3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)

Q: Who is the manufacturer of 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)?

3M Company filed the 510(k) submission for 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) (K233814).

Q: What is the FDA product code for 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)?

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

Q: What is the regulatory pathway for 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)?

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

Q: Who can help prepare an FDA 510(k) submission like 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)?

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.

K233814 · 3M Company · FRC · Mar 15, 2024 · General Hospital

Device Facts

Record ID	K233814
Device Name	3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)
Applicant	3M Company
Product Code	FRC · General Hospital
Decision Date	Mar 15, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2800
Device Class	Class 2

Intended Use

3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD: Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cvcles), STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles). V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles). V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) 3M™ Attest™ Auto-reader (490): The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Auto-reader (490H): The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Mini Auto-reader (490M): The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

Device Story

Device monitors vaporized hydrogen peroxide sterilization processes; consists of 1295PCD challenge pack (clear plastic shell, two channels, foil lid) containing 1295 Biological Indicator (BI) and 1348 Tri-Metric Chemical Indicator (CI). 1295 BI uses Geobacillus stearothermophilus spores; enzyme system produces fluorescence detected by 490/490H/490M Auto-readers at 60°C. Auto-reader provides final fluorescent result at 24 minutes; indicates sterilization failure if fluorescence detected. 1348 CI verifies exposure time, temperature, and concentration. Used in healthcare facilities by staff to monitor sterilizer performance. Output affects clinical decision-making regarding sterilization adequacy; ensures patient safety by confirming effective sterilization of instruments.

Clinical Evidence

No clinical data; bench testing only. Performance verified via PCD resistance characterization, functionality in pass/fail cycles, peel force testing (ASTM F88/F2824), and cycle performance testing in claimed sterilizers.

Technological Characteristics

Clear plastic tray with channels and foil lid; contains Geobacillus stearothermophilus spores (>10^6). Sensing principle: enzymatic fluorescence detection. Energy source: Auto-reader (60°C incubation). Connectivity: Standalone. Software: Version 4.0.0 or greater. Standards: ANSI/AAMI/ISO 11138-1:2017, ASTM F88/F88M-15, ASTM F2824-10.

Indications for Use

Indicated for routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in healthcare facilities using specified STERRAD and V-PRO sterilization systems.

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

Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device (K192001)

Reference Devices

3M 1295 BI (K210277)
3M Tri-Metric CI 1348 (K203284)

