(262 days)
No
The description focuses on the biological and chemical indicators and the auto-reader's function of incubating and detecting fluorescence. There is no mention of AI or ML in the device description, intended use, or performance studies. The software version mentioned (4.0.0) does not inherently indicate AI/ML capabilities.
No.
The device is a biological indicator and challenge pack used to monitor and qualify sterilization cycles for medical equipment, not to diagnose, treat, or prevent disease in a patient.
No
The device is a biological indicator and challenge pack used to monitor the effectiveness of sterilization cycles, not to diagnose a disease or condition in a patient. It indicates sterilization failure, which is a process monitoring function.
No
The device description clearly outlines physical components like biological indicators (plastic sleeves, spore carriers, media ampoules, caps), chemical process indicators, and challenge packs (medical index cards). While software is mentioned as part of the auto-reader, the device itself is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "qualify or monitor" steam sterilization cycles. This is a quality control function 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, designed to detect sterilization failure by indicating the survival of these spores. This process is about assessing the effectiveness of a sterilization process, not analyzing a patient sample for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention analyzing human or animal specimens, diagnosing diseases, or providing information for clinical decision-making related to a patient's health.
The device is clearly intended for use in a healthcare setting to ensure that sterilization equipment is functioning correctly, which is a crucial part of infection control, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
Product codes
FRC
Device Description
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C). The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3M™ Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
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 was conducted on the biological indicator and challenge pack following FDA guidance and standards including ISO 11138-1:2017, ISO 11138-3:2017, and United States Pharmacopeia Chapters and .
Biological Indicator Testing Results:
- Population (Total Viable Spore Count) - Passed (Greater than or equal to 10^6 spores)
- D-Value - Passed (Greater than or equal to 1.5 minutes at 121°C)
- Z-Value - Passed (Greater than or equal to 10°C)
- Survival Time - Passed (Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements)
- Kill Time - Passed (Meets ISO 11138-1 and ISO 11138-3 requirements)
- Component Inhibition Studies - Passed (Components have no impact on the recovery of 10-100 organisms)
- Hold Time Assessment - Passed (D-value does not change when activated 7 days post sterilization)
- Reduced Incubation Time - Passed (Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the 24 minute fluorescent result)
- Simulated Use - Passed (Verification of performance in claimed cycles)
Challenge Pack Testing Results:
- Resistance of the Challenge Pack as compared to AAMI 16 Towel PCD - Passed (Challenge Pack is at least as resistant as the biological indicator AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79: 2017)
- Resistance of the Challenge Pack as compared to the Biological Indicator alone - Passed (Challenge Pack provides a greater resistance than the Biological Indicator alone)
The fluorescent readout at 24 minutes meets the FDA's requirement of > 97% alignment with the result after conventional incubation time of 7 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reduced Incubation Time: > 97% alignment with the conventional incubation time of 7 days for the 24 minute fluorescent result.
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
June 5, 2020
3M Company Hilary Hovde Regulatory Affairs Specialist Bldg. 275-5W-06 St.Paul, Minnesota 55144
Re: K192550
Trade/Device Name: 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack, 3M™ Attest™ Auto- Readers 490 and 490H Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: May 6, 2020 Received: May 7, 2020
Dear Hilary Hovde:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Christopher K. Dugard, M.S. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192550
Device Name
3MTM Attest™ Super Rapid Steam Biological Indicator 1592 and 3MTM Attest™ Auto-reader 490 and 490H
Indications for Use (Describe)
Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Type of Use (Select one or both, as applicable)
J Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number."
3
Indications for Use
510(k) Number (if known) K192550
Device Name
3MTM AttestTM Super Rapid Steam Challenge Pack 51582 and 3M™ Attest™ Auto-reader 490 and 490H
Indications for Use (Describe)
Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software versio n 4.0.0 or greater to qualify or monitor dynamic-air-removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources , gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.go v
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
4
Image /page/4/Picture/1 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The number and letter are in a bold, sans-serif font. The logo is simple and recognizable.
510(k) Summary for K192550 3MTM Attest™ Super Rapid Steam Biological Indicator 1592, 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and 3M™ Attest™ Auto-readers 490 and 490H
3M Company 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Hilary B. Hovde Regulatory Affairs Specialist Phone Number: (651) 736-0364 FAX Number: (651) 737-5320
Submission Date: August 27, 2019
5
Device Name and Classification- Biological Indicator:
| Trade Name: | 3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Auto-reader 490
3M™ Attest™ Auto-reader 490H |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Biological Indicator (BI) |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process
[21 CFR § 880.2800(a), FRC] |
Predicate Device- Biological Indicator:
3MTM Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173437
Indications for Use- Biological Indicator
Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:
| Cycle Type | Exposure Temperature | Exposure Time |
|---|---|---|
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 15 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 20 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 35 minutes |
| Gravity Displacement | 250°F (121°C) | 30 minutes |
Description of Device- Biological Indicator
The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).
The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of
6
fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.
| Feature | Submission Device:
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592 and
3MTM AttestTM Auto-reader
490 and 490H | Predicate Device
(K173437):
3MTM AttestTM
Super Rapid Readout
Biological Indicator 1492V
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Use the 3MTM AttestTM Super
Rapid Steam Biological
Indicator 1592 in conjunction
with the 3MTM AttestTM Auto-
reader 490 having software
version 4.0.0 or greater or the
3MTM AttestTM Auto-reader
490H having software version
4.0.0 or greater to qualify or
monitor the following
sterilization cycles:
Dynamic-air-removal
(pre-vacuum and
SFPP), 250°F (121°C),
15 minutes Dynamic-air-removal
(pre-vacuum and
SFPP), 250°F (121°C),
20 minutes Dynamic-air-removal
(pre-vacuum and
SFPP), 250°F (121°C),
30 minutes Dynamic-air-removal
(pre-vacuum and
SFPP), 250°F (121°C),
35 minutes Gravity Displacement,
250°F (121°C),
30 minutes | Use the 3MTM AttestTM
Super Rapid Readout
Biological Indicator 1492V
in conjunction with both the
3MTM AttestTM Auto-reader
490 or the AttestTM Auto-
reader 490H having
software version 4.0.0 or
greater to qualify or monitor
dynamic-air-removal steam
sterilization cycles of:
3 minutes at 270°F
(132°C) 4 minutes at 270°F
(132°C) 3 minutes at 275°F
(135°C) | The 3MTM AttestTM
Super Rapid Steam
Biological Indicator
1592 is intended to
qualify or monitor both
dynamic-air-removal
(pre-vacuum and SFPP)
and gravity
displacement cycles at
various exposure times
at 250°F (121°C).
Whereas the 3MTM
AttestTM Super Rapid
Readout Biological
Indicator 1492Vis
intended to qualify or
monitor dynamic-air-
removal steam
sterilization cycles at
various exposure times
at 270°F (132°C) and
275°F (135°C).
Both BIs are intended
to be used in
conjunction with the
3MTM AttestTM Auto-
reader 490 and the
3MTM AttestTM Auto-
reader 490H. |
| Indicator Organism | Geobacillus stearothermophilus
traceable to ATCCTM 7953 | Geobacillus
stearothermophilus
traceable to ATCCTM 7953 | Identical |
| Mechanism of
Action | When the enzyme that is
naturally occurring in the spore
is in its active state, it is
detected by measuring the | When the enzyme that is
naturally occurring in the
spore is in its active state, it
is detected by measuring the | Identical |
| Feature | Submission Device:
(K192550):
3MTM Attest™
Super Rapid Steam
Biological Indicator 1592 and
3MTM Attest™ Auto-reader
490 and 490H | Predicate Device
(K173437):
3MTM Attest™
Super Rapid Readout
Biological Indicator 1492V
and
3MTM Attest™
Auto-reader 490 and 490H | Comparison |
| | fluorescence produced by the
enzymatic hydrolysis of a non-
fluorescent substrate. The
resultant fluorescent by-product
is detected by the Auto-reader.
