(198 days)
The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275°F/135°C | 3, 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4, 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3, 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |
Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F / 121°C: 16.5 minutes 270°F/ 132°C: 2.0 minutes 273°F/ 134°C: 1.4 minutes 275°F/ 135°C: 1.2 minutes
3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.
The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the 3M™ Attest™ Steam Chemical Integrators (K191236).
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Test Name | Purpose | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Stated Value (SV) Testing | To identify the critical parameters required to achieve a stated inactivation, by referring to a stated test organism with stated D and z values. The integrator must turn to "ACCEPT" endpoint at the stated value time and must also remain "REJECT" when exposed to conditions of -1°C/-15% set point of the SV time. All testing is completed in a saturated steam resistometer. Integrator temperature coefficient and correlation coefficient are calculated to confirm alignment to biological indicator performance. | SV at 121°C ≥ 16.5 minutesSV at 132°C ≥ 2.0 minutesSV at 134°C ≥ 1.4 minutesSV at 135°C ≥ 1.2 minutesIntegrator temperature coefficient 10 - 27°CCorrelation coefficient ≥ 0.9 | PASS |
| Health Care Facility Simulated Use Testing | Confirm integrators provide acceptable performance in cleared customer use sterilization cycles. | Device reaches "ACCEPT" endpoint reaction when exposed to customer use cycles.Device does not reach endpoint ("REJECT") when exposed to failing conditions in customer use cycles. | PASS |
| Dry Heat Testing | Verify device requires the presence of saturated steam to turn to reach endpoint. | Endpoint must not be met following dry heat exposure at 140°C for 30 min. | PASS |
| Side-by-Side Testing with Biological Indicator | Confirm integrators are parallel in performance to biological indicators (BI). | Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated. | PASS |
| Endpoint Color Stability | Confirm endpoint color stability for samples exposed to passing and failing conditions in a steam resistometer. | Endpoint decision must remain unchanged after 6 months. | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of integrators) used for each test. However, it indicates that the testing was conducted in accordance with "FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003 as well as ANSI/AAM/ISO 11140-1:2014." These standards would define the appropriate sample sizes for such tests.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission to the US FDA, it can be inferred that the studies were conducted by or on behalf of 3M Company, located in St. Paul, Minnesota, USA. The nature of the tests ("Nonclinical testing") suggests prospective laboratory-based studies rather than retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided in the document. The device is a chemical indicator for sterilization processes. Its "ground truth" (i.e., whether sterilization conditions were met or not, or if it indicates "ACCEPT" or "REJECT") is determined by objective physical and chemical reactions under controlled laboratory conditions using resistometers and simulated use cycles, not by expert human interpretation like in medical imaging. The performance is assessed against established physical parameters and the performance of biological indicators, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As explained in point 3, the output of the chemical indicator is an objective visual change (migration of a dark color to an ACCEPT or REJECT window). There is no human interpretation or adjudication process described for determining the device's output.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive chemical indicator, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the core performance of the device itself. The "Nonclinical Testing" summarized in the document is essentially the standalone performance evaluation of the chemical indicator. The device (chemical indicator) intrinsically operates "standalone" as a physical/chemical system without human intervention or an algorithm in the traditional sense of medical devices. Its performance is directly observed and measured against physical parameters of sterilization cycles.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the 3M™ Attest™ Steam Chemical Integrators is established through:
- Physical Parameters: Measured steam temperature and exposure time in controlled resistometers.
- Biological Indicator Inactivation: The performance is correlated and compared to biological indicators (BIs), which contain resistant bacterial spores, serving as a gold standard for sterilization effectiveness. The acceptance criteria state "Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated."
- Defined Pass/Fail Conditions: Precise conditions (e.g., minimum stated values, exposure to failing conditions) are set for evaluation.
