(165 days)
Not Found
No
The document describes a biological indicator and an auto-reader that detects fluorescence produced by an enzymatic reaction. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is based on a chemical/biological reaction and a fluorescent detection system.
No
This device is a biological indicator used to monitor the effectiveness of sterilization cycles, not to treat a medical condition or disease.
No
Explanation: This device is used to monitor the effectiveness of steam sterilization cycles, not to diagnose a medical condition in a patient. It is a quality control tool for sterilization processes.
No
The device description clearly outlines both a physical biological indicator (1491 BI) and a physical auto-reader (490 Auto-reader), both of which are hardware components. The performance studies also include testing of the hardware (Auto-reader Maintenance of Incubation Temperature, safety, and EMC testing).
Based on the provided information, the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to monitor the effectiveness of steam sterilization cycles for medical devices. It assesses whether the sterilization process successfully killed a known population of microorganisms.
- Device Description: The device contains a biological indicator (spores) and media to detect the survival of these spores after a sterilization cycle. The detection method involves enzymatic activity and fluorescence, which indicates the presence of viable spores.
- Lack of Patient/Clinical Application: The device is used to evaluate the sterilization process itself, not to diagnose, treat, or prevent disease in a patient. It does not analyze human specimens or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the biological indicator's resistance to sterilization and the accuracy of the readout system in detecting spore survival, not on clinical performance or diagnostic accuracy in relation to patient samples.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease. This device does not fit that description. It's a quality control tool for sterilization processes in a healthcare setting.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement Immediate Use Steam Sterilization Cycle (Flash) | 270°F (132°C) | 3 minutes |
| 270°F (132°C) | 10 minutes | |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length.
The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam.
The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. The a -glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure.
The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
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)
Testing was conducted following the FDA guidance and standards below:
- . FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007
- ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products . Biological indicators - Part 1: General Requirements
- . ANSI/AAMI/ISO 11138-3: 2006/(R)2010 Sterilization of health care products -Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
- . ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and . Chapter Biological Indicators - Resistance Performance Tests.
Multiple lots of 3MTM Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated for performance when used with the 3MTM Attest™ 490 Auto-reader. A Summary of the nonclinical testing is shown below.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus stearothermophilus to ATCCTM 7953 | Pass |
| D-Value | Greater than or equal to 10 seconds at 132°C Greater than or equal to 8 seconds at 135°C | Pass |
| Population (Total Viable Spore Count) | Greater than or equal to 10^6 spores | Pass |
| Survival/Kill Times | Survival Time = 1 min at 132°C or calculated survive time*, whichever is greater Survival Time = 40 seconds at 135°C or calculated survive time*, whichever is greater Kill time is calculated kill time* at 132°C and at 135°C *ANSI/AAMI/ISO 11138-1:2006, Annex E | Pass |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times: Fluorescent result in 30 minutes Optional visual color change result in 24 hours | Pass |
| Hold Time Assessment | D-value does not change when activated 7 days post-sterilization | Pass |
| Recovery Media Study | Ability to recover 10-100 organisms | Pass |
| Component Inhibition Studies | No impact of components on recovery of 10-100 organisms | Pass |
| Chemical Process Indicator | Chemical Process Indicator on the BI changes from rose to brown upon exposure to steam | Pass |
| Auto-reader Maintenance of Incubation Temperature | Must maintain 56+/- 2°C over a period of 24 hrs | Pass |
The results of these evaluations showed that the new 3M™ Attest™ 1491 Rapid Readout Biological Indicator, when used with the 3M™ Attest™ 490 Auto-reader, complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010. the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The 490 Auto-reader was tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1(2001) Second Edition; Safety requirements for electrical equipment . for measurement, control, and laboratory use – Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition: Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials, and
- IEC 60825-1 (1993) First Edition with Am. 111997) and Am. 2 (2001): Standard for safety of laser products - Part 1: Equipment classification and requirements.
In addition, the 490 Auto-reader has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- · USA Title 47, Code of Federal Regulations (2009) for:
- O Radiated Emissions (FCC Part 15, Subpart B. Class A)
- Conducted Emissions (FCC Part 15, Subpart B. Class A), and
- IEC 61326: Electrical Equipment for Measurement. Control and Laboratorv Use-EMC Requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduced Incubation Time: Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times: Fluorescent result in 30 minutes Optional visual color change result in 24 hours.
