(276 days)
Not Found
No
The device description details a biological indicator that relies on chemical and biological reactions (spore growth and pH change) to indicate sterilization efficacy. There is no mention of AI or ML in the device description, performance studies, or key metrics.
No
This device is a biological indicator used to monitor the efficacy of sterilization processes for medical devices, not to treat or diagnose a medical condition in a patient.
No
Explanation: This device is a biological indicator used to monitor the efficacy of sterilization systems. It determines if the sterilization process successfully killed spores, which is a test of the sterilization equipment's function, not a diagnostic test for a patient's condition or disease.
No
The device description clearly outlines physical components such as a glass fiber disc, glass ampoule, polypropylene vial, polypropylene filter, and polypropylene cap. It also describes a chemical process indicator and a growth medium. These are all hardware components, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for "monitoring hydrogen peroxide sterilization efficacy in healthcare facilities". This involves testing a process (sterilization) using a biological sample (spores) in vitro (outside of a living organism).
- Device Description: The description details a self-contained biological indicator that uses a growth medium and a pH indicator to detect the presence or absence of viable spores after a sterilization cycle. This is a classic example of an in vitro test to assess the effectiveness of a process.
- Mechanism of Action: The device relies on the metabolic activity of the spores (if they survive) to produce acidic waste, which changes the color of the growth medium. This is an in vitro biological reaction used for diagnostic purposes (diagnosing whether the sterilization cycle was effective).
While the device doesn't directly diagnose a disease in a patient, it performs a diagnostic function by evaluating the efficacy of a critical process (sterilization) that directly impacts patient safety in a healthcare setting. This type of device falls under the scope of IVDs as they are used to provide information about the state of a process or sample in vitro.
N/A
Intended Use / Indications for Use
The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system: • STERRAD® 100NX® (Standard Cycle)
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10^6 spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units.
Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.
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
healthcare facilities
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)
Study Performed: Spore Population
Details and Acceptance Criteria: Assay to demonstrate spore population of the BI meets specification of ≥1.0 x 10^6 .
Results: Pass
Study Performed: D Value Determination
Details and Acceptance Criteria: Assessment to demonstrate subject device meets the D value specification of ≥1 second.
Results: Pass
Study Performed: Survival and Kill Response
Details and Acceptance Criteria: Assessment to demonstrate the subject device meets the survival specification of ≥ 6 seconds and the kill specification of ≤ 6 minutes.
Results: Pass
Study Performed: Effect of Holding Time
Details and Acceptance Criteria: Evaluation of 24 hour holding time prior to incubation on resistance characteristics of subject BI. Holding time resistance characteristics met the D value specification and were equivalent to the original resistance characteristics.
Results: Pass
Study Performed: Reduced Incubation Time
Details and Acceptance Criteria: Determination of the minimum incubation time for the subject device. Subject device exhibited 30% to 80% growth following partial cycle exposure, resulted in a ≥97% correlation between the results observed at 24 hours and the results observed at seven days for a reduced incubation time of 24 hours.
Results: Pass
Study Performed: Verification of Growth Media Color Change
Details and Acceptance Criteria: Assessment to verify stability of growth media color change. Subject device growth media exhibited a color change to yellow, which did not revert to the original color of purple following incubation.
Results: Pass
Study Performed: Suitability of Carrier and Primary Packaging Materials
Details and Acceptance Criteria: Suitability testing of carrier and primary packaging materials of the subject device. Carrier and primary packaging material did not absorb sterilant or show degradative effects when exposed to worst case cycle conditions.
Results: Pass
Study Performed: Shelf Life Testing
Details and Acceptance Criteria: Verification of subject device's performance characteristics (spore population, D value, survival and kill response, RIT, and media color change stability) for 9 month labeled product shelf life.
Results: Pass
Study Performed: Sterilization Cycle Performance Validation
Details and Acceptance Criteria: Simulated use test to demonstrate no growth of subject device after exposure to half and full sterilization cycles under worst case conditions.
Results: Pass
Key Metrics (Senspivity, 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).
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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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2018
Crosstex/SPSmedical Supply Corp Mr. Brent Geiger Sr. Director, Global Regulatory Compliance 6789 W. Henrietta Road Rush, NY 14543
Re: K171287 Trade/Device Name: SporView® VH2O2 BI
Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: December 22, 2017 Received: December 26, 2017
Dear Brent Geiger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
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.
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 yours,
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) K171287
Device Name
SporView® VH202 BI
Indications for Use (Describe)
The SporView® VH2O2 BI is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
• STERRAD® 100NX® (Standard
Cycle)
| 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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Image /page/3/Picture/0 description: The image shows two logos side by side. The first logo is for "CROSSTEX A CANTEL MEDICAL COMPANY" in red font. The second logo is for "SPS medical" in blue and gray font, with a black bracket around the letters "SPS".
