(14 days)
STEAMPlus™ Sterilization Integrators are intended to be used to monitor parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (under the presence of saturated steam). The integrators are intended to be used in steam cycles operating at 121°C - 134°C.
The SPSmedical STEAMPlus™ Steam Integrator is designed to monitor sterilization parameters in steam sterilizers. It is a wicking style integrator which provides a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Once the defined sterilization parameters have been reached the integrators pellet will melt and its dye will migrate from the non safe zone into the integrators safe zone. This will indicate to the user that the defined parameters for the integrator have been met.
Here's a breakdown of the acceptance criteria and study information for the K063799 device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The text explicitly states that the device was tested in accordance with AAMI/ANSI ST60:1996 - Sterilization of health care products - Chemical indicators - Part 1: General requirements. It also concludes that the device "meets the performance claims for a class 5 integrator according to AAMI/ANSI ST60." While specific quantitative acceptance criteria (e.g., pass/fail rates at certain deviations from sterilization parameters) are not explicitly detailed in the provided summary, the implication is that the device successfully met all requirements of the AAMI/ANSI ST60 standard for a Class 5 integrator.
| Acceptance Criteria (Implied by standard) | Reported Device Performance |
|---|---|
| Conformance to AAMI/ANSI ST60:1996 | The SPSmedical STEAMPlus™ Steam Integrator is a highly reliable and reproducible chemical integrator for steam sterilization processes and meets the performance claims for a Class 5 integrator according to AAMI/ANSI ST60. It is capable of integrating time and temperature into an easy to interpret "Safe Zone" where the pellet only melts and advances into the safe zone when conditions needed for spore death have been reached. |
| Equivalent to Predicate Device | Data has demonstrated that the SPSmedical STEAMPlus™ Steam Integrator is equivalent to the predicate device (3M Thermalog steam sterilization integrator - K813202). |
2. Sample Size and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts and Qualifications
The provided text does not mention the number of experts used to establish ground truth or their qualifications. Given this is a chemical indicator with a clear visual output ("Safe Zone"), it's likely the ground truth was established by direct observation of the chemical reaction in controlled sterilization conditions, rather than expert interpretation of complex data.
4. Adjudication Method
The provided text does not specify any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable. This device is a chemical indicator that provides a visual "safe zone" indication of sterilization parameters being met. It's not a diagnostic tool requiring human interpretation or a comparison of human reader performance with and without AI assistance.
6. Standalone Performance (Algorithm Only)
A standalone (i.e., algorithm only without human-in-the-loop performance) study was not explicitly done or relevant in the sense of a digital algorithm. This device is a physical chemical indicator. Its "performance" is its ability to accurately reflect sterilization parameters through a chemical reaction and visual change. The evaluation of its performance would be against known, controlled sterilization cycles in a lab setting.
7. Type of Ground Truth Used
The ground truth used would be based on direct measurement and verification of sterilization parameters (time, temperature, saturated steam) within the sterilization chamber during the testing of the integrators. The integrator's performance (i.e., whether the pellet melted and migrated to the "safe zone") would then be compared against these established sterilization conditions that are known to achieve microbial kill (spore death).
8. Sample Size for the Training Set
The provided text does not mention a training set sample size. As a non-AI, chemical indicator device, a typical "training set" in the machine learning sense is not applicable. The device's design and manufacturing are based on chemical principles and validation against established standards.
9. How Ground Truth for the Training Set was Established
As with point 8, the concept of a "training set" in an AI/machine learning context is not applicable here. The "ground truth" for the development of such a chemical indicator would be derived from:
- Scientific principles of sterilization: Understanding the time and temperature relationships required for microbial inactivation, particularly spore death, under saturated steam conditions.
- AAMI/ANSI ST60 standard requirements: The standard itself defines performance expectations for Class 5 integrators, which would guide the design and manufacturing of the device.
- Laboratory testing in controlled environments: Repeated experiments in validated steam sterilizers where time, temperature, and steam saturation are precisely controlled and measured, and the integrator's response is observed.
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510(k) Summary of Safety and Effectiveness
Submitter:
JAN - 5 2007
-
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 12th, 2006 -
Gary J. Socola Printed name of person submitting for 510(k)
-
. ov ocon Signature of person submitting for 510(k)
-
Vice President, Scientific Affairs . Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical STEAMPlus™ Steam Integrator |
|---|---|
| Classification Name: | Physical/Chemical Sterilization Process Indicator |
| Common Name: | Steam Integrator |
| Device Classification: | General Hospital - Class II, Regulation Number880.2800 |
| Product Code: | 80JOJ |
| Predicate Device: | 3M Thermalog steam sterilization integrator(510(k) No. K813202) |
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Device Description
The SPSmedical STEAMPlus™ Steam Integrator is designed to monitor sterilization parameters in steam sterilizers. It is a wicking style integrator which provides a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Once the defined sterilization parameters have been reached the integrators pellet will melt and its dye will migrate from the non safe zone into the integrators safe zone. This will indicate to the user that the defined parameters for the integrator have been met.
Intended Use
The SPSmedical STEAMPlus™ Steam Integrator monitors sterilization parameters in both prevacuum and gravity type steam sterilizers. They are a reliable tool used for the monitoring of steam sterilization processes and provide a visual indication that proper sterilization parameters were present within the sterilizers' chamber. Integrators can be used in wrapped packs, trays, pouches, containers and in unwrapped trays.
Performance Testing
Testing was performed in accordance with AAMVANSI ST60:1996 - Sterilization of health care products - Chemical indicators - Part 1: General requirements.
Recommended Storage Conditions
Store in a cool, dry place (15-30℃).
Shelf life
The shelf life shall be 5 years from the date of manufacture, when stored in a cool, dry place (15-30°C).
Biocompatibility
Risk analysis concludes that the manufacturing and subsequent use of this product has a low associated risk and that the product is safe for its intended use and handling.
Conclusion
Data has demonstrated that the SPSmedical STEAMPlus™ Steam Integrator is equivalent to the predicate device. Results of testing show the SPSmedical STEAMPlus Integrator is a highly reliable and reproducible chemical integrator for steam sterilization processes and meets the performance claims for a class 5 integrator according to AAMI/ANSI ST60. It is capable of integrating time and temperature into an easy to interpret "Safe Zone" where the pellet only melts and advances into the safe zone when conditions needed for spore death have been reached.
The STEAMPlus™ Steam Integrator raises no issues related to safety or effectiveness and therefore should be allowed for market in the United States.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with flowing ribbons or streamers beneath it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 5 2007
SPSmedical Supply Corporation C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K063799
Trade/Device Name: STEAMPlus™ Steam Sterilization Integrator Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: December 21, 2006 Received: December 22, 2006
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.
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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
f
Supa Qunn
fa Chiu Lin, Ph.D.
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
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INDICATIONS for USE STATEMENT
Applicant: SPSmedical Supply Corp.
510(k) Number (if known):
Device Name: STEAMPlus™ Steam Sterilization Integrator
Indications For Use:
STEAMPlus™ Sterilization Integrators are intended to be used to monitor parameters in steam sterilization cycles in healthcare facilities. The critical parameters for which the integrators will respond are time and temperature (under the presence of saturated steam). The integrators are intended to be used in steam cycles pperating at 121°C - 134°C.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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 (ODE)
Sheila F. Murphy, MD
Anesthesiology, General Hosp.
Control, Dental Devices
K063794
Page 1 of 1
§ 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).