(503 days)
No
The device description and performance studies focus on biological and chemical processes (spore growth, pH color change) to indicate sterilization efficacy. There is no mention of AI or ML in the text.
No.
A therapeutic device is used to treat or cure a disease or medical condition. This device is used to monitor the efficacy of steam sterilization processes, not to treat patients.
Yes
This device is designed to monitor the efficacy of steam sterilization processes by indicating a failure or success based on the viability of bacterial spores, which provides diagnostic information about the sterilization process.
No
The device description clearly outlines a physical, self-contained biological indicator with bacterial spores, a nutrient broth, and a plastic vial. It relies on a visual color change due to biochemical activity, not software processing.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for "monitoring the efficacy of saturated steam sterilization processes." This involves testing a process (sterilization) to determine its effectiveness.
- Device Description: The device contains "viable Geobacillus stearothermophilus bacterial spores" and a "nutrient broth culture medium containing bromocresol purple as a pH indicator." The "Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow." This describes a biological test performed in vitro (outside of a living organism) to assess the outcome of the sterilization process.
- Mechanism: The device relies on the growth or lack of growth of the bacterial spores in the culture medium to indicate whether the sterilization process was successful in killing the spores. This is a classic example of an in vitro diagnostic test used to evaluate the effectiveness of a process.
While it doesn't directly diagnose a disease in a patient, it is a diagnostic tool used to assess the performance of a critical process (sterilization) that impacts patient safety. The FDA's definition of an IVD includes devices used to "provide information for the diagnosis, treatment, or prevention of disease or other conditions." Ensuring effective sterilization directly relates to preventing disease transmission.
N/A
Intended Use / Indications for Use
SporView 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SporView 10 self-contained biological indicators have a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
| Sterilization Mode | Temperature | Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 15 minutes |
| Gravity | 134°C | 4 minutes |
| Gravity - Flash | 132°C | 3 minutes |
| Gravity - Flash | 132°C | 10 minutes |
| Dynamic Air | 121°C | 20 minutes |
| Dynamic Air | 121°C | 30 minutes |
| Dynamic Air | 132°C | 3 minutes |
| Dynamic Air | 132°C | 4 minutes |
| Dynamic Air | 134°C | 4 minutes |
| Dynamic Air | 135°C | 3 minutes |
Product codes
FRC
Device Description
The SporView 10 Self Contained Steam BI (SCBI) consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carier and a small glass ampoule containing a nutrient broth culture medium containing bromocresol purple as a pH indicator encased in a plastic vial that serves as the culture tube. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change and/or turbidity indicates' a steam sterilization process failure.
SporView® 10 SCBI's are conventional spore growth readout biological indicators specifically designed for rapid and reliable monitoring of steam sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices.
Sportiew® 10 Steam Self Contained Biological Indicators comply with the performance requirements of ANSVAAMI/SO 11138-1 and ANSVAAMI/ISO 11138-3:2010, the USP requirements for SCBI's and the FDA's Biological Indicator guidance document on Premarket Notification 510(k) Submissions.
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
Non-Clinical Testing:
Testing was performed in order to validate the indicators label claims and performance characteristics according to the reduced incubation time protocol described in the FDA guidance document entitled "Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions''. Multiple lots of indicators and media were tested and all lots met the FDA's defined acceptance criteria of >97% for a reduced incubation time of 10 hours.
Testing was also performed to validate the indicators other label claims and performance characteristics. Multiple lots of indicators were tested for;
- Resistance
- Spore population
- Effects of holding time
- Stability of the color change
- Media Evaporation
- Survival Response Time
- Effects of carrier and package materials
- Media recovery after exposure to a steam cycle of 132°C for 10 minutes
All test results met the defined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety & Effectiveness
Submitter:
.
- SPSmedical Supply Corp. . 6789 West Henrietta Road Rush, NY 14543 U.S.A. Phone: (585)-359-0130 Fax: (585)-359-0167
- Establishment FDA Registration No.: 1319130 .
- . 510K No. K122024
NOV 26 2013
- Date Summary was Prepared Novemeber20th, 2013 .
- Gary J. Socola . Printed name of person submitting for 510(k)
Gary J. Socola
Signature of person submitting for 510(k)
- . Vice President, Scientific Affairs Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SporView® 10 Steam Self Contained Biological Indicator |
|---|---|
| Classification Name: | Sterilization Process Biological Indicator |
| Common Name: | Self-Contained Biological Indicator |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | FRC |
| Predicate Device: | SporView® Steam Self Contained BI (K070595 and K111515) |
1
Device Description:
The SporView 10 Self Contained Steam BI (SCBI) consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carier and a small glass ampoule containing a nutrient broth culture medium containing bromocresol purple as a pH indicator encased in a plastic vial that serves as the culture tube. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow. A visual pH color change and/or turbidity indicates' a steam sterilization process failure.
