(121 days)
No
The document describes a biological indicator and auto-readers for monitoring steam sterilization. The function of the auto-reader is to incubate and read fluorescent results, which is a standard biological process detection method, not indicative of AI/ML. There is no mention of AI, ML, or complex data analysis beyond detecting fluorescence.
No
The device is used to monitor and qualify steam sterilization processes, ensuring instruments are sterile, rather than directly treating a medical condition or affecting the structure/function of the body.
No
The device is used to qualify or monitor steam sterilization cycles, indicating whether the sterilization process has been successful, rather than to diagnose a medical condition in a patient.
No
The device description clearly outlines physical components like biological indicators, challenge packs, and auto-readers, which are hardware. While software is mentioned as being part of the auto-readers, the overall system is not software-only.
Based on the provided text, the devices described are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is to qualify or monitor steam sterilization cycles in healthcare facilities. This is a process control function, ensuring that medical devices are properly sterilized before use on patients.
- Mechanism of Action: The biological indicators contain spores that are killed by effective sterilization. The auto-readers detect the presence or absence of viable spores (through fluorescence), indicating whether the sterilization process was successful. This is a test of the sterilization equipment's performance, not a test performed on a biological sample from a human or animal to diagnose a condition.
- Device Description: The descriptions clearly state their purpose is for monitoring sterilization processes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) for diagnostic purposes, nor is there any indication of providing information about a patient's health status.
These devices fall under the category of sterilization process indicators, which are regulated differently than IVDs.
N/A
Intended Use / Indications for Use
3M™ Attest™ Super Rapid Steam Biological Indicator 1592:
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes |
3M™ Attest™ Super Rapid Steam Challenge Pack 51582:
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3M™ Attest™ Auto-reader 490:
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491. 1492V. and 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3M™ Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed for rapid and reliable qualification testing and routine monitoring of 250°F (121°C) dynamic-air-removal and gravity displacement steam sterilization processes and of dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities. The 1592 BI is used in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Autoreader 490M.
The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1592 BI in the 490 Auto-reader, 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify and monitor dynamic-air-removal (pre-vacuum and SFPP) and gravity displacement steam sterilization processes at 250°F (121°C) and dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. The stacked cards are wrapped with sterilization wrap and secured with a label. The Challenge Packs are identical in design to the predicate device. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3M™ Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device performance was verified through the following tests:
- 1592 BI Population: Evaluated total viable spore count against ISO 11138-1, ISO 11138-3, USP 34-NF29, and FDA Guidance document. Accepted if ≥ 10^6 spores. Results: Passed.
- 1592 BI D-Value: Evaluated resistance characteristics. D121 ≥ 1.5 min, D132 ≥ 10 s, D134 or 135 ≥ 8 s. Results: Passed.
- 1592 BI Z-Value: Evaluated resistance characteristics. Accepted if ≥ 10°C. Results: Passed.
- 1592 BI Survival Time: Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements. Results: Passed.
- 1592 BI Kill Time: Meets ISO 11138-1 and ISO 11138-3 requirements. Results: Passed.
- 1592 BI Component Inhibition Studies: Evaluated effects of carrier and packaging materials on resistance characteristics. Components have no impact on the recovery of 10-100 organisms. Results: Passed.
- 1592 BI Hold Time Assessment: Evaluated effect of labeled holding time on resistance characteristics and spore recovery. D-value does not change when activated 7 days post sterilization. Results: Passed.
- 1592 BI Reduced Incubation Time: Validated reduction in incubation time from 7 days to 24 minutes. Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with conventional incubation time of 7 days for fluorescent result in 24 minutes. Meets requirement for Reduced Incubation Time specified in ISO 11138-8. Results: Passed.
- 1592 BI Simulated Use: Verified performance in claimed cycles. BI performs as intended in claimed cycles. Results: Passed.
- 490 Auto-reader and 490M Mini Auto-reader Verification of equivalent performance: Cross-over study of 1592 BI in 490 Auto-reader and 490M Mini Auto-reader. 1592 BI performs the same in 490 Auto-reader as compared to 490M Mini Auto-reader. Results: Passed.
- 51582 Challenge Pack Resistance as compared to AAMI 16 Towel PCD in claimed cycles: Evaluated against ANSI/AAMI ST79 and FDA Guidance document. Accepted if 51582 Challenge Pack demonstrates equivalent resistance as compared to the AAMI 16 Towel PCD in claimed cycles. Results: Passed.
- 51582 Challenge Pack Resistance as compared to the 1592 Biological Indicator and the 3M™ Attest™ Chemical Integrator alone in claimed cycles: Evaluated against FDA Guidance document. Accepted if 51582 Challenge Pack provides a greater challenge than 1592 Biological Indicator and 3M™ Attest™ Chemical Integrator itself in claimed cycles. Results: Passed.
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
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 & 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.
April 6, 2022
3M Company Hilary Hovde Regulatory Affairs Specialist 3M Center 2510 Conway Ave, Building 275-5W-06 Saint Paul, Minnesota 55144
Re: K213809
Trade/Device Name: 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: March 17, 2022 Received: March 18, 2022
Dear Hilary Hovde:
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.
1
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.
for Clarence Murray, III, Ph.D. 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) K213809
Device Name
3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, 3M™ Attest™ Mini Auto-reader 490M
Indications for Use (Describe)
3MTM Attest™ Super Rapid Steam Biological Indicator 1592:
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle | Exposure | Exposure |
|---|---|---|
| Type | Temperature | Time |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes |
3MTM AttestTM Super Rapid Steam Challenge Pack 51582:
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle
Type | Exposure
Temperature | Exposure
Time |
|-------------------------------------------|-------------------------|------------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
3MTM AttestTM Auto-reader 490:
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491. 1492V. and 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM AttestTM Auto-reader 490H:
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
3MTM Attest™ Mini Auto-reader 490M:
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.
3
The indications for use for Attest™ Biological Indicators are provided in the product's Instructions for Use.
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 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3MTM Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, 3MTM Attest™ Mini Auto-reader 490M
3M Company 3M Health Care 2510 Conway Ave., Bldg. 275-5W-06 St. Paul, MN 55144 USA
Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364 FAX Number: (651) 737-5320 hbhovde@mmm.com
Submission Date: April 5, 2022
5
Device Name and Classification:
| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Super Rapid Steam Challenge Pack 51582
3M™ Attest™ Auto-reader 490
3M™ Attest™ Auto-reader 490H
3M™ Attest™ Mini-Auto-reader 490M |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
[21 CFR § 880.2800(a), FRC] |
Predicate Device:
3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K192550
Reference Device: 3M™ Attest™ Mini Auto-reader 490M. K200092
Indications for Use - 1592 Biological Indicator
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3MTM Attest™ Mini Autoreader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure
Temperature | Exposure
Time |
|-------------------------------------------|-------------------------|------------------------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15, 20, 30, or 35 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 3, 3.5, 4, 5.5, or 6 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 3 or 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3, 3.5, or 10 minutes |
6
Indications for Use – 51582 Challenge Pack
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
| Cycle Type | Exposure
Temperature | Exposure
Time |
|-------------------------------------------|-------------------------|------------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |
Indications for Use - 490 Auto-reader
The 3M™Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.
Indications for Use - 490H Auto-reader
The 3MTM Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.
Indications for Use – 490M Mini Auto-reader
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60ºC for a final fluorescent result at 24 minutes.
The indications for use for Attest™ Biological Indicators are provided in the product's Instructions for Use.
7
Description of Device
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed for rapid and reliable qualification testing and routine monitoring of 250°F (121°C) dynamic-air-removal and gravity displacement steam sterilization processes and of dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities. The 1592 BI is used in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3MTM Attest™ Mini Autoreader 490M.
The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1592 BI in the 490 Auto-reader, 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify and monitor dynamic-air-removal (pre-vacuum and SFPP) and gravity displacement steam sterilization processes at 250°F (121°C) and dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. The stacked cards are wrapped with sterilization wrap and secured with a label. The Challenge Packs are identical in design to the predicate device. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3M™ Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam. 3MTM Attest™ 1592 BI controls are provided with the Challenge Packs.
The 1592 BI is specifically designed for rapid and reliable monitoring of the steam sterilization processes when used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1592 BI in the 490, 490H, or the 490M Auto-reader indicates a steam sterilization process failure.
Comparison of Technological Characteristics with the Predicate and Reference Devices
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 are part of a biological indicator system with the 3M™
8
Attest™ Auto-reader 490, 3MTM Attest™ Auto-reader 490H, or 3MTM Attest™ Mini Autoreader 490M. This 510(k) is to expand the indications for use of the 1592 BI and the 51582 Challenge Pack to qualify and monitor additional steam sterilization cycles and to extend the use of the 490M Mini Auto-reader to include the 1592 BI and the 1592 BI contained within the 51582 Challenge Pack. Safety and efficacy were demonstrated through performance testing.
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592 in conjunction
with the 3MTM AttestTM Auto-
reader 490 having software
version 4.0.0 or greater, the
3MTM AttestTM Auto-reader
490H having software version
4.0.0 or greater, or the 3MTM
AttestTM Mini Auto-reader
490M to qualify or monitor the
following steam sterilization
cycles:
• Gravity Displacement,
250°F (121°C),
30 minutes
• Dynamic-air-removal
(pre-vacuum and SFPP),
250°F (121°C),
15, 20, 30, or 35 minutes
• Dynamic-air-removal
(pre-vacuum and SFPP),
270°F (132°C),
3, 3.5, 4, 5.5, or 6 minutes
• Dynamic-air-removal
(pre-vacuum and SFPP),
273°F (134°C),
3 or 4 minutes
• Dynamic-air-removal | Use the 3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592 in
conjunction with the 3MTM
AttestTM Auto-reader 490
having software version
4.0.0 or greater or the 3MTM
AttestTM Auto-reader 490H
having software version
4.0.0 or greater to qualify or
monitor the following
sterilization cycles:
• Gravity Displacement,
250°F (121°C),
30 minutes
• Dynamic-air-removal
(pre-vacuum and SFPP),
250°F (121°C),
15, 20, 30, or 35 minutes | Both the predicate and
the submission BIs are
indicated for use in
gravity displacement
and dynamic air-
removal (pre-vacuum
and SFPP) sterilization
cycles at 250°F
(121°C). The intent of
this submission is to
expand the indications
for use to include
dynamic air-removal
(pre-vacuum and SFPP)
sterilization cycles at
270°F (132°C), 273°F
(134°C), and 275°F
(135°C).
Both the submission
and predicate BIs are
intended to be used in
conjunction with the
3MTM AttestTM Auto-
reader 490 or the 3MTM
AttestTM Auto-reader
490H. The intent of
this submission is to
expand the indications
for use to include the
use of the reference
device, the 3MTM | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device:
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
| | (pre-vacuum and SFPP),
275°F (135°C),
3, 3.5, or 10 minutes | | Attest™ Mini Auto-
reader 490M (cleared
per K200092). | |
| Indicator Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Geobacillus
stearothermophilus
traceable to ATCCTM 7953 | Identical | |
| Mechanism of
Action | When the enzyme that is
naturally occurring in the spore
is in its active state, it is
detected by measuring the
fluorescence produced by the
enzymatic hydrolysis of a non-
fluorescent substrate. The
resultant fluorescent by-product
is detected by the Auto-reader.
The presence of fluorescence
upon incubation in the Auto-
reader indicates a sterilization
process failure. | When the enzyme that is
naturally occurring in the
spore is in its active state, it
is detected by measuring the
fluorescence produced by
the enzymatic hydrolysis of
a non-fluorescent substrate.
The resultant fluorescent
by-product is detected by
the Auto-reader. The
presence of fluorescence
upon incubation in the
Auto-reader indicates a
sterilization process failure. | Identical | |
| Auto-reader | 3MTM AttestTM Auto-reader 490
having software version 4.0.0 or
greater, 3MTM Attest™ Auto-
reader, or 490H having software
version 4.0.0 or greater, or
3MTM AttestTM Mini Auto-
reader 490M | 3MTM Attest™ Auto-reader
490 having software version
4.0.0 or greater or 3MTM
Attest™ Auto-reader 490H
having software version
4.0.0 or greater | Both the submission
and predicate BIs are
intended to be used in
conjunction with the
3MTM Attest™ Auto-
reader 490 or the 3MTM
Attest™ Auto-reader
490H. The intent of
this submission is to
expand the indications
for use to include the
use of the reference
device, the 3MTM
Attest™ Mini Auto-
reader 490M (cleared
per K200092).
