(28 days)
No
The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide, temperature, and time. There is no mention of any computational analysis or learning algorithms.
No
This device is a chemical indicator used for monitoring sterilization processes, not for treating any medical condition.
No
The device is a chemical indicator used to monitor the sterilization process by verifying exposure to vaporized hydrogen peroxide; it does not diagnose medical conditions in patients. It is used in sterilization processes for medical devices, not on patients.
No
The device description clearly states it is a "chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate." This describes a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pack control monitoring of... hydrogen peroxide sterilization sterilizers and cycles." This indicates the device is used to monitor the effectiveness of a sterilization process for medical devices, not to diagnose a condition or analyze a biological sample from a human body.
- Device Description: The device is a "chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide." It works by changing color based on exposure to the sterilizing agent. This is a chemical process, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological specimens, or providing information for the diagnosis, treatment, or prevention of disease.
Therefore, the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a sterilization process indicator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles).
Product codes
QKM
Device Description
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
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)
Study Type: Nonclinical testing (Health Care Facility Simulated Use Testing)
Sample Size: Not explicitly stated, but implies multiple CIs were tested ("All Tri-Metric CIs tested met acceptance criteria.").
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
The 3M Tri-Metric CI turns from blue toward pink in the ACCEPT region of the indicator window to indicate a "PASS" (reaches endpoint) when exposed to a complete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System.
The 3M Tri-Metric CI turns from blue toward pink only within the REJECT region of the indicator window to indicate a "FAIL" (does not reach endpoint) when exposed to an incomplete Lumen, Non-Lumen, Flexible, or Fast Cycle in the STERIS V-PRO s2 Low Temperature Sterilization System.
All Tri-Metric CIs tested met acceptance criteria.
All Tri-Metric CIs tested met acceptance criteria. (Duplicated in the source document)
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 7, 2020
3M Company Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Ave, Bldg 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K203284
Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: November 6, 2020 Received: November 9, 2020
Dear Andrew Wingen:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,
Clarence W. Murray, III, PhD 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) K203284
Device Name
3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (1348/1348E)
Indications for Use (Describe)
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast 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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Special 510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K203284
Sponsor Information:
3M Company 3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact: Andrew Wingen Regulatory Affairs Commercialization Strategy Lead Phone Number: (651) 733-0929 Fax Number: (651) 737-5320
Date of Summary: 4 December 2020
4
1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3MTM AttestTM Vaporized Hydrogen Peroxide Tri-Metric |
| Chemical Indicator 1348/1348E | |
| Classification Name: | Indicator, physical/chemical sterilization process |
| Device Classification: | Class II, 21 CFR § 880.2800 |
| Product Code: | QKM |
2. Predicate Device:
K193110, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
3. Description of Device:
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and amount of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber.
Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and amount of vaporized hydrogen peroxide.
4. Indications for Use
Use the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX® System (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ Technology
5
PREMARKET NOTIFICATION [Special 510(k)] 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
(Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and STERIS® V-PRO® 1 (Lumen cycle), STERIS ® V-PRO® 1 Plus (Lumen and Non-Lumen cycles) and STERIS ® V-PRO® maX Low Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® 60 Temperature Sterilization System (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles), and the STERIS® V-PRO® s2 Low Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast cycles).
| Feature | Submission Device: 3MTM AttestTM
Vaporized Hydrogen Peroxide Tri-
Metric Chemical Indicator | Predicate Device:
3MTM Attest™ Vaporized Hydrogen
Peroxide Tri-Metric Chemical
Indicator (K193110) | Comparison |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Models | 1348, 1348E | 1348, 1348E | Identical |
| Device
Design | The 3MTM Attest™ Vaporized
Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E is a
chemical indicator consisting of a non-
cellulose based coated indicator strip
sensitive to vaporized hydrogen
peroxide, contained in a film laminate.
The 3M™ Attest™ CI 1348/1348E
verifies that the stated values for the
three critical parameters of exposure
time, temperature, and concentration of
vaporized hydrogen peroxide have been
achieved within a package or
containment device (i.e. wrapped trays,
rigid containers, sterilization pouches,
and other types of packs) and/or at a
specific location within the load or
empty chamber.
