(194 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 AI/ML in the description or performance studies.
No
The device is a chemical indicator used to verify exposure to vaporized hydrogen peroxide in sterilizers, not a device used for treating medical conditions or diseases.
No
Explanation: 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 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, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to verify exposure to vaporized hydrogen peroxide in specific sterilization systems. This is a process indicator for sterilization, not a test performed on biological samples (in vitro) to diagnose a condition or provide information about a patient's health.
- Device Description: The device is a chemical indicator printed on a plastic material. It changes color based on exposure to a chemical (hydrogen peroxide), not by analyzing biological samples.
- Lack of Biological Sample Analysis: The description does not mention any interaction with or analysis of biological materials like blood, urine, tissue, etc., which are characteristic of IVD devices.
- Focus on Sterilization Process: The performance studies and intended use clearly focus on the effectiveness of the sterilization process by indicating exposure to the sterilant.
Therefore, this device falls under the category of a process indicator for sterilization, 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® 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.
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
samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Color Change in Health Care Facility Cycle: Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle: Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PROTM maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
- End Point Color Stability: Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
- Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue to pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicators to indicate a "pass" in relation to the color match was found to be between 10 and 15 minutes.
- Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned from blue to pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for all indicators to indicate a "pass" in relation to the color match was found to be between 4 and 8 minutes.
- Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns from blue to pink to indicate a "pass" in relation to the device color match printed on the indicator when exposed to complete Standard and Advanced cycles in the STERRAD® NX® sterilizer. The minimum time required for all samples to indicate a "pass" in these cycles is listed below: Standard cycle: Between 5.25 minutes and 7 minutes; Advanced cycle: Between 11.25 minutes and 15 minutes.
- Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns from blue to pink to indicate a "pass" in relation to the device color match printed on the indicator when exposed to complete Standard, Flex, Express, and Duo cycles in the STERRAD® 100NX® sterilizer. The minimum time required for all samples to indicate a "pass" in these cycles is listed below: Flex cycle: Between 12.75 minutes and 17 minutes; Express cycle: Between 4.5 and 6 minutes; Duo cycle: Between 10 seconds and 8 minutes.
- Testing verified that the 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 turns from blue to pink to indicate a "pass" in relation to the color match when exposed to a complete Lumen, Non Lumen or Flexible cycle in an AMSCO® V-PROTM maX Low Temperature Sterilization System. The minimum time required for all samples to indicate a “pass” in these cycles is listed below: Lumen cycle: Between 7 seconds and 8 minutes; Non Lumen cycle: Between 6 minutes and 9 minutes; Flexible cycle: Between 9 minutes and 12 minutes.
- Stability of the endpoint reaction: At least four (4) weeks (28 days).
- Shelf life: Two (2) years.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a standard black and white image with the address information.
August 14, 2017
3M Company Nadia Battah Regulatory Affairs Associate 3M Health Center 3M Center, Building 275-5W-06 St Paul. Minnesota 55144-1000
Re: K170321
Trade/Device Name: 3M Comply Hydrogen Peroxide Chemical Indicator 1248 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: July 12, 2017 Received: July 13, 2017
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 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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Michael J. Ryan -S
for Lori Wiggins 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)
K170321
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® 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.
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
Premarket Notification [510(k)] Summary
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person: Nadia Battah Regulatory Affairs Associate Phone Number: (651) 733-0929 FAX Number: (651) 737-5320
Date of Summary: July 31, 2017
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 (21 |
| CFR §880.2800) | |
| Device Classification: | Class II |
| Product Code: | JOJ |
Predicate Device:
3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K150622)
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
Nonclinical Comparison to the Predicate Device
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 (K150622). There has been no change to the device's materials, performance specifications, or fundamental scientific technology. The intent of this submission is to expand the indications for use to include use in the 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.
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ ComplyTM 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.