The presence of fluorescence
upon incubation in the Auto-
reader indicates a sterilization
process failure. | fluorescence produced by
the enzymatic hydrolysis of
a non-fluorescent substrate.
The resultant fluorescent
by-product is detected by
the Auto-reader. The
presence of fluorescence
upon incubation in the
Auto-reader indicates a
sterilization process failure. | |
| Auto-reader | 3MTM Attest™ Auto-reader 490
having software version 4.0.0 or
greater or 3MTM Attest™ Auto-
reader 490H having software
version 4.0.0 or greater | 3MTM Attest™ Auto-reader
490 or 3MTM Attest™ Auto-
reader 490H having
software version 4.0.0 or
greater | The 3MTM Attest™
Super Rapid Steam
Biological Indicator
1592 BI has a 24
minute readout and is
intended to be used
with a 490 or 490H
having software version
4.0.0 or greater.
Indications for a 24
minute time to result
were cleared under
K173437. |
| Viable spore
population | $\ge$ 1 x 106 | $\ge$ 1 x 106 | Identical |
| Resistance | D121 $\ge$ 1.5 min | D121 is N/A
D132 $\ge$ 10 s
D135 $\ge$ 8 s | The 3MTM Attest™
Super Rapid Steam
Biological Indicator
1592 BI is indicated for
qualifying and
monitoring sterilization
cycles at 121°C
whereas the predicate
device is indicated for
qualifying and
monitoring sterilization
cycles at 132°C and
135°C. |
| Survival Time | Meets the longer of FDA and
ISO 11138-1 and ISO 11138-3
requirements | Meets the longer of FDA
and ISO 11138-1 and ISO
11138-3 requirements | Identical |
| Kill Time | Meets the ISO 11138-1 and ISO
11138-3 requirements | Meets the ISO 11138-1 and
ISO 11138-3 requirements | Identical |
| Feature | Submission Device:
(K192550):
3MTM AttestTM
Super Rapid Steam
Biological Indicator 1592 and
3MTM AttestTM Auto-reader
490 and 490H | Predicate Device
(K173437):
3MTM AttestTM
Super Rapid Readout
Biological Indicator 1492V
and
3MTM AttestTM
Auto-reader 490 and 490H | Comparison |
| Carrier material | Plastic | Plastic | Identical |
| Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Readout time | 24 minute final fluorescent
result in both the 490 and 490H
Auto-readers having software
version 4.0.0 or greater.
Optional visual pH color
change result in 7 days | 24 minute final fluorescent
result in both the 490 and
490H Auto-readers having
software version 4.0.0 or
greater.
1 hour final fluorescent
result in 490 Auto-readers
having software versions
less than 4.0.0.
Optional visual pH color
change result in 48 hours. | The 3MTM AttestTM
Super Rapid Steam
Biological Indicator
1592 BI has a 24
minute readout and is
intended to be used
with a 490 or 490H
having software version
4.0.0 or greater.
Indications for a 24
minute time to result
were cleared under
K173437. |
| Chemical indicator | Turns from pink to light brown
or darker upon steam exposure | Turns from pink to light
brown or darker upon steam
exposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing is
ongoing. |
Technological Characteristics Comparison Table – Biological Indicator
7
TRADITIONAL PREMARKET NOTIFICATION [K192550]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3MTM Attest™ Super Rapid Steam Challenge Pack 51582
3M™ Attest™ Auto-readers 490 and 490H
8
TRADITIONAL PREMARKET NOTIFICATION [K192550]
3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Super Rapid Steam Challenge Pack 51582
3MTM Attest™ Auto-readers 490 and 490H
Summary of Nonclinical Testing- Biological Indicator
Testing was conducted on the biological indicator following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- ISO 11138-1:2017 Sterilization of health care products Biological indicators, Part 1: ● General Requirements
- ISO 11138-3:2017 Sterilization of health care products Biological indicators, Part 3: ● Biological indicators for moist heat sterilization processes
- . United States Pharmacopeia, Chapter Biological Indicators for Sterilization and Chapter Biological Indicators - Resistance Performance Tests
9
The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:
| Test | Results |
|---|---|
| Population (Total Viable Spore Count) | |
| Greater than or equal to $10^6$ spores | Passed |
| D-Value | |
| Greater than or equal to 1.5 minutes at 121°C | Passed |
| Z-Value | |
| Greater than or equal to $10$ °C | Passed |
| Survival Time | |
| Meets the longer of FDA and ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Kill Time | |
| Meets ISO 11138-1 and ISO 11138-3 requirements | Passed |
| Component Inhibition Studies | |
| Components have no impact on the recovery of 10-100 organisms | Passed |
| Hold Time Assessment | |
| D-value does not change when activated 7 days post sterilization | Passed |
| 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 time: | |
| • Fluorescent result in 24 minutes | Passed |
| Simulated Use | |
| Verification of performance in claimed cycles | Passed |
3MT™ Attest™ Auto-reader 490 having software version 4.0.0 or greater and 3MTM Attest™ Auto-reader 490H
The 3M™ Attest™ Auto-reader 490 and the 3M™ Attest™ Auto-reader 490H were cleared for use with the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V under K173437. This submission extends the use of the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to the 3MTM Attest™ Super Rapid Steam Biological Indicator 1592.