8. The sample size for the training set
Not applicable. This device is a chemical indicator, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's performance is based on its inherent chemical and physical properties and manufacturing consistency, not on learned data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device type.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 22, 2019
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K191236
Trade/Device Name: 3MTM Attest™ Steam Chemical Integrators Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: October 22, 2019 Received: October 23, 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
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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 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 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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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
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Indications for Use
510(k) Number (if known) K191236
Device Name
3MTM Attest™ Steam Chemical Integrators
Indications for Use (Describe)
The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3, 4, 10, 15, 25 minutes |
| Gravity | 275°F/135°C | 3, 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4, 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3, 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |
Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F / 121°C: 16.5 minutes 270°F/ 132°C: 2.0 minutes 273°F/ 134°C: 1.4 minutes 275°F/ 135°C: 1.2 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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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" and the letter "M" in a bold, sans-serif font. The logo is simple and recognizable.
510(k) Summary for 3MTM Attest™ Steam Chemical Integrators
Sponsor Information:
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 Email: mfretland@mmm.com
Date of Summary: November 21, 2019
Submission Number: K191236
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1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicators |
|---|---|
| Trade Name: | 3MTM AttestTM Steam Chemical Integrators |
| Classification Name: | Physical/chemical sterilization process indicators |
| Device Classification: | Class II, 21 CFR § 880.2800(b) |
| Product Code: | JOJ |
2. Predicate Device:
3MTM ComplyTM SteriGage™ Chemical Integrator for Steam (K101249)
3. Description of Device:
3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.
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4. Indications for Use
The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250°F/121°C | 30 minutes |
| Gravity | 270°F/132°C | 3 minutes |
| Gravity | 270°F/132°C | 4 minutes |
| Gravity | 270°F/132°C | 10 minutes |
| Gravity | 270°F/132°C | 15 minutes |
| Gravity | 270°F/132°C | 25 minutes |
| Gravity | 275°F/135°C | 3 minutes |
| Gravity | 275°F/135°C | 10 minutes |
| Dynamic Air Removal | 250°F/121°C | 30 minutes |
| Dynamic Air Removal | 270°F/132°C | 4 minutes |
| Dynamic Air Removal | 270°F/132°C | 10 minutes |
| Dynamic Air Removal | 273°F/134°C | 3 minutes |
| Dynamic Air Removal | 273°F/134°C | 4 minutes |
| Dynamic Air Removal | 275°F/135°C | 3 minutes |
Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:
| 250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C |
|---|---|---|---|
| 16.5 Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes |
5. Nonclinical Comparison to the Predicate Device
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™ Chemical Integrator for Steam (K101249).
There has been no change to the device's performance specifications or fundamental scientific technology. The intent of this submission is to expand the indications for use. re-brand the device, and modify the materials used to construct the device.
The differences between 3M™ Attest™ Steam Chemical Integrator and the predicate do not raise any new questions of safety and effectiveness as demonstrated by the performance testing and biocompatibility assessment.
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6. Technical Characteristics
Technological Characteristics Comparison Between Subject and Predicate Device:
| Feature | Submission Device:3MTM AttestTM Steam Chemical Integrators | Predicate Device (K101249):3MTM ComplyTM SteriGageTM ChemicalIntegrators for Steam |
|---|---|---|
| Device Models | 1243RE and 1243RES | 1243RE |
| Device Design | 3MTM AttestTM Steam Chemical Integrators arechemical indicators consisting of a paper wick andsteam and temperature sensitive chemical pelletcontained in a paper/film/foil laminate. Thechemical pellet melts and migrates as a dark coloralong the paper wick. The migration is visiblethrough a window marked ACCEPT or windowmarked REJECT; the extent of migration dependson steam, time, and temperature. | Identical. |
