(77 days)
No
The device description and intended use clearly describe a chemical indicator strip that changes color based on the concentration of a disinfectant. There is no mention of any computational processing, algorithms, or learning capabilities.
No.
The device is a test strip designed to monitor the concentration of a disinfectant, not to treat a patient or disease.
No
The device monitors the concentration of a disinfectant solution, not a physiological or biological state of a patient. It's used in disinfectant preparation, not for diagnosing medical conditions.
No
The device description clearly states it is a chemical indicator strip consisting of an absorbent paper pad impregnated with reactive chemicals bonded to a polymer film, indicating it is a physical, hardware-based device.
Based on the provided information, the STERIS Resert XL Test Strip is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended to determine the concentration of a high-level disinfectant solution. This involves testing a sample (the disinfectant solution) in vitro (outside of the body) to assess its properties.
- Device Description: It's a chemical indicator strip designed to react with the disinfectant solution to provide information about its concentration. This is a common characteristic of IVD devices used for testing substances.
- Predicate Devices: The listed predicate devices (SPOROX™ Test Strips and Browne Metrex 1.8% Glutaraldehyde Indicator) are also IVD devices used for monitoring disinfectant concentrations. This further supports the classification of the STERIS Resert XL Test Strip as an IVD.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use and nature of the device clearly align with the definition of an IVD. It's a test performed on a sample outside the body to provide information relevant to a medical or healthcare process (in this case, ensuring proper disinfection).
N/A
Intended Use / Indications for Use
The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.
The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.
Product codes
JOJ
Device Description
The STERIS Resert XL Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The STERIS Resert XL Test Strip has been developed to monitor the Resert® XL HLD High-Level Disinfectant (K080420) that has an MRC of 1.5%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the word "STERIS" in a bold, sans-serif font. There is a small graphic in the upper right corner of the word. Below the word is a black square with a white design in the center.
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AUG 2 2 2008
510(k) Summary For STERIS Resert XL Test Strip
is
STERIS Corporation 5960 Heisley Road Mentor OH 44060-1834
Contact:
i:
》》
John Robert (Jack) Scoville Fellow Regulatory Affairs Telephone: (440) 392-7330 (440) 357-9198 Fax No:
Summary Date:
August 08, 2008
STERIS Corporation = 5960 Heisley Road = Mentor, OH 44060-1834 USA = 440-354-2600
CONFIDENTIAL
August 08, 2008
B-2
1
1. Device Name
| Trade Name: | STERIS Resert XL Test Strip |
|---|---|
| Common/Usual Name: | Resert XL Test Strip |
| Classification Name: | Physical/chemical sterilization process indicator |
| (21 CFR 880.2800 (b), Product Code JOJ). |
1
2. Predicate Devices
3. Description of Device
The STERIS Resert XL Test Strip is a chemical indicator strip consisting of an absorbent paper pad impregnated with the reactive chemicals, which is adhesively bonded to one end of a polymer film. The STERIS Resert XL Test Strip has been developed to monitor the Resert® XL HLD High-Level Disinfectant (K080420) that has an MRC of 1.5%.
4. Intended Use
The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.
The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.
5. Description of Safety and Substantial Equivalence
The proposed and predicate devices are all single use indicators used to monitor either hydrogen peroxide or glutaraldehyde concentration in specific solutions. The differences between the proposed STERIS Resert XL Test Strip and predicate devices are limited to differences in the device design, materials and concentration range being monitored. These differences do not raise any new issues of safety and efficacy.
2
A summary of the technological characteristics of the new device in comparison to those of the predicate devices is provided in Section 12 of this premarket notification.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2008
Mr. John Scoville Fellow, Regulatory Affairs STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
Re: K081600
Trade/Device Name: STERIS Resert XL Test Strip Regulation Number: 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 6, 2008 Received: June 6, 2008
Dear Mr. Scoville:
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.
4
Page 2 - Mr. Scoville
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contant the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Sreall 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 vours.
Chiu S. Lin, Ph. D.
Chiu S. Lin, Ph. D Division 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): K081600
Device Name:
STERIS Resert XL Test Strip
Indications for Use:
The STERIS Resert XL Test Strip is a high level disinfectant concentration monitor dedicated for use with Resert® XL HLD High-Level Disinfectant. The purpose of the STERIS Resert XL Test Strip is to determine whether the concentration of a Resert XL HLD High-Level Disinfectant solution is above the minimum recommended concentration (MRC) of 1.5%.
The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and does not confirm disinfection.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ X_____________________________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A Murphy
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
で
510(k) Number: K081600
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CONFIDENTIAL