The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes. The fluorescent readout at 24 minutes meets the FDA's requirement of > 97% alignment with the result after conventional incubation time of 7 days.
10
Device Name and Classification- Challenge Pack:
| Trade Name: | 3MTM AttestTM Super Rapid Steam Challenge Pack 51582 |
|---|---|
| Common/Usual Name: | Biological Indicator (BI) Challenge Pack |
| Device Classification: | Class II |
| Classification Name: | Indicator, Biological Sterilization Process |
| [21 CFR § 880.2800(a), FRC] |
Predicate Device- Challenge Pack:
3MTM Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H, K173519
Indications for Use- Challenge Pack
Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
Description of Device- Challenge Pack
The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).
The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam.
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| Feature | Submission Device:
(K192550):
3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582 and
3MTM AttestTM Auto-reader
490 and 490H | Predicate Device
(K173519):
3MTM AttestTM Super Rapid 5
Steam-Plus Challenge Pack
41482V
and
3MTM AttestTM Auto-reader
490 and 490H | Comparison |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
use | Use the 3MTM AttestTM Super
Rapid Steam Challenge Pack
51582 in conjunction with the
3MTM AttestTM Auto-reader
490 having software version
4.0.0 or greater or the 3MTM
AttestTM Auto-reader 490H
having software version 4.0.0
or greater to qualify or
monitor dynamic-air removal
(pre-vacuum and SFPP) or
gravity displacement steam
sterilization cycles of 30
minutes at 250°F (121°C). | Use the 3MTM AttestTM Super
Rapid 5 Steam-Plus Challenge
Pack 41482V in conjunction
with the 3MTM AttestTM Auto-
reader 490 or 3MTM AttestTM
Auto-reader 490H having
software version 4.0.0 or
greater to qualify or monitor
dynamic-air-removal steam
sterilization cycles of 4 minutes
at 270°F (132°C) and 3 minutes
at 275°F (135°C). | The 3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582 is
intended to qualify or
monitor both dynamic-
air-removal (pre-vacuum
and SFPP) and gravity
displacement
sterilization cycles of 30
minutes at 250°F
(121°C). Whereas the
3MTM AttestTM Super
Rapid 5 Steam-Plus
Challenge Pack is
intended to qualify or
monitor dynamic-air-
removal steam
sterilization cycles at
various exposure times
at 270°F (132°C) and
275°F (135°C). |
| General Design | Layers of medical index
cards, some of which are die-
cut to contain indicators,
overwrapped and secured
with a label. | Layers of medical index cards,
some of which are die-cut to
contain indicators, overwrapped
and secured with a label. | Identical |
| Biological
Indicator | 3MTM AttestTM Super Rapid
Steam Biological Indicator
1592 | 3MTM AttestTM Super Rapid
Readout Biological Indicator
1492V | The 51582 Challenge
Pack contains the new
1592 BI as proposed in
this submission. |
| Biological
Indicator
Incubation
temperature | 60 ± 2°C | 60 ± 2°C | Identical |
| Biological
Indicator Readout
time | 24 minute final fluorescent
result in both the 490 and
490H Auto-readers having
software versions 4.0.0 or
greater. | 24 minute final fluorescent
result in both the 490 and 490H
Auto-readers having software
versions 4.0.0 or greater.
