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 Description

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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) and associated Auto-readers, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

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	Demonstrate indicators within the 3M™ 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
1295PCD Challenge Packs	PCD Functionality	FDA Guidance¹ and ANSI/AAMI/ISO 11138-1:2017	Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a pass cycle.	Indicators perform as intended	Passed
1295PCD Challenge Packs	PCD Functionality	FDA Guidance¹ and ANSI/AAMI/ISO 11138-1:2017	Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a fail cycle.	Indicators perform as intended	Passed
1295PCD Challenge Pack	PCD Peel Force	ASTM F88 / F88M-15 and ASTM F2824 – 10	Demonstrate acceptable peel force of Clear Challenge Pack 1295PCD heat seal foil lid from plastic shell	≥8.5lbF and ≤20lbF (lbF = pounds force)	Passed
1295PCD Challenge Pack	Cycle Performance	FDA Guidance¹	Demonstrate performance of the 3M™ Attest™ Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in the claimed sterilizers and cycles in the Indications for Use.	Indicators perform as intended	Passed

Study Details from the Provided Document:

2. Sample Size Used for the Test Set and Data Provenance

PCD Resistance Characterization: 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 CIs) were tested side-by-side with standalone 1295 BIs and 1348 CIs. The document does not specify the exact number of units or replicates within each lot.
PCD Functionality (Pass Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
PCD Functionality (Fail Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
PCD Peel Force: Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were tested. The exact number of units or replicates is not specified.
Cycle Performance: Four lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were subjected to simulated use testing. The exact number of units or replicates is not specified.
Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involves active testing of newly manufactured lots of the device and comparing them against standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document describes non-clinical performance testing of mechanical and biological indicators. There is no mention of human experts being used to establish ground truth for the performance of the sterilization indicators. The ground truth for biological indicator performance (survival/kill) would be determined by microbiological culturing and fluorescence detection as described in the mechanism of action. Chemical indicator performance is determined by visual color change and quantitative measurement of critical parameters.

4. Adjudication Method for the Test Set

Not applicable, as this was non-clinical laboratory testing, not a study involving human interpretation or subjective judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not mentioned as part of this submission).
The device is a sterilization process indicator and auto-reader system; its performance is evaluated objectively based on biological and chemical reactions, not human diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, the concepts of "algorithm only" or "standalone" performance in the context of AI are not directly applicable to this device.
The 3M™ Attest™ Auto-readers (490, 490H, 490M) are designed to automatically read the biological indicators for a final fluorescent result at 24 minutes. This is an automated detection system. However, it's not described as an "AI algorithm" in the common sense for diagnostic imaging or similar applications. Its performance is intrinsically "standalone" in its reading function, without human interpretation of the fluorescent signal, but the overall system involves human handling of the challenge pack and interpretation of the auto-reader display.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests would be:

Microbiological Growth/No Growth: For biological indicators (BIs), the definitive ground truth for sterilization effectiveness is the absence of microbial growth after exposure to a sterilization process, and growth after inadequate exposure or no exposure. This is typically determined by standard microbiological culture methods. The document mentions the 1295 BI utilizes an enzyme system and fluorescence measurement, with an optional pH indicator, indicating these are the readouts used, which are correlated to the viability of Geobacillus stearothermophilus spores.
Known Sterilization Parameters: For chemical indicators (CIs) and for challenging the system, the ground truth is established by precisely controlling sterilization parameters (time, temperature, concentration of vaporized hydrogen peroxide) in a laboratory setting to create "pass" and "fail" conditions.
Mechanical Measurement: For peel force, the ground truth is based on physical measurement using calibrated equipment.

8. Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The Auto-readers are described as devices that incubate and automatically read biological indicators, implying a fixed automated process rather than a machine learning model that would require a distinct training set.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI training set, this question is not applicable based on the provided document. The functionality of the auto-readers is based on detecting fluorescence and relating it to biological indicator activity, which is a deterministic process rather than a learned one from a training set.

Summary

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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.

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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

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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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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)

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)

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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

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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 PeroxideClear 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 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

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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):

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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).

