(196 days)
STERRAD NX Test Pack, STERRAD CycleSure Biological Indicator
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No
The document describes a biological and chemical indicator test pack for monitoring sterilization cycles, with no mention of AI or ML technology.
No
The device is used for monitoring the sterilization cycle of another device, not for treating patients.
No
This device is used for monitoring the effectiveness of a sterilization cycle, not for diagnosing a medical condition in a patient.
No
The device description explicitly lists physical components (biological indicator, chemical indicator, vial, vial cap, pouch), indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring and testing a sterilization cycle (STERRAD® 100NX). This is a quality control and process monitoring function, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The components are related to biological and chemical indicators used to assess the effectiveness of sterilization, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnosing a disease, or providing information about a patient's health status.
The device is clearly intended for use in a hospital setting for quality control of sterilization equipment.
N/A
Intended Use / 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.
Product codes
FRC
Device Description
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.
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
hospital-defined loads.
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
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 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.
Key Metrics
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Predicate Device(s)
STERRAD NX Test Pack, STERRAD CycleSure Biological Indicator
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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).
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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: