(17 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to hydrogen peroxide. There is no mention of any computational analysis, learning, or decision-making processes.
No
The device is a chemical indicator used to verify exposure to vaporized hydrogen peroxide in sterilizers, not to treat a medical condition or ailment.
No
This device is a chemical indicator used to verify exposure to vaporized hydrogen peroxide in sterilizers, not to diagnose a medical condition in a patient.
No
The device description clearly states it is a physical chemical indicator consisting of a plastic material with a printed chemical indicator bar and comparison color match. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to verify exposure to vaporized hydrogen peroxide in sterilization systems. This is a quality control measure for sterilization processes, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: The device is a chemical indicator printed on a plastic material. It changes color based on exposure to a chemical (vaporized hydrogen peroxide), not based on a reaction with a biological sample.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with blood, urine, tissue, or any other biological specimen.
- Purpose: The purpose is to confirm that a sterilization cycle has reached the necessary conditions, not to provide information about a patient's health.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hyrdogen peroxide in the following sterilizers and cycles.
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
Product codes
JOJ
Device Description
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.
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
Nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Testing was completed in V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) sterilizer.
Tests performed:
- Color Change in Health Care Facility Cycle: Pass
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: Pass
- End Point Color Stability: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
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December 11, 2020
3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K203458
Trade/Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 20, 2020 Received: November 24, 2020
Dear Yumi Wackerfuss:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203458
Device Name
3M Comply Hydrogen Peroxide Chemical Indicator 1248
Indications for Use (Describe)
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hyrdogen peroxide in the following sterilizers and cycles.
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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K203458 510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Yumi Wackerfuss Senior Regulatory Affairs Associate Phone Number: (651) 736-5286 Fax Number: (651) 737-5320
Date of Summary: November 20, 2020
4
PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248
1. Device Name and Classification:
| Common Name: | Chemical Indicators |
|---|---|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR 880.2800(b) |
| Product Code: | JOJ |
2. Predicate Device:
K192937, 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248
3. Description of Device:
The 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.
4. Indications for Use
Proposed indication for use for this submission is:
Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:
STERRAD 100® Sterilization System
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
5
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
5. Technological Characteristic Comparison
The 3M™ Comply ™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of same model number (predicate device: K192937). No change has been made to the device materials, performance specifications, or fundamental technology.
| Items | Predicate Device (K192937) | Proposed device (this submission) |
|---|---|---|
| 3MTM Comply™ Hydrogen | ||
| Peroxide Chemical Indicator 1248 | 3MTM Comply™ Hydrogen Peroxide | |
| Chemical Indicator 1248 | ||
| Indications for | ||
| use | Use the 3M™ Comply™ Hydrogen | |
| Peroxide Chemical Indicator 1248 as | ||
| an internal pack process indicator to | ||
| verify exposure to vaporized | ||
| hydrogen peroxide in the | ||
| STERRAD® 100, STERRAD® | ||
| 100S, STERRAD® NX (Standard | ||
| and Advanced cycles), STERRAD® | ||
| 100NX (Standard, Flex, Express and | ||
| Duo cycles), STERRAD® NX with | ||
| ALLClear™ Technology (Standard | ||
| and Advanced cycles), STERRAD® | ||
| 100NX with ALLClear™ | ||
| Technology (Standard, Flex, Express | ||
| and Duo cycles), AMSCO® V- | ||
| PRO® 1 (Lumen cycle), AMSCO® | ||
| V-PRO® 1 Plus (Lumen and Non | ||
| Lumen cycles), AMSCO® V-PRO® | ||
| maX Low Temperature Sterilization | ||
| System (Lumen, Non Lumen, and | ||
| Flexible cycles), AMSCO® V-PRO® | ||
| 60 Low Temperature Sterilization | ||
| System (Lumen, Non Lumen and | ||
