(27 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 minute |
| 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 the study that proves the 3M™ Attest™ Steam Chemical Integrators device meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Purpose | Acceptance Criteria | Reported 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" end point 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 | ≥ 16.5 minutes≥ 2.0 minutes≥ 1.4 minutes≥ 1.2 minutes10 - 27°C≥ 0.9 (All 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 explicitly state the numerical sample size used for each test. It refers to "testing" and "samples" implying multiple units were tested per condition.
Data Provenance:
- Country of Origin: Not specified, but implied to be from the manufacturer (3M) based in the US (St. Paul, Minnesota).
- Retrospective or Prospective: Not explicitly stated, but the nature of the "Nonclinical Testing" and "Simulated Use Testing" suggests a prospective testing methodology where the device's performance is observed under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a chemical indicator, and its performance is determined by a chemical reaction resulting in a visible color change, not by human interpretation or expert consensus in the way medical images are. The "ground truth" is defined by the physical and chemical parameters of the sterilization cycles (temperature, time, steam saturation) and the comparison to biological indicators.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the endpoint is a direct physical change ("ACCEPT" or "REJECT" window) based on the chemical reaction, not a subjective interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images and the AI assists in that interpretation. This device is a chemical indicator for sterilization processes.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is typically asked for AI/software devices. For this chemical indicator, its "performance" is inherently "standalone" in that its chemical reaction and color change are intrinsic to the device and do not involve an "algorithm" or "human-in-the-loop" once exposed to the sterilization conditions. The results are observed/read by a human, but the indicator's performance itself is a direct chemical response.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by:
- Objective physical and chemical parameters: Specific temperatures and exposure times for steam sterilization cycles (e.g., 250°F/121°C for 30 minutes, 270°F/132°C for 3 minutes).
- Comparison to Biological Indicators (BI): The "Side-by-Side Testing with Biological Indicator" confirms that the chemical integrator's performance parallels that of a BI, which is the established standard for demonstrating sterility.
- Controlled resistometer testing: A resistometer provides precisely controlled and verifiable steam, time, and temperature conditions.
8. The Sample Size for the Training Set
Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a chemical indicator.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 23, 2019
3M Company Mary Fretland Senior Regulatory Affairs Associate 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K193254
Trade/Device Name: 3M Attest Steam Chemical Integrator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: November 25, 2019 Received: November 26, 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.
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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 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.
Sreekanth Gutala, PhD 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
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Indications for Use
510(k) Number (if known) K193254
Device Name
3M™ 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 minute |
| 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 consists of 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: December 23, 2019
Submission Number: K193254
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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 Attest™ Steam Chemical Integrators (K191236)
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 |
ട. Nonclinical Comparison to the Predicate Device
The design, fundamental technology and performance specifications for 3M™ Attest™ Steam Chemical Integrators are identical to the previously cleared device which is sold under the same tradename 3MTM Attest™ Steam Chemical Integrators (K191236).
There has been no change to the device's performance specifications or fundamental scientific technology. The differences between the subject device and the predicate are limited to a change in shape and removal of the extender.
The differences between 3MTM 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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Technical Characteristics 6.
| Feature | Submission Device:3MTM AttestTM Steam ChemicalIntegrators (K193254) | Predicate Device:3MTM AttestTM Steam ChemicalIntegrators (K191236) | Comparison |
|---|---|---|---|
| Device Models | 1243A and 1243B | 1243RE and 1243RES | Similar |
| Device Design | 3MTM AttestTM Steam ChemicalIntegrators are chemical indicatorsconsisting of a paper wick and steam andtemperature sensitive chemical pelletcontained in a paper/film/foil laminate.The chemical pellet melts and migrates asa dark color along the paper wick. Themigration is visible through a windowmarked ACCEPT or window markedREJECT; the extent of migration dependson steam, time, and temperature. | 3MTM AttestTM Steam ChemicalIntegrators are chemical indicatorsconsisting of a paper wick and steam andtemperature sensitive chemical pelletcontained in a paper/film/foil laminate.The chemical pellet melts and migrates asa dark color along the paper wick. Themigration is visible through a windowmarked ACCEPT or window markedREJECT; the extent of migration dependson steam, time, and temperature. | Identical |
| Indicator Agent | Proprietary formulation. | Proprietary formulation. | Identical |
| Sterilizationmethod and cycles | Steam sterilization processes 250°F to275°F (121°C to 135°C) | Steam sterilization processes 250°F to275°F (121°C to 135°C) | Identical |
| Shelf-life | One (1) year | One (1) year | Identical |
Technological Characteristics Comparison Between Subject and Predicate Device:
Indications for Use Comparison:
| Indications for Use Comparison: | ||||
|---|---|---|---|---|
| Cycle Type | Temperature | Submission Device (K193254):3MTM AttestTM Steam ChemicalIntegrators (1243A and 1243B)Exposure Time | Predicate Device (K191236):3MTM AttestTM Steam ChemicalIntegrators (1243RE and 1243RES)Exposure Time | Comparison |
| Gravity | 250°F/121°C | 30 minutes | 30 minutes | Identical |
| Gravity | 270°F/132°C | 3 minutes4 minutes10 minutes15 minutes25 minutes | 3 minutes4 minutes10 minutes15 minutes25 minutes | Identical |
| Gravity | 275°F/135°C | 3 minutes10 minutes | 3 minutes10 minutes | Identical |
| Dynamic AirRemoval | 250°F/121°C | 30 minutes | 30 minutes | Identical |
| Dynamic AirRemoval | 270°F/132°C | 4 minutes10 minutes | 4 minutes10 minutes | Identical |
| Dynamic AirRemoval | 273°F/134°C | 3 minutes4 minutes | 3 minutes4 minutes | Identical |
| Dynamic AirRemoval | 275°F/135°C | 3 minutes | 3 minutes | Identical |
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| Feature | Submission Device (K193254):3MTM AttestTM Steam ChemicalIntegrators (1243A and 1243B) | Predicate Device (K191236):3MTM AttestTM Steam Chemical Integrators(1243RE and 1243RES) | Comparison | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The minimum stated values for the 3MTMAttestTM Steam Chemical Integrators asdetermined using a resistometer areprovided in the table below. | The minimum stated values for the 3MTMAttestTM Steam Chemical Integrators asdetermined using a resistometer areprovided in the table below. | Identical | |||||||||||||||||
| EndpointSpecifications(Minimum StatedValues) | Minimum Stated Values for 3MTMAttestTM Steam Chemical Integrators250°F/121°C 270°F/132°C 273°F/134°C 275°F/135°C 16.5min 2.0min 1.4min 1.2min | Minimum Stated Values for 3MTMAttestTM Steam Chemical Integrators250°F/121°C 270°F/132°C 273°F/134°C 275°F/135°C 16.5min 2.0min 1.4min 1.2min |
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 | |
|---|---|---|---|---|
| StatedValue (SV)Testing | To identify the critical parameters required toachieve a stated inactivation, by referring to astated test organism with stated D and zvalues. The integrator must turn to "ACCEPT"end point at the stated value time and must alsoremain "REJECT" when exposed to conditionsof -1°C/-15% set point of the SV time. Alltesting is completed in a saturated steamresistometer. Integrator temperature coefficientand correlation coefficient are calculated toconfirm alignment to biological indicatorperformance. | SV at 121°CSV at 132°CSV at 134°CSV at 135°CIntegratortemperaturecoefficientCorrelationcoefficient | ≥ 16.5 minutes≥ 2.0 minutes≥ 1.4 minutes≥ 1.2 minutes10 - 27°C≥ 0.9 | PASS |
| Health CareFacility SimulatedUse Testing | Confirm integrators provide acceptableperformance in cleared customer usesterilization cycles. | Device reaches “ACCEPT” endpointreaction when exposed to customer usecycles.Device does not reach endpoint(“REJECT”) when exposed to failingconditions in 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 3M™ Attest™ Steam Chemical Integrator is as safe, as effective and performs as well as or better than the legally marketed predicate, 3M™ Attest™ Steam Chemical Integrators cleared under K191236, 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).