(72 days)
No
The document describes a biological indicator test pack for steam sterilization, which is a physical device used to challenge the sterilization process. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
This device is used to test the effectiveness of steam sterilization cycles for other medical devices, not to treat a patient.
No
Explanation: This device is for testing the effectiveness of steam sterilization cycles, not for diagnosing medical conditions in patients. It's a quality control device for sterilization equipment.
No
The device description clearly states it consists of a biological indicator placed inside a package of porous and non-porous material, indicating it is a physical device, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "routine and challenge testing of steam gravity displacement cycles" and "prevacuum steam sterilization cycles." This indicates it's used to evaluate the effectiveness of a sterilization process, which is a critical step in ensuring the safety of medical devices and preventing the spread of infections.
- Device Description: The device contains a "SporView® steam biological indicator containing Geobacillus stearothermophilus spores." Biological indicators are a common type of IVD used to monitor sterilization processes by challenging them with a known population of resistant microorganisms.
- Summary of Performance Studies: The performance studies compare the device's performance to an "AAMI biological indicator test pack," further reinforcing its role as a biological indicator used for testing sterilization.
While the text doesn't explicitly use the term "In Vitro Diagnostic," the function and components described align perfectly with the definition of an IVD used to assess the efficacy of a sterilization process.
N/A
Intended Use / Indications for Use
The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.
Product codes
80FRC
Device Description
The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.
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
Two hundred ten (210) sterilization tests were nun to compare performance standards/results of the SPSmedical SportView® Steam Bl Test Pack to the AAMI biological indicator test pack. A SporView® self-contained biological indicator containing Geobacillus stearothermophilus spores was used within the AAMI biological indicator test. Of the two hundred and ten stedlization tasts that were run: 60 comparison tests for failures were orchestrated, 90 comparison tests for passifallures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure stenilization testing of SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack.
Key Metrics
Not Found
Predicate Device(s)
StenTec Biological Indicator Test Pack (K001444)
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
OCT 2 5 2002
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 October 21, 2002 .
- Gary J. Socola . Printed name of person submitting for 510(k) seen in
- Signature of person submitting for 510(k)
- Director of Quality Assurance . Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical SporView® Steam Bl Test Pack |
|---|---|
| Classification Name: | Biological Indicator |
| Common Name: | Biological Test Pack |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | 80FRC |
| Predicate Device: | StenTec Biological Indicator Test Pack (K001444) |
1
Device Description:
The SPSmedical SporView® Steam Bl Test Pack consists of a SporView® steam biological indicator placed inside a package of porous and non-porous material. The SPSmedical SporVlew® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration.
Intended Use:
The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer and can be used in conjunction with a integrator test pack.
Technical Characteristics:
The SPSmedical SporView® Steam Bl Test Pack has the same intended use and technological characteristics as the AAMI biological indicator test pack and other commercially available test packs. The SPSmedical SporView® Steam Bl Test Pack is designed to create a significant challenge to air removal and steam penetration. The SPSmedical SporView® Steam Bl Test Pack adds resistance and impedes steam penetration to the SporViews steam biological indicator located within the pack. This provides a significant challenge to the steam sterilization process.
Non-Clinical Testing:
Two hundred ten (210) sterilization tests were nun to compare performance standards/results of the SPSmedical SportView® Steam Bl Test Pack to the AAMI biological indicator test pack. A SporView® self-contained biological indicator containing Geobacillus stearothermophilus spores was used within the AAMI biological indicator test. Of the two hundred and ten stedlization tasts that were run: 60 comparison tests for failures were orchestrated, 90 comparison tests for passifallures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure stenilization testing of SPSmedical SporView® Steam BI Pack consistently showed results comparable to the AAMI biological indicator test pack.
Conclusion:
Supportive data has demonstrated that the SPSmedical SporView® Steam Bl Pack is equivalent to the predicate device. Results of performance testing indicate that the SPSmedical SporView @ Steam Bl Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C/250°F for 30 minutes exposure time and prevacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer. The SPSmedical SporViews Steam Bl Pack is an effective and reliable, single use device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
od and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2002
Mr. Gary J. Socola Director of QA & Sterilization Projects SPS Medical Supply Corporation 6789 West Henrietta Road Rush. New York 14543
Re: K022706
Trade/Device Name: Sporview® Steam BI Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: August 6, 2002 Received: August 14, 2002
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.
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.
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.
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Page 2 .- Mr. Socola
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulbrich
Timothy A. Ulatowski 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 STATEME
SPSmedical Supply Corp. Applicant:
510(k) Number (if known): _ K022706
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Ure:
The SPSmedical SporView® Steam Bl Test Pack is indicated for use in routine and challenge testing of steam gravity displacement cycles at 121°C/250°F for 30 minutes exposure time and provacuum steam sterilization cycles at 132°C/270°F for 4 minutes exposure time or longer.
(Pl.Ease DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
Qitin S-Lin
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number. K022706