(108 days)
Not Found
No
The device is a simple chemical indicator that changes color based on chemical concentration, with no mention of computational processing or learning algorithms.
No.
This device is a chemical indicator used to monitor the concentration of a sterilant, not to provide therapy directly to a patient.
No
This device is a chemical indicator used to monitor the concentration of a sterilant, not to diagnose a medical condition in a patient. It assesses the performance of a processing system.
No
The device description clearly states it is a physical chemical indicator consisting of a polymeric strip with indicator ink, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "peracetic acid concentration indicator for routine monitoring of the SYSTEM IE Liquid Chemical Sterilant Processing System." This indicates it's used to test a chemical solution (the sterilant) to determine if it meets a specific concentration requirement for a sterilization process.
- Device Description: The description reinforces its function as a chemical indicator to "monitor the peracetic acid (PAA) concentration... at the point of use."
- Function: The device works by reacting with the peracetic acid in the sterilant solution and changing color based on the concentration. This is a classic example of an in vitro diagnostic test – analyzing a sample (the sterilant solution) outside of the body to provide information about a process (sterilization).
- Performance Studies: The performance studies focus on the device's ability to accurately indicate the peracetic acid concentration (sensitivity, specificity, color read time, analytic specificity, etc.). These are typical performance metrics for IVD devices.
- Predicate Devices: The listed predicate devices are also chemical monitoring strips/process indicators, which are generally considered IVDs in the context of monitoring sterilization processes.
While it's not directly testing a biological sample from a patient, it's performing a test in vitro (outside of a living organism) to assess the efficacy of a process that is critical for patient safety (sterilization of medical devices). This falls under the scope of IVD regulation.
N/A
Intended Use / Indications for Use
The Verify® SYSTEM IE Chemical Indicator (SYSTEM 1E Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEM IE Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate.
The unprocessed Verify® SYSTEM 1E Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.
Product codes (comma separated list FDA assigned to the subject device)
JQJ
Device Description
The Verify® SYSTEM IE Chemical Indicator is a single-use chemical indicator consisting of a polymeric strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevents the indicator ink from leaching from the substrate. The indicator was developed to monitor the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in a SYSTEM IE Liquid Chemical Sterilant Processing System during a processing cycle.
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)
Performance testing was conducted to determine that the Verify® SYSTEM 1E Chemical Indicator is an effective monitor for the peracetic acid concentration of the use dilution of the SYSTEM 1E Liquid Chemical Sterilant Processing Cycle.
The following table summarizes the non-clinical testing performed to demonstrate that the Verify® SYSTEM 1E Chemical Indicator is safe and effective. The performance testing has demonstrated that the Verify SYSTEM 1E Chemical Indicator is substantially equivalent to its predicates and raises no new questions of safety or effectiveness.
| Testing | Results |
|---|---|
| Comparative Sensitivity and Specificity | PASS The Verify SYSTEM 1E Chemical Indicator can correctly identify PASS or FAIL conditions for PAA concentrations in the SYSTEM 1E Liquid Chemical Sterilant Processing System. |
| Color Read Time | PASS The observed color of Verify SYSTEM 1E Chemical Indicators has been shown to be stable for 30 minutes following completion of the processor cycle. However, it is recommended that the PASS/FAIL evaluation be made immediately after the CI strip is removed from the processor. |
| Analytic Specificity | PASS Under conditions of normal storage and use, as indicated in the labeling, any color change observed in a processed Verify SYSTEM 1E Chemical Indicator will be the result of the presence of PAA in the processor use dilution. |
| Blind Reader | PASS Blind Readers correctly evaluated 179 of 179 randomly displayed processed Verify SYSTEM 1E Chemical Indicators. |
| Simulated Use Testing | PASS The addition of a medical device to the processing chamber does not affect the performance of the Verify SYSTEM 1E Chemical Indicator. |
| UV Study | PASS The bottle used to ship and store the Verify SYSTEM 1E Chemical Indicators protects the unprocessed strips from the effects of UV light. |
| Shelf Life | PASS The Verify SYSTEM 1E Chemical Indicator maintains appropriate indicator characteristics after 15 months of storage. |
| Effects of Aggressive Chemicals | PASS The bottle used to ship and store the Verify SYSTEM 1E Chemical Indicator protects the unprocessed strips from the effects of aggressive chemicals. |
| Effects of Contaminants | PASS The presence of possible contaminants from inadequate cleaning or rinsing of the medical devices does not affect the expected color change of processed Verify SYSTEM 1E Chemical Indicators. |
| Open Bottle Stability | PASS At the 13 month time point, The Verify SYSTEM 1E Chemical Indicators demonstrated the appropriate FAIL results. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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).
0
K102217 p.104 STERIS®
NOV 2 2 2010
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510(k) Summary For Verify® SYSTEM 1E Chemical Indicator
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 639-4459
Contact:
Robert F. Sullivan Senior Director, FDA Regulatory Affairs Telephone: (440) 392-7695 Fax No: (440) 357-9198
Submission Date:
November 17, 2010
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
November 17, 2010
Appendix B: Page 2 of 5
1
K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator
1. Device Name
| Trade Name: | Verify® SYSTEM IE Chemical Indicator |
|---|---|
| Models: | N/A |
| Common Name: | Chemical Indicator |
| Classification Name: | Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ) |
2. Predicate Devices
Verify Chemical Monitoring Strip for Resert Solutions (K081600) cleared as Resert XL Test Strip
Reliance CI Process Indicator (K063285)
3. Device Description
The Verify® SYSTEM IE Chemical Indicator is a single-use chemical indicator consisting of a polymeric strip with indicator ink printed on one end. The indicator is covered by a clear, sterilant-permeable laminate to protect the strip from damage during handling and prevents the indicator ink from leaching from the substrate. The indicator was developed to monitor the peracetic acid (PAA) concentration of the STERIS S40 Sterilant Concentrate at the point of use in a SYSTEM IE Liquid Chemical Sterilant Processing System during a processing cycle.
