(99 days)
No
The device is a chemical indicator that relies on a physical change (melting and migration of a chemical pellet) in response to steam, time, and temperature, not on computational analysis or algorithms.
No
The device is used to monitor the steam sterilization process in healthcare facilities, not to treat or diagnose patients.
No.
The device is designed to monitor the effectiveness of steam sterilization cycles and confirm that the conditions necessary for sterilization have been met, rather than to diagnose a specific medical condition in a patient.
No
The device is a physical test pack containing a chemical integrator, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to 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 is a chemical integrator test pack that reacts to steam, time, and temperature. It does not analyze biological samples or provide information about a patient's health status.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens for diagnostic purposes.
Therefore, the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is a device used for monitoring sterilization processes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:
- 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes
- 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes
- 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes
Product codes
JOJ
Device Description
3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed.
Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3M™ Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature.
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
routinely challenge the steam sterilization process in 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
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 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements
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 |
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 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (cleared under K193154), Class II (21 CFR 880.2800), product code FRC.
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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July 2, 2020
3M Center Mary Fretland Senior Regulatory Affairs Associate 2510 Conway Avenue, Building 275-5W-06 St. Paul, MN 55144
Re: K200766
Trade/Device Name: 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: June 03, 2020 Received: June 04, 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 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 (OS) 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 medical devices and radiation-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,
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) K200766
Device Name
3MTM Attest™ Steam Chemical Integrator Test Pack 41360
Indications for Use (Describe)
- Use the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:
- · 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes
- · 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes
- · 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes
| Type of Use (Select one or both, as applicable) |
|---|
|Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for
3MTM Attest™ Steam Chemical Integrator Test Pack 41360
K200766
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: July 02, 2020
4
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360
Device Names and Classification:
| Trade Name: | 3MTM AttestTM Steam Chemical Integrator Test
Pack 41360 |
|------------------------|----------------------------------------------------------------------------|
| Common/Usual Name: | Chemical Indicator (CI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
[21 CFR § 880.2800(b), FRC] |
Predicate Device:
3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, K193154
Indications for Use:
3MTM Attest™ Steam Chemical Integrator Test Pack 41360:
Use the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:
- 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes .
- 132°C (270°F) dynamic-air-removal steam sterilization cvcle at 4 minutes .
- 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes ●
Description of Device:
3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed.
Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3MTM Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature.
Nonclinical Comparison to the Predicate Device
This submission is addressing a change to the 3M™ Attest™ Steam Chemical Integrator contained within the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360. 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 3MTM ComplyTM SteriGage™ Steam Chemical Integrator Test Pack (K894399).
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Steam Chemical Integrator Test Pack 41360
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.
| | Subject Device
(K200766): | Predicate Device
(K193154): | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Feature | 3M™ Attest™ Steam
Chemical Integrator Test Pack
41360 | 3M™ Attest™ Super Rapid 5
Steam-Plus Challenge Pack
41482V | Comparison |
| Indications for use | Use the 3M™ Attest™ Steam
Chemical Integrator Test Pack
41360 to monitor:
• 121°C (250°F) gravity
displacement steam sterilization
cycle at 30 minutes
• 132°C (270°F) dynamic-air-
removal steam sterilization cycle
at 4 minutes
• 135°C (275°F) dynamic-air-
removal steam sterilization cycle
at 3 minutes | Use the 3M™ Attest™ Super
Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction with
the 3M™ 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). | Two shared
cycles 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 | NA | 3M™ Attest™ Super Rapid
Readout Biological Indicator
1492V
(cleared via K173437) | Subject device
does not
contain a BI. |
| Biological Indicator
Incubation temperature | NA | 60 ± 2°C | Subject device
does not
contain a BI. |
| Biological Indicator
Readout time | NA | 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. | Subject device
does not
contain a BI. |
| 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 | 3M™ Attest™ Steam Chemical
Integrator (cleared via K191236) | 3M™ Attest™ Steam Chemical
Integrator (cleared via K191236) | Identical |
| Shelf life | Two (2) years | 21 months | Similar |
Technical Characteristics Comparison Table
6
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3MTM Attest™ Steam Chemical Integrator Test Pack 41360
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 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements
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 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V (cleared under K193154), Class II (21 CFR 880.2800), product code FRC.