Upon exposure to vaporized hydrogen
peroxide, the color of the coated
indicator strip progressively changes
from blue toward pink along the strip.
The progression of the blue to pink
color change along the strip is visible
through a window with marked
"REJECT" and "ACCEPT" zones. The
extent of the progression depends on
exposure time, temperature, and
concentration of vaporized hydrogen
peroxide. | The 3MTM Attest™ Vaporized
Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E is a
chemical indicator consisting of a non-
cellulose based coated indicator strip
sensitive to vaporized hydrogen
peroxide, contained in a film laminate.
The 3MTM Attest™ CI 1348/1348E
verifies that the stated values for the
three critical parameters of exposure
time, temperature, and concentration of
vaporized hydrogen peroxide have been
achieved within a package or
containment device (i.e. wrapped trays,
rigid containers, sterilization pouches,
and other types of packs) and/or at a
specific location within the load or
empty chamber.
Upon exposure to vaporized hydrogen
peroxide, the color of the coated
indicator strip progressively changes
from blue toward pink along the strip.
The progression of the blue to pink
color change along the strip is visible
through a window with marked
"REJECT" and "ACCEPT" zones. The
extent of the progression depends on
exposure time, temperature, and
concentration of vaporized hydrogen
peroxide. | Identical |
| Sterilizers in
which Color | STERRAD® 100S
STERRAD® NX (Standard and | STERRAD® 100S
STERRAD® NX (Standard and | Similar. The
submission |
| Change | Advanced cycles) | Advanced cycles) | device adds |
| | | | |
| Performance was
Demonstrated
(Blue toward Pink) | STERRAD® NX with ALLClear™
Technology (Standard and Advanced
cycles)
STERRAD® 100NX (Standard, Flex,
Express, and Duo cycles)
STERRAD® 100NX with ALLClear™
Technology (Standard, Flex, Express,
and Duo cycles)
STERIS® V-PRO® maX (Lumen,
Non-Lumen, and Flexible cycles)
STERIS® V-PRO® maX2 (Lumen,
Non-Lumen, Flexible, and Fast Non-
Lumen cycles)
STERIS® V-PRO® 60 (Lumen, Non-
Lumen, and Flexible cycles)
STERIS® V-PRO® s2 (Lumen, Non-
Lumen, Flexible, and Fast cycles)
Use the 3MTM Attest™ Vaporized
Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E for
pack control monitoring of the
following hydrogen peroxide
sterilization sterilizers and cycles:
STERRAD® 100S System,
STERRAD® NX® System (Standard
and Advanced cycles), STERRAD®
NX® System with AllClear™
Technology (Standard and Advanced
cycles), STERRAD® 100NX® System
(Standard, Flex, Express and Duo
cycles) STERRAD® 100NX® System
with AllClear™ Technology (Standard,
Flex, Express and Duo cycles) | STERRAD® NX with ALLClear™
Technology (Standard and Advanced
cycles)
STERRAD® 100NX (Standard, Flex,
Express, and Duo cycles)
STERRAD® 100NX with ALLClear™
Technology (Standard, Flex, Express,
and Duo cycles)
STERIS® V-PRO® maX (Lumen,
Non-Lumen, and Flexible cycles)
STERIS® V-PRO® maX2 (Lumen,
Non-Lumen, Flexible, and Fast Non-
Lumen cycles)
STERIS® V-PRO® 60 (Lumen, Non-
Lumen, and Flexible cycles)
Use the 3MTM Attest™ Vaporized
Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E for
pack control monitoring of the
following hydrogen peroxide
sterilization sterilizers and cycles:
STERRAD® 100S System,
STERRAD® NX® System (Standard
and Advanced cycles), STERRAD®
NX® System with AllClear™
Technology (Standard and Advanced
cycles), STERRAD® 100NX® System
(Standard, Flex, Express and Duo
cycles) STERRAD® 100NX® System
with AllClear™ Technology (Standard,
Flex, Express and Duo cycles) | the
STERIS®
V-PRO® s2
sterilizer to
the
indications
for use and
testing was
conducted to
demonstrate
color change
performance. |
| Indications
for Use | vaporized hydrogen peroxide sterilizers