510(k) Summary
1.0 Submitter
Crosstex/SPSmedical 6789 W. Henrietta Road Rush, NY 14543
| Phone: | (800) 722-1529 |
|---|---|
| Fax: | (585) 359-0167 |
| Contact: | Brent Geiger |
|---|---|
| Phone: (763) 553-3345 | |
| Email: bgeiger@cantelmedical.com |
510(k) Number: K171287 Date Submitted: 1/26/2018
2.0 Device
| Trade Name: | SporView® VH₂O₂ BI |
|---|---|
| Common Name: | Biological Indicator |
| Classification: | Biological Sterilization Process Indicator (21 CFR 880.2800 |
| Device Class: | II |
| Product Code: | FRC |
3.0 Predicate Device
STERRAD® CYCLESURE® 24 Biological Indicator (K151971)
4.0 Device Description
The SporView® VH2O2 Bl is a self-contained biological indicator (SCBI) designed to monitor hydrogen peroxide sterilization efficacy in healthcare facilities, specifically within a STERRAD® 100NX® Standard Cycle. Each unit consists of a glass fiber disc inoculated with a minimum of 10° spores of Geobacillus stearothermophilus ATCC® 7953 and a hermetically sealed glass ampoule of modified growth medium, both contained within a polypropylene vial with a polypropylene filter lined within the top of a polypropylene cap. A chemical process indicator on the vial label allows for differentiation between processed and unprocessed units.
Following exposure to the sterilization cycle, the Bl is activated by squeezing the sides of the vial, causing the media ampoule to break and immerse the inoculated carrier in growth medium. The Bl is then incubated at 55 - 60°C for 24 hours. The growth medium, comprised of soybean casein digest broth modified with bromocresol purple (a pH
4
Image /page/4/Picture/0 description: The image shows two logos side by side. The first logo is for "CROSSTEX A CANTEL MEDICAL COMPANY" in red font. The second logo is for "SPS medical" in blue and gray font, with a black outline of a hexagon around the letters "SPS".
indicator), remains purple and free of turbidity if the sterilization cycle was effective. Spore growth produces acidic waste (carbonic acid) which causes a shift down in pH (acidic) within the growth medium, transitioning the media from a purple to a yellow color and/or exhibiting turbidity which both indicate a failed sterilization cycle.
5.0 Indications for Use
The SporView® VH2O2 Bl is a self-contained biological indicator intended for use in the following STERRAD® sterilization system:
- STERRAD® 100NX® (Standard Cycle)
6.0 Comparison of Technological Characteristics with the Predicate Device
The SporView® VH2O2 Bl and its predicate device – STERRAD® CYCLESURE® 24 Biological Indicator legally marketed under K151971 – are substantially equivalent in that they both have the same intended use, fundamental technology and general performance.
Similarities between subject and predicate devices - The subject and predicate devices are both intended to routinely monitor vaporized hydrogen peroxide sterilization of the STERAD® 100NX Standard Cycle. Both devices have the same self-contained biological indicator components - inoculated glass fiber disc, glass ampoule, growth media, vial, cap and liner. Both Bls have spore carriers containing ≥ 1.0 x 10° Geobacillus stearothermophilus and produce a growth media color change of purple to yellow in the presence of spore growth.
Differences between subject and predicate devices - The only notable difference between the subject and predicate device is that the survival and kill times are longer in duration for the SporView VH2O2 Bl than the predicate device. The performance testing has demonstrated that this difference raises no questions of safety or efficacy and the subject device performs equivalently to the predicate device.
The following table outlines the similarities and differences between the subject and predicate devices:
| Element | Subject Device | Predicate Device |
|---|---|---|
| SporView® VH2O2 BI | STERRAD® CYCLESURE | |
| 24 Biological Indicator | ||
| Biological Indicator | ||
| Design | Same as predicate | Self-Contained Biological |
| Indicator | ||
| Method of Sterilization | Same as predicate | Vaporized hydrogen |
| peroxide | ||
| Indications for Use | The SporView® VH2O2 BI is | |
| a self-contained biological | ||
| indicator intended for use in | ||
| the following STERRAD® | ||
| sterilization system: | ||
| • STERRAD 100NX® | ||
| (Standard Cycle) | The device is intended for | |
| use in the following | ||
| STERRAD® sterilization | ||
| systems: | ||
| • STERRAD 100S | ||
| • STERRAD 50 | ||
| • STERRAD 200 |
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Image /page/5/Picture/0 description: The image features two company logos side-by-side. On the left is the "CROSSTEX" logo in a bold, red font, with the tagline "A CANTEL MEDICAL COMPANY" underneath. To the right is the "SPS medical" logo, with "SPS" in blue and "medical" in gray, enclosed within a stylized black bracket shape. The logos are clean and professional, suggesting a corporate or medical industry affiliation.