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Feature	Submission Device:3MTM AttestTMSuper Rapid VaporizedHydrogen PeroxideClear Challenge Pack1295PCD and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M	Predicate Device(K192001):Sterilucent Self-Contained BiologicalIndicator, SterilucentLumen Cycle ProcessChallenge Device,Sterilucent FlexibleCycle ProcessChallenge Device	Comparison
Intended Use	Single Use sterilizationprocess indicator	Single Use sterilizationprocess indicator	Identical
Indications for use	Use the 3MTM AttestTMSuper Rapid VaporizedHydrogen Peroxide ClearChallenge Pack1295PCD in conjunctionwith the 3MTM AttestTMAuto-reader 490 havingsoftware version 4.0.0 orgreater or a 3MTMAttestTM Mini Auto-reader 490M or a 3MTMAttestTM Auto-reader490H as a standardmethod of routinemonitoring andperformance qualificationof vaporized hydrogenperoxide sterilizationprocesses in the followsystems:STERRAD 100S®Sterilization System,STERRAD NX®Sterilization System(Standard and Advancedcycles), STERRAD100NX® SterilizationSystem (Standard, Flex,Express, and Duocycles), STERRAD NX®with ALLClear®Technology Sterilization	The Sterilucent ProcessChallenge Device (PCD)test pack is used forroutine monitoring of theSterilucent HC 80TTSterilizer Lumen andFlexible Cycles. TheSterilucent PCD mayalso be used forperformancequalification of theSterilucent HC 80TTsterilizer Lumen andFlexible Cycles duringinitial installation, afterrelocation, major repairsor mal functions, or aftersterilization processfailures.Both the SterilucentLumen Cycle PCD andthe Sterilucent FlexibleCycle PCD are intendedto have greater resistancethan the stand aloneSCBI. Both devices aredesigned to haveincreased resistancebeyond the sterilizationhalf-cycle, but completeinactivation upon	The Indications forUse are similar inthat the subjectdevice and thepredicate device areused for routinemonitoring andperformancequalification ofvaporized hydrogenperoxide sterilizationprocesses. Thesubject device coversdifferent sterilizersand cycles comparedto the predicatedevice.The Indications forUse for the subjectdevice are identicalto the 3M 1295 BI(K210277) and 3MTri-Metric CI 1348(K203284) in termsof sterilizers andcycles covered.The subjectchallenge packcontains the 3M1295 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 AttestTMSuper Rapid VaporizedHydrogen PeroxideClear Challenge Pack1295PCD and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M(Tested at 10 mg/Lvaporized hydrogenperoxide)	Predicate Device(K192001):Sterilucent Self-Contained BiologicalIndicator, SterilucentLumen Cycle ProcessChallenge Device,Sterilucent FlexibleCycle ProcessChallenge Device	Comparison
BI - ResistanceCharacteristics• D-value	≥ 1 sec.	5.7 - 9.1 sec.	Similar, both BIs arecharacterized with aD-value.
BI - ResistanceCharacteristics• Survival/KillWindow	(Tested at 10 mg/Lvaporized hydrogenperoxide)Survival Time ≥ 5 sec.Kill Time = 7 min.	25.0 sec. (All survive)140 sec. (All kill)	Similar, both BIs arecharacterized withSurvival and Killtesting.
BI – CultureConditions	Crushable glass ampoulecontaining a growthmedia and a fluorescenceindicator which iscorrelated to an optionaluse pH indicator	Crushable glass ampoulecontaining modifiedTryptic Soy Broth with apH indicator	Similar
Chemical Indicator(CI)	3MTM AttestTM VaporizedHydrogen Peroxide Tri-Metric ChemicalIndicator 1348		The ChemicalIndicator in thesubject challengepack is able toindependentlymonitor three criticalparameters: exposuretime, temperature,and concentration ofvaporized hydrogenperoxide. Thepredicate devicedoes not contain aseparate chemicalindicator.
CI – EndpointSpecifications(Minimum StatedValues)	VH2O2 Concentration –5.1 mg/LExposure Time – 1minuteTemperature – 50°C	NA	independentlymonitor three criticalparameters: exposuretime, temperature,and concentration ofvaporized hydrogenperoxide. The
CI - Color change	Blue toward pink alongthe reactive chemistrystrip		predicate devicedoes not contain aseparate chemicalindicator.
GeneralDesign/Construction	Clear plastic tray withchannels to the cavity	Clear polymer vial withpolymer caps and	Both the subject andpredicate challenge
Feature	Submission Device: 3MTM AttestTMSuper Rapid VaporizedHydrogen PeroxideClear Challenge Pack1295PCD and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M	Predicate Device(K192001):Sterilucent Self-Contained BiologicalIndicator, SterilucentLumen Cycle ProcessChallenge Device,Sterilucent FlexibleCycle ProcessChallenge Device	Comparison
	containing the indicators,acting as a challenge tolimit air removal andVH2O2 penetration,sealed with a foil lid.	challenge tube on oneend.Tube of various innerdiameter and lengthstailored to individualsterilization cycle.	packs are designedto increase resistancebeyond thatmeasured with astandalone BI andboth represent achallenge to thesterilization processbased on worse casecycle with load.
Mechanism todistinguish processedand unprocessedchallenge pack	Process indicator presenton 1295 BI cap is visiblethrough PCD and turnscolor from blue towardspink upon vaporizedhydrogen peroxideexposure.	SPSmedical VH2O2Chemical Indicatorplaced on the outside ofthe vial.	Both the subject andpredicate devicecontain a processindicator thatchanges color uponvaporized hydrogenperoxide exposurethat is used by thecustomer to verifythat the challengepack was exposed toVH2O2.
Shelf Life	6 months	12 months from date ofmanufacture	Shelf life will beextended as real timedata is available.

