Who is the manufacturer of 3M Attest Rapid Readout Biological Indicator?

3M Company filed the 510(k) submission for 3M Attest Rapid Readout Biological Indicator (K200996).

What is the FDA product code for 3M Attest Rapid Readout Biological Indicator?

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

What is the regulatory pathway for 3M Attest Rapid Readout Biological Indicator?

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

What are the predicate devices for 3M Attest Rapid Readout Biological Indicator?

3M™ Attest™ Rapid Readout Biological Indicator 1295 (K173435).

Who can help prepare an FDA 510(k) submission like 3M Attest Rapid Readout Biological Indicator?

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 Rapid Readout Biological Indicator

K200996 · 3M Company · FRC · Dec 11, 2020 · General Hospital

Device Facts

Record ID	K200996
Device Name	3M Attest Rapid Readout Biological Indicator
Applicant	3M Company
Product Code	FRC · General Hospital
Decision Date	Dec 11, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Indications for Use

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles),

Device Story

3M Attest 1295 is a self-contained biological indicator (BI) for monitoring vaporized hydrogen peroxide sterilization. Device consists of plastic sleeve, spore carrier (Geobacillus stearothermophilus), and media ampoule. External cap features chemical process indicator ink (blue to pink). After sterilization, BI is incubated in 3M Attest Auto-reader (490H, 490, or 490M). Auto-reader detects fluorescence; positive fluorescence indicates sterilization failure. Used in clinical settings to verify sterilization efficacy; provides rapid readout to inform healthcare providers if instruments are safe for use. Benefits include rapid confirmation of sterilization process, ensuring patient safety by preventing use of non-sterile equipment.

Clinical Evidence

Bench testing only. Performance verified in AMSCO V-PRO maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). Testing included full cycle and fractional cycle performance, confirming negative fluorescent and growth responses, and chemical indicator color change verification.

Technological Characteristics

Self-contained biological indicator; polyethylene terephthalate carrier; Geobacillus stearothermophilus spores (≥1x10^6); H2O2-sensitive chemical indicator ink; incubation at 60 ± 2°C; fluorescence-based detection; compatible with 3M Attest Auto-readers (490H, 490, 490M).

Indications for Use

Indicated for routine monitoring of vaporized hydrogen peroxide sterilization processes in specified AMSCO and STERRAD systems. Used by healthcare personnel in clinical settings.

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™ Attest™ Rapid Readout Biological Indicator 1295 (K173435)