The 3MTM Attest™
Super Rapid Steam
Biological Indicator | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
| | | | 1592 BI has a 24
minute readout and can
be used in conjunction
with a 490 or 490H
Auto-reader having
software version 4.0.0
or greater or a 490M
Auto-reader. | |
| Viable spore
population | ≥ 1 x 106 | ≥ 1 x 106 | Identical | |
| Resistance | D121 ≥ 1.5 min
D132 ≥ 10 s
D134 or 135 ≥ 8 s | D121 ≥ 1.5 min | The submission BI is
indicated for qualifying
and monitoring
sterilization cycles at
121°C, 132°C, 134°C,
and 135°C whereas the
predicate BI is
indicated for qualifying
and monitoring
sterilization cycles at
121°C. | |
| Survival Time | Meets the longer of FDA and
ISO 11138-1 and ISO 11138-3
requirements | Meets the longer of FDA
and ISO 11138-1 and ISO
11138-3 requirements | Identical | |
| Kill Time | Meets the ISO 11138-1 and ISO
11138-3 requirements | Meets the ISO 11138-1 and
ISO 11138-3 requirements | Identical | |
| Carrier material | Plastic | Plastic | Identical | |
| Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Readout time | 24 minute final fluorescent
result in:
• The 490 Auto-reader
having software version
4.0.0 or greater
or
• The 490H Auto-reader
having software version
4.0.0 or greater
or
• The 490M Mini Auto-
reader | 24 minute final fluorescent
result in:
• The 490 Auto-reader
having software version
4.0.0 or greater
or
• The 490H Auto-reader
having software version
4.0.0 or greater | Both the submission
and predicate BIs are
intended to be used in
conjunction with the
3MTM AttestTM Auto-
reader 490 or the 3MTM
AttestTM Auto-reader
490H. The intent of
this submission is to
expand the indications
for use to include the
use of the reference | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
| | Optional visual pH color
change result in 7 days. | Optional visual pH color
change result in 7 days | device, the 3MTM
AttestTM Mini Auto-
reader 490M (cleared
per K200092).
The 3MTM AttestTM
Super Rapid Steam
Biological Indicator
1592 BI has a 24
minute readout and can
be used in conjunction
with a 490 or 490H
Auto-reader having
software version 4.0.0
or greater or a 490M
Auto-reader. | |
| Chemical indicator | Turns from pink to light brown
or darker upon steam exposure | Turns from pink to light
brown or darker upon steam
exposure | Identical | |
| Shelf-life | 12 months | 6 months | Shelf life will be
extended as real time
data is available. | |
| | | Submission Device: | Reference Device
(K200092): | |
| Feature | | 3MTM AttestTM
Auto-reader 490,
3MTM AttestTM
Auto-reader 490H,
3MTM AttestTM
Mini Auto-reader 490M, | 3MTM AttestTM
Mini Auto-reader 490M | Comparison |
| Indications for use | 490
490H
490M | The 3MTMAttestTM Auto
reader 490 is designed to
incubate and
automatically read 3MTM
AttestTM Rapid Readout
Biological Indicators
1295 and 3MTM AttestTM
Super Rapid Readout
Biological Indicators,
catalog numbers 1491,
1492V, and 1592 at
60°C for a final
fluorescent result at 24
minutes.
The 3MTM AttestTM
Auto-reader 490H is
designed to incubate and
automatically read 3MTM
AttestTM Rapid Readout
Biological Indicators
1295, 3MTM AttestTM
Super Rapid Readout
Biological Indicators,
catalog numbers 1491
and 1492V, and 3MTM
Attest Super Rapid
Steam Biological
Indicators 1592 at 60°C
for a final fluorescent
result at 24 minutes.
The 3MTM AttestTM Mini
Auto-reader 490M is
designed to incubate and
automatically read 3MTM
AttestTM Rapid Readout
Biological Indicators
1295 and 3MTM AttestTM
Super Rapid Readout
Biological Indicators,
catalog numbers 1491,
1492V and 1592, at
60°C for a final | The 3MTM AttestTM Mini
Auto-reader 490M is
designed to incubate and
automatically read 3MTM
AttestTM Rapid Readout
Biological Indicators 1295
and 3MTM AttestTM Super
Rapid Readout Biological
Indicators, catalog numbers
1491 and 1492V, at 60°C
for a final fluorescent result
at 24 minutes.
