(83 days)
No
The device description and performance studies focus on biological indicators and their response to sterilization, with no mention of AI or ML technologies.
No
Explanation: This device is a biological indicator used for monitoring the efficacy of sterilization processes, not for treating any medical condition or disease.
No
This device is a biological indicator used for monitoring the efficacy of sterilization processes, not for diagnosing a medical condition in a patient.
No
The device description clearly states it is a self-contained unit including bacterial spores, a paper filter carrier, a glass ampoule, and a plastic vial, which are all physical components, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "monitoring the efficacy of saturated steam sterilization processes." This involves testing a process (sterilization) to determine if it has been effective in killing microorganisms.
- Device Description: The device contains bacterial spores and a culture medium with a pH indicator. This setup is designed to detect the presence of viable microorganisms after a sterilization process. If the sterilization is ineffective, the spores will grow in the culture medium, causing a color change in the indicator.
- Nature of the Test: The test performed by this device is an in vitro test. It involves taking a sample (the biological indicator itself, which contains the spores) and testing it outside of a living organism to determine the effectiveness of the sterilization process.
While the device doesn't directly diagnose a disease in a patient, it is used to assess the effectiveness of a process (sterilization) that is critical for preventing the spread of infections and ensuring the safety of medical devices and materials used in patient care. This falls under the scope of IVD devices, which are used to examine specimens derived from the human body or to provide information about a physiological state, a state of health or disease, or a congenital abnormality. In this case, the information provided is about the effectiveness of a process that directly impacts human health.
The presence of a predicate device (K963841; SGM EZTest® - Steam), which is also a biological indicator for steam sterilization, further supports the classification of this device as an IVD.
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℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.
Product codes
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 Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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. 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, Effects of carrier and package materials. All test results met the defined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
SGM EZTest® - Steam (K963841)
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
MAY 2 4 2607
510(k) Summary of Safety and 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 .
- Date Summary was Prepared May 24th, 2007 .
- 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: | SGM EZTest® - Steam (K963841) |
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 Bromnocresol Purple acting as a pH indicator encased in a plastic vial that serves as the culture tube.
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℃ and 132℃ gravity displacement, 132℃ flash gravity displacement and 121°C - 134°C prevacuum cycles.
Statement of Similarity to the Legally Marketed Predicate Device:
- Both are intended to monitor steam sterilization cycles from 121°C to134°C. .
- . Both utilize the same strain of bacterial spores.
- . Both utilize the same carrier material.
- . Both use virtually the same media.
- . Both are similar in size and shape.
- . 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
- . 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 therefore, as safe and effective as the legally marketed device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
SPSmedical Supply Corporation C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road Twinsburg, Ohio 44087
Re: K070595
Trade/Device Name: SporView® Steam Self Contained BI Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: May 15, 2007 Received: May 16, 2007
Dear Mr. Lehtonen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lehtonen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Clues
Chiu Lin, Ph.D. 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.
f Chemical Supply Corp.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K070595
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.
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)
Shula H. Murphy MD
ന of Anesthesiology, General Hospital, on Control, Dental Devices
*k) NumberPage 1 of 1 K020595