(84 days)
Not Found
No
The device is a chemical indicator tape that changes color based on exposure to steam sterilization parameters. There is no mention of any computational or learning-based technology.
No.
This device is an indicator tape used to confirm that an item has been exposed to a sterilization process, not to treat a medical condition.
No.
Explanation: The device is a chemical indicator tape used to confirm exposure to a sterilization process, not to diagnose a medical condition in a patient.
No
The device is a physical indicator tape with adhesive, backing, and chemical indicator stripes, 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 "demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units." This is a quality control function for sterilization, not a diagnostic test performed on biological samples.
- Device Description: The device is a tape with a chemical indicator that changes color when exposed to steam sterilization. It does not interact with or analyze biological specimens.
- Performance Studies: The performance studies focus on the indicator's response to sterilization conditions (saturated steam, dry heat) and its stability, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
- Predicate Device: The predicate device is also an "Indicator Tape," further supporting its classification as a sterilization process indicator, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinquish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Lead Free Steam Indicator Tape 1322 to demonstrate that packs have Comply ! been exposed to the sterilization process. The 3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps.
3M™ Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
3M™ ComplyTM Lead Free Steam Indicator Tape 1322:
The 3M™ Comply™ Lead Free Indicator Tape 1322 for steam sterilization consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of wraps, including untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper and paper/ plastic wraps in order to secure the pack during steam sterilization. After sterilization, the tape is designed to remove easily and cleanly from untreated woven wraps. The backing is a beige colored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Comply™ Lead Free Steam Indicator Tape is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014. This Product Is Not Made With Natural Rubber Latex.
3MTM Attest™ Lead Free Steam Indicator Tape 1355:
The 3MTM Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of disposable non-woven, paper and paper/plastic wraps in order to secure the pack during steam sterilization. The backing is bluecolored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Attest™ Lead Free Steam Indicator Tape for Disposable Wraps is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014. This Product Is Not Made With Natural Rubber Latex.
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
health care provider
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)
Nonclinical testing was performed in accordance with:
- FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003
- ISO 11140-1:2014 Sterilization of healthcare products—Chemical Indicators—Part 1: General requirements for Type 1 (e1) Process Indicators.
Table 6.1 Summary of Nonclinical Testing:
- Saturated Steam Testing (ISO 11140-1: 2014, Type 1): Purpose to confirm device meets the Type 1 process indicator for steam requirements. All testing is completed in a saturated steam Resistometer. Acceptance Criteria: 2.0 Min at 121°C - No change or change that is markedly different from the visible color change.; 10.0 Min at 121°C - Visible color change.; 0.3 Min at 134°C - No change or change that is markedly different from the visible color change.; 2.0 Min at 134°C - Visible color change. Result: Pass.
- Dry Heat Testing (ISO 11140-1: 2014, Type 1): Purpose to verify device requires the presence of saturated steam to turn to reach endpoint. Acceptance Criteria: 30 min at 140°C - No change or change that is markedly different from the visible color change. Result: Pass.
- Health Care Facility Simulated Use Testing: Purpose to confirm device provides acceptable performance in cleared customer use sterilization cycles. Acceptance Criteria: Device reaches endpoint color when exposed to customer use cycles. Device does not reach endpoint when exposed to failing conditions in customer use cycles. Result: Pass.
- End Point Color Stability for 6 months: Purpose to confirm endpoint color stability for samples exposed to passing and failing conditions in a steam Resistometer. Acceptance Criteria: Endpoint decision remains unchanged after 6 months. Result: Pass.
The mechanism of action is identical to the predicate device as there is no change to the indicator ink (fundamental technology). The description of the end point specification for the subject devices was updated from dark brown or black color to darker color for more customer clarity since the type 1 (e1) process indicator is intended to distinguish between exposed or not exposed to a steam sterilization process.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
May 23, 2022
3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K220564
Trade/Device Name: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: February 25, 2022 Received: February 28, 2022
Dear Yumi Wackerfuss:
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
3M™ Comply™ Lead Free Steam Indicator Tape 1322
3M™ Attest™ Lead Free Steam Indicator Tape 1355
Indications for Use (Describe)
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinquish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Lead Free Steam Indicator Tape 1322 to demonstrate that packs have Comply ! been exposed to the sterilization process. The 3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps.
