(11 days)
No
The document describes an auto-reader for biological indicators used in sterilization processes. The function is incubation and automated reading of fluorescence or pH changes, which are standard biological indicator reading methods. There is no mention of AI, ML, or any complex data analysis that would suggest the use of these technologies.
No.
The device is an auto-reader designed to incubate and read biological indicators to assess the effectiveness of sterilization cycles, not to treat any medical condition or directly affect the body.
No
The device is an auto-reader designed to incubate and read biological indicators for sterilization cycle monitoring. Its purpose is to assess the effectiveness of sterilization, not to diagnose a medical condition in a patient.
No
The device description explicitly states it is comprised of hardware units (Attest 290 and 290G units within a single case) and is designed to incubate and read biological indicators, which are physical components.
Based on the provided text, the 3M™ Attest ™ 293 Auto-reader and 3M™ Attest ™ 293G Auto-reader are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is to incubate and read biological indicators (BIs). These BIs are used to assess the effectiveness of sterilization cycles (steam and ethylene oxide). This is a quality control process for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The description clearly states that the devices are accessories to biological indicators and their purpose is to assess the failure of sterilization cycles.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition in a patient.
- Mentioning any anatomical site, patient age range, or intended user/care setting related to patient diagnosis.
Therefore, these devices fall under the category of sterilization process indicators or quality control devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 3M™ Attest ™ 293 Auto-reader is designed to incubate and automatically The SM Attest read the SM - Allest - - TEO Parfinal negative fluorescence reading at 1 hour for 1291 or 3 hours for 1292.
The 3M™ Attest ™ 293 Auto-reader is also designed to allow for further The SM - Attest 1291 and/or the Attest 1292 Rapid Readout Biological Indicators for a final negative, visual pH color change of the growth media at 24 hours for 1291 and 48 hours for 1292.
The 3M™ Attest ™ 293G Auto-reader is designed to incubate and automatically The SM - Attest - 2300 Auto Todor 16 Cougical Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.
Product codes (comma separated list FDA assigned to the subject device)
FRC
Device Description
Device Desorripati The own Attoot 2007 late reas (BI), which are incubated at 60 °C. The initial Bls in this series to receive market clearance were the 1291 (K900771) and 1292 (K926364).
The purpose of these Bls is to assess whether a potential failure of a steam sterilization cycle has occurred. Please note that both of these initial premarket sterfilizations (K900771) and (K926364) listed the 3M Attest 190 Auto-reader as houncations (13007 17 and (102000 1) 1102000 1) 1100 Auto-reader was cleared (K004009) for use with these Bls and serves as the predicate device for the new Model 293 Auto-reader.
The Attest 293 is comprised of three (3) Attest 290 units within a single case.
The 3M Attest 293G Auto-reader is an accessory to the 3M Attest 1294 Rapid Readout EO Biological Indicator (RRBI) which is to be incubated at 37 °C.
The purpose of these Bls is to assess whether a potential failure of an ethylene oxide sterilization cycle has occurred. The model 290G was cleared (K031012) with the Attest 1294 Bl and serves as the predicate for the 293G.
The Attest 293G is comprised of three (3) Attest 290G units within a single case.
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)
Not Found
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.
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
AUG 1 6 2005
Premarket Notification (510(k)) Summary
General Information
Sponsor
3M Company 3M Medical Division 3M Center Building 275-5W-06 St. Paul, MN 55144-1000
Contact
Cynthia Lamarucciola Phone: 651-736-1523 Fax: 651-737-5320 Email: cllamarucciola@mmm.com
August 4, 2005 Prepared
Device Name
Common or Usual Name: Auto-reader
| Proprietary Name: | 3MTM AttestTM 293 Auto-reader
3MTM AttestTM 293G Auto-reader |
|----------------------|---------------------------------------------------------------------------|
| Classification Name: | Biological Sterilization Process Indicators accessories (21CFR§880.2800). |
Establishment Registration Number
The establishment registration number for 3M Company is 2110898.
The 3M™ Attest™ 293/293G Auto-readers are manufactured and packaged at the following facility:
3M Company 1617 North Front Street New Ulm, MN 56073
Phone: 507-359-0434 Fax. 507-359-0334 Establishment Number 2183581
3M Confidential
1
Device Classification
Class: Classification Panel: Product Code:
Class II General Hospital (80) FRC (accessory)
Indications for Use
The 3MTM Attest ™ 293 Auto-reader is designed to incubate and automatically The SM Attest read the SM - Allest - - TEO Parfinal negative fluorescence reading at 1 hour for 1291 or 3 hours for 1292.
