What is the regulatory pathway for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Q: Who is the manufacturer of 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

3M Healthcare filed the 510(k) submission for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K193110).

Q: What is the FDA product code for 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E?

QKM. It is classified under 21 CFR 880.2800 as a Class 2 device in the General Hospital panel.

K193110 · 3M Healthcare · QKM · Mar 13, 2020 · General Hospital

Device Facts

Record ID	K193110
Device Name	3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Applicant	3M Healthcare
Product Code	QKM · General Hospital
Decision Date	Mar 13, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Indications for Use

Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).

Device Story

Chemical indicator strip for vaporized hydrogen peroxide sterilization monitoring; non-cellulose coated strip in film laminate. Input: exposure to vaporized hydrogen peroxide (time, temperature, concentration). Operation: color changes from blue to pink along strip; progression visible through window with 'REJECT'/'ACCEPT' zones. Used in healthcare facilities by sterilization technicians; placed inside wrapped trays, rigid containers, or pouches. Output: visual color-coded status. Benefit: verifies sterilization parameters achieved within pack; ensures sterility assurance for medical instruments.

Clinical Evidence

Bench testing only. Simulated use testing performed across multiple STERRAD and STERIS V-PRO sterilizer models and cycles. Testing confirmed color change performance, endpoint stability, and shelf life (6 months). Worst-case sterilant exposure testing confirmed indicator behavior in overexposure conditions.

Technological Characteristics

Non-cellulose based coated indicator strip in film laminate. Sensing principle: chemical color change (blue to pink) responsive to vaporized hydrogen peroxide concentration (5.1 mg/L), exposure time (1 minute), and temperature (50°C). Form factor: strip. Shelf life: 6 months.

Indications for Use

Indicated for pack control monitoring of vaporized hydrogen peroxide sterilization cycles in specified STERRAD and STERIS V-PRO systems. Used within packages, containment devices, or at specific locations within the load/chamber to verify exposure to critical process variables.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K183211)

Submission Summary (Full Text)