3M™ Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The "3" is larger than the "M". The logo is simple and recognizable.
TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3MTM ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
1. Device Name and Classification:
| Common or Usual Name | Sterilization Process Indicator | |
|---|---|---|
| Proprietary Name: | 3M TM ComplyTM Lead Free Steam Indicator Tape 1322 | |
| 3MTM AttestTM Lead Free Steam Indicator Tape 1355 | ||
| Classification Name: | Indicator, physical/chemical sterilization process | |
| Submission Number | K220564 | |
| Device Classification: | Class II, 21 CFR § 880.2800(b) | |
| Product Code: | JOJ |
2. Date of Preparation: May 18, 2022
3. Predicate Device:
K101528, Comply 1322 Lead Free Indicator Tape
4. Device Description:
3M™ ComplyTM Lead Free Steam Indicator Tape 1322
The 3M™ Comply™ Lead Free Indicator Tape 1322 for steam sterilization consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of wraps, including untreated woven (i.e., reusable 100% cotton and cotton/poly blends) and disposable non-woven, paper and paper/ plastic wraps in order to secure the pack during steam sterilization. After sterilization, the tape is designed to remove easily and cleanly from untreated woven wraps. The backing is a beige colored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Comply™ Lead Free Steam Indicator Tape is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014. This Product Is Not Made With Natural Rubber Latex.
3MTM Attest™ Lead Free Steam Indicator Tape 1355
The 3MTM Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps consists of an adhesive, backing, and chemical indicator stripes. The adhesive is an aggressive, pressuresensitive adhesive designed to adhere to a variety of disposable non-woven, paper and paper/plastic wraps in order to secure the pack during steam sterilization. The backing is bluecolored crepe paper and provides the stretch needed for pack expansion during sterilization. The chemical indicator lines will show a visual color change from off-white/tan to darker color when exposed to a steam sterilization process. 3M™ Attest™ Lead Free Steam Indicator Tape for Disposable Wraps is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.
This Product Is Not Made With Natural Rubber Latex.
5
Image /page/5/Picture/0 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3M™ ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
5. Indications for Use
3MTM ComplyTM Lead Free Steam Indicator Tape 1322
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 to demonstrate that packs have been exposed to the sterilization process. The 3MIM Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps.
3MTM Attest™ Lead Free Steam Indicator Tape 1355
3MTM Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate thatthe unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121°C | 30 minutes |
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275 °F/135°C | 3, 10 minutes |
| Dynamic air-removal | 250 °F/121°C | 15, 20, 30 minutes |
| Dynamic air-removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes |
| Dynamic air-removal | 273 °F/134°C | 3, 3.5, 4 minutes |
| Dynamic air-removal | 275 °F/135°C | 3, 3.5, 4, 10 minutes |
Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 to demonstrate that packs have been exposed to the sterilization process. The 3MM Attest™ Lead Free Steam Indicator Tape 1355 is designed to secure packs wrapped with disposable non-woven, paper andpaper/plastic wraps.
6
Image /page/6/Picture/0 description: The image contains the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number "3" has a white horizontal line going through it. The logo is simple and recognizable.
TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3M™ Comply™ Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
510(k) Summary
Summary of Technological Characteristics compared to Predicate Device 6.
