(197 days)
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" 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.
The provided text describes a 510(k) premarket notification for a medical device: the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, especially for expanded indications for use with specific sterilizer models.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228
Purpose of the Device: To secure packs and act as an external process indicator to differentiate unprocessed items from items processed in certain STERRAD® hydrogen peroxide sterilization processes (specifically STERRAD® 100, 100S, NX® - Standard and Advanced cycles, and 100NX® - Standard, Flex, Express and Duo cycles). The indicator stripes turn from blue to pink when exposed to vaporized hydrogen peroxide.
Overall Goal of the Submission: To expand the indications for use of an existing device (the 3M™ Comply™ 1228 Gas Plasma Indicator Tape, K020589) to include new STERRAD® sterilizer models (STERRAD® NX® and STERRAD® 100NX®). The core technology (indicator agent, design) is largely identical to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly listed in a "criteria" column with specific numerical targets but are inferred from the tests performed and the statements of successful verification. The reported device performance is described in the "Effectiveness" section and the "Comparison to Predicate Device" table.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Detectable color change from blue to pink when exposed to STERRAD® NX® (Standard & Advanced cycles) | Samples from six different lots were verified to meet the requirements for detectable color change in the STERRAD® NX® (Standard and Advanced cycles) sterilizers. Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color specification was found. |
| Detectable color change from blue to pink when exposed to STERRAD® 100NX® (Standard, Flex, Express & Duo cycles) | Samples from six different lots were verified to meet the requirements for detectable color change in the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers. Minimum time required for all indicator tape samples to indicate a "pass" in relation to the color specification was found. |
| Post-sterilization adhesion in STERRAD® NX® (Standard & Advanced cycles) | Samples from six different lots were verified to meet the requirements for post-sterilization adhesion in the STERRAD® NX® (Standard and Advanced cycles) sterilizers. |
| Post-sterilization adhesion in STERRAD® 100NX® (Standard, Flex, Express & Duo cycles) | Samples from six different lots were verified to meet the requirements for post-sterilization adhesion in the STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) sterilizers. |
| Stability of the endpoint color reaction to storage under typical office lighting conditions for at least twelve months post-exposure | 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. |
| Performance in STERRAD® 100 and 100S cycles (consistent with predicate, K020589) | Testing verified that the device turned from blue to pink when exposed to STERRAD® 100 and 100S cycles, and the minimum time for "pass" was consistent with original submission K020589. |
| Shelf life | Eighteen (18) months (Identical to predicate) |
| Biocompatibility (components of ink) | Components of the indicator ink are all of low general toxicity. Exposure to health care professionals is minimal and well below identified toxic thresholds. No anticipated exposure to medical instruments or patients. |
2. Sample Size used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For performance (color change and adhesion) in STERRAD® NX® and 100NX® cycles: "Samples from six different lots" were used.
- For End Point Color Stability: "Samples from four different lots" were used.
- The exact number of individual tapes per lot or per test condition is not specified in the provided text.
- Data Provenance: The studies were conducted as "Nonclinical Comparison" and "Effectiveness" testing by 3M Health Care. The text indicates "Health Care Facility Cycle" but does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket submission for a new indication, it would inherently be prospective testing.
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the text. The device is a chemical indicator that changes color. The "ground truth" for whether it passed or failed (i.e., turned pink) would likely be based on a visual assessment against a pass/fail reference color, which doesn't directly require radiologists or similar medical experts to establish a "ground truth" in the same way an AI diagnostic imaging system would. The document mentions "color match" and "color specification," implying objective criteria.