1 hour final fluorescent result in
490 Auto-readers having | The 3MTM AttestTM
Super Rapid Steam
Biological Indicator
1592 BI has a 24 minute
readout and is intended
to be used with a 490 or |
| Feature | Submission Device:
(K192550):
3MTM AttestTM
Super Rapid Steam
Challenge Pack 51582 and
3MTM AttestTM Auto-reader
490 and 490H | Predicate Device
(K173519):
3MTM AttestTM Super Rapid 5
Steam-Plus Challenge Pack
41482V
and
3MTM AttestTM Auto-reader
490 and 490H | Comparison |
| | | software versions less than
4.0.0. | 490H having software
version 4.0.0 or greater.
Indications for a 24
minute time to result
were cleared under
K173519. |
| Resistance
Comparison to
the AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Equivalent in resistance to the
AAMI ST79
16 Towel PCD | Identical |
| Chemical
Integrator | 3MTM AttestTM Chemical
Integrator | 3MTM SteriGageTM Chemical
Integrator | Both integrators meet
FDA requirements and
are Type 5 Integrating
Indicators as classified
per ISO 11140-1. |
| External
Chemical Process
Indicator | Turns from yellow to brown
or darker upon steam
exposure | Turns from yellow to brown or
darker upon steam exposure | Identical |
| Shelf-life | 6 months | 21 months | Real-time testing is
ongoing. |
Technological Characteristics Comparison Table – Challenge Pack
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TRADITIONAL PREMARKET NOTIFICATION [K192550] 3M™ Attest™ Super Rapid Steam Biological Indicator 1592
3M™ Attest™ Super Rapid Steam Challenge Pack 51582
3MTM Attest™ Auto-readers 490 and 490H
Summary of Nonclinical Testing- Challenge Pack
Testing was conducted on the challenge packs following the FDA guidance and the standards below:
- Guidance for Industry and FDA Staff, Biological Indicator Premarket Notification [510(k)] Submissions, October 4, 2007
- Premarket Notification [510(k)] Submission for Chemical Indicators: Guidance for ● Industry and FDA Staff, December 19, 2003
- ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility ● assurance in health care facilities
- ISO 11138-1:2017 Sterilization of health care products – Biological indicators, Part 1: General Requirements
- . ISO 11138-3:2017 Sterilization of health care products – Biological indicators, Part 3: Biological indicators for moist heat sterilization processes
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- ISO 11140-1:2014 Sterilization of health care products Chemical indicators, Part 1: ● General Requirements
- United States Pharmacopeia, Chapter Biological Indicators for Sterilization and ● Chapter Biological Indicators - Resistance Performance Tests
The performance testing below demonstrate that the subject device met the acceptance criteria of the specified standards:
| Test | Acceptance Criteria | Results |
|---|---|---|
| Resistance of the | ||
| Challenge Pack as | ||
| compared to AAMI 16 | ||
| Towel PCD | Challenge Pack is at least as resistant as the | |
| biological indicator AAMI 16 Towel Process | ||
| Challenge Device (PCD) described in ANSI/AAMI | ||
| ST79: 2017 | Passed | |
| Resistance of the | ||
| Challenge Pack as | ||
| compared to the | ||
| Biological Indicator | ||
| alone | Challenge Pack provides a greater resistance than | |
| the Biological Indicator alone | Passed |
Conclusion
The conclusions drawn from the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices, the 3MM Attest™ Super Rapid Readout Biological Indicator 1492V, 3MTM Attest™ Auto-reader 490, and 3MTM Attest™ Auto-reader 490H (cleared under K173437) and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H (cleared under K173519), Class II (21 CFR 880.2800), product code FRC.