5
Comparison to Predicate Device
| Feature | Submission Device:
3M™ Comply™ Hydrogen Peroxide
Chemical Indicator 1248 | Predicate Device (K150622):
3M™ Comply™ Hydrogen Peroxide
Chemical Indicator 1248 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, 100S, NX® (Standard and
Advanced cycles), 100NX® (Standard, Flex,
Express and Duo cycles), AMSCO® V-
PROTM 1 (Lumen cycle), AMSCO® V-
PROTM 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. | 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, 100S, NX® (Standard and
Advanced cycles) and 100NX® (Standard,
Flex, Express and Duo cycles) sterilization
processes. The chemical indicator bar turns
from blue to pink after exposure to vaporized
hydrogen peroxide. |
| Sterilizers | 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) | STERRAD® 100
STERRAD® 100S
STERRAD® NX (Standard and Advanced
cycles)
STERRAD® 100NX (Standard, Flex,
Express, and Duo cycles) |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditions
for Color Change in
STERRAD® 100 | Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned
from blue to pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum
time required for all indicators to indicate a "pass" in relation to the color match was found to
be between 10 and 15 minutes.
Demonstrated per submission K013228. | |
| Cycle Conditions
for Color Change in
STERRAD® 100S | Testing verified that the 3MTM Comply™ Hydrogen Peroxide Chemical Indicators 1248 turned
from blue to pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum
time required for all indicators to indicate a "pass" in relation to the color match was found to
be between 4 and 8 minutes.
Demonstrated per submission K013228. | |
| Cycle Conditions
for Color Change in
STERRAD® NX
(Standard and
Advanced cycles) | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns
from blue to pink to indicate a "pass" in relation to the device color match printed on the
indicator when exposed to complete Standard and Advanced cycles in the STERRAD® NX®
sterilizer. The minimum time required for all samples to indicate a "pass" in these cycles is
listed below:
Standard cycle: Between 5.25 minutes and 7 minutes
Advanced cycle: Between 11.25 minutes and 15 minutes
Demonstrated per submission K150622. | |
| Cycle Conditions
for Color Change in
STERRAD®
100NX (Standard,
Flex Express and
Duo cycles) | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 turns
from blue to pink to indicate a "pass" in relation to the device color match printed on the
indicator when exposed to complete Standard, Flex, Express, and Duo cycles in the
STERRAD® 100NX® sterilizer. The minimum time required for all samples to indicate a
"pass" in these cycles is listed below: | |
| | Flex cycle: Between 12.75 minutes and 17 minutes | |
| | Express cycle: Between 4.5 and 6 minutes | |
| | Duo cycle. Between 10 seconds and 8 minutes | |
| | Demonstrated per submission K150622. | |
| Cycle Conditions
for Color Change in
AMSCO® V-
PROTM 1 (Lumen
cycle), AMSCO®
V-PROTM 1 Plus
(Lumen and Non
Lumen cycles), and
AMSCO® V-
PROTM maX Low
Temperature
Sterilization System
(Lumen, Non
Lumen, and
Flexible cycles)
sterilizers | Testing verified that the 3MTM ComplyTM
Hydrogen Peroxide Chemical Indicator 1248
turns from blue to pink to indicate a “pass” in
relation to the color match when exposed to a
complete Lumen, Non Lumen or Flexible
cycle in an AMSCO® V-PROTM maX Low
Temperature Sterilization System. The
minimum time required for all samples to
indicate a “pass” in these cycles is listed
below: | |
| | Lumen cycle: Between 7 seconds and 8
minutes | |
| | Non Lumen cycle: Between 6 minutes and 9
minutes. | |
| | Flexible cycle: Between 9 minutes and 12
minutes. | |
| | | |
| | | |
| | | |
| | | |
| | | |
| Stability of the
endpoint reaction | At least four (4) weeks (28 days) | Identical |
| Shelf life | Two (2) years | Identical |
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Biocompatibility
The components of the indicator ink used on the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248 are all of low general toxicity. The exposure to the health care professional is minimal and well below any identified toxic thresholds for the compounds. There is no anticipated direct exposure to the patient. Indirect exposure to the patient via potential exposure to medical instruments with the indicator ink is minimal and well below any identified toxic thresholds for the compounds.
Summary of Nonclinical Testing
The effectiveness of the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is demonstrated by the following tests:
- Color Change in Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change in the AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizer.
- Minimum Exposure Parameters to Affect the Change of the Indicator in Health Care Facility Cycle - Samples from six different lots were evaluated to determine the minimum time required for the color change of the indicator when used in the AMSCO® V-PROTM maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles).
7
- End Point Color Stability Samples from six different lots were verified to be stable to storage under typical office lighting conditions for at least one month (4 weeks) post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
Conclusion
The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 is as safe, as effective, and performs as well as the predicate, K150622, 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248.