The indications for use for
AttestTM Biological
Indicators are provided in
the product's Instructions
for Use. | Both the submission
and predicate BIs are
intended to be used in
conjunction with the
3MTM AttestTM Auto-
reader 490 or the 3MTM
AttestTM Auto-reader
490H. The intent of
this submission is to
expand the indications
for use to include the
use of the reference
device, the 3MTM
AttestTM Mini Auto-
reader 490M. |
| Feature | Submission Device: | | Reference Device (K200092): | Comparison |
| | 3MTM AttestTM Auto-reader 490,
3MTM AttestTM Auto-reader 490H,
3MTM AttestTM Mini Auto-reader 490M | fluorescent result at 24 minutes.
The indications for use for AttestTM Biological Indicators are provided in the product's Instructions for Use. | 3MTM AttestTM Mini Auto-reader 490M | |
| Incubation
temperature | 490 | 60 ± 2°C | 60 ± 2°C | Identical |
| | 490H | 60 ± 2°C | | |
| | 490M | 60 ± 2°C | | |
| Readout time | 490 | 24 minutes | | |
| | 490H | 24 minutes | 24 minutes | Identical |
| | 490M | 24 minutes | | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device
(K192550):
3MTM Attest TM
Super Rapid Steam
Challenge Pack 51582 and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
| Indications for
use | Use the 3MTM AttestTM Super
Rapid Steam Challenge Pack
51582 in conjunction with the
3MTM AttestTM Auto-reader
490 having software version
4.0.0 or greater, the 3MTM
AttestTM Auto-reader 490H
having software version 4.0.0
or greater, or the 3MTM
AttestTM Mini Auto-reader
490M to qualify or monitor:
• Gravity Displacement,
250°F (121°C),
30 minutes
• Dynamic-air-removal
(pre-vacuum and SFPP),
250°F (121°C),
30 minutes
• Dynamic-air removal
(pre-vacuum and SFPP),
270°F (132°C),
4 minutes
• Dynamic-air removal
(pre-vacuum and SFPP),
273°F (134°C),
4 minutes
• Dynamic-air removal
(pre-vacuum and SFPP),
275°F (135°C),
3 minutes | Use the 3MTM AttestTM Super
Rapid Steam Challenge Pack
51582 in conjunction with the
3MTM AttestTM Auto-reader
490 having software version
4.0.0 or greater or the 3MTM
AttestTM Auto-reader 490H
having software version 4.0.0
or greater to qualify or
monitor dynamic-air removal
(pre-vacuum and SFPP) or
gravity displacement steam
sterilization cycles of 30
minutes at 250°F (121°C). | Both the predicate and
the submission
Challenge Packs are
indicated for use in
Gravity Displacement
and Dynamic air-
removal (pre-vacuum
and SFPP) steam
sterilization cycles at
250°F (121°C). The
intent of this submission
is to expand the
indications for use to
include Dynamic air-
removal (pre-vacuum
and SFPP) sterilization
cycles at 270°F (132°C),
273°F (134°C), and
275°F (135°C).