and STERIS® V-PRO® 1 (Lumen
cycle), STERIS ® V-PRO® 1 Plus
(Lumen and Non-Lumen cycles) and
STERIS ® V-PRO® maX Low
Temperature Sterilization System
(Lumen, Non-Lumen and Flexible
cycles), STERIS® V-PRO® 60
Temperature Sterilization System
(Lumen, Non-Lumen and Flexible
cycles), STERIS® V-PRO® maX 2
Temperature Sterilization System
(Lumen, Non-Lumen, Flexible, and
Fast Non-lumen cycles), STERIS® V-
PRO® s2 Low Temperature
Sterilization System (Lumen, Non-
Lumen, Flexible, and Fast cycles). | vaporized hydrogen peroxide sterilizers
and STERIS® V-PRO® 1 (Lumen
cycle), STERIS ® V-PRO® 1 Plus
(Lumen and Non-Lumen cycles) and
STERIS ® V-PRO® maX Low
Temperature Sterilization System
(Lumen, Non-Lumen and Flexible
cycles), STERIS® V-PRO® 60
Temperature Sterilization System
(Lumen, Non-Lumen and Flexible
cycles), and STERIS® V-PRO® maX 2
Temperature Sterilization System
(Lumen, Non-Lumen, Flexible, and
Fast Non-lumen cycles). | Similar. The
submission
device adds
the
STERIS®
V-PRO® s2
sterilizer to
the
indications
for use. |
| Indicator
Agent | Proprietary | Proprietary | Identical |
| Stability of
the endpoint
reaction | At least one month (4 weeks) | At least one month (4 weeks) | Identical |
5. Summary of Technological Characteristics compared to Predicate Device
6
PREMARKET NOTIFICATION [Special 510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
7
PREMARKET NOTIFICATION [Special 510(k)] 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
| Shelf life | 15 months | | | 6 months | | | Similar. 15
month shelf
life data has
been
generated for
the
submission
device using
the same
protocol
used in the
predicate
submission. |
|-------------------------------------------------------------|------------------------|------------------|-----------------|------------------------|------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endpoint
Specifications
(Minimum
Stated
Values) | VH2O2
Concentration | Exposure
Time | Temperature | VH2O2
Concentration | Exposure
Time | Temperature | Identical |
| | 5.1 mg/L | 1
minute | 50 degrees
C | 5.1 mg/L | 1
minute | 50 degrees
C | |
6. Summary of Nonclinical Testing
Provided below are the non-clinical test methodologies performed to demonstrate the Tri-Metric CI met the acceptance criteria of the standard.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Health Care | |||
| Facility | |||
| Simulated | |||
| Use Testing | |||
| on STERIS | |||
| V-PRO s2 | |||
| sterilizer | Assess color | ||
| change of | |||
| indicator after | |||
| exposure to | |||
| representative | |||
| complete and | |||
| incomplete | |||
| cycles for the | |||
| STERIS V- | |||
| PRO s2 | |||
| sterilizer | The 3M Tri-Metric CI turns from blue | ||
| toward pink in the ACCEPT region of | |||
| the indicator window to indicate a | |||
| "PASS" (reaches endpoint) when | |||
| exposed to a complete Lumen, Non- | |||
| Lumen, Flexible, or Fast Cycle in the | |||
| STERIS V-PRO s2 Low Temperature | |||
| Sterilization System. | |||
| The 3M Tri-Metric CI turns from blue | |||
| toward pink only within the REJECT | |||
| region of the indicator window to | |||
| indicate a "FAIL" (does not reach | |||
| endpoint) when exposed to an | |||
| incomplete Lumen, Non-Lumen, | |||
| Flexible, or Fast Cycle in the STERIS | |||
| V-PRO s2 Low Temperature | |||
| Sterilization System. | All Tri- | ||
| Metric CIs | |||
| tested met | |||
| acceptance | |||
| criteria. | |||
| All Tri- | |||
| Metric CIs | |||
| tested met | |||
| acceptance | |||
| criteria. |
7. Conclusion
Based on the non-clinical performance data, the submission device 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the predicate of the same name (K193110), Class II (21 CFR 880.2800), product code QKM.