(85 days)
No
The device description and performance studies indicate a chemical indicator that responds to physical parameters (steam, time, temperature) through a chemical reaction and physical migration, not through computational analysis or learning algorithms. There is no mention of AI, ML, or related concepts.
No.
The device is a chemical indicator used to monitor steam sterilization cycles for medical instruments, not to treat a medical condition directly.
No
The device is a chemical indicator designed to monitor the critical parameters of steam sterilization cycles, not to diagnose a condition.
No
The device description clearly states it is a physical chemical indicator consisting of a paper wick, chemical pellet, and laminate, which are hardware components.
Based on the provided information, the 3M™ Attest™ Steam Chemical Integrators are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the critical parameters of steam sterilization cycles (temperature, time, and steam). This is a quality control function for a sterilization process, not a test performed on a biological sample to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to steam, time, and temperature. It does not analyze biological samples.
- Lack of Biological Sample Analysis: IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such samples.
- Performance Studies: The performance studies described focus on the device's ability to accurately reflect the sterilization parameters, not on its ability to diagnose or detect a biological marker.
- Intended User/Care Setting: While used in a healthcare setting, the "Over-The-Counter Use" classification in the context of 21 CFR 801 Subpart C typically relates to devices that can be used by the general public without professional supervision, which is not characteristic of IVD devices used for diagnosis.
In summary, the 3M™ Attest™ Steam Chemical Integrators are a sterilization process indicator, not an IVD device.
N/A
Intended Use / 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, 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 | 5 minutes |
| Dynamic Air Removal | 270°F/132°C | 6 minutes |
| Dynamic Air Removal | 270°F/132°C | 7 minutes |
| Dynamic Air Removal | 270°F/132°C | 8 minutes |
| Dynamic Air Removal | 270°F/132°C | 9 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 |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Comparison to the Predicate Device:
3M™ Attest™ Steam Chemical Integrators are identical to the previously cleared devices which are sold under the same tradename 3M™ Attest™ Steam Chemical Integrators (K193254) and was tested using the identified test methodology shown below.
The results of performance testing on 3M™ Attest™ Steam Chemical Integrators demonstrate the device performs and meet the acceptance criteria shown below.
Table 6.1: Summary of Nonclinical Testing
| Test Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| SV at 250°F/121°C | 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 the SV temperature 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. | > 16.5 minutes | Pass |
| SV at 270°F/132°C | > 2.0 minutes | Pass | |
| SV at 273°F/134°C | ≥ 1.4 minutes | Pass | |
| SV at 275°F/135°C | > 1.2 minutes | Pass | |
| Integrator coefficient | 10 - 27°C -1°C/-15% set point of the SV | Pass | |
| Correlation | > 0.9 | Pass | |
| Health Care Facility Simulated Use Testing | Confirm integrators provide acceptable performance in cleared customer use cycles. | Device reaches "ACCEPT" endpoint 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 parallel 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 |
Conclusion: Based on the intended uses, technological characteristics and non-clinical performance data, 3M™ Attest™ Steam Chemical Integrators are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Attest™ Steam Chemical Integrators cleared under K193254, Class II (21 CFR 880.2800(b)), product code JOJ.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
June 24, 2022
3M Company Yumi Wackerfuss Senior Regulatory Affairs Associate 2510 Conway Avenue, Bldg. 275-5W-06 Saint Paul, Minnesota 55144-1000
Re: K220942
Trade/Device Name: 3M Attest Steam Chemical Integrators (1243A, 1243RE, 1243RES) Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: JOJ Dated: May 25, 2022 Received: May 27, 2022
Dear Yumi Wackerfuss:
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,
Clarence W. Murray, III, PhD 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) K220942
Device Name
3MTM Attest™ Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
Indications for Use (Describe)
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, 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 | 5 minutes |
| Dynamic Air Removal | 270°F/132°C | 6 minutes |
| Dynamic Air Removal | 270°F/132°C | 7 minutes |
| Dynamic Air Removal | 270°F/132°C | 8 minutes |
| Dynamic Air Removal | 270°F/132°C | 9 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 | ||
| 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) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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510(k) Summary for 3M™ Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
Sponsor Information:
3M Company 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Yumi Wackerfuss Senior Regulatory Affairs Associate Phone Number: (651) 737-3556 Fax Number: (651) 737-5320
Date of Summary: March 29th, 2022
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1. Device Name and Classification:
| Common or Usual Name | Chemical Indicators |
|---|---|
| Proprietary Name: | 3M™ Attest™ Steam Chemical Integrators |
| Classification Name: | Physical/chemical sterilization process indicator |
| Device Classification: | Class II, 21 CFR § 880.2800(b) |
| Product Code: | JOJ |
2. Predicate Device:
K193254, 3MTM Attest™ Steam Chemical Integrators
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.
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 | 5 minutes |
| Dynamic Air Removal | 270°F/132°C | 6 minutes |
| Dynamic Air Removal | 270°F/132°C | 7 minutes |
| Dynamic Air Removal | 270°F/132°C | 8 minutes |
| Dynamic Air Removal | 270°F/132°C | 9 minutes |
| Dynamic Air Removal | 270°F/132°C | 10 minutes |
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Image /page/6/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.
3M™ Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| 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 |
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Image /page/7/Picture/0 description: The image shows the 3M logo. The logo is in red and features the number "3" followed by the letter "M". The font is bold and sans-serif. The logo is simple and recognizable.