Reference Devices

3M™ Attest™ Auto-reader 490 (K173437)
3M™ Attest™ Auto-reader 490 (K173584)
3M™ Attest™ Mini Auto-reader 490M (K200092)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. December 11, 2020 3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center. Building 275-5W-06 St.Paul, Minnesota 55144 Re: K200996 Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 13, 2020 Received: November 16, 2020 Dear Mary Fretland: 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, 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) K200996 #### Device Name 3M™ Attest™ Rapid Readout Biological Indicator 1295 #### Indications for Use (Describe) Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo 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. The logo is in red and consists of the number "3" followed by the letter "M". The font is bold and sans-serif. # 510(k) Summary for 3MTM Attest™ Rapid Readout Biological Indicator 1295 K200996 #### Sponsor Information: 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000 Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 Fax Number: (651) 737-5320 Date of Summary: December 09, 2020 510(k) Reference: K200996 {4}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 #### 1. Device Name and Classification: | Common or Usual Name: | Biological Indicator | |------------------------|-----------------------------------------------------| | Proprietary Name: | 3M™ Attest™ Rapid Readout Biological Indicator 1295 | | Classification Name: | Indicator, biological sterilization process | | Device Classification: | Class II, 21 CFR § 880.2800(a) | | Product Code: | FRC | ### 2. Predicate Device: K173435 3M™ Attest™ Rapid Readout Biological Indicator 1295 #### 3. Description of Device: The 3MTM AttestTM Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure. ### 4. Indications for Use Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles). {5}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid Readout Biological Indicator 1295 | | Submission Device: 3MTM AttestTM Rapid Readout Biological Indicator 1295 | Predicate Device (K173435): 3MTM AttestTM Rapid Readout Biological Indicator 1295 | Comparison | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Use the 3MTM Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V- PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V- PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClearTM Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClearTM Technology (Standard, Flex, Express and Duo cycles). | Use the 3MTM Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PROTM 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PROTM 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PROTM maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PROTм 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClearTM Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). | Addition of the 490 and 490M Auto- readers and Addition of the STERIS® V-PRO® max 2 Low Temperature Sterilization System (Fast Non Lumen, Lumen, Non Lumen, and Flexible cycles) sterilizer | | Indications for use | | | | | Organism | Geobacillus stearothermophilus traceable to ATCCTM 7953 | Geobacillus stearothermophilus traceable to ATCCTM 7953 | Identical | | Viable spore population | $≥1x10^6$ | $≥1x10^6$ | Identical | | Resistance characteristics | (Tested at 10 mg/L vaporized hydrogen peroxide) | (Tested at 10 mg/L vaporized hydrogen peroxide) | | | • D-value | $D_{10 mg/L} ≥ 1 second$ | $D_{10 mg/L} ≥ 1 second$ | Identical | | • Survival/Kill Window | Survival Time ≥ 5 seconds Kill Time = 7 minutes | Survival Time ≥ 5 seconds Kill Time = 7 minutes | | | Carrier material | Polyethylene terephthalate | Polyethylene terephthalate | Identical | | Incubation temperature | 60 ± 2°C | 60 ± 2°C | Identical | | Feature | Submission Device: 3MTM AttestTM Rapid Readout Biological Indicator 1295 | Predicate Device (K173435): 3MTM AttestTM Rapid Readout Biological Indicator 1295 | Comparison | | Chemical indicator | H2O2 sensitive ink; changes from blue towards pink | H2O2 sensitive ink; changes from blue towards pink | Identical | | Shelf life | Two (2) years | Two (2) years | Identical | #### 5. Technological Characteristic Comparison Table {6}------------------------------------------------ #### PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Rapid Readout Biological Indicator 1295 #### 6. Nonclinical Comparison to the Predicate Device The 3MTM Attest™ Rapid Readout Biological Indicator 1295 is identical to the previously cleared device of the same model number (the predicate) which is sold under the same tradename and cleared via K173435. To demonstrate performance in the newly claimed sterilizer and cycles, nonclinical testing was performed in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of health care products- Biological Indicators- Part 1: General requirements (FDA Recognition Number 14-502). Reference Table 6.1 for testing completed in AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). | Test Name | Purpose | Acceptance Criteria | Result | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------| | Full Cycle Performance | Verify performance in each of the full cycles in the AMSCO® V- PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non- Lumen, Flexible, and Fast Non- Lumen cycles) sterilizer. | All biological indicators display a negative fluorescent and negative growth response. | Pass | | Fractional Cycle Performance | Verify performance in fractional cycles for each of the cycles within the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non- Lumen, Flexible, and Fast Non- Lumen cycles). | All biological indicators display a negative fluorescent and negative growth response. | Pass | | Chemical Indicator (CI) Color Change | Demonstrate the color change of the CI when exposed to the AMSCO® V-PRO™ maX 2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles). | Color change from blue toward pink. | Pass | Table 6.1 Summary of Nonclinical Testing - Addition of 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or ● greater per K173437 and K173584. - Addition of 3MTM Attest™ Mini Auto-reader 490M per K200092. ● {7}------------------------------------------------ ## 7. Conclusion Based on the non-clinical performance data, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 is as safe, as effective, and performs as well as or better than the legally marketed predicate, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 cleared under K173435, Class II (21 CFR 880.2800), product code FRC.

3M Attest Rapid Readout Biological Indicator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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3M Attest Rapid Readout Biological Indicator

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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