Both the submission and
predicate Challenge
Packs contain a 1592 BI
that is intended to be
used in conjunction with
the 3MTM AttestTM Auto-
reader 490 or the 3MTM
AttestTM Auto-reader
490H. The intent of this
submission is to expand
the indications for use to
include the use of the
reference device, the
3MTM AttestTM Mini
Auto-reader 490M
(cleared per K200092). | |
| General Design | Layers of medical index cards,
some of which are die-cut to
contain indicators | Layers of medical index cards,
some of which are die-cut to
contain indicators | Identical | |
| Feature | Submission Device:
3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582,
3MTM AttestTM
Auto-reader 490 and 490H,
and 3MTM AttestTM
Mini Auto-reader 490M | Predicate Device
(K192550):
3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582 and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison | |
| | overwrapped and secured with
a label. | overwrapped and secured with
a label. | | |
| Biological
Indicator | 3MTM AttestTM Super Rapid
Steam Biological Indicator
1592 | 3MTM AttestTM Super Rapid
Steam Biological Indicator
1592 | Identical | |
| Biological
Indicator
Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Biological
Indicator Readout
time | 24 minute final fluorescent
result in the 490 or 490H
Auto-readers having software
versions 4.0.0 or greater or the
490M Mini Auto-reader. | 24 minute final fluorescent
result in both the 490 and
490H Auto-readers having
software versions 4.0.0 or
greater. | Both the submission and
the predicate BIs have a
24 minute readout and
are indicated to be used
with a 490 or 490H
Auto-reader having
software version 4.0.0 or
greater. The intent of
this submission is to
expand the indications
for use to include the use
of the reference device,
the 3MTM AttestTM Mini
Auto-reader 490M
which also has a 24
minute readout (cleared
per K200092). | |
| Resistance
Comparison to
the AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Identical | |
| Chemical
Integrator | 3MTM AttestTM Chemical
Integrator | 3MTM AttestTM Chemical
Integrator | Identical | |
| External
Chemical Process
Indicator | Turns from yellow to brown or
darker upon steam exposure | Turns from yellow to brown or
darker upon steam exposure | Identical | |
| Shelf-life | 12 months | 6 months | Shelf life will be
extended as real time
data is available. | |
Technical Characteristics Comparison Table – Biological Indicator
9
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582
3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
10
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
11
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3MTM Attest™ Super Rapid Steam Biological Indicator 1592 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 3MTM Attest™ Auto-readers 490 and 490H
3MTM Attest™ Mini Auto-reader 490M
Technical Characteristics Comparison Table - Auto-readers
Both the submission and predicate BIs are intended to be used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (both having software version 4.0.0 or greater). The intent of this submission is to expand the indications for use to include the use of the reference device, the 3M™ Attest™ Mini Auto-reader 490M (cleared per K200092). The table below is a comparison of the three Auto-reader models that can be used in conjunction with the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592.
12
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
13
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H
3M™ Attest™ Mini Auto-reader 490M
14
Technical Characteristics Comparison Table – Challenge Pack
15
TRADITIONAL PREMARKET NOTIFICATION [510(k)]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3M™ Attest™ Mini Auto-reader 490M
16
Summary of Non-Clinical Testing
The differences between the subject and predicate devices have been evaluated through performance tests to provide evidence of substantial equivalence for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582.
The device performance was verified through the following tests:
| Item
Tested | Test | Standard | Purpose | Acceptance
Criteria | Results |
|----------------|---------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 1592 BI | Population | ISO 11138-1,
ISO 11138-3,
USP 34-NF29,
and
FDA Guidance
document¹ | To evaluate the
total viable spore
count | ≥ 106 spores | Passed |
| 1592 BI | D-Value | ISO 11138-1,
ISO 11138-3,
and
FDA Guidance
document¹ | | D121 ≥ 1.5 min
D132 ≥ 10 s
D134 or 135 ≥ 8 s | Passed |
| 1592 BI | Z-Value | ISO 11138-1,
ISO 11138-3,
and
FDA Guidance
document¹ | To evaluate the
resistance
characteristics of
the BI. | ≥ 10°C | Passed |
| 1592 BI | Survival Time | ISO 11138-1,
ISO 11138-3,
and
