(99 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational processing, learning, or data analysis involved in its function.
No
The device is a chemical indicator used to verify exposure to vaporized hydrogen peroxide in sterilizers, not to treat a medical condition.
No
Explanation: The 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 explicitly states it consists of a "noncellulosic plastic material onto which a chemical indicator bar is printed," indicating it is a physical product, 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 sterilizers. 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 that changes color based on exposure to a chemical (vaporized hydrogen peroxide). It does not interact with biological specimens.
- Lack of Biological Sample Interaction: IVDs 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 such specimens.
Therefore, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is a sterilization process indicator, not an In Vitro Diagnostic device.
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® 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) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.
Product codes (comma separated list FDA assigned to the subject device)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Testing was completed in the AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex and Express cycles) sterilizer.
Key results:
- 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 (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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 26, 2019
3M Company Nadia Battah Regulatory Affairs Associate 3m Center Building 275-5w-06 St.paul. Minnesota 55144
Re: K183211
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: February 8, 2019 Received: February 11, 2019
Dear Nadia Battah:
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 mav, 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 avare 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183211
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® 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) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible 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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3
Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number and letter are connected to each other.
510(k) Summary for 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248
K183211
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Nadia Battah Senior Regulatory Affairs Associate Phone Number: (651) 733-0929 Fax Number: (651) 737-5320
Date of Summary: February 22, 2019
4
1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3MTM ComplyTM 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:
K170321 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
3. Description of Device:
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.
4. Indications for Use
Use the 3MTM ComplyTM 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.
5
| Submission Device: K183211: | Predicate Device (K170321): | |
|---|---|---|
| Feature | 3M™ Comply™ Hydrogen Peroxide Chemical | 3M™ Comply™ Hydrogen Peroxide |
| Chemical Indicator 1248 | ||
| 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) 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. | 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, 100S, NX® | ||
| (Standard and Advanced cycles), | ||
| 100NX® (Standard, Flex, Express and | ||
| Duo cycles), AMSCO® V-PRO™ 1 | ||
| (Lumen cycle), AMSCO® V-PRO™ 1 | ||
| Plus (Lumen and Non Lumen cycles), and | ||
| AMSCO® V-PRO™ maX Low | ||
| Temperature Sterilization System | ||
| (Lumen, Non Lumen, and Flexible | ||
| cycles) sterilizers. The chemical indicator | ||
| bar turns from blue to pink after exposure | ||
| to vaporized hydrogen peroxide. | ||
| 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) | ||
| AMSCO® V-PRO™ 60 (Lumen, Non Lumen and | ||
| Flexible cycles) | STERRAD® 100 | |
| STERRAD® 100S | ||
| STERRAD® NX (Standard and Advanced | ||
| cycles) | ||
| STERRAD® 100NX (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) | ||
| Substrate | Polyethylene | Identical |
| Biocompatibility | The exposure to health care professional 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 |
5. Summary of Technological Characteristics compared to Predicate Device
6
6. Summary of Non-Clinical Testing
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 (K170321). As no change has been made to the device materials, performance specifications, or fundamental technology, the biocompatibility and nonclinical testing provided in K170321 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, 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 the AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex and Express cycles) sterilizer.
Table 6.1 Summary of Nonclinical Testing
| Test | 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 intended uses, technological characteristics and non-clinical performance data, the 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as or better than the legally marketed device, the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 cleared under K170321, Class II (21 CFR 880.2800), product code JOJ.