(85 days)
No
The description focuses on the physical components of the challenge pack and the biological/chemical indicators, with no mention of AI or ML in the device itself or the associated auto-reader's function beyond reading a fluorescent result.
No.
This device is designed to monitor and qualify steam sterilization cycles, not to provide therapy or treatment to patients.
No
This device is used to qualify or monitor steam sterilization cycles, indicating whether the sterilization process was successful or not. While it provides an "Accept/Reject" result, it does not diagnose a medical condition in a patient. Instead, it assesses the functionality of a sterilization machine.
No
The device description clearly outlines physical components like medical index cards, a biological indicator, a chemical integrator, and a process indicator. While it interacts with software in an autoreader, the device itself is a physical challenge pack.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "qualify or monitor dynamic-air-removal steam sterilization cycles." This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample to determine the presence of a disease or condition.
- Device Description: The device contains a biological indicator and a chemical integrator, which are used to assess the effectiveness of a sterilization process. It does not analyze biological samples from a patient.
- No mention of biological samples: The text does not mention the device being used with blood, urine, tissue, or any other biological specimen.
- Purpose of Performance Studies: The performance studies compare the device's resistance to sterilization conditions against a standard process challenge device and the biological indicator alone. This is related to the device's function in monitoring sterilization, not diagnosing a medical condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Autoreader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamicair-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V is specifically designed to qualify or routinely challenge dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 41482V Challenge Packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Pack has the same design as the predicate device except for a change to the chemical integrator contained within the Challenge Pack. Each 41482V Challenge Pack contains a 1492V BI and a 3M™ Attest™ Steam Chemical Integrator. The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. The 3M™ Attest™ Chemical Integrator offers an immediate Accept/Reject result that allows for implant load early release in emergency situations as defined in AAMI ST79. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
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: Non-clinical tests.
Purpose:
- Comparison to AAMI 16 Towel PCD: Determine the resistance of the Challenge Pack as compared to an AAMI 16 Towel PCD.
- Comparison to Biological Indicator: Determine the resistance of the Challenge Pack as compared to the Biological Indicator alone.
Acceptance Criteria: - Comparison to AAMI 16 Towel PCD: Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017.
- Comparison to Biological Indicator: Challenge Pack provides a greater resistance than the Biological Indicator alone.
Key Results: Both tests Passed
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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February 7, 2020
3M Company Mary Fretland Senior Regulatory Affairs Associate Bldg. 275-5W-06 St. Paul, Minnesota 55144
Re: K193154
Trade/Device Name: 3M Attest Super Rapid 5 Steam-Plus Challenge Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: November 1, 2019 Received: November 14, 2019
Dear Mary Fretland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Sreekanth Gutala, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193154
Device Name
3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
Indications for Use (Describe)
Use the 3MM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Autoreader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamicair-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|× Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary for 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V K193154
3M Company, 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Mary Fretland Senior Regulatory Affairs Associate Phone Number: (651) 737-2296 FAX Number: (651) 737-5320
Date of Summary: February 04, 2020
4
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
Device Name and Classification:
| Trade Name: | 3MTM AttestTM Super Rapid 5 Steam-Plus Challenge Pack
41482V |
|------------------------|----------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
[21 CFR § 880.2800(a), FRC] |
Predicate Device:
3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173519
Indications for Use
Use 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3MTM Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
Description of Device:
The 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V is specifically designed to qualify or routinely challenge dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).
The 41482V Challenge Packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Pack has the same design as the predicate device except for a change to the chemical integrator contained within the Challenge Pack. Each 41482V Challenge Pack contains a 1492V BI and a 3M™ Attest™ Steam Chemical Integrator. The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3MTM Attest™ 1492V BI controls are provided with the Challenge Packs. The 3M™ Attest™ Chemical Integrator offers an immediate Accept/Reject result that allows for implant load early release in emergency situations as defined in AAMI ST79. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
Technological Characterization
Provided below is a comparison of the technological similarities and differences between the subject device and the predicate device.