Related Devices

K211705 — 3M Attest Rapid Readout Biological Indicator, 1295 · 3M Company · Jun 28, 2022
K241542 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) · 3M Company · Jun 27, 2024
K173435 — 3M Attest Rapid Readout Biological Indicator · 3M Company · Feb 9, 2018
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) · Terragene S.A. · Sep 18, 2024
K160546 — 3M Attest Rapid Readout Biological Indicator · 3M Company · Jun 9, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. March 15, 2024 3M Company Michelle Larsen Advanced Regulatory Affairs Specialist 3M Center 2510 Conway Ave., Building 275-5W-06 St. Paul, Minnesota 55144 #### Re: K233814 Trade/Device Name: 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3MTM Attest™ Auto-reader (490); 3MTM Attest™ Auto-reader (490H); 3MTM Attest™ Mini Auto-reader (490M) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: February 14, 2024 Received: February 14, 2024 Dear Michelle Larsen: 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 (the 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 available 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Stephen A. Anisko -S Digitally signed by Stephen A. Anisko -S Date: 2024.03.15 11:42:02 -04'00' for Christopher Dugard Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices {2}------------------------------------------------ OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K233814 Device Name 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3MTM Attest™ Mini Auto-reader (490M) ndications for Use (Describe) 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD): Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cvcles), STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles). V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® 60 Low Temperature Sterilization System (Lumen, and Flexible cycles), V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles). V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) 3M™ Attest™ Auto-reader (490): The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Auto-reader (490H): The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes. 3M™ Attest™ Mini Auto-reader (490M): The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) {4}------------------------------------------------ #### 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." {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable. The color red is bold and eye-catching. # 510(k) Summary for 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M K233814 #### Sponsor Information: 3M Company 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144-1000 Contact: Michelle M. Larsen Advanced Regulatory Affairs Specialist Phone Number: (651) 467-3991 Fax Number: (651) 737-5320 Email: mmlarsen@solventum.com #### Date of Summary: 13, March 2024 #### 1. Device Name and Classification: Common or Usual Name: Sterilization Biological Indicator {6}------------------------------------------------ #### TRADITIONAL PREMARKET NOTIFICATION [510(k) 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M | Proprietary Name: | 3MTM Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification Name: | Indicator, Biological Sterilization Process | | Device Classification: | Class II, 21 CFR 880.2800(a) | | Product Code: | FRC | # 2. Predicate Device: Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device, K192001 # 3. Description of Device: The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is designed as a standard method of rapid and reliable routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The 1295PCD Challenge Pack consists of a clear plastic shell, with two individual channels allowing for air removal and sterilant penetration. Those two individual channels connect to a cavity containing the monitoring products and all are covered by a foil lid. The 1295PCD is a single-use device. Each 1295PCD Challenge Pack contains a 3M™ Attest™ Rapid Readout Biological Indicator (BI) 1295 (pink cap) and a 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (CI) 1348. The 1348 CI verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved and offers an ACCEPT or REJECT reading. The 1295 BI is specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Autoreader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H. The presence of fluorescence within the specified incubation time for the 1295 BI in the 490, 490M, or the 490H Auto-reader indicates a sterilization process failure. A printed chemical process indicator is present on the cap of the 1295 BI and is visible through the clear plastic shell of the challenge pack. The {7}------------------------------------------------ process indicator turns color upon exposure to vaporized hydrogen peroxide and is used by the customer to verify that the challenge pack was exposed to vaporized hydrogen peroxide. # 4. Indications for Use #### 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD): Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cvcles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cvcles) V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) # 3MTM Attest™ Auto-reader (490): The 3M™Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes. # 3MTM Attest™ Auto-reader (490H): The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes. {8}------------------------------------------------ ### 3MTM Attest™ Mini Auto-reader (490M): The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3MTM Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60ºC for a final fluorescent result at 24 minutes. # 5. Comparison of Subiect Device to Predicate Device # Indications for Use The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and the predicate device Sterilucent Process Challenge Device (PCD) test pack have the same intended use. Both the subject device and the predicate device are Single Use biological indicator process challenge devices that are intended to be used in healthcare facilities to accompany products being sterilized and to monitor adequacy of the sterilization process. The Indications for Use are similar in that both the predicate and subject challenge test packs are specifically designed as a method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The subject device covers different sterilizers and cycles compared to the predicate device. The differences in Indications for Use do not alter the fundamental Intended Use