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.
Not Found
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
Premarket Notification (510(k)) Summary
Image /page/0/Picture/2 description: The image shows the logo for 3M. The logo is in black and white. The number 3 is next to the letter M.
APR 1 9 2011
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
| Contact Person: | Suzanne Leung |
|---|---|
| Regulatory Affairs | |
| Phone Number: | (651) 575-8052 |
| FAX Number: | (651) 737-5320 |
Date of Summary: April 18, 2011
Device Name and Classification:
| Common or Usual Name: | Sterilization Biological Indicator |
|---|---|
| Proprietary Name: | 3MTM Attest™ 1491 Super Rapid Readout |
| Biological Indicator | |
| 3MTM Attest™ 490 Auto-reader | |
| Classification Name: | Indicator, Biological Sterilization Process |
Predicate Devices:
-
3M™ Attest™ 1291 Rapid Readout Biological Indicator for Steam .
(21 CFR § 880.2800(a)) -
3MTM Attest™ 290 Auto-reader .
1
Description of Device:
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator (hereafter referred to as the 1491 Bl) is a self-contained biological indicator designed to be used with the 3M™ Attest™ 490 Auto-reader (hereafter referred to as the 490 Auto-reader) to routinely challenge 270°F (132°C) and 275°F (135°C) gravity-displacement steam sterilization cycles having exposure times > 3 minutes in length.
The 1491 BI is composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a blue cap. On each 1491 BI is a chemical process indicator that changes color from rose to brown when exposed to steam.
The 1491 Bl is a further improvement over the current 3M Attest Rapid Readout technology. Both the Attest Rapid Readout BIs and the Attest Super Rapid Readout Bls utlize the a-glucosidase enzyme system, which is generated naturally within growing G. stearothermophilus spores. The a -glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 490 Auto-reader. The detection of fluorescence upon incubation of the 1491 BI in the 490 Auto-reader indicates steam sterilization failure.
The 490 Auto-reader is designed to incubate at 56°C and automatically read the 1491 BI for a fluorescent result within 30 minutes. The 490 Auto-reader is also designed to allow further incubation of the 1491 BI for an optional visual pH color change of the growth media at 24 hours. Both the fluorescent readout at 30 minutes and the optional visual color readout at 24 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days.
2
Indications for Use:
Use the 3MTM Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement | ||
| Immediate Use Steam | ||
| Sterilization Cycle | ||
| (Flash) | 270°F (132°C) | 3 minutes |
| 270°F (132°C) | 10 minutes | |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.
3
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Testing was conducted following the FDA guidance and standards below:
- . FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions; October 4, 2007
- ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products . Biological indicators - Part 1: General Requirements
- . ANSI/AAMI/ISO 11138-3: 2006/(R)2010 Sterilization of health care products -Biological indicators – Part 3: Biological indicators for moist heat sterilization processes
- . ANSI/AAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and . Chapter Biological Indicators - Resistance Performance Tests.
Multiple lots of 3MTM Attest™ 1491 Super Rapid Readout Biological Indicators were evaluated for performance when used with the 3MTM Attest™ 490 Auto-reader. A Summary of the nonclinical testing is shown below.
