(29 days)
No
The device is a chemical indicator that changes color based on exposure to hydrogen peroxide. There is no mention of any computational processing, learning, or AI/ML components in the description or performance studies.
No.
This device is an internal pack process indicator used to verify exposure to vaporized hydrogen peroxide in sterilizers, not a therapeutic device for treating medical conditions.
No
This device is an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in sterilizers, not a diagnostic device for medical conditions.
No
The device description explicitly states it consists of a "noncellulosic plastic material onto which a chemical indicator bar is printed," indicating it is a physical, hardware-based 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 specific sterilization systems. This is a quality control measure for the sterilization process, not a diagnostic test performed on a biological sample to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to a chemical (vaporized hydrogen peroxide). It does not interact with biological samples.
- Lack of Biological Sample Interaction: IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue). This device does not use or analyze any biological samples.
- Purpose: The purpose is to confirm that a sterilization cycle has reached the necessary conditions, not to provide information about a patient's health status.
Therefore, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is a sterilization process indicator, not an IVD.
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 hydrogen peroxide in the STERRAD® 1 00S, 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 , Flexible cycles), and AMSCO® V-PROTM maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
Product codes
JOJ
Device Description
The 3M™ ComplyTM 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.
Test Method / Name: Color Change in Health Care Facility Cycle
Purpose: To demonstrate the color change of the device when used in the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System
Acceptance Criteria: Color change from blue toward pink
Result: Pass
Test Method / Name: Minimum Exposure Parameters
Purpose: To determine the minimum time required for the color change of the device when used in the AMSCO® V-PROTM maX 2 Low Temperature Sterilization System
Acceptance Criteria: Determination of the minimum time for color to change from blue toward pink
Result: Pass
Test Method / Name: End Point Color Stability
Purpose: To demonstrate the post-sterilization color stability of the device after use in the AMSCO® V-PROTM maX 2 Low Temperature Sterilization System
Acceptance Criteria: No significant color change after exposure to fluorescent light for a minimum of 1 month (4 weeks).
Result: 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).
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November 16, 2019
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K192937
Trade/Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 17, 2019 Received: October 18, 2019
Dear Mary Fretland:
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
1
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 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,
Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192937
Device Name
3MTM ComplyTM 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 hydrogen peroxide in the STERRAD® 1 00S, 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 , Flexible cycles), and AMSCO® V-PROTM maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) sterilizers. 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)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 K192937
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320
Date of Summary: November 04, 2019
4
PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Chemical Indicator |
| 1248 | |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | JOJ |
2. Predicate Device:
K183211 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
3. Description of Device:
The 3M™ ComplyTM 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
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, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, 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.
5
PREMARKET NOTIFICATION [510(k)] 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
| 5. Technological Characteristic Comparison Table | |||
|---|---|---|---|
| Feature | Submission Device (K192937): | ||
| 3M™ Comply™ Hydrogen | |||
| Peroxide Chemical Indicator 1248 | Predicate Device (K183211): | ||
| 3M™ Comply™ Hydrogen | |||
| Peroxide Chemical Indicator 1248 | Comparison | ||
| 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 | |||
| 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) and AMSCO® V- | |||
| PRO® 60 Low Temperature | |||
| Sterilization System (Lumen, Non | |||
| Lumen and Flexible cycles) | |||
| sterilizers. The chemical indicator bar | |||
| turns from blue toward pink after | |||
| exposure to vaporized hydrogen | |||
| peroxide. | Similar | ||
| Sterilizers and | |||
| Sterilization | |||
| Cycles | STERRAD® 100 | ||
| STERRAD® 100S | |||
| STERRAD® NX (Standard and | |||
| Advanced cycles) | |||
| STERRAD® NX with ALLClear™ | |||
| Technology (Standard and Advanced | |||
| cycles) | |||
| STERRAD® 100NX (Standard, Flex, | |||
| Express, and Duo 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) | STERRAD® 100 | ||
| STERRAD® 100S | |||
| STERRAD® NX (Standard and | |||
| Advanced cycles) | |||
| STERRAD® NX with ALLClear™ | |||
| Technology (Standard and Advanced | |||
| cycles) | |||
| STERRAD® 100NX (Standard, Flex, | |||
| Express, and Duo 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) | Similar | ||
| Submission Device (K192937): | Predicate Device (K183211): | Comparison | |
| Feature | 3M™ Comply™ Hydrogen | ||
| Peroxide Chemical Indicator 1248 | 3M™ Comply™ Hydrogen | ||
| Peroxide Chemical Indicator 1248 | |||
| AMSCO® V-PRO™ 60 (Lumen, | |||
| Non Lumen and Flexible cycles) | |||
| AMSCO® V-PRO™ maX 2 Low | |||
| Temperature Sterilization System | |||
| (Lumen, Non-Lumen, Flexible, and | |||
| Fast Non-Lumen cycles) | AMSCO® V-PRO™ 60 (Lumen, | ||
| Non Lumen and Flexible cycles) | |||
| Substrate | Polyethylene | Polyethylene | Identical |
| Biocompatibility | The exposure to health care | ||
| professionals is minimal and well | |||
| below any identified toxic thresholds | |||
| for the compounds. | The exposure to health care | ||
| professionals is minimal and well | |||
| below any identified toxic thresholds | |||
| for the compounds. | Identical | ||
| Color Change | Blue toward pink | Blue toward pink | Identical |
| Detection | Hydrogen Peroxide | Hydrogen Peroxide | Identical |
| Stability of the | |||
| endpoint | |||
| reaction | At least one month (4 weeks) | At least one month (4 weeks) | Identical |
| Shelf life | Two (2) years | Two (2) years | Identical |
5. Technological Characteristic Comparison Table
6
PREMARKET NOTIFICATION [510(k)] 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248
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 (K18321). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K183211 was referenced in this submission to support performance of the device in the claimed sterilizers.
6. Summary of Nonclinical Testing
To demonstrate performance in the newly claimed sterilizers and 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 6.1 for testing completed in AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles) sterilizer.
| Test Method / Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Color Change in | |||
| Health Care | |||
| Facility Cycle | To demonstrate the color change of | ||
| the device when used in the | |||
| AMSCO® V-PRO™ maX 2 Low | |||
| Temperature Sterilization System | Color change from blue toward | ||
| pink | Pass | ||
| Minimum | |||
| Exposure | |||
| Parameters | To determine the minimum time | ||
| required for the color change of the | |||
| device when used in the AMSCO® | Determination of the minimum | ||
| time for color to change from | |||
| blue toward pink | Pass |
Table 6.1 Summary of Nonclinical Testing
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PREMARKET NOTIFICATION [510(k)] 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
| Test Method /
| Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| End Point Color | |||
| Stability | V-PROTM maX 2 Low | ||
| Temperature Sterilization System | No significant color change after | ||
| exposure to fluorescent light for a | |||
| minimum of 1 month (4 weeks). | Pass | ||
| To demonstrate the post- | |||
| sterilization color stability of the | |||
| device after use in the AMSCO® | |||
| V-PROTM maX 2 Low | |||
| Temperature Sterilization System |
7. Conclusion
Based on the non-clinical testing performance data, the 3MTM Comply™ 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 K183211, Class II (21 CFR 880.2800), product code JOJ.