(11 days)
The 3MTM Attest ™ 293 Auto-reader is designed to incubate and automatically 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.
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.
The provided document is a 510(k) Premarket Notification summary for the 3M™ Attest™ 293/293G Auto-reader. It states that the new device is "substantially equivalent" to predicate devices (Attest 290 and 290G Auto-readers) because they use the same technology, software, and have the same indications for use and intended use. The new device is essentially a "three units within one case" configuration of the predicate.
Therefore, the submission does not contain information about a new study with acceptance criteria and device performance evaluation as would be typical for a device with a new technological approach or significantly different intended use. Instead, it relies on the established performance of its predicate devices due to its substantial equivalence in design and function.
As such, many of the requested details about a study for acceptance criteria cannot be extracted from this document, as a new, standalone performance study demonstrating new acceptance criteria was not conducted or reported in this 510(k) summary. The "acceptance criteria" here is implicitly demonstrating substantial equivalence to the predicate.
Here's an attempt to answer based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a performance table for a new study. The acceptance criteria for the 510(k) itself is demonstrating "substantial equivalence" to the predicate devices. The "reported device performance" is implicitly considered to be the same as the predicate devices:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same product technology | Uses the same product technology as predicate. |
| Same software | Uses the same "look and feel" software as predicate. |
| Same indications for use | Has the same indications for use as predicate. |
| Same intended use | Has the same intended use as predicate. |
| Configuration as "three units within one case" of predicates | Device is essentially three individual predicate units enclosed in one case. |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set data is provided as the submission relies on substantial equivalence to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set requiring expert ground truth establishment is reported.
4. Adjudication method for the test set
Not applicable. No new test set requiring adjudication is reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an auto-reader for biological indicators, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone auto-reader. However, no new standalone performance study (beyond demonstrating it functions as three predicate units) is mentioned. Its performance is considered equivalent to the predicate devices which have established standalone performance.
7. The type of ground truth used
For the predicate devices, the ground truth for evaluating biological indicators (BI) would typically involve microbiological confirmation of sterility (or failure to achieve sterility) in a controlled laboratory setting, which could be considered a form of "pathology" or definitive outcome data regarding the sterilization process. However, this document does not detail how the ground truth for the predicates was established, only that the new device is equivalent.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning algorithm or a new training set. The device's operation is based on established auto-reading technology for biological indicators.
9. How the ground truth for the training set was established
Not applicable. No training set is described in this document.
{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-reader3MTM 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
§ 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).