| Test | Acceptance Criteria | Result |
|---|---|---|
| Characterization of spores | > 90% Genetic similarity to Geobacillus | |
| stearothermophilus to ATCCTM 7953 | Pass | |
| D-Value | Greater than or equal to 10 seconds at 132°C | |
| Greater than or equal to 8 seconds at 135°C | Pass | |
| Population (Total Viable | ||
| Spore Count) | Greater than or equal to 10^6 spores | Pass |
| Survival/Kill Times | Survival Time = 1 min at 132°C or calculated survive | |
| time*, whichever is greater | ||
| Survival Time = 40 seconds at 135°C or calculated | ||
| survive time*, whichever is greater | ||
| Kill time is calculated kill time* at 132°C and at 135°C | ||
| *ANSI/AAMI/ISO 11138-1:2006, Annex E | Pass | |
| Reduced Incubation Time | Meets FDA's requirements for Reduced Incubation Time | |
| with > 97% alignment with the conventional incubation | ||
| time of 7 days for the following readout times: | ||
| Fluorescent result in 30 minutes | ||
| Optional visual color change result in 24 hours | Pass | |
| Hold Time Assessment | D-value does not change when activated 7 days post- | |
| sterilization | Pass | |
| Recovery Media Study | Ability to recover 10-100 organisms | Pass |
| Component Inhibition | ||
| Studies | No impact of components on recovery of 10-100 | |
| organisms | Pass | |
| Chemical Process | ||
| Indicator | Chemical Process Indicator on the BI changes from rose | |
| to brown upon exposure to steam | Pass | |
| Auto-reader Maintenance | ||
| of Incubation Temperature | Must maintain 56+/- 2°C over a period of 24 hrs | Pass |
4
The results of these evaluations showed that the new 3M™ Attest™ 1491 Rapid Readout Biological Indicator, when used with the 3M™ Attest™ 490 Auto-reader, complies with ANSI/AAMI/ISO 11138-1:2006/(R)2010 and ANSI/AAMI/ISO 11138-3:2006/(R)2010. the USP requirements for biological indicators, as well as the FDA's Guidance for Biological Indicators.
The 490 Auto-reader was tested for safety by Underwriters Laboratory to verify compliance to:
- IEC 61010-1(2001) Second Edition; Safety requirements for electrical equipment . for measurement, control, and laboratory use – Part 1: General requirements,
- IEC 61010-2-010 (2003) Second Edition: Safety requirements for electrical . equipment for measurement, control, and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the heating of materials, and
- IEC 60825-1 (1993) First Edition with Am. 111997) and Am. 2 (2001): Standard for safety of laser products - Part 1: Equipment classification and requirements.
In addition, the 490 Auto-reader has been tested by a certified Testing Laboratory to verify electromagnetic compatibility per:
- · USA Title 47, Code of Federal Regulations (2009) for:
- O Radiated Emissions (FCC Part 15, Subpart B. Class A)
- Conducted Emissions (FCC Part 15, Subpart B. Class A), and
- IEC 61326: Electrical Equipment for Measurement. Control and Laboratorv Use-EMC Requirements.
Conclusion
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator and the 3MTM Attest™ 490 Auto-reader are substantially equivalent to the predicate devices, the 3MTM Attest™ 1291 Rapid Readout Biological Indicator for Steam, cleared under K900771, and 3MTM Attest™ 290 Auto-reader, cleared under K004009, in terms of their intended use, physical properties and technological characteristics. There are no new questions of safety or effectiveness.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suzanne Leung Ph.D. Manager, Regulatory Affairs 3M Company-3M Healthcare 3M Center, Building 275-5W-06 St. Paul, Minnesota 55133-1006
APR 1 9 2011
Re: K103277
Trade/Device Name: 3M™ Attest™ 1491 Super Rapied Readout, Biological Indicator for Steam, 3MTM Attest 490 Auto-reader Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: FRC Dated: March 14, 2011 Received: March 25, 2011 ·
Dear Dr. Leung:
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. 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 111 (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.
6
Page 2- Dr. Leung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Z
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
| 510(k) Number (if known): | K103277 |
|---|---|
| Device Name: | 3M™ Attest™ 1491 Super Rapid Readout |
| Biological Indicator for Steam | |
| 3M™ Attest™ 490 Auto-reader |
Indications For Use:
Use the 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator in conjunction with the 3M™ Attest™ 490 Auto-reader to monitor the cycles below.
| Sterilization Type | Temperature | Time |
|---|---|---|
| Gravity Displacement | 270°F (132°C) | 3 minutes |
| Immediate Use Steam | ||
| Sterilization Cycle | ||
| (Flash) | 270°F (132°C) | 10 minutes |
| 275°F (135°C) | 3 minutes | |
| 275°F (135°C) | 10 minutes |
The 3M™ Attest™ 1491 Super Rapid Readout Biological Indicator provides a final fluorescent result in 30 minutes. An optional visual pH color change result is observed in 24 hours.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Eldgett $. Clamie-Will
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________