SporView® 10 SCBI's are conventional spore growth readout biological indicators specifically designed for rapid and reliable monitoring of steam sterilization processes without the use of enzyme based technology or specific and specialized incubators or monitoring devices.
Sportiew® 10 Steam Self Contained Biological Indicators comply with the performance requirements of ANSVAAMI/SO 11138-1 and ANSVAAMI/ISO 11138-3:2010, the USP requirements for SCBI's and the FDA's Biological Indicator guidance document on Premarket Notification 510(k) Submissions.
SPSmedical Supply Corp. is using its SporView® Self Contained Steam BI (K070595 and K111515) to show equivalence to the proposed Spor View 10 Self Contained Steam BI device modification. Both devices are essentially the same device with only one difference; that is the proposed device has a modified media formulation that was validated for a lower reduced incubation time than the predicate device.
Intended Use:
Spor View 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam sterilization processes. SporView 10 self-contained biological indicators have a validated reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
| Sterilization Mode | Temperature | Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 15 minutes |
| Gravity | 134°C | 4 minutes |
| Gravity - Flash | 132°C | 3 minutes |
| Gravity - Flash | 132°C | 10 minutes |
| Dynamic Air | 121°C | 20 minutes |
| Dynamic Air | 121°C | 30 minutes |
| Dynamic Air | 132°C | 3 minutes |
| Dynamic Air | 132°C | 4 minutes |
| Dynamic Air | 134°C | 4 minutes |
| Dynamic Air | 135°C | 3 minutes |
Statement of Similarity to the Legally Marketed Predicate Device:
- Both devices are essentially the same device tested at different incubation times. ●
- Both are intended to monitor steam sterilization cycles. 0
- . Both utilize the same strain of bacterial spores.
- Both utilize the same carrier material. .
- Both are activated in the same manner. .
- Both are incubated at the same temperature.
- Both use USP compliant culture mediums. .
- Both had media growth promotion studies validated for growth of the G. stearothermophilus ● organism after exposure to a steam cycle of 132°C for 10 minutes exposure time.
2
Non-Clinical Testing:
Testing was performed in order to validate the indicators label claims and performance characteristics according to the reduced incubation time protocol described in the FDA guidance document entitled "Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions''. Multiple lots of indicators and media were tested and all lots met the FDA's defined acceptance criteria of >97% for a reduced incubation time of 10 hours.
Testing was also performed to validate the indicators other label claims and performance characteristics. Multiple lots of indicators were tested for;
- Resistance .
- Spore population �
- . Effects of holding time
- o Stability of the color change
- . Media Evaporation
- . Survival Response Time
- Effects of carrier and package materials .
- Media recovery after exposure to a steam cycle of 132°C for 10 minutes .
All test results met the defined acceptance criteria.
Conclusion:
Supportive data has demonstrated that the SPSmedical SporView® 10 Steam Self Contained Biological Indicator is equivalent to the legally marketed predicate devices but with a lower reduced incubation time. The proposed device is as safe and effective as the legally marketed device.
3
Image /page/3/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or publication.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
November 26, 2013
SPS Medical Supply Corporation Mr. Gary J. Socola Vice President, Scientific Affairs 6789 West Henrietta Road RUSH, NEW YORK 14543
Re: K122024
Trade/Device Name: Spor View 10 Steam Self Contained Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: November 12, 2013 Received: November 14, 2013
Dear Mr. Socola:
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 advised in a mease 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 from 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.
4
Page 2 - Mr. Socola
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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/McdicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
Sincerely yours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Erin Keith Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS for USE STATEMENT
Applicant: SPSmedical Supply Corp.
510(k) Number (if known): ___ K122024
Spor View 10 Steam Self Contained BI Device Name:
Indications For Use:
SporView 10 Steam is a self-contained biological indicator inoculated with viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of saturated steam SporView 10 self-contained biological indicators have a validated sterilization processes. reduced incubation time of 10 hours and may be used in the following steam sterilization cycles:
| Sterilization Mode | Temperature | Time |
|---|---|---|
| Gravity | 121°C | 30 minutes |
| Gravity | 132°C | 15 minutes |
| Gravity | 134°C | 4 minutes |
| Gravity - Flash | 132°C | 3 minutes |
| Gravity - Flash | 132°C | 10 minutes |
| Dynamic Air | 121°C | 20 minutes |
| Dynamic Air | 121°C | 30 minutes |
| Dynamic Air | 132°C | 3 minutes |
| Dynamic Air | 132°C | 4 minutes |
| Dynamic Air | 134°C | 4 minutes |
| Dynamic Air | 135°C | 3 minutes |
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation Page 1 of 1
AND/OR
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