Intended Use: 4.
The Verify® SYSTEM IE Chemical Indicator (SYSTEM 1E Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEM IE Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate.
The unprocessed Verify® SYSTEM 1E Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.
2
K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator
p 3.
· 5. Description of Safety and Substantial Equivalence
The proposed device and the Reliance CI Process Indicator predicate device both consist of a printed indicator spot on an inert polymeric substrate. The Resert XL Test Strip predicate device consists of a paper pad impregnated with indicator ink attached to an inert polymeric substrate. The active ingredients of the inks used for the proposed and predicate devices are dyes/salts that change color upon oxidation by the active (peracetic acid or hydrogen peroxide).
The proposed device, like the predicates, indicates exposure to a targeted effective concentration or dose of active by a color change to the designated end point. The proposed device changes from blue to pink when exposed to concentrations of peracetic acid greater than 1820 ppm; the predicate devices also each indicate exposure to the effective concentration or dose of the active germicide by a color change as described in their respective labeling.
Therefore, the differences between the proposed and predicate oxidative chemistry concentration monitors are limited to differences in the indicator ink composition, in the active being detected and device materials (for one predicate device) and/or the concentration range being monitored. These differences in technological characteristics do not raise any new issues of safety and effectiveness.
6. Performance Testing
Performance testing was conducted to determine that the Verify® SYSTEM 1E Chemical Indicator is an effective monitor for the peracetic acid concentration of the use dilution of the SYSTEM 1E Liquid Chemical Sterilant Processing Cycle.
The following table summarizes the non-clinical testing performed to demonstrate that the Verify® SYSTEM 1E Chemical Indicator is safe and effective. The performance testing has demonstrated that the Verify SYSTEM 1E Chemical Indicator is substantially equivalent to its predicates and raises no new questions of safety or effectiveness.
3
K102217
$P^{4}fy$
K102217/S002 STERIS Response to 11/15/10 Request for Clarification Verify SYSTEM 1E Chemical Indicator
.
| Testing | Results |
|---|---|
| Comparative | |
| Sensitivity and | |
| Specificity | PASS |
| The Verify SYSTEM 1E Chemical Indicator can correctly identify PASS | |
| or FAIL conditions for PAA concentrations in the SYSTEM 1E Liquid | |
| Chemical Sterilant Processing System. | |
| Color Read Time | PASS |
| The observed color of Verify SYSTEM 1E Chemical Indicators has been | |
| shown to be stable for 30 minutes following completion of the processor | |
| cycle. However, it is recommended that the PASS/FAIL evaluation be | |
| made immediately after the CI strip is removed from the processor. | |
| Analytic Specificity | PASS |
| Under conditions of normal storage and use, as indicated in the labeling, | |
| any color change observed in a processed Verify SYSTEM 1E Chemical | |
| Indicator will be the result of the presence of PAA in the processor use | |
| dilution. | |
| Blind Reader | PASS |
| Blind Readers correctly evaluated 179 of 179 randomly displayed | |
| processed Verify SYSTEM 1E Chemical Indicators. | |
| Simulated Use | |
| Testing | PASS |
| The addition of a medical device to the processing chamber does not affect | |
| the performance of the Verify SYSTEM 1E Chemical Indicator. | |
| UV Study | PASS |
| The bottle used to ship and store the Verify SYSTEM 1E Chemical | |
| Indicators protects the unprocessed strips from the effects of UV light. | |
| Shelf Life | PASS |
| The Verify SYSTEM 1E Chemical Indicator maintains appropriate | |
| indicator characteristics after 15 months of storage. | |
| Effects of | |
| Aggressive | |
| Chemicals | PASS |
| The bottle used to ship and store the Verify SYSTEM 1E Chemical | |
| Indicator protects the unprocessed strips from the effects of aggressive | |
| chemicals. | |
| Effects of | |
| Contaminants | PASS |
| The presence of possible contaminants from inadequate cleaning or rinsing | |
| of the medical devices does not affect the expected color change of | |
| processed Verify SYSTEM 1E Chemical Indicators. | |
| Open Bottle Stability | PASS |
| At the 13 month time point, The Verify SYSTEM 1E Chemical Indicators | |
| demonstrated the appropriate FAIL results. |
·
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Robert F. Sullivan Senior Director STERIS Corporation 5960 Heisley Road Mentor, Ohio 44060
NOV 2 2 2010
Re: K102217
Trade/Device Name: Verify® SYSTEM 1E Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JQJ Dated: November 17, 2010 Received: November 18, 2010
Dear Mr. Sullivan:
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 reguire 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
Page 2- Mr.Sullivan
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance..
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.M., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
6
K↓02217
NOV 2 2 2010
Indications for Use
510(k) Number (if known):
Device Name:
Verify SYSTEM 1E Chemical Indicator
Indications For Use:
The Verify® SYSTEM IE Chemical Indicator (SYSTEM 1E Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEMIE Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate. The unprocessed Verify® SYSTEM 1E Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.
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)
L. Shullk
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
Page 1 of 1
510(k) Number: 4102217
Page 4-1