(245 days)
The STERRAD NX Test Pack is used for routine monitoring of the STERRAD® NX Sterilization cycle and is also used for the periodic testing of a STERRAD NX System using hospital-defined loads.
The STERRAD® NX 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 NX Test Pack and its evaluation, but it does not contain information suitable for a typical acceptance criteria table and study details as might be found for a medical diagnostic device's clinical performance study.
Instead, this document is a 510(k) summary for a sterilization process indicator (biological indicator test pack). The "performance" here refers to its ability to accurately challenge a sterilization cycle, not diagnose a condition in a patient.
Here's an attempt to interpret the request based on the provided text, focusing on the available information about the device's technical performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Test Pack resistance to sterilization process (Standard Cycle) is at least as resistant as the biological model. | Survival curves and fraction negative data indicate the Test Pack configuration was at least as resistant as the biological model for the Standard Cycle. |
| Test Pack resistance to sterilization process (Advanced Cycle) is at least as resistant as the biological model. | Survival curves and fraction negative data indicate the Test Pack configuration was at least as resistant as the biological model for the Advanced Cycle. |
| Chemical Indicator in the Test Pack shows appropriate indicative functionality. | Response was determined to be appropriate for a chemical indicator when evaluated using half-cycle parameters of the Standard Cycle. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Three lots of CycleSure Biological Indicators were used within the Test Packs for exposure to various peroxide doses and increasing peroxide volumes for both Standard and Advanced Cycles. Specific numeric sample sizes (e.g., number of test packs per lot, number of exposures) are not provided.
- Data Provenance: The document does not specify the country of origin of the data. The study is non-clinical, involving laboratory testing of the device's resistance to sterilization. It is implied to be prospective testing conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this device. Ground truth for a sterilization indicator's performance is established by the known lethality of the sterilization agent (peroxide) and the resistance of the biological model (microorganisms), not by expert human interpretation.
4. Adjudication method for the test set
This section is not applicable. There's no human interpretation or decision-making that would require adjudication. Performance is assessed by objective measurements (survival curves, fraction negative data).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The device is a sterilization indicator, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable in the sense of an algorithm for diagnosis. However, if interpreted as a "device-only" performance evaluation, then yes, the entire study described is a standalone evaluation of the STERRAD NX Test Pack's physical and biological performance against established sterilization parameters, without human intervention in its function.
7. The type of ground truth used
The ground truth used is based on the biological model developed for the Standard and Advanced Sterilization Cycles. This model represents the expected resistance of microorganisms to the sterilization process. The Test Pack's performance (survival curves, fraction negative data) is compared directly to this established biological model to determine if it is "at least as resistant."
8. The sample size for the training set
This section is not applicable. The document describes the evaluation of a physical device against a biological model, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. (See point 8).
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Advanced Sterilization Products May 9, 2005
STERRAD" NX Test Pack Confidential
510(k) Summary
MAY 1 2 2005
Applicant's Name, Address, Telephone, FAX, Contact Person
Advanced Sterilization Products Division of Ethicon, Inc. 33 Technology Drive Irvine, CA 92618
Contact Person
Joseph M. Ascenzi, PhD Sr. Manager, Regulatory Affairs Telephone (949) 453-6352 Fax (949) 789-3900
Or
Kevin Corrigan Director, Regulatory Affairs Telephone (949) 453-6410 Fax (949) 789-3900
Summary Date May 9, 2005
Common Name
Biological Indicator (Test Pack)
Classification Name
ﻣﻦ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Class II
Officially Marketed Equivalent Device Name(s)
... ... .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
STERRAD® BI Test Pack STERRAD® CycleSure® Biological Indicator
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Advanced Sterilization Products May 9, 2005
STERRAD" NX Test Pack Confidential
Description of Device
The STERRAD® NX 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 NX Test Pack is used for routine monitoring of the STERRAD® NX Sterilization cycle and is also used for the periodic testing of a STERRAD NX System using hospital-defined loads.
Summary of Non-clinical Tests
The STERRAD NX Test Pack has been evaluated for its resistance to both the Standard and Advanced sterilization cycles in the STERRAD NX Sterilizer.
A comparison of the Test Pack to the biological model developed for both the Standard and Advanced 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 Advanced Cycles. The survival curves for these were compared to the survival curves for the biological models developed for the
a management and the comments of the comments of
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Standard and Advanced 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 Advanced 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 NX Test Pack has the necessary resistance relative to the biological model to be an appropriate challenge for testing both the Standard and Advanced Cycles of the STERRAD NX Sterilizer. The STERRAD NX Test Pack is substantially equivalent to the predicate devices STERRAD CycleSure Biological Indicator and STERRAD BI Test Pack
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:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in capital letters.
MAY 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Sterilization Products Dr. Joseph M. Ascenzi Senior Manager, Regulatory Affairs Benfor Manager, Isson Company/Division of Ethicon, Incorporated 33 Technology Drive Irvine, California 92618
Re: K042450
Trade/Device Name: STERRAD® NX Test Pack Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: April 1, 2005 Received: April 19, 2005
Dear Dr. Ascenzi:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother. The was your was a 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives 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 approval applied.ion (1 the Act. The general controls provisions of the Act include confors providens of an 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 IT your device is classified (been additional controls. Existing major regulations affecting (1 Mrx), it may of subject to tuat of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firster announcements concerning your device in the Federal Register.
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Page 2 - Dr. Ascenzi
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisou that 1 DTC Issualites on that your device complies with other requirements Incall that I DA nas made a actess and regulations administered by other Federal agencies. of the Act of ally I edelar statules and squirements, including, but not limited to: registration You must comply with an the Fiel brog (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality by sections (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) Fills letter will anow you to begal mading of substantial equivalence of your device to a premiarket notification. The PDF 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), II you desire specific advise to: Join are 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 Inay obtain other general meetirs, International and Consumer Assistance at its toll-free Division of 01 01 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suita Y. Michio, m.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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VANCED STERILIZATION PRODUCTS®
on company
Division of Ethicon, Inc.
Indications for Use Form
510(k) Number: K042450
Device Name: STERRAD® NX Test Pack
Indications for Use:
The STERRAD NX Test Pack is used for routine monitoring of the STERRAD® NX Sterilization cycle and is also used for the periodic testing of a STERRAD NX System using hospital-defined loads.
Prescription Use (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOPTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheila M Murphy, R
Civision of Anesthesiology, Ge a a loespital, Intection Control, Dental Devic
- 10(k) Number:
Appendix 1 - 2
Draft 7-2
§ 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).