3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader
Device Facts
| Record ID | K213809 |
|---|---|
| Device Name | 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader |
| Applicant | 3M Company |
| Product Code | FRC · General Hospital |
| Decision Date | Apr 6, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
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: 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: 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.
Device Story
System monitors steam sterilization efficacy in healthcare facilities. Input: Geobacillus stearothermophilus spores in 1592 biological indicator (BI) or 51582 challenge pack. Operation: BI incubated at 60°C in 490/490H/490M auto-readers; auto-reader detects fluorescence from enzymatic hydrolysis of non-fluorescent substrate. Output: Fluorescent signal at 24 minutes indicates sterilization failure; chemical process indicator on cap/pack provides immediate visual status. Used by healthcare staff to verify sterilization cycle success. Benefits: Rapid confirmation of sterilization, ensuring patient safety by preventing use of non-sterile instruments.
Clinical Evidence
Bench testing only. Performance verified via ISO 11138-1/3 and FDA guidance. Tests included spore population counts, D-value/Z-value resistance, survival/kill times, component inhibition, hold time assessment, and reduced incubation time validation (24-minute fluorescent result vs 7-day visual). Simulated use testing confirmed performance in claimed cycles. Cross-over study verified equivalent performance of 1592 BI across 490 and 490M auto-readers.
Technological Characteristics
Biological indicator system: plastic sleeve, spore carrier, media ampoule. Indicator organism: Geobacillus stearothermophilus (ATCC 7953). Sensing: fluorescence detection of enzymatic activity. Incubation: 60 ± 2°C. Connectivity: 490/490H/490M auto-readers. Chemical indicators: pink-to-brown (BI cap) and yellow-to-brown (pack).
Indications for Use
Indicated for healthcare facilities to qualify and monitor steam sterilization cycles (gravity displacement and dynamic-air-removal) at temperatures ranging from 250°F to 275°F using 3M Attest biological indicators and auto-readers.
Regulatory Classification
Identification
Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.
Predicate Devices
- 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (K192550)
Reference Devices
- 3M™ Attest™ Mini Auto-reader 490M (K200092)
Submission Summary (Full Text)
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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.
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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.
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
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# 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<br>Type | Exposure<br>Temperature | Exposure<br>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.
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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
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### Device Name and Classification:
| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 1592<br>3M™ Attest™ Super Rapid Steam Challenge Pack 51582<br>3M™ Attest™ Auto-reader 490<br>3M™ Attest™ Auto-reader 490H<br>3M™ Attest™ Mini-Auto-reader 490M |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process<br>[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<br>Temperature | Exposure<br>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 |
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## 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<br>Temperature | Exposure<br>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.
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## 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™
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K213809
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:<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592,<br>3MTM AttestTM<br>Auto-reader 490 and 490H,<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison | |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Super<br>Rapid Steam Biological<br>Indicator 1592 in conjunction<br>with the 3MTM AttestTM Auto-<br>reader 490 having software<br>version 4.0.0 or greater, the<br>3MTM AttestTM Auto-reader<br>490H having software version<br>4.0.0 or greater, or the 3MTM<br>AttestTM Mini Auto-reader<br>490M to qualify or monitor the<br>following steam sterilization<br>cycles:<br>• Gravity Displacement,<br>250°F (121°C),<br>30 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and SFPP),<br>250°F (121°C),<br>15, 20, 30, or 35 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and SFPP),<br>270°F (132°C),<br>3, 3.5, 4, 5.5, or 6 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and SFPP),<br>273°F (134°C),<br>3 or 4 minutes<br>• Dynamic-air-removal | Use the 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592 in<br>conjunction with the 3MTM<br>AttestTM Auto-reader 490<br>having software version<br>4.0.0 or greater or the 3MTM<br>AttestTM Auto-reader 490H<br>having software version<br>4.0.0 or greater to qualify or<br>monitor the following<br>sterilization cycles:<br>• Gravity Displacement,<br>250°F (121°C),<br>30 minutes<br>• Dynamic-air-removal<br>(pre-vacuum and SFPP),<br>250°F (121°C),<br>15, 20, 30, or 35 minutes | Both the predicate and<br>the submission BIs are<br>indicated for use in<br>gravity displacement<br>and dynamic air-<br>removal (pre-vacuum<br>and SFPP) sterilization<br>cycles at 250°F<br>(121°C). The intent of<br>this submission is to<br>expand the indications<br>for use to include<br>dynamic air-removal<br>(pre-vacuum and SFPP)<br>sterilization cycles at<br>270°F (132°C), 273°F<br>(134°C), and 275°F<br>(135°C).<br>Both the submission<br>and predicate BIs are<br>intended to be used in<br>conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 or the 3MTM<br>AttestTM Auto-reader<br>490H. The intent of<br>this submission is to<br>expand the indications<br>for use to include the<br>use of the reference<br>device, the 3MTM | |