4. Adjudication method for the test set
- This information is not provided. Given the nature of a chemical indicator, which changes from blue to pink (a binary outcome), formal adjudication methods like 2+1 or 3+1 typically used for subjective human interpretation of complex medical images are not generally applicable or necessary. The "color specification" implies an objective assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is not mentioned as this device is a standalone chemical indicator, not an AI-assisted diagnostic tool that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is a standalone chemical indicator. Its performance (color change and adhesion) is evaluated directly, and its function is to provide a visible indication. There is no human-in-the-loop aspect for its performance; humans simply read the indicator's result. The tests described ("Performance in a Health Care Facility Cycle," "Minimum Exposure Parameters," "End Point Color Stability") are standalone evaluations of the device's physical and chemical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the device's performance appears to be established by controlled laboratory and "health care facility cycle" testing where the known exposure to the sterilant (hydrogen peroxide) under validated conditions (specific STERRAD® sterilizers and cycles) serves as the "truth." The "pass" or "fail" is determined by whether the indicator changes color according to a pre-defined "color specification" or "color match" and if adhesion is maintained. This falls under physical and chemical property verification against defined specifications.
8. The sample size for the training set
- This information is not applicable. This is a physical chemical indicator, not a machine learning/AI algorithm that requires a "training set." The device's color-changing chemistry is inherent to its design, not "trained."
9. How the ground truth for the training set was established
- This information is not applicable as there is no training set for this device.
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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.
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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
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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)
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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.
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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.
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Comparison to Predicate Device
| Feature | Submission Device:3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 | Predicate Device (K020589):3M™ Comply™ 1228 Gas PlasmaIndicator Tape |
|---|---|---|
| Indications foruse | Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape1228 to secure packs and as an external pack process indicator todifferentiate unprocessed items from items processed in theSTERRAD® 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-wovendisposable wraps and peel pouches. The chemical indicatorstripes turn from blue to pink after exposure to vaporizedhydrogen peroxide. | The 3M™ Comply™ 1228 Gas PlasmaIndicator Tape is indicated for use to securepacks as an external pack indicator todifferentiate processed from unprocesseditems when exposed to vapor hydrogenperoxide in the STERRAD® sterilizationprocesses (100, 100S, 50). The Comply 1228is suitable for use on non-woven disposablewraps and peel pouches. The diagonal stripesof chemical indicator ink turn from blue topink after exposure to vapor hydrogenperoxide in these sterilization processes. |
| Sterilizers andCycles | STERRAD® 100STERRAD® 100SSTERRAD® NX® (Standard and Advanced cycles)STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) | STERRAD® 100STERRAD® 100SSTERRAD® 50 |
| Indicator Agent | Alkali blue 6B dye | Identical |
| Cycle Conditionsfor Color Changein STERRAD®100 | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue topink when exposed to the STERRAD® 100 Sterilization cycle and the minimum time required for all indicator tapesamples to indicate a "pass" in relation to the color match was found.Demonstrated per original submission K020589. | |
| Cycle Conditionsfor Color Changein STERRAD®100S | Testing verified that the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 samples turned from blue topink when exposed to the STERRAD® 100S Sterilization cycle and the minimum time required for all indicatortape samples to indicate a "pass" in relation to the color match was found.Demonstrated per original submission K020589. | |
| Cycle Conditionsfor Color Changein STERRAD®50 | Not Applicable. | Testing verified that the 3M™ Comply™Hydrogen Peroxide Indicator Tape 1228samples turned from blue to pink whenexposed to the STERRAD® 50 Sterilizationcycle and the minimum time required for allindicator tape samples to indicate a "pass" inrelation to the color match was found.Demonstrated per original submissionK020589. |
| Cycle Conditionsfor Color Changein STERRAD®NX® | Testing verified that the 3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228 samples turned from blue to pink and theminimum time required for all indicator tape samples to indicatea "pass" in relation to the color specification was found whenexposed to the following STERRAD® NX® Sterilization Cycles:StandardAdvanced | |
| Cycle Conditionsfor Color Changein STERRAD®100NX® | Testing verified that the 3M™ Comply™ Hydrogen PeroxideIndicator Tape 1228 samples turned from blue to pink and theminimum time required for all indicator tape samples to indicatea "pass" in relation to the color specification was found whenexposed to the following STERRAD® 100NX® SterilizationCycles:StandardFlexExpressDuo | |
| Stability of theendpoint reaction | Twelve (12) months | |
| Shelf life | Eighteen (18) months | Identical |
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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.
§ 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).