(197 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to hydrogen peroxide, a purely chemical reaction. There is no mention of any computational analysis or learning algorithms.
No
This device is an indicator tape used to confirm sterilization processes, not to treat or diagnose a medical condition.
No
The device is an external pack process indicator used to differentiate unprocessed items from items processed in sterilization processes, not to diagnose a medical condition in a patient.
No
The device is a physical indicator tape with chemical stripes, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to secure packs and act as an external process indicator for sterilization. It differentiates between processed and unprocessed items. This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample.
- Device Description: The device is a tape with a chemical indicator. It does not involve the analysis of biological specimens.
- Lack of Biological Sample Analysis: The description does not mention any interaction with or analysis of biological materials (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Function: Its function is to indicate exposure to a sterilization agent (vaporized hydrogen peroxide), not to diagnose a disease or condition in a patient.
Therefore, the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is a sterilization process indicator, not an IVD.
N/A
Intended Use / Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to 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 Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.
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)
The effectiveness of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is demonstrated by the following tests:
- Performance in a Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change and post-sterilization adhesion in the STERRAD® NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- Minimum Exposure Parameters to Affect the Change of the Indicator in a 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 STERRAD NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- End Point Color Stability Samples from four different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
Testing was conducted to confirm performance of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 with the STERRAD® NX® and STERRAD® 100NX® per FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators; Guidance for Industry and FDA Staff, December 19, 2003.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff entwined with a serpent, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 1, 2015
3M Health Care Ms. Hilary B. Hovde Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144
Re: K150694
Trade/Device Name: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization process indicator Regulatory Class: II Product Code: JOJ Dated: August 19, 2015 Received: August 21, 2015
Dear Ms. Hovde,
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
Page 2 - Ms. Hovde
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 (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 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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) K150694
Device Name
3MTM ComplyTM Hydrogen Peroxide Indicator Tape 1228
Indications for Use (Describe)
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.
| Type of Use (Select one or both, as applicable) | ☐Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act)☑Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | ☐Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | ☑Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) |
|---|---|---|---|---|---|---|---|
| ☐Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | ☑Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) | ||
| ☐ | Research Use (Part 21 CFR 201.3 Subject to Section 520(g) of the Act) | ||||||
| ☑ | Some Other Use (21 CFR 201.3 Subject to Section 520(g) of the Act) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Premarket Notification [510(k)] Summary
Image /page/3/Picture/1 description: The image shows the 3M logo. The logo consists of the number "3" followed by the letter "M", both in a bold, sans-serif font. The color of the text is red, and the background is white.
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person: Hilary B. Hovde Regulatory Affairs Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Date of Summary: September 28, 2015
Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 |
| Classification Name: | Indicator, physical/chemical sterilization process (21 CFR § |
| 880.2800) | |
| Device Classification: | Class II |
| Product Code: | JOJ |
Predicate Device:
- 3M™ Comply™ 1228 Gas Plasma Indicator Tape (K020589) .
Description of Device:
The 3M™ Comply" Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.
4
Nonclinical Comparison to the Predicate Device
The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is similar in design to the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Comply™ 1228 Gas Plasma Indicator Tape (K020589). After the original clearance, but prior to product launch and commercialization in 2002, the adhesive was changed to improve adhesion. The change was managed according to 3M quality system design controls. The intent of this submission is to expand the indications for use to include use in the STERRAD® NX® and STERRAD® 100NX® sterilizers.
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
Indications for Use
Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.
5
Comparison to Predicate Device
| Feature | Submission Device:
3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | Predicate Device (K020589):
3M™ Comply™ 1228 Gas Plasma
Indicator Tape |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape
1228 to secure packs and as an external pack process indicator to
differentiate unprocessed items from items processed in the
STERRAD® 100, 100S, NX® (Standard and Advanced cycles)
and 100NX® (Standard, Flex, Express and Duo cycles)
sterilization processes. The tape is suitable for use on non-woven
disposable wraps and peel pouches. The chemical indicator
stripes turn from blue to pink after exposure to vaporized
hydrogen peroxide. | The 3M™ Comply™ 1228 Gas Plasma
Indicator Tape is indicated for use to secure
packs as an external pack indicator to
differentiate processed from unprocessed
items when exposed to vapor hydrogen
peroxide in the STERRAD® sterilization
processes (100, 100S, 50). The Comply 1228
is suitable for use on non-woven disposable
wraps and peel pouches. The diagonal stripes
of chemical indicator ink turn from blue to
pink after exposure to vapor hydrogen
peroxide in these sterilization processes. |
| Sterilizers and
Cycles | STERRAD® 100
STERRAD® 100S
STERRAD® NX® (Standard and Advanced cycles)
STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) | STERRAD® 100
STERRAD® 100S
STERRAD® 50 |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditions
for Color Change
in STERRAD®
100 | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue to
pink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicator tape
samples to indicate a "pass" in relation to the color match was found.
Demonstrated per original submission K020589. | |
| Cycle Conditions
for Color Change
in STERRAD®
100S | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue to
pink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for all indicator
tape samples to indicate a "pass" in relation to the color match was found.
Demonstrated per original submission K020589. | |
| Cycle Conditions
for Color Change
in STERRAD®
50 | Not Applicable. | Testing verified that the 3M™ Comply™
Hydrogen Peroxide Indicator Tape 1228
samples turned from blue to pink when
exposed to the STERRAD® 50 Sterilization
cycle and the minimum time required for all
indicator tape samples to indicate a "pass" in
relation to the color match was found.
Demonstrated per original submission
K020589. |
| Cycle Conditions
for Color Change
in STERRAD®
NX® | Testing verified that the 3M™ Comply™ Hydrogen Peroxide
Indicator Tape 1228 samples turned from blue to pink and the
minimum time required for all indicator tape samples to indicate
a "pass" in relation to the color specification was found when
exposed to the following STERRAD® NX® Sterilization Cycles:
Standard
Advanced | |
| Cycle Conditions
for Color Change
in STERRAD®
100NX® | Testing verified that the 3M™ Comply™ Hydrogen Peroxide
Indicator Tape 1228 samples turned from blue to pink and the
minimum time required for all indicator tape samples to indicate
a "pass" in relation to the color specification was found when
exposed to the following STERRAD® 100NX® Sterilization
Cycles:
Standard
Flex
Express
Duo | |
| Stability of the
endpoint reaction | Twelve (12) months | |
| Shelf life | Eighteen (18) months | Identical |
6
Biocompatibility
The components of the indicator ink used on the 3M™ Comply™Hydrogen Peroxide Indicator Tape 1228 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 exposure to medical instruments with the ink, nor to the patient.
Effectiveness
The effectiveness of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 is demonstrated by the following tests:
- Performance in a Health Care Facility Cycle Samples from six different lots were verified to meet the requirements for detectable color change and poststerilization adhesion in the STERRAD® NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- Minimum Exposure Parameters to Affect the Change of the Indicator in a 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 STERRAD NX® (Standard and Advanced cycles) and the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers.
- End Point Color Stability Samples from four different lots were verified to be stable to storage under typical office lighting conditions for at least twelve months post-exposure in a Hydrogen Peroxide Health Care Facility Cycle.
Conclusion
Testing was conducted to confirm performance of the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 with the STERRAD® NX® and STERRAD® 100NX® per FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators; Guidance for Industry and FDA Staff, December 19, 2003.
The 3M™ Comply" Hydrogen Peroxide Indicator Tape 1228 is substantially equivalent to the predicate device. There are no new questions of safety or effectiveness.