(90 days)
No
The device description focuses on chemical and biological indicators and their physical reactions to sterilization processes, read by an auto-reader. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
This device is designed to monitor and qualify steam sterilization processes, ensuring that medical instruments are properly disinfected. It does not directly treat or diagnose a disease or condition in a patient.
No
This device is designed to monitor and qualify steam sterilization cycles, not to diagnose a medical condition in a patient. It assesses the effectiveness of a sterilization process using biological and chemical indicators.
No
The device is a physical test pack containing biological and chemical indicators, designed to be placed in a steam sterilizer. It is not software.
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" steam sterilization cycles in healthcare facilities. This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device contains components like biological indicators and chemical integrators that assess the effectiveness of the sterilization process by challenging it with resistant organisms or chemical reactions. It does not analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of human or animal specimens, detection of diseases, conditions, or states of health, or any other typical characteristics of an in vitro diagnostic device.
The device is clearly designed for monitoring and validating sterilization equipment performance, which falls outside the scope of IVD regulation.
N/A
Intended Use / Indications for Use
Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
· 121°C (250°F) 30-minute gravity steam sterilization cycles;
· 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.
Product codes
FRC
Device Description
The 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 is specifically designed to qualify and monitor 250°F (121°C) gravity and 270°F (132°C) dynamic-air-removal steam sterilization processes in healthcare facilities. The test pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. Each test pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. This convenient disposable test pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The test pack is a single use device.
Each test pack contains a 3M™ Attest™ Rapid Readout Biological Indicator 1292 (brown cap, hereinafter referred to as a 1292 BI), a 3M™ Attest™ Steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process challenge device (PCD) containing a biological indicator and an integrating indicator. 3MTM Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent of migration depends on steam, time, and temperature. The 3MTM AttestTM Steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79.
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
healthcare facilities
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
This submission is addressing a change to the 3M™ Attest™ Steam Chemical Integrator contained within the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382. The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3M™ ComplyTM SteriGage™ Chemical Integrator for Steam (K771080).
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, re-branding of the device, and a modification to the materials used to construct the device. Test Packs have the same intended use as the previously marketed devices and make use of the same fundamental scientific technology.
Summary of Non-clinical Testing
Testing was conducted on the Test 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
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 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K090569, K191236, K771080, K173437
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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June 1, 2020
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul. Minnesota 55144
Re: K200536
Trade/Device Name: 3MTM Attest™ Rapid 5 Steam-Plus Test Pack Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 2, 2020 Received: March 3, 2020
Dear Mary Fretland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 Christopher K. Dugard, M.S. 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) K200536
Device Name
3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
Indications for Use (Describe)
3MTM AttestTM Rapid 5 Steam-Plus Test Pack 41382:
Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
· 121°C (250°F) 30-minute gravity steam sterilization cycles;
· 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary for K200536
3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
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: March 3, 2020
4
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
Device Names and Classification:
| Trade Name: | 3MTM AttestTM Rapid 5 Steam-Plus Test Pack | |
|---|---|---|
| 41382 | ||
| 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:
3MTM Attest™ Super Rapid 5 Steam-Plus Test Pack 41482V, K193154
Indications for Use:
3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382:
Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
- · 121°C (250°F) 30-minute gravity steam sterilization cycles;
- · 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.
Description of Device:
The 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 is specifically designed to qualify and monitor 250°F (121°C) gravity and 270°F (132°C) dynamic-air-removal steam sterilization processes in healthcare facilities. The test pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. Each test pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. This convenient disposable test pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The test pack is a single use device.
Each test pack contains a 3M™ Attest™ Rapid Readout Biological Indicator 1292 (brown cap, hereinafter referred to as a 1292 BI), a 3M™ Attest™ Steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process challenge device (PCD) containing a biological indicator and an integrating indicator. 3MTM Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent of migration depends on steam, time, and temperature. The 3MTM AttestTM Steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79.
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
3M™ Attest™ Rapid Readout Biological Indicators 1292 comply with the requirements of ISO 11138-1:2017 and ISO 11138-3:2017. The 1292 BI is a dual readout biological indicator specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3MTM Attest™ 290 Auto-reader or the 3M™ Attest™ Auto-reader 390. When steam processed, the process indicator on the 1292 BI label changes from rose to brown/black. Control 1292 BIs are provided with the test packs.
The 1292 BI detects the presence of Geobacillus stearothermophilus by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the auto-reader. A fluorescence change indicates a steam sterilization process failure.
The 1292 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow, which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Due to the high sensitivity of the 3-hour fluorescent results, however, there is no advantage to incubating the 1292 BI beyond 3 hours.
Nonclinical Comparison to the Predicate Device
This submission is addressing a change to the 3M™ Attest™ Steam Chemical Integrator contained within the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382. The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are similar to the previously cleared device which is sold under the tradename 3M™ ComplyTM SteriGage™ Chemical Integrator for Steam (K771080).
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, re-branding of the device, and a modification to the materials used to construct the device. Test Packs have the same intended use as the previously marketed devices and make use of the same fundamental scientific technology.
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
Technical Characteristics Comparison Table
| Feature | Submission Device
(K200536):
3MTM Attest™ Rapid 5 Steam-
Plus Test Pack 41382 | Predicate Device
(K193154):
3MTM Attest™ Super Rapid 5
Steam-Plus Challenge Pack
41482V | Comparison |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for use | Use the 3M™ Attest™ Rapid 5
Steam-Plus Test Pack 41382 to
qualify or monitor:
• 121°C (250°F) 30-minute
gravity steam sterilization
cycles;
• 132°C (270°F) 4-minute
dynamic-air-removal steam
sterilization cycles. | Use the 3M™ Attest™ Super
Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction
with the 3MTM Attest™ 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). | One shared
cycle with
predicate
device, one
unique cycle. |
| 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 Attest™ Rapid Readout
Biological Indicator 1292
(cleared via K090569) | 3MTM Attest™ Super Rapid
Readout Biological Indicator
1492V
(cleared via K173437) | Different BI |
| Biological Indicator
Incubation temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological Indicator
Readout time | 3-hour final fluorescent result in
both the 290 and 390 Auto-
readers. | 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. | Similar |
| 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 Attest™ Steam Chemical
Integrator
(cleared via K191236) | 3MTM Attest™ Steam Chemical
Integrator
(cleared via K191236) | Identical |
| 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 | Two (2) years | 21 months | Similar |
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382
Summary of Non-clinical Testing
Testing was conducted on the Test 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
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 perform as well as or better than the legally marketed predicate device, the 3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (cleared under K193154), Class II (21 CFR 880.2800), product code FRC.