FDA Guidance
document¹ | | Meets the longer of
FDA and ISO
11138-1 and ISO
11138-3
requirements | Passed |
| 1592 BI | Kill Time | ISO 11138-1,
ISO 11138-3,
and
FDA Guidance
document¹ | | Meets ISO 11138-1
and ISO 11138-3
requirements | Passed |
| 1592 BI | Component Inhibition
Studies | ISO 11138-1 and
FDA Guidance
document¹ | To evaluate the
effects of carrier
and packaging
materials on the
resistance
characteristics of
the BI. | Components have
no impact on the
recovery of 10-100
organisms | Passed |
| 1592 BI | Hold Time
Assessment | ISO 11138-1 and
FDA Guidance
document¹ | To evaluate the
effect of the
labeled holding
time on the
resistance
characteristics | D-value does not
change when
activated 7 days
post sterilization | Passed |
| Item
Tested | Test | Standard | Purpose | Acceptance
Criteria | Results |
| | | | and spore | | |
| | | | recovery. | | |
| 1592 BI | Reduced Incubation
Time | ISO 11138-1 and
FDA Guidance
document1 | To validate the
reduction in
incubation time
from 7 days to 24
minutes. | Meets FDA's
requirements for
Reduced
Incubation Time
with > 97%
alignment with the
conventional
incubation time of
7 days for the
following readout
time:
Fluorescent result | Passed |
| 1592 BI | Reduced Incubation
Time | ISO 11138-1 and
ISO 11138-8 | To validate the
reduction in
incubation time
from 7 days to 24
minutes. | in 24 minutes
Meets requirement
for Reduced
Incubation Time
specified in ISO
11138-8 | Passed |
| 1592 BI | Simulated Use | FDA Guidance
document1 | Verification of
performance in
claimed cycles | BI performs as
intended in claimed
cycles | Passed |
17
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3MTM Attest™ Super Rapid Steam Challenge Pack 51582 3M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
1 Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
| Item Tested | Test | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| 490 | ||||
| Auto-reader | ||||
| and 490M | ||||
| Mini | ||||
| Auto-reader | Verification of | |||
| equivalent | ||||
| performance- | ||||
| 1592 BI in 490 | ||||
| Auto-reader and | ||||
| 490M Mini Auto- | ||||
| reader | Cross-over study of | |||
| 1592 BI in 490 Auto- | ||||
| reader and 490M Mini | ||||
| Auto-reader | 1592 BI performs the | |||
| same in 490 Auto- | ||||
| reader as compared to | ||||
| 490M Mini Auto- | ||||
| reader | Passed |
18
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 M™ Attest™ Auto-readers 490 and 490H 3MTM Attest™ Mini Auto-reader 490M
| Item
| Tested | Test | Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| 51582 | |||||
| Challenge | |||||
| Pack | Resistance of | ||||
| the 51582 | |||||
| Challenge Pack | |||||
| as compared to | |||||
| AAMI 16 | |||||
| Towel PCD in | |||||
| claimed cycles | ANSI/AAMI ST79 | ||||
| and | |||||
| FDA Guidance | |||||
| document1 | To evaluate the | ||||
| 51582 Challenge | |||||
| Pack as compared | |||||
| to the AAMI 16 | |||||
| Towel PCD in | |||||
| claimed cycles | 51582 Challenge | ||||
| Pack demonstrates | |||||
| equivalent resistance | |||||
| as compared to the | |||||
| AAMI 16 Towel | |||||
| PCD in claimed | |||||
| cycles | Passed | ||||
| 51582 | |||||
| Challenge | |||||
| Pack | Resistance of | ||||
| the 51582 | |||||
| Challenge Pack | |||||
| as compared to | |||||
| the 1592 | |||||
| Biological | |||||
| Indicator and | |||||
| the 3MTM | |||||
| AttestTM | |||||
| Chemical | |||||
| Integrator alone | |||||
| in claimed | |||||
| cycles | FDA Guidance | ||||
| document1 | To evaluate the | ||||
| 51582 Challenge | |||||
| Pack as compared | |||||
| to the 1592 | |||||
| Biological | |||||
| Indicator itself | |||||
| and the 3MTM | |||||
| AttestTM Chemical | |||||
| Integrator alone in | |||||
| claimed cycles | 51582 Challenge | ||||
| Pack provides a | |||||
| greater challenge | |||||
| than 1592 Biological | |||||
| Indicator and 3MTM | |||||
| AttestTM Chemical | |||||
| Integrator itself in | |||||
| claimed cycles | Passed |
1 Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007
Conclusion
Based on the intended use, technological characteristics, and non-clinical performance data, the subject devices, the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, the 3MTM Attest™ Auto-reader 490, the 3MTM Attest™ Auto-reader 490H, and the 3MTM Attest™ Mini Auto-reader 490M, are substantially equivalent to, and are as safe and as effective as the legally marketed predicate device, the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3MTM Attest™ Auto-reader 490, 3MTM Attest™ Autoreader 490H (cleared under K192550) and the reference device, the 3MTM Attest™ Mini Autoreader 490M (cleared under K200092), Class II (21 CFR 880.2800), product code FRC.