliance of Radiated and Conducted Emissions per US Code of Federal Regulations (CFR), Title 47, Part 15, Subpart B (Class A). Test results met the requirements of the regulation and standards as shown in the following table:
| Test Description | Standards | Test Result |
|---|---|---|
| Radiated Emissions | ||
| Class A | FCC Part 15, Subpart B | |
| ICES-003 | ||
| ANSI C63.4:2014 | Compliant | |
| Conducted Emissions | ||
| Class A | FCC Part 15, Subpart B | |
| ICES-003 | ||
| ANSI C63.4:2014 | Compliant |
Software Verification and Validation Testing was conducted and documentation was provided within the submission as recommended by Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005. Unit, Integration, and System level testing were successfully completed.
Clinical Data
No clinical data was generated in support of this Premarket Notification.
Summarv
The STERRAD VELOCITY BI and Reader and its predicate devices, the STERRAD CYCLESURE 24 Biological Indicator and the 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Auto-Reader 490H, have the same intended use and indications for use with minor exceptions that are related to the incorporation of new product clearances and removal of obsolete products. Further, the subject device and predicate devices largely share the same technological characteristics, i.e., some technological differences exist: however, these differences were successfully assessed through performance testing, and do not raise any questions of safety and effectiveness. Therefore, the subject device is as safe and effective as the predicate devices.
Conclusion
The subject devices (STERRAD VELOCITY Biological Indicator and Reader) are substantially equivalent to the claimed predicate devices.