| Feature | Submission Device:<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592,<br>3MTM AttestTM<br>Auto-reader 490 and 490H,<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device:<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison | |
| | (pre-vacuum and SFPP),<br>275°F (135°C),<br>3, 3.5, or 10 minutes | | Attest™ Mini Auto-<br>reader 490M (cleared<br>per K200092). | |
| Indicator Organism | Geobacillus stearothermophilus<br>traceable to ATCCTM 7953 | Geobacillus<br>stearothermophilus<br>traceable to ATCCTM 7953 | Identical | |
| Mechanism of<br>Action | When the enzyme that is<br>naturally occurring in the spore<br>is in its active state, it is<br>detected by measuring the<br>fluorescence produced by the<br>enzymatic hydrolysis of a non-<br>fluorescent substrate. The<br>resultant fluorescent by-product<br>is detected by the Auto-reader.<br>The presence of fluorescence<br>upon incubation in the Auto-<br>reader indicates a sterilization<br>process failure. | When the enzyme that is<br>naturally occurring in the<br>spore is in its active state, it<br>is detected by measuring the<br>fluorescence produced by<br>the enzymatic hydrolysis of<br>a non-fluorescent substrate.<br>The resultant fluorescent<br>by-product is detected by<br>the Auto-reader. The<br>presence of fluorescence<br>upon incubation in the<br>Auto-reader indicates a<br>sterilization process failure. | Identical | |
| Auto-reader | 3MTM AttestTM Auto-reader 490<br>having software version 4.0.0 or<br>greater, 3MTM Attest™ Auto-<br>reader, or 490H having software<br>version 4.0.0 or greater, or<br>3MTM AttestTM Mini Auto-<br>reader 490M | 3MTM Attest™ Auto-reader<br>490 having software version<br>4.0.0 or greater or 3MTM<br>Attest™ Auto-reader 490H<br>having software version<br>4.0.0 or greater | Both the submission<br>and predicate BIs are<br>intended to be used in<br>conjunction with the<br>3MTM Attest™ Auto-<br>reader 490 or the 3MTM<br>Attest™ Auto-reader<br>490H. The intent of<br>this submission is to<br>expand the indications<br>for use to include the<br>use of the reference<br>device, the 3MTM<br>Attest™ Mini Auto-<br>reader 490M (cleared<br>per K200092).<br>The 3MTM Attest™<br>Super Rapid Steam<br>Biological Indicator | |
| Feature | Submission Device:<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592,<br>3MTM AttestTM<br>Auto-reader 490 and 490H,<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison | |
| | | | 1592 BI has a 24<br>minute readout and can<br>be used in conjunction<br>with a 490 or 490H<br>Auto-reader having<br>software version 4.0.0<br>or greater or a 490M<br>Auto-reader. | |
| Viable spore<br>population | ≥ 1 x 106 | ≥ 1 x 106 | Identical | |
| Resistance | D121 ≥ 1.5 min<br>D132 ≥ 10 s<br>D134 or 135 ≥ 8 s | D121 ≥ 1.5 min | The submission BI is<br>indicated for qualifying<br>and monitoring<br>sterilization cycles at<br>121°C, 132°C, 134°C,<br>and 135°C whereas the<br>predicate BI is<br>indicated for qualifying<br>and monitoring<br>sterilization cycles at<br>121°C. | |
| Survival Time | Meets the longer of FDA and<br>ISO 11138-1 and ISO 11138-3<br>requirements | Meets the longer of FDA<br>and ISO 11138-1 and ISO<br>11138-3 requirements | Identical | |
| Kill Time | Meets the ISO 11138-1 and ISO<br>11138-3 requirements | Meets the ISO 11138-1 and<br>ISO 11138-3 requirements | Identical | |
| Carrier material | Plastic | Plastic | Identical | |
| Incubation<br>temperature | 60 ± 2°C | 60 ± 2°C | Identical | |
| Readout time | 24 minute final fluorescent<br>result in:<br>• The 490 Auto-reader<br>having software version<br>4.0.0 or greater<br>or<br>• The 490H Auto-reader<br>having software version<br>4.0.0 or greater<br>or<br>• The 490M Mini Auto-<br>reader | 24 minute final fluorescent<br>result in:<br>• The 490 Auto-reader<br>having software version<br>4.0.0 or greater<br>or<br>• The 490H Auto-reader<br>having software version<br>4.0.0 or greater | Both the submission<br>and predicate BIs are<br>intended to be used in<br>conjunction with the<br>3MTM AttestTM Auto-<br>reader 490 or the 3MTM<br>AttestTM Auto-reader<br>490H. The intent of<br>this submission is to<br>expand the indications<br>for use to include the<br>use of the reference | |
| Feature | Submission Device:<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592,<br>3MTM AttestTM<br>Auto-reader 490 and 490H,<br>and 3MTM AttestTM<br>Mini Auto-reader 490M | Predicate Device<br>(K192550):<br>3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator 1592<br>and<br>3MTM AttestTM<br>Auto-reader 490 and 490H | Comparison | |
| | Optional visual pH color<br>change result in 7 days. | Optional visual pH color<br>change result in 7 days | device, the 3MTM<br>AttestTM Mini Auto-<br>reader 490M (cleared<br>per K200092).<br>The 3MTM AttestTM<br>Super Rapid Steam<br>Biological Indicator<br>1592 BI has a 24<br>minute readout and can<br>be used in conjunction<br>with a 490 or 490H<br>Auto-reader having<br>software version 4.0.0<br>or greater or a 490M<br>Auto-reader. | |
| Chemical indicator | Turns from pink to light brown<br>or darker upon steam exposure | Turns from pink to light<br>brown or darker upon steam<br>exposure | Identical |…