| Flexible cycles) and AMSCO® V- | ||
| PRO™ maX 2 Low Temperature | ||
| Sterilization System (Lumen, Non | ||
| Lumen, Flexible, and Fast Non | ||
| Lumen cycles) sterilizers. The | ||
| chemical indicator bar turns from | ||
| blue toward pink after exposure to | ||
| vaporized hydrogen peroxide. | Use the 3M™ Comply™ Hydrogen | |
| Peroxide Chemical Indicator 1248 as | ||
| an internal pack process indicator to | ||
| verify exposure to vaporized hydrogen | ||
| peroxide in the following sterilizers | ||
| and cycles: | ||
| STERRAD® 100 Sterilization | ||
| System | ||
| STERRAD® 100SSterilization | ||
| System | ||
| STERRAD® NX Sterilization | ||
| System (Standard and Advanced | ||
| cycles) | ||
| STERRAD® 100NX Sterilization | ||
| System (Standard, Flex, Express, | ||
| and Duo cycles) | ||
| STERRAD® NX with ALLClear® | ||
| Technology Sterilization System | ||
| (Standard and Advanced cycles) | ||
| STERRAD® 100NX with | ||
| ALLClear® Technology Sterilization | ||
| System (Standard, Flex, Express, | ||
| and Duo cycles) | ||
| V-PRO® 1 Low Temperature | ||
| Sterilization System (Lumen cycle) | ||
| V-PRO® 1 Plus Low Temperature | ||
| Sterilization System (Lumen and | ||
| Non Lumen cycles) | ||
| V-PRO® maX Low Temperature | ||
| Sterilization System (Lumen, Non | ||
| Lumen, and Flexible cycles) | ||
| V-PRO® 60 Low Temperature | ||
| Sterilization System (Lumen, Non | ||
| Lumen, and Flexible cycles) | ||
| V-PRO® maX 2 Low Temperature | ||
| Sterilization System (Lumen, Non | ||
| Lumen, Flexible, and Fast Non | ||
| Lumen cycles) | ||
| V-PRO® s2 Low Temperature | ||
| Sterilization System (Lumen, Non | ||
| Lumen, Flexible, and Fast cycles) | ||
| Items | Predicate Device (K192937) | Proposed device (this submission) |
| 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 | |
| The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. | ||
| Sterilizers and Sterilization Cycles | (1) STERRAD® 100 | (1) STERRAD® 100 |
| (2) STERRAD® 100S | (2) STERRAD® 100S | |
| (3) STERRAD® NX (Standard and Advanced cycles) | (3) STERRAD® NX (Standard and Advanced cycles) | |
| (4) STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) | (4) STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) | |
| (5) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) | (5) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) | |
| (6) STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express, and Duo cycles) | (6) STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express, and Duo cycles) | |
| (7) AMSCO® V-PRO™ 1 (Lumen cycle) | (7) V-PRO™ 1 (Lumen cycle) | |
| (8) AMSCO® V-PRO™ 1 Plus (Lumen and NonLumen cycles) | (8) V-PRO™ 1 Plus (Lumen and NonLumen cycles) | |
| (9) AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) | (9) V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) | |
| (10) AMSCO® V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) | (10) V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) | |
| (11) AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) | (11) V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) | |
| (12) V-PRO™ s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) | ||
| Substrate | Polyethylene | Identical |
| Biocompatibility | The exposure to health care professionals is minimal and well below any identified toxic thresholds for the compounds. | Identical |
| Color Change | Blue toward pink | Identical |
| Detection | Hydrogen Peroxide | Identical |
| Stability of the endpoint reaction | At least one month (4 weeks) | Identical |
| Shelf life | Two (2) years | Identical |
Table 6.1: Technological Characteristic Comparison Table
6
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
7
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
6. Nonclinical Comparison to the Predicate Device
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is identical to the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K192937). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K192937 was referenced in this submission to support performance of the device in the claimed sterilizers.
To demonstrate performance in the newly claimed sterilizers and cycles for the V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles), nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. Reference Table 6.2 for testing completed in V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) sterilizer and the tests were resulted passed.
Table 6.2 Summarv of Nonclinical Testing
| Test Method/Name | Result |
|---|---|
| Color Change in Health Care Facility Cycle | Pass |
| Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care | |
| Facility Cycle | Pass |
| End Point Color Stability | Pass |
7. Conclusion
Based on the non-clinical testing performance data, the 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K192937, Class II (21 CFR 880.2800), product code JOJ.