(98 days)
No
The device description and performance studies focus on the biological and chemical indicators and the auto-reader's detection of fluorescence, with no mention of AI or ML.
No
The device is a biological indicator used to monitor the effectiveness of sterilization processes for medical equipment, not to treat a medical condition in a patient.
No
Explanation: The device is a biological indicator used to monitor the effectiveness of sterilization processes, not to diagnose a condition in a patient.
No
The device description clearly outlines a physical biological indicator (BI) and an auto-reader, both of which are hardware components. The software component is likely part of the auto-reader's functionality, but the device as a whole is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for routine monitoring of vaporized hydrogen peroxide sterilization processes. This is a quality control measure for sterilization equipment, not a diagnostic test performed on a biological sample from a patient to diagnose a disease or condition.
- Device Description: The device is a biological indicator containing spores and media. It's used to assess the effectiveness of a sterilization process by checking if the spores are killed. This is a test of the sterilization equipment's performance, not a test on a patient sample.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) from a patient, which is a core characteristic of IVD devices.
Therefore, the 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a device used for sterilization process monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles). AMSCO® V-PRO™ max Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles).
Product codes
FRC
Device Description
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
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)
Nonclinical testing of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 was conducted in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSV/AAMI/ISO 11138-1:2006/(R) 2010 Sterilization of health care products- Biological indicators- Part 1: General requirements (FDA Recognition Number 14-296).
The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H with a final fluorescent readout of 24 minutes is demonstrated in the following tests:
Performance Test Results
Full Cycle Performance Verification – STERRAD® NX with ALLClearTM Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 - Pass
Half Cycle Performance Verification – STERRAD® NX with ALLClearTM Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 - Pass
Chemical Indicator (CI) Color Change - Pass
Verification of population characteristics - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2018
3M Health Care Ms. Nadia Battah Regulatory Affairs Associate 3M Center, Bldg. 275-5W-06 St. Paul. MN 55144-1000
Re: K173435
Trade/Device Name: 3M™ Attest™ Rapid Readout Biological Indicator 1295 Regulation Number: 21 CFR 880.2800 Regulation Name: Biological Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 05, 2018 Received: January 08, 2018
Dear Ms. Nadia Battah:
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 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173435
Device Name
3MTM Attest™ Rapid Readout Biological Indicator 1295
Indications for Use (Describe)
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles). AMSCO® V-PRO™ max Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles).
| 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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3
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510(k) Summary for 3MTM Attest™ Rapid Readout Biological Indicator 1295
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Nadia Battah Regulatory Affairs Associate Phone Number: (651) 733-0929 Fax Number: (651) 737-5320
Date of Summary: February 6, 2018
Submission Number: K173435
4
Device Name and Classification:
| Common or Usual Name: | Biological Indicator |
|---|---|
| Proprietary Name: | 3M TM Attest TM Rapid Readout Biological Indicator 1295 |
| Classification Name: | Indicator, Biological Sterilization Process |
| Device Classification: | Class II, 21 CFR $ \S $ 880.2800(a) |
| Product Code: | FRC |
Predicate Device:
- . K171003 - 3MTM Attest™ Rapid Readout Biological Indicator 1295
Description of Device:
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.
Indications for Use
Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto reader 490H as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PROIM 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), AMSCO® V-PRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles).
Nonclinical Comparison to the Predicate Device
The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is the same design as the previously cleared device of the same model number (the predicate) which is sold under the tradename 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K171003).
5
There has been no change to the device's design, materials, physical/chemical characteristics, performance specifications or fundamental scientific technology or to the device's accessory, the 3M Attest™ Auto-reader 490H. The intent of this submission is to expand the indications for use to include use in additional sterilizers.
Summary of Nonclinical Testing
Nonclinical testing of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 was conducted in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSV/AAMI/ISO 11138-1:2006/(R) 2010 Sterilization of health care products- Biological indicators- Part 1: General requirements (FDA Recognition Number 14-296).
The effectiveness of the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H with a final fluorescent readout of 24 minutes is demonstrated in the following tests:
| Performance Test | Results |
|---|---|
| Full Cycle Performance Verification – STERRAD® NX with ALLClearTM | |
| Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® | |
| V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 | Pass |
| Half Cycle Performance Verification – STERRAD® NX with ALLClearTM | |
| Technology, STERRAD® 100NX with ALLClearTM Technology, AMSCO® | |
| V-PROTM 1, AMSCO® V-PROTM 1 Plus and AMSCO® V-PRO 60 | Pass |
| Chemical Indicator (CI) Color Change | Pass |
| Verification of population characteristics | Pass |
Summary of Clinical Testing
No clinical data was included in this premarket application submission.