| Indicator Agent | Proprietary formulation. | Identical. |
| Sterilizationmethod and cycles | Steam sterilization processes 250°F to 275°F(121°C to 135°C) | Identical. |
| Shelf-life | One (1) year | Three (3) years |
Indications for Use Comparison:
| Cycle Type | Temperature | Submission Device:3MTM AttestTM Steam ChemicalIntegratorsExposure Time | Predicate Device (K101249):3MTM Comply™ SteriGage™ ChemicalIntegrators for SteamExposure Time |
|---|---|---|---|
| Gravity | 250°F/121°C | 30 minutes | ≥ 30 minutes |
| Gravity | 270°F/132°C | 3 minutes4 minutes10 minutes15 minutes25 minutes | ≥ 3 minutes (unwrapped) |
| Gravity | 275°F/135°C | 3 minutes10 minutes | Not present. |
| Dynamic AirRemoval | 250°F/121°C | 30 minutes | Not present. |
| Dynamic AirRemoval | 270°F/132°C | 4 minutes10 minutes | ≥ 3 minutes (unwrapped)≥ 4 minutes (wrapped) |
| Dynamic AirRemoval | 273°F/134°C | 3 minutes4 minutes | ≥ 3.5 minutes (unwrapped)≥ 4 minutes (wrapped) |
| Dynamic AirRemoval | 275°F/135°C | 3 minutes | ≥ 3 minutes |
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| Feature | Submission Device:3MTM Attest™ Steam Chemical Integrators | Predicate Device (K101249):3MTM Comply™ SteriGage™ ChemicalIntegrators for Steam | ||||||
|---|---|---|---|---|---|---|---|---|
| EndpointSpecifications(Minimum StatedValues) | The minimum stated values for the 3MTM Attest™ Steam Chemical Integrators as determined using a resistometer are provided in the table below. | The minimum stated values for the 3MTM Comply™ SteriGage™ Chemical Integrators for Steam as determined using a resistometer are provided in the table below. | ||||||
| Minimum Stated Values for 3MTM Attest™ Steam Chemical Integrators | Minimum Stated Values for 3M™ ComplyTM SteriGage™ Steam Chemical Integrators | |||||||
| 250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C | 250°F/121°C | 270°F/132°C | 273°F/134°C | 275°F/135°C | |
| 16.5Minutes | 2.0Minutes | 1.4Minutes | 1.2Minutes | 16.5Minutes | 2.0Minutes | 1.4Minutes | 1.1Minutes |
7. Summary of Nonclinical Testing
Nonclinical testing of the 3M™ Attest™ Steam Chemical Integrators was conducted in accordance with the FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003 as well as ANSI/AAM/ISO 11140-1:2014.
The effectiveness of the 3MTM Attest™ Steam Chemical Integrator was demonstrated in the following tests:
| Test Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Stated Value (SV)Testing | To identify the critical parametersrequired to achieve a stated inactivation,by referring to a stated test organismwith stated D and z values. Theintegrator must turn to "ACCEPT" endpoint at the stated value time and mustalso remain "REJECT" when exposed toconditions of -1°C/-15% set point of theSV time. All testing is completed in asaturated steam resistometer. Integratortemperature coefficient and correlationcoefficient are calculated to confirmalignment to biological indicatorperformance. | SV at 121°C $\geq$ 16.5 minutesSV at 132°C $\geq$ 2.0 minutesSV at 134°C $\geq$ 1.4 minutesSV at 135°C $\geq$ 1.2 minutesIntegratortemperaturecoefficient 10 - 27°CCorrelationcoefficient $\geq$ 0.9 | PASS |
| Health CareFacility SimulatedUse Testing | Confirm integrators provide acceptableperformance in cleared customer usesterilization cycles. | Device reaches "ACCEPT"endpoint reaction whenexposed to customer usecycles.Device does not reachendpoint ("REJECT") whenexposed to failing conditionsin customer use cycles. | PASS |
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| Test Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dry Heat Testing | Verify device requires the presence of saturated steam to turn to reach endpoint. | Endpoint must not be met following dry heat exposure at 140°C for 30 min. | PASS |
| Side-by-SideTesting withBiologicalIndicator | Confirm integrators are parallel in performance to biological indicators (BI). | Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated. | PASS |
| Endpoint ColorStability | Confirm endpoint color stability for samples exposed to passing and failing conditions in a steam resistometer. | Endpoint decision must remain unchanged after 6 months. | PASS |
The results of performance testing on 3M™ Attest™ Steam Chemical Integrator demonstrate the device performs as intended in the claimed steam sterilization cycles.
8. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the 3MTM AttestTM Steam Chemical Integrator is as safe, as effective and performs as well as or better than the legally marketed predicate, 3M™ Comply™ SteriGage™ Chemical Integrator for Steam cleared under K101249, Class II (CFR 880.2800, product code JOJ).
§ 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).