(106 days)
No
The device description and performance studies focus on the biological and chemical indicators and their interaction with an auto-reader for fluorescence detection, which are standard methods for sterilization monitoring and do not indicate the use of AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is used to monitor and qualify sterilization processes, not to treat patients.
No
This device is used to monitor and qualify VHP sterilization processes, ensuring the sterilizer is functioning correctly, rather than diagnosing a patient's medical condition. It's a quality control device for equipment, not a diagnostic tool for human health.
No
The device description clearly outlines physical components like a clear plastic shell, channels, a cavity, a foil lid, a biological indicator (BI), and a chemical indicator (CI). While it interacts with auto-readers that have software, the device itself is a physical challenge pack containing indicators, not software only.
Based on the provided information, the devices described are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack and the associated Auto-readers is for monitoring and performance qualification of sterilization processes. This is a quality control function for medical device sterilization, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The devices are described as containing a biological indicator (BI) and a chemical indicator (CI) to assess the effectiveness of a sterilization cycle. The Auto-readers are used to incubate and read the results of the BI. This aligns with sterilization monitoring, not in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, treatment, or prevention of disease.
Therefore, these devices fall under the category of sterilization process indicators/monitors, not In Vitro Diagnostic devices.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical 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.
The device performance was verified through the following tests:
- PCD Resistance Characterization: Purpose - 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. Results - Passed.
- PCD Functionality (Pass Cycle): Purpose - Demonstrate performance of the 3M™ Attest Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a pass cycle. Results - Passed.
- PCD Functionality (Fail Cycle): Purpose - Demonstrate performance of the 3M™ Attest Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in a fail cycle. Results - Passed.
- PCD Peel Force: Purpose - Demonstrate acceptable peel force of Clear Challenge Pack 1295PCD heat seal foil lid from plastic shell. Acceptance Criteria - ≥8.5lbF and ≤20lbF. Results - Passed.
- Cycle Performance: Purpose - Demonstrate performance of the 3M™ Attest Vaporized Hydrogen Peroxide Clear Test Pack 1295PCD in the claimed sterilizers and cycles in the Indications for Use. Results - Passed.
Clinical Comparison to the Predicate Device:
Clinical testing was not required or completed for the submission device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
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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.
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)
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)
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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
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 | FDA | ||||
| Guidance¹ and, | |||||
| ANSI/AAMI/I | |||||
| SO 11138- | |||||
| 1:2017 | |||||
| Sterilization of | |||||
| Health Care | |||||
| Products— | |||||
| Biological | |||||
| Indicators— | |||||
| Part 1: | |||||
| General | |||||
| Requirements | 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/I | |||||
| SO 11138- | |||||
| 1:2017 | |||||
| Sterilization of | |||||
| Health Care | |||||
| Products— | |||||
| Biological | |||||
| Indicators— | |||||
| Part 1: | |||||
| General | |||||
| Requirements | 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: | |||||
| 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 | Demonstrate | ||||
| acceptable peel | |||||
| force of Clear | |||||
| Challenge Pack | |||||
| 1295PCD heat | |||||
| seal foil lid | |||||
| from plastic | |||||
| shell | ≥8.5lbF and | ||||
| ≤20lbF |
lbF = pounds
force | Passed |
| Item Tested | Test | Standard | Purpose | Acceptance Criteria | Results |
| 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 |
The device performance was verified through the following tests:
16
3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
17
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.