(196 days)
The STERRAD® 100NX Test Pack is used for routine monitoring of the STERRAD® 100NX sterilization cycle and is also used for the periodic testing of a STERRAD® 100NX system using hospital-defined loads.
The STERRAD® 100NX Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle.
The provided text describes the STERRAD 100NX Test Pack, a biological indicator used for monitoring sterilization cycles. It details a non-clinical study conducted to evaluate its resistance compared to biological models.
Here's the information regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| At least as resistant to the sterilization process as the biological model (based on survival curves). | "With both cycles the Test Pack configuration was at least as resistant as the biological model." |
| At least as resistant to the sterilization process as the biological model (based on fraction negative data). | "fraction negative data collected using Test Pack containing three lots of CycleSure BI when exposed to increasing volumes of peroxide in both the Standard and Flex Scope Cycles indicate that the Test Pack configuration is at least as resistant as the biological models." |
| Indicative functionality of the chemical indicator (appropriate response for a chemical indicator). | "Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the response was determined to be appropriate for a chemical indicator." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text mentions "Test Packs containing three lots of CycleSure Biological Indictor" were exposed to various doses. No specific numerical sample size for the test set (number of individual test packs or repetitions) is provided.
- Data Provenance: Not explicitly stated, but the study is described as "non-clinical tests" and was conducted by the applicant, Advanced Sterilization Products. It does not mention country of origin or whether it was retrospective or prospective, although the nature of the testing implies a prospective, controlled laboratory study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device is based on the biological efficacy of sterilization (killing microorganisms) as measured by the response of the biological indicator and its comparison to a pre-defined "biological model," not on expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is based on biological efficacy and comparison to a model, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study focuses on the physical and biological performance of a sterilization indicator, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not an AI/algorithm-based device in the context of image analysis or similar applications. The "standalone" performance here refers to the device's ability to accurately indicate sterilization, which is what the non-clinical tests assessed. The device itself (the biological indicator) is the "algorithm," and its performance was evaluated.
7. The Type of Ground Truth Used
The ground truth used is based on biological efficacy and a biological model. Specifically, the resistance of the Test Pack (containing biological indicators) to the sterilization process was compared to "biological models developed for both the Standard and Flex Scope Cycles." This involves:
* Survival curves (measuring organism survival at various sterilization doses).
* Fraction negative data (indicating the proportion of indicators that show growth vs. no growth).
* Chemical indicator response (appropriateness for detection).
Essentially, the ground truth for performance is the established efficacy requirements for a sterilization biological indicator.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set in the typical sense. The "training" for such a device would be its design and manufacturing process to consistently meet the biological resistance criteria.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a "training set" in the context of machine learning. The "biological models" used for comparison are the reference points, which would have been established through prior biological efficacy studies of sterilization processes and the resistance of standard test organisms.
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510(k) Summary
Image /page/0/Picture/3 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '071537'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvinc, CA 92618
Contact Person
Reuben Lawson Regulatory Affairs Manager Email rlawson4(a)aspus.jnj.com Telephone (949) 789-8545 Fax (949) 789-3900
Or
Kevin Corrigan Director, Regulatory Affairs Email kcorriga@aspus.jnj.com Telephone (949) 453-6410 Fax (949) 789-3900
Summary Date
June 4, 2007
Common Name
Biological Indicator (Test Pack)
Classification Name
Class II
Officially Marketed Equivalent Device Name(s)
STERRAD® NX Test Pack STERRAD® CycleSure® Biological Indicator
Image /page/0/Picture/18 description: The image shows a date stamp that reads "DEC 1 8 2007". The stamp is slightly tilted. The text is in all caps and is a sans-serif font. The ink appears to be black.
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Description of Device
The STERRAD® 100NX Test Pack consists of several components, CycleSure® Self-Contained Biological Indicator (biological and chemical indicator), a vial into which the CycleSure is placed, a vial cap with orifice, and a pouch for holding the vial during the sterilization cycle.
Indications for Use
. . . . .
The STERRAD 100NX Test Pack is used for routine monitoring of the STERRAD® 100NX Sterilization cycle and is also used for the periodic testing of a STERRAD 100NX System using hospital-defined loads.
Summary of Non-clinical Tests
The STERRAD 100NX Test Pack has been evaluated for its resistance to both the Standard and Flex Scope sterilization cycles in the STERRAD 100NX Sterilizer.
A comparison of the Test Pack to the biological model developed for both the Standard and Flex Scope Cycles indicates that the Test Pack is at least as resistant to the sterilization process as the biological model. This is based on both survival curves and fraction negative data as a function of dose.
Test Packs containing three lots of CycleSure Biological Indictor were exposed to several doses of peroxide in both the Standard and Flex Scope Cycles. The survival curves for these were compared to the survival curves for the biological models developed for the
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Standard and Flex Scope Cycles. With both cycles the Test Pack configuration was at least as resistant as the biological model.
Additionally, fraction negative data collected using Test Pack containing three lots of CycleSure BI when exposed to increasing volumes of peroxide in both the Standard and Flex Scope Cycles indicate that the Test Pack configuration is at least as resistant as the biological models.
Indicative functionality of the chemical indicator in the Test Pack configuration was evaluated using half cycle parameters of the Standard Cycle and the response was determined to be appropriate for a chemical indicator.
Overall Performance Conclusions
The STERRAD 100NX Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing both the Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer. The STERRAD 100NX Test Pack is substantially equivalent to the predicate devices, STERRAD NX Test Pack and STERRAD CycleSure Biological Indicator.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2007
Mr. Reuben Lawson Regulatory Affairs Manager Advanced Sterilization Products, Incorporated 33 Technology Drive Irvine, California 92618
Re: K071537
Trade/Device Name: STERRAD 100NX Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: November 30, 2007 Received: December 3, 2007
Dear Mr. Lawson:
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. Lawson
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,
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
510(k) Number (if known): K071537 Device Name: STERRAD 100NX Test Pack Indications for Use:
The STERRAD® 100NX Test Pack is used for routine monitoring of the STERRAD® 100NX sterilization cycle and is also used for the periodic testing of a STERRAD® 100NX system using hospital-defined loads.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela H. Murphy, M.D.
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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).