| Technical Characteristics Comparison Table | ||
|---|---|---|
| -------------------------------------------- | -- | -- |
| Feature | Subject Device: K193154
3MTM AttestTM Super Rapid 5
Steam-Plus Challenge Pack
41482V | Predicate Device
(K173519):
3MTM AttestTM Super Rapid 5
Steam-Plus Challenge Pack
41482V
and
3MTM AttestTM Auto-reader 490
and 490H | Comparison |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Indications for
use | Use the 3MTM AttestTM Super
Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction with
the 3MTM AttestTM Auto-reader
490 or 3MTM AttestTM Auto-
reader 490H having software
version 4.0.0 or greater to qualify
or monitor dynamic-air-removal
steam sterilization cycles of 4
minutes at 270°F (132°C) and 3
minutes at 275°F (135°C). | Use the 3MTM AttestTM Super
Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction with
the 3MTM AttestTM Auto-reader
490 or 3MTM AttestTM Auto-
reader 490H having software
version 4.0.0 or greater to qualify
or monitor dynamic-air-removal
steam sterilization cycles of 4
minutes at 270°F (132°C) and 3
minutes at 275°F (135°C). | Identical |
| General Design | Layers of medical index cards,
some of which are die-cut to
contain indicators, overwrapped
and secured with a label. | Layers of medical index cards,
some of which are die-cut to
contain indicators, overwrapped
and secured with a label. | Identical |
| Biological
Indicator | 3MTM AttestTM Super Rapid
Readout Biological Indicator
1492V | 3MTM AttestTM Super Rapid
Readout Biological Indicator
1492V | Identical |
| Biological
Indicator
Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological
Indicator Readout
time | 24 minute final fluorescent result
in both the 490 and 490H Auto-
readers having software versions
4.0.0 or greater.
1 hour final fluorescent result in
490 Auto-readers having
software versions less than 4.0.0. | 24 minute final fluorescent result
in both the 490 and 490H Auto-
readers having software versions
4.0.0 or greater.
1 hour final fluorescent result in
490 Auto-readers having
software versions less than 4.0.0. | Identical |
| Resistance
Comparison to
the AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Identical |
| Chemical
Integrator | 3MTM AttestTM Steam Chemical
Integrator | 3MTM ComplyTM SteriGageTM
Chemical Integrator for Steam | Both integrators
meet FDA
requirements for a
chemical integrator |
| Feature | Subject Device: K193154
3MTM Attest™ Super Rapid 5
Steam-Plus Challenge Pack
41482V | Predicate Device
(K173519):
3MTM Attest™ Super Rapid 5
Steam-Plus Challenge Pack
41482V
and
3MTM Attest™ Auto-reader 490
and 490H | Comparison |
| External
Chemical Process
Indicator | Turns from yellow to brown or
darker upon steam exposure | Turns from yellow to brown or
darker upon steam exposure | Identical |
| Shelf-life | 21 months | 21 months | Identical |
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
The design, fundamental technology and performance specifications for 3MTM Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3M™ ComplyTM SteriGage™ Chemical Integrator for Steam (K101249). There have been no changes to the integrator's performance specifications or fundamental scientific technology. The changes to the integrator included an expansion of the indications for use, rebranding of the device, and a modification to the materials used to construct the device. There have been no other changes to the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V nor to the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V contained within the Challenge Pack. Other than the change to the integrator, the Challenge Pack has the same materials and fundamental scientific technology.
Summary of Non-clinical Testing
Testing was conducted on the Challenge Pack following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- Premarket Notification [510(k)] Submission for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- . ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- ISO 11138-3:2017 Sterilization of health care products Biological indicators, Part 3: ● Biological indicators for moist heat sterilization processes
- ISO 11140-1:2014 Sterilization of health care products Chemical indicators, Part 1 : ● General Requirements
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and ● Chapter Biological Indicators - Resistance Performance Tests
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V
Performance testing to demonstrate substantial equivalence to the predicate device has been completed and is summarized below:
| Test | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| Comparison | |||||
| to | |||||
| AAMI 16 | |||||
| Towel PCD | Determine the resistance of | ||||
| the Challenge Pack as | |||||
| compared to an AAMI 16 | |||||
| Towel PCD | Challenge Pack is at least as | ||||
| resistant as the biological indicator | |||||
| AAMI 16 Towel Process Challenge | |||||
| Device (PCD) described in | |||||
| ANSI/AAMI ST79: 2017 | Passed | ||||
| Comparison | |||||
| to Biological | |||||
| Indicator | Determine the resistance of | ||||
| the Challenge Pack as | |||||
| compared to the Biological | |||||
| Indicator alone | Challenge Pack provides a greater | ||||
| resistance than the Biological | |||||
| Indicator alone | Passed |
Conclusion
The conclusion drawn from the non-clinical tests performed demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (cleared under K173519), Class II (21 CFR 880.2800), product code FRC.