6
Comparison to Predicate Device
| Submission Device: | Predicate Device (K171003): | |
|---|---|---|
| Feature | 3MTM AttestTM Rapid Readout | 3MTM AttestTM Rapid Readout |
| Biological Indicator 1295 | Biological Indicator 1295 | |
| Device Models | 1295 | Identical. |
| Intended Use | Monitoring of vaporized hydrogen | |
| peroxide sterilization processes. | Identical. | |
| Indications for use | Use the 3MTM AttestTM Rapid Readout | |
| Biological Indicator 1295 in conjunction | ||
| with the 3MTM AttestTM Auto reader 490H | ||
| as a standard method of routine | ||
| monitoring of vaporized hydrogen | ||
| peroxide sterilization processes in the | ||
| following systems: AMSCO® V-PROTM | ||
| 1 Low Temperature Sterilization System | ||
| (Lumen cycle), AMSCO® V-PROTM 1 | ||
| Plus Low Temperature Sterilization | ||
| System (Lumen and Non Lumen cycles), | ||
| AMSCO® V-PROTM maX Low | ||
| Temperature Sterilization System | ||
| (Lumen, Non Lumen, and Flexible | ||
| cycles), AMSCO® V-PROTM 60 Low | ||
| Temperature Sterilization System | ||
| (Lumen, Non Lumen and Flexible cycles) | ||
| and in STERRAD® 100S, STERRAD® | ||
| NX (Standard and Advanced cycles), | ||
| STERRAD® 100NX (Standard, Flex, | ||
| Express and Duo cycles) systems, | ||
| STERRAD® NX with ALLClearTM | ||
| Technology (Standard and Advanced | ||
| cycles) and STERRAD® 100NX with | ||
| ALLClearTM Technology (Standard, Flex, | ||
| Express and Duo cycles). | Use the 3MTM AttestTM Rapid | |
| Readout Biological Indicator 1295 in | ||
| conjunction with the 3M AttestTM | ||
| Auto reader 490H as a standard | ||
| method of routine monitoring of | ||
| vaporized hydrogen peroxide | ||
| sterilization processes in the | ||
| AMSCO® V-PRO® maX Low | ||
| Temperature Sterilization System | ||
| (Lumen, Non Lumen, and Flexible | ||
| cycles), and in STERRAD® 100S, | ||
| STERRAD® NX (Standard and | ||
| Advanced cycles) and STERRAD® | ||
| 100NX (Standard, Flex, Express and | ||
| Duo cycles) systems. | ||
| Device Design | The 3M AttestTM 1295 Rapid Readout | |
| Biological Indicator (1295 BI) is a self- | ||
| contained biological indicator that | ||
| contains greater than 1x106 Geobacillus | ||
| stearothermophilus spores on a carrier | ||
| within the device. During activation, the | ||
| cap is depressed fully onto the sleeve | ||
| which pushes the growth media ampoule | ||
| into the ampoule crusher, causing the | ||
| glass ampoule to break and allowing the | ||
| liquid growth media to flow down to the | ||
| spores. After activation, the cap has a | ||
| surface that seals against the sleeve which | ||
| closes the sterilant entry ports and | ||
| contains the liquid growth media within | ||
| the BI. | Identical. | |
| Organism | Geobacillus stearothermophilus | |
| traceable to ATCCTM 7953 | Identical. | |
| Viable spore | ||
| population | $≥1x106$ | Identical. |
| Resistance | ||
| characteristics | ||
| • D-value | ||
| • Survival/ | ||
| Kill | ||
| Window | (Tested at 10 mg/L vaporized hydrogen | |
| peroxide) | ||
| $D10 mg/L≥ 1 second$ | ||
| Survival Time $≥$ 5 seconds | ||
| Kill Time = 7 minutes | Identical. | |
| Carrier material | Polyethylene terephthalate | Identical. |
| Incubation | ||
| temperature | 60 ± 2°C | Identical. |
| Readout time | 24 minute fluorescence result read | Identical. |
| Chemical | ||
| indicator | H2O2 sensitive ink; changes from blue | |
| towards pink | Identical. | |
| Shelf-life | 24 months. | Identical. |
7
Conclusion
The results of the studies demonstrate that the biological indicator performs as intended, and based on the nonclinical tests performed, the subject device is substantially equivalent to, and is as safe and as effective as the legally marketed predicate device, K171003, Class II (21 CFR 880.2800, Product code FRC).