| Element | Subject Devices: K220564 | Predicate Device (K101528) | Comparison | ||||
|---|---|---|---|---|---|---|---|
| 3MTM ComplyTM Lead Free Steam Indicator Tape 1322 | Comply 1322 Lead Free Indicator Tape | ||||||
| 3MTM AttestTM Lead Free Steam Indicator Tape 1355 | |||||||
| Indications for use | 3MTM ComplyTM Lead Free Steam Indicator Tape 1322 | ||||||
| is designed for use by a health care provider to | |||||||
| accompany individual units (e.g. wrapped packs) to | |||||||
| demonstrate that the unit has been exposed to the | |||||||
| sterilization process and to distinguish between | |||||||
| processed and unprocessed units. | The 3MTM ComplyTM Lead Free Process Indicators | ||||||
| for Steam are designed to demonstrate that the unit | |||||||
| or load has been exposed to a steam sterilization | |||||||
| process and to distinguish between processed and | |||||||
| unprocessed units or loads. | |||||||
| 3M Comply Lead Free Process indicators for | |||||||
| Steam include: | |||||||
| • Comply 1322 Lead Free Indicator Tape | Similar. The | ||||||
| indications for | |||||||
| use for the | |||||||
| subject devices | |||||||
| include specific | |||||||
| cycle exposure | |||||||
| times compared | |||||||
| to the predicate | |||||||
| with a | |||||||
| maximum | |||||||
| exposure time | |||||||
| provided. | |||||||
| Use the 3MTM ComplyTM Lead Free Steam Indicator | |||||||
| Tape 1322 in steam process below: | Use the 3MTM ComplyTM Lead Free Process | ||||||
| Indicators for Steam in steam sterilization | |||||||
| processes described below. | |||||||
| Cycle Type | Temperature | Exposure Time | Cycle Type | Temperature | Exposure Time | ||
| Gravity | 250 °F/121°C | 30 minutes | Gravity | 250 °F/121°C | ≥30 minutes | ||
| (wrapped) | |||||||
| Gravity | 270 °F/132°C | 3, 4, 10, 15, 25 | |||||
| minutes | Gravity | 270 °F/132°C | ≥3 minutes | ||||
| (unwrapped) | |||||||
| ≥15 minutes | |||||||
| (wrapped) | The subject | ||||||
| devices may be | |||||||
| utilized in a | |||||||
| Dynamic Air | |||||||
| Removal cycle | |||||||
| compared to | |||||||
| the predicate | |||||||
| which is | |||||||
| intended for | |||||||
| "Vacuum- | |||||||
| assisted | |||||||
| (prevacuum)" | |||||||
| cycles. | |||||||
| Gravity | 275 °F/135°C | 3, 10 minutes | Gravity | 275 °F/135°C | ≥3 minutes | ||
| (unwrapped) | |||||||
| ≥10 minutes | |||||||
| (wrapped) | |||||||
| Dynamic air- | |||||||
| removal | 250 °F/121°C | 15, 20, 30 | |||||
| minutes | Vacuum- | ||||||
| assisted | |||||||
| (prevacuum) | 270 °F/132°C | ≥3 minutes | |||||
| (unwrapped) |
4 minutes
(wrapped) | The subject
device can be
used for both
wrapped and |
| | Dynamic air-
removal | 270 °F/132°C | 3, 3.5, 4, 5.5, 6, 9,
10, 15 minutes | | | | |
| | Dynamic air-
removal | 273 °F/134°C | 3, 3.5, 4 minutes | | | | |
| | Dynamic air-
removal | 275 °F/135°C | 3, 3.5, 4, 10
minutes | | | | |
7
Image /page/7/Picture/0 description: The image shows the 3M logo. The logo is red and consists of the number "3" followed by the letter "M". The logo is simple and recognizable. The background is white.
TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3M™ ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
Predicate Device (K101528) Subject Devices: K220564 Element Comparison 3MTM ComplyTM Lead Free Steam Indicator Tape Comply 1322 Lead Free Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355 secure packs wrapped with untreated woven and 273 °F/134°C ≥3.5 minutes unwrapped Vacuumloads. disposable non-woven paper and paper/plastic wraps. assisted (unwrapped) (prevacuum) ≥4 minutes 3MTM Attest™ Lead Free Steam Indicator Tape 1355 (wrapped) for disposable wraps is designed for use by a health care Vacuum-275 °F/135°C ≥3 minutes provider to accompany individual units (e.g., wrapped assisted (wrapped or packs) to demonstrate that the unit has been exposed to unwrapped) (prevacuum) the sterilization process and to distinguish between processed and unprocessed units. Use the 3MTM Attest™ Lead Free Steam Indicator Tape 1355 in steam process below: Cycle Type Temperature Exposure Time 250 °F/121°C 30 minutes Gravity Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes Gravity 275 °F/135°C 3, 10 minutes Dynamic air-250 °F/121°C 15, 20, 30 removal minutes Dynamic air-270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, removal 10, 15 minutes Dynamic air-273 °F/134°C 3, 3.5, 4 minutes removal Dynamic air-275 °F/135°C 3, 3.5, 4, 10 removal minutes Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 to demonstrate that packs have been exposed to the sterilization process. The 3M™ Attest™ Lead Free Steam Indicator Tape 1355 is designed to secure packs
510(k) Summary
8
Image /page/8/Picture/0 description: The image features the 3M logo, which is a well-known multinational corporation. The logo consists of the number '3' followed by the letter 'M', both rendered in a bold, sans-serif typeface. The color of the logo is a vibrant red, which stands out prominently.
TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3MTM ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
Subject Devices: K220564 Predicate Device (K101528) Comparison Element 3MTM ComplyTM Lead Free Steam Indicator Tape Comply 1322 Lead Free Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355 wrapped with disposable non-woven, paper and paper/plastic wraps. Indicator Type Type 1 (Category e1) Process Indicators per ISO 11140-Class 1 Process Indicator per Similar. ANSI/AAMI/ISO11140-1:2005 Subject devices 1: 2014 claim Type 1 (Category e1) Process Indicators per ISO 11140-1:2014 The chemical indicator ink can be printed onto suitable Device Design The chemical indicator ink can be printed onto Same. paper substrates suitable paper substrates. Indicator agent Proprietary Proprietary Same. Endpoint Turns darker color when exposed to the sterilization A dark brown or black color on the indicator Similar. Endpoint Specifications process specification is updated for darker color which includes dark brown and black. Endpoint Stability 6 months 6 months Same. Shelf life 18 months 18 months Same.
510(k) Summary
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TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3M™ ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
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7. Nonclinical Comparison to the Predicate Device
3M conducted performance tests in the newly claimed sterilization cycle and conditions, nonclinical testing was performance in accordance with :
- FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions ● for Chemical Indicators, issued December 19, 2003
- ISO 11140-1:2014 Sterilization of healthcare products—Chemical Indicators—Part 1: ● General requirements for Type 1 (e1) Process Indicators.
Reference Table 6.1 for summary of nonclinical testing.
There is no change to the indicator ink (fundamental technology) for the subject devices, therefore, the mechanism of action is identical. The description of the end point specification for the subject devices was updated from dark brown or black color to darker color for more customer clarity since the type 1 (e1) process indicator is intended to distinguish between exposed or not exposed to a steam sterilization process.
| Test Name | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| Saturated Steam | ||||
| Testing (ISO | ||||
| 11140-1: 2014, | ||||
| Type 1) | Confirm device | |||
| meets the Type 1 | ||||
| process indicator | ||||
| for steam | ||||
| requirements. | ||||
| All testing is | ||||
| completed in a | ||||
| saturated steam | ||||
| Resistometer. | 2.0 Min at 121°C |
10.0 Min at 121°C
0.3 Min at 134°C
2.0 Min at 134°C | No change or change that is
markedly different from the
visible color change.
Visible color change.
No change or change that is
markedly different from the
visible color change.
Visible color change. | Pass |
| Dry Heat
Testing
(ISO 11140-1:
2014, Type 1) | Verify device
requires the
presence of
saturated steam
to turn to reach
endpoint. | 30 min at 140°C | No change or change that is
markedly different from the
visible color change. | Pass |
| Health Care
Facility
Simulated Use
Testing | Confirm device
provides
acceptable
performance in
cleared customer
use sterilization
cycles. | Device reaches endpoint color when
exposed to customer use cycles.
Device does not reach endpoint when
exposed to failing conditions in customer use
cycles. | | Pass |
| End Point Color
Stability for 6
months | Confirm
endpoint color
stability for
samples exposed
to passing and
failing conditions
in a steam
Resistometer. | Endpoint decision remains unchanged after 6
months. | | Pass |
Table 6.1 Summary of Nonclinical Testing
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TRADITIONAL PREMARKET NOTIFICATION 510(k) K220564 3MTM ComplyTM Lead Free Steam Indicator Tape 1322 3MTM Attest™ Lead Free Steam Indicator Tape 1355
510(k) Summary
7. Conclusion
The conclusions drawn from the nonclinical testing demonstrate that the subject devices, 3M™ Comply™ Lead Free Steam Indicator Tape 1322 and 3M™ Attest™ Lead Free Steam Indicator Tape 1355, are as safe, as effective, and performs as well as or better than the legally marketed predicate, 3M Comply 1322 Lead Free Steam Indicator Tape (K101528), Class II (21 CFR 880.2800), product code JOJ.