{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. March 13, 2020 3M Health Care Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, Minnesota 55144-1000 #### Re: K193110 Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: February 13, 2020 Received: February 14, 2020 #### Dear Andrew Wingen: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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, For Sreekanth Gutala, Ph.D. Acting 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 510(k) Number (if known) K193110 Device Name 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (1348/1348E) Indications for Use (Describe) Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX ® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the 3M logo, which is a well-known brand. 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 a vibrant red, and the background is white, creating a strong contrast that makes the logo easily recognizable. # 510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Sponsor Information: 3M Company 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: (651) 733-9209 Fax Number: (651) 737-5320 Date of Summary: 9 March 2020 {4}------------------------------------------------ #### 1. Device Name and Classification: | Common or Usual Name: | Chemical Indicator | |------------------------|-------------------------------------------------------------------------------------| | Proprietary Name: | 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | | Classification Name: | Indicator, physical/chemical sterilization process | | Device Classification: | Class II, 21 CFR § 880.2800 | | Product Code: | QKM | #### 2. Predicate Device: K183211 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 #### 3. Description of Device: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide. #### 4. Indications for Use Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cvcles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and {5}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E STERIS® V-PRO® 1 (Lumen cycle), STERIS® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Nonlumen cycles). Stated Values (SV) Stated values of a critical process variable are values at which the indicator is designed to reach its endpoint as defined by the manufacturer. The critical process variables measured by the 3M™ Attest™ CI 1348/1348E are exposure time, temperature, and concentration of vaporized hydrogen peroxide. The stated critical values for the 3MTM Attest™ CI 1348/1348E are contained in Table 1. #### Table 1: Stated Values of 3M™ Attest™ CI 1348/1348E | Attribute | Measurement | |---------------|-------------| | VH2O2 | 5.1 mg/L | | Exposure Time | 1 minute | | Temperature | 50 C | {6}------------------------------------------------ # 5. Summary of Technological Characteristics compared to Predicate Device | | Submission Device: 3MTM AttestTM Vaporized Hydrogen Peroxide Tri- | Predicate Device: 3MTM ComplyTM | | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Metric Chemical Indicator (K193110) | Hydrogen Peroxide Chemical Indicator 1248 (K183211) | Comparison | | Device Models | 1348, 1348E | 1248 | Different | | Device Design | The 3MTM AttestTM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. The 3MTM AttestTM CI 1348/1348E verifies that the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked “REJECT” and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide. | The 3MTM ComplyTM Hydrogen Peroxide Chemical Indicator 1248 consists of a non-cellulosic 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. Upon exposure to vaporized hydrogen peroxide, the chemical indicator bar turns from blue toward pink. | Similar | | Sterilizers in which Color Change Performance was Demonstrated (Blue toward Pink) | STERRAD® 100S STERRAD® NX (Standard and Advanced cycles) STERRAD® NX with ALLClearTM Technology (Standard and Advanced cycles) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) STERRAD® 100NX with ALLClearTM Technology (Standard, Flex, Express, and Duo cycles) STERIS® V-PRO® maX (Lumen, Non- Lumen, and Flexible cycles) STERIS® V-PRO® maX2 (Lumen, Non- Lumen, Flexible, and Fast Non-Lumen cycles) STERIS® V-PRO® 60 (Lumen, Non-Lumen, and Flexible cycles) | STERRAD® 100 STERRAD® 100S STERRAD® NX (Standard and Advanced cycles) STERRAD® NX with ALLClearTM Technology (Standard and Advanced cycles) STERRAD® 100NX (Standard, Flex, Express, and Duo cycles) STERRAD® 100NX with ALLClearTM Technology (Standard, Flex, | Similar. The Tri- Metric CI is not indicated to be used with the STERRAD® 100 sterilizer. Testing with the STERIS® V-PRO® maX is equivalent to V- PRO® 1 and V- PRO® 1 Plus cycles. | #### Table 2: Comparison of Submission Device and Predicate Device {7}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | | | | | Indicator Agent | | | | | | | | |------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Express, and Duo cycles) | | | Proprietary | | Identical | | | | | | | | AMSCO® V-PRO™ 1 (Lumen cycle) | | Stability of the endpoint reaction | At least one month (4 weeks) | At least one month (4 weeks) | Identical | | | | | | | | AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles) | | Shelf life | 6 months | Two (2) years | Similar | | | | | | | | AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) | | Endpoint Specifications (Minimum Stated Values) | VH2O2 Concentration | Exposure Time | Temperature | | | | | | | | AMSCO® V-PRO™ 60 (Lumen, Non Lumen and Flexible cycles) | | | 5.1 mg/L | 1 minute | 50 degrees C | | | | | | Indications for use | | Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-lumen cycles). | | Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100, STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles), AMSCO® V-PRO® 1 (Lumen cycle), AMSCO® V- PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) AMSCO® V-PRO® 60 (Lumen, Non Lumen and Flexible cycles) | Sterilization System (Lumen, Non Lumen, | Similar. Tri-Metric removes STERRAD® 100 and updates brand names associated with the former AMSCO® V-PRO sterilizers. Tri- Metric notes color change in the device description portion of the instructions for use rather than in the indications for use portion of the instructions for use. | | | | | Different. The predicate is sensitive to VH2O2 exposure only, while the submission device is sensitive to VH2O2 concentration, exposure time, and temperature. | | | | | | | | | Not applicable. The CI turns from blue toward pink after exposure to vaporized hydrogen peroxide. | | | | | | | | | and Flexible cycles) and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. | | | | | | | | | {8}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E ### 6. Nonclinical Comparison to the Predicate Device The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E has similar design, fundamental technology, and performance specification to the predicate device sold under the tradename 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K183211). The key difference between the Tri-Metric CI 1348/1348E and the Hydrogen Peroxide CI 1248 is that Tri-Metric is sensitive to three critical process variables (sterilant exposure duration, concentration, and temperature), while the predicate is sensitive to sterilant exposure. Given differences in device construction and performance specifications between the predicate and new device, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003. {9}------------------------------------------------ ## Table 3: Summary of Nonclinical Testing | Test | Result | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Health Care Facility Simulated Use Testing: Color change of the indicator was assessed after exposure to representative complete and incomplete cycles for the STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles), STERRAD® NX® with AllClear™ (Standard and Advanced cycles), STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ (Standard, Flex, Express and Duo cycles), STERIS ® V- PRO® maX (Lumen, Non-Lumen and Flexible cycles), STERIS® V- PRO® maX 2 (Lumen, Non-Lumen, Flexible, and Fast Non-lumen cycles), and STERIS® V-PRO® 60 (Lumen, Non-Lumen, Flexible and Fast Non-Lumen cycles) sterilizers. | Pass | | Worst Case Sterilant Exposure Testing: Testing was conducted using overexposure conditions in a commercial sterilizer to ensure color change in overexposure conditions was similar to color change observed for in-pack monitoring of the same cycle. | Pass | | Endpoint Color Stability: Following VH2O2 processing, chemical indicator samples were placed in a shelf life study to confirm the chemical indicator samples conserved their color change reading over time. | Pass | | Shelf Life Testing: 6 months of shelf life testing assessing endpoint and non-endpoint conditions was conducted. | Pass | #### 7. Conclusion Based on the intended uses, technological characteristics and non-clinical performance data, the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, cleared under K183211.

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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Indications for Use

Device Story

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Indications for Use

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Identification

Predicate Devices

Submission Summary (Full Text)

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