Table 1: Device Comparison Table

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H

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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 AttestTMSuper Rapid VaporizedHydrogen PeroxideClear Challenge Pack1295PCD and3MTM AttestTM Auto-reader 490 and 490Hand 3MTM AttestTMMini Auto-reader 490M	Predicate Device(K192001):Sterilucent Self-Contained BiologicalIndicator, SterilucentLumen Cycle ProcessChallenge Device,Sterilucent FlexibleCycle ProcessChallenge Device	Comparison
Accessories	3MTM AttestTM Auto-reader 490 or the 3MTMAttestTM Auto-reader490H or the 3MTMAttestTM Mini Auto-reader	NA	The subjectchallenge packcontains the 3M1295 BI which isintended to be usedin conjunction withthe 3MTM AttestTMAuto-reader 490 orthe 3MTM AttestTMAuto-reader 490H orthe 3MTM AttestTMMini Auto-reader490M cleared underK210277.

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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
1295PCDChallengePacks andStandalonechemical andbiologicalindicators	PCD ResistanceCharacterization	FDAGuidance1 and,ANSI/AAMI/ISO 11138-1:2017Sterilization of Health CareProducts—BiologicalIndicators—Part 1:GeneralRequirements	Demonstrateindicatorswithin the3MTM AttestVaporizedHydrogenPeroxide ClearTest Pack1295PCD havegreaterresistancecompared tostandaloneindicators in afractionalexposure cycle.	Indicatorsperform asintended	Passed
Item Tested	Test	Standard	Purpose	Acceptance Criteria	Results
1295PCDChallengePacks	PCDFunctionality	FDAGuidance¹ and,ANSI/AAMI/ISO 11138-1:2017Sterilization ofHealth CareProducts—BiologicalIndicators—Part 1:GeneralRequirements	Demonstrateperformance ofthe 3M™AttestVaporizedHydrogenPeroxide ClearTest Pack1295PCD in apass cycle.	Indicatorsperform asintended	Passed
1295PCDChallengePacks	PCDFunctionality	FDAGuidance¹ and,ANSI/AAMI/ISO 11138-1:2017Sterilization ofHealth CareProducts—BiologicalIndicators—Part 1:GeneralRequirements	Demonstrateperformance ofthe 3M™AttestVaporizedHydrogenPeroxide ClearTest Pack1295PCD in afail cycle.	Indicatorsperform asintended	Passed
1295PCDChallengePack	PCD Peel Force	ASTM F88 /F88M-15:Standard TestMethod forSeal Strengthof FlexibleBarrier andASTM F2824 –10: StandardTest Methodfor MechanicalSeal StrengthTesting forRound Cupsand BowlContainerswith FlexiblePeelable Lids	Demonstrateacceptable peelforce of ClearChallenge Pack1295PCD heatseal foil lidfrom plasticshell	≥8.5lbF and≤20lbFlbF = poundsforce	Passed
Item Tested	Test	Standard	Purpose	Acceptance Criteria	Results
1295PCDChallenge Pack	CyclePerformance	FDAGuidance¹	Demonstrateperformance ofthe 3M™AttestVaporizedHydrogenPeroxide ClearTest Pack1295PCD inthe claimedsterilizers andcycles in theIndications forUse.	Indicatorsperform asintended	Passed

The device performance was verified through the following tests:

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M

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TRADITIONAL PREMARKET NOTIFICATION [510(k) 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD [TM Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M

1 FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007

7. Clinical Comparison to the Predicate Device

Clinical testing was not required or completed for the submission device.

8. Conclusion

Based on the intended use, technological characteristics, and non-clinical performance data, the subject devices, the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD, the 3MTM Attest™ Auto-reader 490, the 3MTM Attest™ Autoreader 490H, and the 3M™ Attest™ Mini Auto-reader 490M, are as safe and as effective as the legally marketed predicate device, the Sterilucent Process Challenge Device (PCD) test pack (cleared under K192001), Class II (21 CFR 880.2800), product code FRC.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).