(98 days)
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-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).
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.
The document describes a 510(k) premarket notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. This submission aims to expand the indications for use of an existing device to include additional sterilizers.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria (Internal Standard) | Reported Device Performance |
|---|---|---|
| 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 | Implied "Pass" (effective sterilization monitoring) | 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 | Implied "Pass" (detection of sterilization failure) | Pass |
| Chemical Indicator (CI) Color Change | Implied "Pass" (correct color transition) | Pass |
| Verification of population characteristics | Implied "Pass" (spore count and resistance) | Pass |
Note: The document states that testing was "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." These standards outline specific performance requirements for biological indicators, which would serve as the detailed acceptance criteria, although they are not explicitly listed in this summary. For example, ISO 11138-1 specifies D-value requirements (resistance) and population count. The table in the document implicitly refers to meeting these established standards by indicating "Pass."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size used for each "Performance Test." It refers to "testing of the 3M™ Attest™ Rapid Readout Biological Indicator 1295" in conjunction with various sterilizers. The specific number of BIs tested in each cycle, or in total, is not provided in this summary.
- Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification to the US FDA, so the testing was likely conducted in the US or under US regulatory guidelines. The data is nonclinical, focusing on device performance under controlled laboratory conditions, not on patient outcomes or clinical usage. It is prospective in the sense that the tests were specifically conducted to demonstrate the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable to this type of device and study. The "ground truth" for a biological indicator is established by controlled laboratory sterilization conditions (e.g., exposure to known sterilant concentrations for specific times) and subsequent microbiological culturing to determine spore viability, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set:
- Not applicable in the context of biological indicator performance testing. The "ground truth" (sterilization success/failure, population count, D-value) is determined by objective laboratory methods (e.g., culture growth, spectrophotometry).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This submission describes a biological indicator, which is a device for monitoring sterilization processes, not for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was effectively done. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a device that interacts with the 3M™ Attest™ Auto-reader 490H to produce a "fluorescent readout of 24 minutes." The performance tests (Full Cycle, Half Cycle, CI Color Change, Population Characteristics) evaluated the integrity and function of the BI system (BI + Auto-reader) without human intervention in the interpretation of the biological outcome beyond observing the auto-reader's output or visual color change. The phrase "detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure" describes the automated, standalone output of the device combination.
7. The Type of Ground Truth Used:
- The ground truth for this device is based on microbiological viability (survival or kill of Geobacillus stearothermophilus spores) under controlled sterilization conditions. This involves:
- Known exposure to sterilant: Exposing the biological indicators to specific cycles in various sterilizers (e.g., Full Cycle and Half Cycle conditions).
- Microbiological culture: Incubating the BIs after exposure to determine if the spores are alive (growth indicated by fluorescence) or killed (no growth).
- Population counts: Determining the initial number of viable spores on the carrier.
- Resistance characteristics (D-value, Survival/Kill Window): Quantifying the resistance of the spores to the sterilant under controlled conditions.
8. The Sample Size for the Training Set:
- The document does not report a training set sample size. This is because the device described is a biological indicator, not an AI/ML algorithm that requires a training set. The device operates based on established microbiological principles and chemical reactions.
9. How the Ground Truth for the Training Set was Established:
- As there is no training set for an AI/ML algorithm, this question is not applicable. The underlying principles of how biologic indicators should perform (e.g., spore resistance, growth media reaction, fluorescence detection) are based on well-established microbiology and analytical chemistry, not on machine learning from a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a caduceus, with three human profiles facing right.
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
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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
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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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Image /page/3/Picture/1 description: The image shows the 3M logo. The logo is red and consists of the number "3" and the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.
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
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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).
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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 ALLClearTMTechnology, 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 ALLClearTMTechnology, 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.
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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 hydrogenperoxide sterilization processes. | Identical. |
| Indications for use | Use the 3MTM AttestTM Rapid ReadoutBiological Indicator 1295 in conjunctionwith the 3MTM AttestTM Auto reader 490Has a standard method of routinemonitoring of vaporized hydrogenperoxide sterilization processes in thefollowing systems: AMSCO® V-PROTM1 Low Temperature Sterilization System(Lumen cycle), AMSCO® V-PROTM 1Plus Low Temperature SterilizationSystem (Lumen and Non Lumen cycles),AMSCO® V-PROTM maX LowTemperature Sterilization System(Lumen, Non Lumen, and Flexiblecycles), AMSCO® V-PROTM 60 LowTemperature 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 ALLClearTMTechnology (Standard and Advancedcycles) and STERRAD® 100NX withALLClearTM Technology (Standard, Flex,Express and Duo cycles). | Use the 3MTM AttestTM RapidReadout Biological Indicator 1295 inconjunction with the 3M AttestTMAuto reader 490H as a standardmethod of routine monitoring ofvaporized hydrogen peroxidesterilization processes in theAMSCO® V-PRO® maX LowTemperature Sterilization System(Lumen, Non Lumen, and Flexiblecycles), and in STERRAD® 100S,STERRAD® NX (Standard andAdvanced cycles) and STERRAD®100NX (Standard, Flex, Express andDuo cycles) systems. |
| Device Design | The 3M AttestTM 1295 Rapid ReadoutBiological Indicator (1295 BI) is a self-contained biological indicator thatcontains greater than 1x106 Geobacillusstearothermophilus spores on a carrierwithin the device. During activation, thecap is depressed fully onto the sleevewhich pushes the growth media ampouleinto the ampoule crusher, causing theglass ampoule to break and allowing theliquid growth media to flow down to thespores. After activation, the cap has asurface that seals against the sleeve whichcloses the sterilant entry ports andcontains the liquid growth media withinthe BI. | Identical. |
| Organism | Geobacillus stearothermophilustraceable to ATCCTM 7953 | Identical. |
| Viable sporepopulation | $≥1x106$ | Identical. |
| Resistancecharacteristics• D-value• Survival/KillWindow | (Tested at 10 mg/L vaporized hydrogenperoxide)$D10 mg/L≥ 1 second$Survival Time $≥$ 5 secondsKill Time = 7 minutes | Identical. |
| Carrier material | Polyethylene terephthalate | Identical. |
| Incubationtemperature | 60 ± 2°C | Identical. |
| Readout time | 24 minute fluorescence result read | Identical. |
| Chemicalindicator | H2O2 sensitive ink; changes from bluetowards pink | Identical. |
| Shelf-life | 24 months. | Identical. |
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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).
§ 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).