The 3M™ Attest ™ 293 Auto-reader is also designed to allow for further The SM - Attest 1291 and/or the Attest 1292 Rapid Readout Biological Indicators for a final negative, visual pH color change of the growth media at 24 hours for 1291 and 48 hours for 1292.
The 3M™ Attest ™ 293G Auto-reader is designed to incubate and automatically The SM - Attest - 2300 Auto Todor 16 Cougical Indicators (RRBI) for EO at 37℃ for a final negative fluorescence reading at 4 hours.
Device Description
Device Desorripati The own Attoot 2007 late reas (BI), which are incubated at 60 °C. The initial Bls in this series to receive market clearance were the 1291 (K900771) and 1292 (K926364).
The purpose of these Bls is to assess whether a potential failure of a steam sterilization cycle has occurred. Please note that both of these initial premarket sterfilizations (K900771) and (K926364) listed the 3M Attest 190 Auto-reader as houncations (13007 17 and (102000 1) 1102000 1) 1100 Auto-reader was cleared (K004009) for use with these Bls and serves as the predicate device for the new Model 293 Auto-reader.
The Attest 293 is comprised of three (3) Attest 290 units within a single case.
The 3M Attest 293G Auto-reader is an accessory to the 3M Attest 1294 Rapid Readout EO Biological Indicator (RRBI) which is to be incubated at 37 °C.
The purpose of these Bls is to assess whether a potential failure of an ethylene oxide sterilization cycle has occurred. The model 290G was cleared (K031012) with the Attest 1294 Bl and serves as the predicate for the 293G.
The Attest 293G is comprised of three (3) Attest 290G units within a single case.
3M Confidential
2
Substantial Equivalence
The Attest 293 and 293G Auto-readers are substantially equivalent to the predicate Attest 290 and 290G Auto-readers in that they use the same product 7 litted. Loo and Leane software, have the same indications for use land the same intended use. They are in fact a "three units within one case" configuration of the predicate.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and a wavy line below, all in black. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." arranged in a circular fashion.
AUG 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cynthia Lamanrucciola Senior Regulatory Affairs Associate 3M Company 3M Center, Bldg. 275-5W-06 St. Paul Minnesota 55144-1000
Re: K052128
Trade/Device Name: 3M™ ATTEST™ 293 Auto-Reader Regulation Number: 21 CFR 880.2800 Regulation Name: Biological sterilization process indicator Regulatory Class: II Product Code: FRC Dated: August 4, 2005 Received: August 30, 2005
Dear Ms. Lamanrucciola:
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 for associated in 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 –Ms. Lamanrucciola
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 that I Drines Internates and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fur 607), adoling systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product raction of one begin marketing your device as described in your Section 510(k) I mis lotter notification. The FDA finding of substantial equivalence of your device to a legally premaince nevice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Notification for the 3M™Attest™ 293/293G Autoreader
Indications for Use Statement
510(k) Number (if known): K052128
3M™ Attest™ 293 Auto-reader Device Name:
Indications for Use:
The 3M™ Attest™ 293 Auto-reader is designed to incubate and automatically The SM - Attest™ 1291 and/or 3M™ Attest™1292 Rapid Readout read the Uni- All.com, at 60°C for a final negative fluorescence reading at 1 hour for Attest 1291 or 3 hours for Attest 1292.
The 3M™ Attest™ 293 Auto-reader is also designed to allow for further incubation of the Attest 1291 and/or Attest 1292 Rapid Readout Biological Indicators for Steam, for a final negative, visual pH color change of the growth media at 24 hours for Attest 1291 and 48 hours for Attest 1292.
3M™ Attest™ 293G Auto-reader Device Name:
Indications for Use:
The 3M™ Attest™ 293G Auto-reader is designed to incubate and automatically The UNI - MTM Attest™ 1294 Rapid Readout Brological Indicators (RRBI) for EO, at 37°C for a final negative fluorescence reading at 4 hours.
Over the Counter X OR Prescription Use
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.
Shal Condliffe, at CDRH, Office of Device Evaluation (ODE)
Division of nergi Hoself Infection Control. Dantal
510(k) Number: K0521
3M Confidential