(161 days)
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No
The document describes a physical test pack for steam sterilization and does not mention any software, algorithms, or AI/ML components.
No
This device is a sterilizer test pack used for routine and challenge testing of steam sterilization cycles, not for treating or diagnosing any medical condition.
No
This device is a sterilizer test pack designed to challenge steam sterilization cycles. It evaluates the effectiveness of a sterilization process, but it does not diagnose a medical condition in a patient.
No
The device description explicitly states it "consists of a steam sterilization integrator placed inside a package of porous and non-porous material," indicating it is a physical product with hardware components, not software only.
Based on the provided information, the SPSmedical STEAMPlus™ Sterilizer Test Pack is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for testing the performance of steam sterilizers, not for diagnosing a disease or condition in a patient using a sample from the human body.
- Device Description: The device consists of materials and an integrator designed to challenge the sterilization process, not to analyze biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device being used to test or analyze any biological samples (blood, urine, tissue, etc.) from a patient.
- Focus on Sterilizer Performance: The entire description and performance study focus on the device's ability to indicate whether a sterilization cycle was successful, which is a quality control measure for medical equipment, not a diagnostic test for a patient.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SPSmedical STEAMPlus™ Sterilizer Test Pack does not fit this definition.
N/A
Intended Use / Indications for Use
The SPSmedical STEAMPlus ™ Sterilizer Test Pack is designed to monitor sterilization cycles in gravity displacement steam sterilizers at 121°C and in prevacuum steam sterilizers at 132°C. It is to be used for routine monitoring and challenge testing of steam sterilizers and can be used in conjunction with a biological indicator test pack.
The SPSmedical STEAMPlus™ Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.
Product codes (comma separated list FDA assigned to the subject device)
80JOJ
Device Description
The SPSmedical STEAMPlus™ Sterilizer Test Pack consists of a steam sterilization integrator placed inside a package of porous and non-porous material. The SPSmedical STEAMPlus TM Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: Two hundred ten (210) sterllization tests were run to compare performance standards/results of the SPSmedical STEAMPlus™ Sterilizer Test Pack to the AAMI biological indicator test pack. A biological indicator strip containing Bacillus stearothermophilus spores was used within the AAM biological indicator test pack along with a STEAMPlus™ integrator. Of the two hundred and ten sterilization tests that were run; 60 comparison tests for failures were orchestrated, 90 comparison tests for passfiailures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure sterilization testing of SPSmedical STEAMPlus™ Sterilizer Test Pack consistently showed results comparable to the AAMI biological indicator test pack.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Propper Pass/Fail Steam Challenge Pack (K991276)
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.
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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).
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§ 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
JUL 1 8 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 July 12, 2002 .
- Gary J. Socola ● Printed name of person submitting for 510(k) 0)
- der X lar ot . Signature of be son submitting for 510(k)
- Director of Quality Assurance . Title of person submitting for 510(k)
Device Name and Classification
| Trade Name: | SPSmedical STEAMPlus™ Sterilizer Test Pack |
|---|---|
| Classification Name: | Sterilization Process Indicator |
| Common Name: | Steam Challenge Test |
| Device Classification: | Class II, Regulation Number 880.2800 |
| Product Code: | 80JOJ |
| Predicate Device: | Propper Pass/Fail Steam Challenge Pack (K991276) |
1
Device Description:
The SPSmedical STEAMPlus™ Sterilizer Test Pack consists of a steam sterilization integrator placed inside a package of porous and non-porous material. The SPSmedical STEAMPlus TM Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration.
Intended Use:
The SPSmedical STEAMPlus ™ Sterilizer Test Pack is designed to monitor sterilization cycles in gravity displacement steam sterilizers at 121°C and in prevacuum steam sterilizers at 132°C. It is to be used for routine monitoring and challenge testing of steam sterilizers and can be used in conjunction with a biological indicator test pack.
Technical Characteristics:
The SPSmedical STEAMPlus™ Sterilizer 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 STEAMPlus™ Sterilizer Test Pack is designed to create a significant challenge to air removal and steam penetration. The SPSmedical STEAMPlus™ Sterilizer Test Pack adds resistance and impedes steam penetration to the steam sterilization integrator located within the pack. This provides a significant challenge to the steam sterilization process.
Non-Clinical Testing:
Two hundred ten (210) sterllization tests were run to compare performance standards/results of the SPSmedical STEAMPlus™ Sterilizer Test Pack to the AAMI biological indicator test pack. A biological indicator strip containing Bacillus stearothermophilus spores was used within the AAM biological indicator test pack along with a STEAMPlus™ integrator. Of the two hundred and ten sterilization tests that were run; 60 comparison tests for failures were orchestrated, 90 comparison tests for passfiailures were orchestrated and 60 tests for passing results were orchestrated. The pass and failure sterilization testing of SPSmedical STEAMPlus™ Sterilizer Test Pack consistently showed results comparable to the AAMI biological indicator test pack.
Conclusion:
Supportive data has demonstrated that the SPSmedical STEAMPlus ™ Sterilizer Test Pack is equivalent to the predicate device. Results of performance testing indicate that the SPSmedical STEAMPlus™ Sterilizer Test Pack provides a sufficient load challenge to monitor steam gravity displacement sterilization cycles at 121°C and for prevacuum steam sterilization cycles at 132°C. The SPSmedical STEAMPlus ™ Sterilizer Test Pack is an effective and reliable, single use 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JUL 1 8 2002
Mr. Gary J. Socola Director of Quality Assurance & Sterilization Projects SPS Medical Supply Corporation 6789 West Henrietta Road Rush, New York 14543
Re: K020409
Trade/Device Name: STEAMplus™ Sterilization Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: May 2, 2002 Received: May 3, 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. Ulatowski
Timoth 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
SPSmedical Supply Corp. Applicant:
510(k) Number (if known): _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The SPSmedical STEAMPlus™ Sterilizer Test Pack is indicated for use in routine and challenge testing of steam sterilization cycles in both gravity displacement and prevacuum steam sterilizers.
(PLEASE 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)
Qùin Si him
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _