(245 days)
No
The document describes a biological indicator for steam sterilization, which is a physical/chemical process. There is no mention of any computational analysis, image processing, or data-driven decision making that would suggest the use of AI/ML.
No.
The device is a biological indicator used for monitoring the efficacy of steam sterilization processes, not for treating any medical condition or disease.
No
The device is a biological indicator intended for monitoring the efficacy of sterilization processes, not for diagnosing a medical condition in a patient.
No
The device description clearly indicates it is a physical biological indicator containing bacterial spores, a glass ampoule, and a plastic vial. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor the efficacy of saturated steam sterilization processes." This is a quality control measure for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device contains bacterial spores and culture media. It's designed to be placed in a sterilizer and then incubated to see if the spores were killed. This process is about evaluating the sterilization process itself, not analyzing a patient sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing information about a patient's health status
- Being used in a clinical laboratory setting for patient diagnosis or monitoring
The device is clearly intended for use in monitoring sterilization processes, which falls under the category of sterilization process indicators, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
SporView® 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 operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.
Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
SPSmedical Supply Corp. is using its SporView® Self Contained Steam BI (K070595) to show equivalence to the proposed SporView® self contained steam Bl. Both devices are essentially the same device however; the proposed device was tested at 135°C, where as the device cleared under K070595 was tested at 121°C, 132°C and 134°C.
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 Testing:
Testing was performed in order to validate the indicators label claims and performance characteristics. Multiple lots of indicators were tested for;
- Resistance
- Spore population
- Media recovery in extended steam sterilization cycles
- Effects of holding time
- Reduced incubation period
- Stability of the color change
- Media Evaporation
- Survival Response Time
- Effects of carrier and package materials
All test results met the defined acceptance criteria.
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
510(k) Summary of Safety and Effectiveness
FEB - 1 2012
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- · · ·
- Date Summary was Prepared January 27th, 2012 ●
- 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® 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: | SPSmedical SporView® Steam Self Contained BI (K070595) |
1
Device Description:
The SPSmedical SporView® biological indicator consists of a self-contained unit that includes bacterial spores of Geobacillus stearothermophilus ATCC #7953 inoculated onto a paper filter carrier and a small glass ampoule containing Tryptic Soy Broth with Bromocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
SPSmedical Supply Corp. is using its SporView® Self Contained Steam BI (K070595) to show equivalence to the proposed SporView® self contained steam Bl. Both devices are essentially the same device however; the proposed device was tested at 135°C, where as the device cleared under K070595 was tested at 121°C, 132°C and 134°C.
Intended Use:
SporView 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 operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.
Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.
Statement of Similarity to the Legally Marketed Predicate Device:
- Both devices are essentially the same device tested at different sterilization temperatures. �
- Both are intended to monitor steam sterilization cycles. .
- Both utilize the same strain of bacterial spores. ●
- . Both utilize the same carrier material.
- . Both use Tryptic Soy Broth as media.
- Both are activated in the same manner. ●
- Both are incubated at the same temperature ●
Non-Clinical Testing:
Testing was performed in order to validate the indicators label claims and performance characteristics. Multiple lots of indicators were tested for;
- Resistance ●
- Spore population ●
- Media recovery in extended steam sterilization cycles .
- Effects of holding time .
- Reduced incubation period .
- Stability of the color change �
- Media Evaporation ●
- Survival Response Time .
- Effects of carrier and package materials ●
All test results met the defined acceptance criteria.
Conclusion:
Supportive data has demonstrated that the SPSmedical SporView® Steam Self-Contained Biological Indicator is equivalent to the legally marketed predicate device and is the same device tested at a different sterilization temperature. Therefore, the proposed device is as safe and effective as the legally marketed device.
P. 20f 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle or other national bird, with its wings outstretched.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SPSMedical Supply Corporation C/O Mr. Gary J. Socola Vice President, Scientific Affairs 6789 West Henrietta Road Rush, New York 14543
REB - 1 2012
Re: K111515
Trade/Device Name: SporView® Steam Self Contained BI Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: January 27, 2012 Received: January 31, 2012
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 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.
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fer Anthras. Duktsm
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS for USE STATEMENT
Applicant: SPSmedical Supply Corp.
510(k) Number (if known): K11515
SporView® Steam Self Contained BI Device Name:
Indications For Use:
SporView® 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 operating at 121°C and 132°C gravity displacement, 132°C flash gravity displacement and 121°C - 134°C prevacuum cycles.
Spor View self-contained biological indicators are also appropriate for use in monitoring the efficacy of saturated steam prevacuum sterilization processes operating at 135°C for 3 minutes exposure time.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (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 (ODE)
Elizabeth F. Clausing-Wille
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: KIIL515