of these products as sterilization process monitors and do not raise new questions of safety and effectiveness. # Technological Characteristics The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD has similar technological characteristics compared to the predicate Sterilucent Process Challenge Device (PCD) test pack. The subject device is designed and constructed with a clear plastic tray with channels to the cavity containing the Biological Indicator and Chemical Indicator sealed with a foil lid whereas the predicate device consists of a clear polymer vial containing the Biological Indicator and a challenge tube on one end. Both the subject and predicate challenge packs are designed to increase resistance beyond that measured with a standalone BI and both represent a challenge to the sterilization process based on worse case cycle with load. The process indicator on the predicate challenge pack is present on the PCD whereas the process indicator on the subject device is present on the 1295 BI cap which is visible through the clear test pack. Both process indicators change color upon exposure to vaporized hydrogen peroxide (VH2O2) and is used by the customer to verify the challenge pack was exposed to VH2O2. The differences in technological characteristics between the subject and predicate challenge pack are illustrated in the Device Comparison Table (Table 1). {9}------------------------------------------------ | Feature | Submission Device: 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto- reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M | Predicate Device (K192001): Sterilucent Self- Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Comparison | |----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Single Use sterilization process indicator | Single Use sterilization process indicator | Identical | | Indications for use | Use the 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3MTM AttestTM Auto-reader 490 having software version 4.0.0 or greater or a 3MTM AttestTM Mini Auto- reader 490M or a 3MTM AttestTM Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles), STERRAD NX® with ALLClear® Technology Sterilization | The Sterilucent Process Challenge Device (PCD) test pack is used for routine monitoring of the Sterilucent HC 80TT Sterilizer Lumen and Flexible Cycles. The Sterilucent PCD may also be used for performance qualification of the Sterilucent HC 80TT sterilizer Lumen and Flexible Cycles during initial installation, after relocation, major repairs or mal functions, or after sterilization process failures. Both the Sterilucent Lumen Cycle PCD and the Sterilucent Flexible Cycle PCD are intended to have greater resistance than the stand alone SCBI. Both devices are designed to have increased resistance beyond the sterilization half-cycle, but complete inactivation upon | The Indications for Use are similar in that the subject device and the predicate device are used for routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The subject device covers different sterilizers and cycles compared to the predicate device. The Indications for Use for the subject device are identical to the 3M 1295 BI (K210277) and 3M Tri-Metric CI 1348 (K203284) in terms of sterilizers and cycles covered. The subject challenge pack contains the 3M 1295 BI which is | | Feature | Submission Device: | Predicate Device (K192001): | Comparison | | | 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto-reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M | Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | | | | System (Standard and Advanced cycles), STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles), V-PRO® 1 Low Temperature Sterilization System (Lumen cycle), V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles), V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) | exposure to the full cycle. | intended to be used in conjunction with the 3MTM AttestTM Auto-reader 490 or the 3MTM AttestTM Auto-reader 490H or the 3MTM AttestTM Mini Auto-reader 490M cleared under K210277. | | Biological Indicator (BI) | 3MTM AttestTM Rapid Readout Biological Indicator 1295 with ≥ 1 x 106 Geobacillus | Sterilucent HC 80TT SCBI, quartz fiber carrier inoculated with >106 Geobacillus | Both the subject device and the predicate device utilize Biological | | | Submission Device: | Predicate Device (K192001): | | | Feature | 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto-reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M | Sterilucent Self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Comparison | | | stearothermophilus spores | stearothermophilus spores per disc | Indicators with >106 Geobacillus stearothermophilus spores. | | BI - Mechanism of Action | The 1295 BI utilizes an enzyme system, which is generated naturally within growing cells of Geobacillus stearothermophilus . The enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic reaction with a non-fluorescent substrate. The resultant fluorescent by product is detected in an Auto-reader. The presence of fluorescence within the specified incubation time in the Auto-reader indicates a sterilization process failure. The 1295 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. | The Sterilucent HC 80TT SCBI indicates the presence of G. stearothermophilus organisms by a visual pH color change reaction. | Similar, the 1295 BI utilizes a fluorescence result and also a visual pH color change reaction. | | Feature | Submission Device: 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto- reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M (Tested at 10 mg/L vaporized hydrogen peroxide) | Predicate Device (K192001): Sterilucent Self- Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Comparison | | BI - Resistance Characteristics • D-value | ≥ 1 sec. | 5.7 - 9.1 sec. | Similar, both BIs are characterized with a D-value. | | BI - Resistance Characteristics • Survival/Kill Window | (Tested at 10 mg/L vaporized hydrogen peroxide) Survival Time ≥ 5 sec. Kill Time = 7 min. | 25.0 sec. (All survive) 140 sec. (All kill) | Similar, both BIs are characterized with Survival and Kill testing. | | BI – Culture Conditions | Crushable glass ampoule containing a growth media and a fluorescence indicator which is correlated to an optional use pH indicator | Crushable glass ampoule containing modified Tryptic Soy Broth with a pH indicator | Similar | | Chemical Indicator (CI) | 3MTM AttestTM Vaporized Hydrogen Peroxide Tri- Metric Chemical Indicator 1348 | | The Chemical Indicator in the subject challenge pack is able to independently monitor three critical parameters: exposure time, temperature, and concentration of vaporized hydrogen peroxide. The predicate device does not contain a separate chemical indicator. | | CI – Endpoint Specifications (Minimum Stated Values) | VH2O2 Concentration – 5.1 mg/L Exposure Time – 1 minute Temperature – 50°C | NA | independently monitor three critical parameters: exposure time, temperature, and concentration of vaporized hydrogen peroxide. The | | CI - Color change | Blue toward pink along the reactive chemistry strip | | predicate device does not contain a separate chemical indicator. | | General Design/Construction | Clear plastic tray with channels to the cavity | Clear polymer vial with polymer caps and | Both the subject and predicate challenge | | Feature | Submission Device: 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto- reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M | Predicate Device (K192001): Sterilucent Self- Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Comparison | | | containing the indicators, acting as a challenge to limit air removal and VH2O2 penetration, sealed with a foil lid. | challenge tube on one end. Tube of various inner diameter and lengths tailored to individual sterilization cycle. | packs are designed to increase resistance beyond that measured with a standalone BI and both represent a challenge to the sterilization process based on worse case cycle with load. | | Mechanism to distinguish processed and unprocessed challenge pack | Process indicator present on 1295 BI cap is visible through PCD and turns color from blue towards pink upon vaporized hydrogen peroxide exposure. | SPSmedical VH2O2 Chemical Indicator placed on the outside of the vial. | Both the subject and predicate device contain a process indicator that changes color upon vaporized hydrogen peroxide exposure that is used by the customer to verify that the challenge pack was exposed to VH2O2. | | Shelf Life | 6 months | 12 months from date of manufacture | Shelf life will be extended as real time data is available. | # Table 1: Device Comparison Table {10}------------------------------------------------ # 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H {11}------------------------------------------------ # 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H {12}------------------------------------------------ # 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H {13}------------------------------------------------ # 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H {14}------------------------------------------------ # 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H | | | 3M™ Attest™ Mini Auto-reader 490M | | |--|--|-----------------------------------|--| |--|--|-----------------------------------|--| | Feature | Submission Device: 3MTM AttestTM Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD and 3MTM AttestTM Auto- reader 490 and 490H and 3MTM AttestTM Mini Auto-reader 490M | Predicate Device (K192001): Sterilucent Self- Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device | Comparison | |-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Accessories | 3MTM AttestTM Auto- reader 490 or the 3MTM AttestTM Auto-reader 490H or the 3MTM AttestTM Mini Auto- reader | NA | The subject challenge pack contains the 3M 1295 BI which is intended to be used in conjunction with the 3MTM AttestTM Auto-reader 490 or the 3MTM AttestTM Auto-reader 490H or the 3MTM AttestTM Mini Auto-reader 490M cleared under K210277. | ______________________________________________________________________________________________________________________________________________________________________________ {15}------------------------------------------------ ### 6. Nonclinical Comparison to the Predicate Device The differences between the subject and predicate device have been evaluated through performance tests for the 3MTM Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD. Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD, containing three lots of 1295 BIs and three lots of 1348 Cls, were tested side by side with standalone indicators 1295 BIs and 1348Cls. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007, and ANSI/AAMI/ISO 11138-1:2017 Sterilization of Health Care Products-Biological Indicators-Part 1: General Requirements. Four lots of 3MTM Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were subjected to simulated use testing in healthcare sterilizers. Testing was completed per the Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007. Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were tested for peel force of the heat seal foil lid from the plastic shell. The validated method used to perform the testing is based on ASTM F88 / F88M-15: Standard Test Method for Seal Strength of Flexible Barrier and ASTM F2824 – 10: Standard Test Method for Mechanical Seal Strength Testing for Round Cups and Bowl Containers with Flexible Peelable Lids. | Item Tested | Test | Standard | Purpose | Acceptance Criteria | Results | |---------------------------------------------------------------------------------------------|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------| | 1295PCD Challenge Packs and Standalone chemical and biological indicators | PCD Resistance Characterization | FDA Guidance1 and, ANSI/AAMI/ISO 11138- 1:2017 Sterilization of Health Care Products— Biological Indicators— Part 1: General Requirements | Demonstrate indicators within the 3MTM Attest Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD have greater resistance compared to standalone indicators in a fractional exposure cycle. | Indicators perform as intended | Passed | | Item Tested | Test | Standard | Purpose | Acceptance Criteria | Results | | 1295PCD Challenge Packs | PCD Functionality |…

3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)

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3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)

Device Facts

Intended Use

Device Story

Clinical Evidence

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Predicate Devices

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3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)