| STERRAD NX® STERRAD 100NX (Standard, Flex and Express Cycles) – For STERRAD 100NX Duo Cycle in the United States, the STERRAD CYCLESURE 24 Biological Indicator should only be used in a test pack configuration (REF 20243) | ||
|---|---|---|
| Organism | Same as predicate | Geobacillus |
| stearothermophilus, | ||
| ATCCTM 7953 | ||
| Viable Spore Population | Same as predicate | ≥ 1.0 x 106 |
| BI Components | Same as predicate | Inoculated glass fiber disc and glass ampoule with growth media contained within a vial and enclosed with a cap with liner |
| Carrier Material | Same as predicate | Glass fiber |
| Growth Medium Color | ||
| Change | Same as predicate | Purple to yellow |
| Resistance | ||
| Characteristics | Using 2.5 mg/L of hydrogen | |
| peroxide: | ||
| • D value: ≥ 1 second | ||
| • Survival: ≥ 6 seconds | ||
| • Kill: ≤6 minutes | Using 2.5 mg/L of hydrogen | |
| peroxide: | ||
| • D value: ≥~1 second | ||
| • Survival: Calculated | ||
| based on D value | ||
| • Kill: 60 seconds | ||
| Incubation Temperature | Same as predicate | 55 – 60°C |
| Incubation Duration | 24 hours | 24 – 72 hours |
| Shelf Life | 9 Months | 12 Months |
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Image /page/6/Picture/0 description: The image features two company logos side-by-side. On the left is the "CROSSTEX" logo in bold, red letters, with the tagline "A CANTEL MEDICAL COMPANY" underneath. To the right is the "SPS medical" logo, with "SPS" in blue and "medical" in gray, enclosed within a bracket-like design.
7.0 Performance Data
Testing was performed to support substantial equivalence of the SporView® VH2O2 Bl to the predicate device.
| Study Performed | Details and Acceptance Criteria | Results |
|---|---|---|
| Spore Population | Assay to demonstrate spore population of the BI | |
| meets specification of ≥1.0 x $10^6$ . | Pass | |
| D Value | ||
| Determination | Assessment to demonstrate subject device meets the | |
| D value specification of ≥1 second. | Pass | |
| Survival and Kill | ||
| Response | Assessment to demonstrate the subject device meets | |
| the survival specification of ≥ 6 seconds and the kill | ||
| specification of ≤ 6 minutes. | Pass | |
| Effect of Holding | ||
| Time | Evaluation of 24 hour holding time prior to incubation | |
| on resistance characteristics of subject BI. Holding | ||
| time resistance characteristics met the D value | ||
| specification and were equivalent to the original | ||
| resistance characteristics. | Pass | |
| Reduced Incubation | ||
| Time | Determination of the minimum incubation time for the | |
| subject device. Subject device exhibited 30% to 80% | ||
| growth following partial cycle exposure, resulted in a | ||
| ≥97% correlation between the results observed at 24 | ||
| hours and the results observed at seven days for a | ||
| reduced incubation time of 24 hours. | Pass | |
| Verification of | ||
| Growth Media Color | ||
| Change | Assessment to verify stability of growth media color | |
| change. Subject device growth media exhibited a | ||
| color change to yellow, which did not revert to the | ||
| original color of purple following incubation. | Pass | |
| Suitability of Carrier | ||
| and Primary | ||
| Packaging Materials | Suitability testing of carrier and primary packaging | |
| materials of the subject device. Carrier and primary | ||
| packaging material did not absorb sterilant or show | ||
| degradative effects when exposed to worst case cycle | ||
| conditions. | Pass | |
| Shelf Life Testing | Verification of subject device's performance | |
| characteristics (spore population, D value, survival | ||
| and kill response, RIT, and media color change | ||
| stability) for 9 month labeled product shelf life. | Pass | |
| Sterilization Cycle | ||
| Performance | ||
| Validation | Simulated use test to demonstrate no growth of | |
| subject device after exposure to half and full | ||
| sterilization cycles under worst case conditions. | Pass |
8.0 Conclusion
Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject device is substantially equivalent to, and is as safe and as effective as the legally marketed predicate device, STERRAD® CYCLESURE® 24 Biological Indicator cleared in K151971, Class II (21 CFR 880.2800), product code FRC.