510(k) Summary 3M™ Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
5. Summary of Technological Characteristics compared to Predicate Device
| Element | Subject Devices: (this submission)
3M™ Attest™ Steam Chemical Integrators | Predicate Device (K193254: Cleared on Dec 23rd, 2019)
3M™ Attest™ Steam Chemical Integrators | Comparison | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Device Models | 1243A, 1243B, 1243RE and 1243RES | 1243A and 1243B | 1243A and 1243B are substantially equivalent as 1243RE and 1243RES (K191236). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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: | 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: | Similar. This submission proposes the additional exposure times for 5, 6, 7, 8 and 9 mintues for Dynamic Air Removal, 270°F/132° C. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | 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 5 minutes Dynamic Air Removal 270°F/132°C 6 minutes | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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Image /page/8/Picture/0 description: The image shows the 3M logo. The logo consists of the number "3" and the letter "M" in a bold, sans-serif font. The color of the text is red. The background is white.
510(k) Summary 3M™ Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
| Element | Subject Devices: (this submission)
3MTM Attest™ Steam Chemical Integrators | | | Predicate Device (K193254: Cleared on Dec 23rd, 2019)
3MTM Attest™ Steam Chemical Integrators | | | | Comparison | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-------------|-------------|--------------------------------------------------|--|
| | Dynamic Air
Removal | 270°F/132°C | 7 minutes | Dynamic Air
Removal | 273°F/134°C | 3 minutes | | | |
| | Dynamic Air
Removal | 270°F/132°C | 8 minutes | Dynamic Air
Removal | 273°F/134°C | 4 minutes | | | |
| | Dynamic Air
Removal | 270°F/132°C | 9 minutes | Dynamic Air
Removal | 275°F/135°C | 3 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 | | | | | | |
| Indicator
Agent | Proprietary formulation. | | | Proprietary formulation. | | | | Identical | |
| Sterilization
method and
cycles | Steam sterilization processes 250°F to 275°F (121°C to 135°C) | | | Steam sterilization processes 250°F to 275°F (121°C to 135°C) | | | | Identical | |
| Endpoint
Specificatio
ns
(Minimum
Stated
Values) | The minimum stated values for the 3M™ Attest™ Steam
Chemical Integrators as determined using a resistometer are
provided in the table below. | | | The minimum stated values for the 3MTM Attest™ Steam
Chemical Integrators as determined using a resistometer
are provided in the table below. | | | | Identical | |
| | 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 | |
| | 16.5
Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes | 16.5
Minutes | 2.0 Minutes | 1.4 Minutes | 1.2 Minutes | |
| Shelf life | Three (3) years | | | One (1) year for 1243A and 1243B | | | | Extended
via
identical
protocol.
The | |
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Image /page/9/Picture/0 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 3M™ Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
| Element | Subject Devices: (this submission) | Predicate Device (K193254: Cleared on Dec 23rd, 2019) | Comparison |
|---|---|---|---|
| 3M™ Attest™ Steam Chemical Integrators | 3M™ Attest™ Steam Chemical Integrators | 1243RE | |
| and RES | |||
| was cleared | |||
| for 6 | |||
| months | |||
| shelf life | |||
| originally. |
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Image /page/10/Picture/0 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The logo is simple and recognizable. The red color is bold and eye-catching.
510(k) Summary 3MTM Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
6. Nonclinical Comparison to the Predicate Device
3MTM Attest™ Steam Chemical Integrators are identical to the previously cleared devices which are sold under the same tradename 3M™ Attest™ Steam Chemical Integrators (K193254) and was tested using the identified test methodology shown below.
The results of performance testing on 3MTM Attest™ Steam Chemical Integrators demonstrate the device performs and meet the acceptance criteria shown below.
Results Test Name Acceptance Criteria Purpose SV at 250°F/121°C Stated Value To identify the critical > 16.5 minutes Pass (SV) Testing parameters required to achieve a stated inactivation, by SV at 270°F/132°C > 2.0 minutes referring to a stated test organism with stated D and z SV at 273°F/134°C ≥ 1.4 minutes values. The integrator must turn to "ACCEPT" end point SV at 275°F/135°C > 1.2 minutes at the stated value time and must also remain "REJECT" when exposed to conditions of Integrator 10 - 27°C -1°C/-15% set point of the SV temperature time. All testing is completed coefficient in a saturated steam Correlation > 0.9 resistometer. Integrator coefficient temperature coefficient and correlation coefficient are calculated to confirm alignment to biological indicator performance. Health Care Confirm integrators provide Device reaches "ACCEPT" endpoint Pass Facility reaction when exposed to customer acceptable performance in Simulated Use cleared customer use use cvcles. Testing sterilization cycles. Device does not reach endpoint ("REJECT") when exposed to failing conditions in customer use cycles. Dry Heat Verify device requires the Endpoint must not be met following Pass Testing presence of saturated steam to dry heat exposure at 140°C for 30 turn to reach endpoint. min. Side-by-Side Confirm integrators are Chemical integrator parallels Pass Testing with parallel in performance to performance of BI and does not reach Biological endpoint before BI is inactivated. biological indicators (BI). Indicator Endpoint Confirm endpoint color Endpoint decision must remain Pass unchanged after 6 months. Color Stability stability for samples exposed to passing and failing
Table 6.1: Summary of Nonclinical Testing
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510(k) Summary 3MTM Attest™ Steam Chemical Integrators 1243A, 1243B, 1243RE and 1243RES
| Test Name | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| conditions in a steam | |||
| resistometer. |
7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, 3M™ Attest™ Steam Chemical Integrators are as safe, as effective, and performs as well as or better than the legally marketed predicate device, Attest™ Steam Chemical Integrators cleared under K193254, Class II (21 CFR 880.2800(b)), product code JOJ.