(122 days)
Not Found
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, learning, or adaptive algorithms.
No.
This device is an indicator used to monitor the effectiveness of sterilization processes for medical devices, not for therapeutic purposes on a patient.
No
The device is a chemical indicator used to verify that critical parameters for sterilization have been met, not to diagnose a medical condition in a patient.
No
The device is a chemical indicator, which is a physical product that changes color based on exposure to vaporized hydrogen peroxide. It is 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 sterilizers and cycles. This is a quality control measure for sterilization processes, not a diagnostic test performed on biological samples to diagnose a disease or condition.
- Device Description: The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide. It verifies that sterilization parameters have been met within a package or chamber. This is a process indicator, not a diagnostic tool.
- Lack of Biological Sample Testing: The description does not mention the device being used to test any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Focus on Sterilization Parameters: The device measures the presence and concentration of vaporized hydrogen peroxide, temperature, and time – parameters related to the sterilization process, not patient health.
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 sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº 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), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen cycles).
Product codes (comma separated list FDA assigned to the subject device)
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)
Health Care Facility Simulated Use Testing:
Color change of the indicator was assessed after exposure to representative complete and incomplete cycles for the STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles), STERRAD® NX® with AllClear™ (Standard and Advanced cycles), STERRAD® 100NX® (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System with AllClear™ (Standard, Flex, Express and Duo cycles), STERIS ® V-PRO® maX (Lumen, Non-Lumen and Flexible cycles), STERIS® V-PRO® maX 2 (Lumen, Non-Lumen, Flexible, and Fast Non-lumen cycles), and STERIS® V-PRO® 60 (Lumen, Non-Lumen, Flexible and Fast Non-Lumen cycles) sterilizers.
Result: Pass
Worst Case Sterilant Exposure Testing:
Testing was conducted using overexposure conditions in a commercial sterilizer to ensure color change in overexposure conditions was similar to color change observed for in-pack monitoring of the same cycle.
Result: Pass
Endpoint Color Stability:
Following VH2O2 processing, chemical indicator samples were placed in a shelf life study to confirm the chemical indicator samples conserved their color change reading over time.
Result: Pass
Shelf Life Testing:
6 months of shelf life testing assessing endpoint and non-endpoint conditions was conducted.
Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
March 13, 2020
3M Health Care Andrew Wingen Regulatory Affairs Commercialization Strategy Lead 2510 Conway Avenue, Bldg. 275-5W-06 St. Paul, Minnesota 55144-1000
Re: K193110
Trade/Device Name: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: QKM Dated: February 13, 2020 Received: February 14, 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 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 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,
For Sreekanth Gutala, Ph.D. 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)
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 sterilizers and cycles: STERRAD® 100S System, STERRAD® NX® System (Standard and Advanced cycles), STERRAD® NX® System with AllClear™ Technology (Standard and Advanced cycles), STERRAD® 100NXº 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), and STERIS® V-PRO® maX 2 Temperature Sterilization System (Lumen, Non-Lumen, Flexible, and Fast Non-Lumen 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
Image /page/3/Picture/1 description: The image shows the 3M logo, which is a well-known brand. The logo consists of the number "3" followed by the letter "M", both in a bold, sans-serif font. The color of the text is a vibrant red, and the background is white, creating a strong contrast that makes the logo easily recognizable.
510(k) Summary for 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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) 733-9209 Fax Number: (651) 737-5320
Date of Summary: 9 March 2020
4
1. Device Name and Classification:
| Common or Usual Name: | Chemical Indicator |
|---|---|
| Proprietary Name: | 3M™ Attest™ 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:
K183211 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248
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 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 cvcles) STERRAD® 100NX® System with AllClear™ Technology (Standard, Flex, Express and Duo cycles) vaporized hydrogen peroxide sterilizers and
5
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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, Flexible, and Fast Nonlumen cycles).
Stated Values (SV)
Stated values of a critical process variable are values at which the indicator is designed to reach its endpoint as defined by the manufacturer. The critical process variables measured by the 3M™ Attest™ CI 1348/1348E are exposure time, temperature, and concentration of vaporized hydrogen peroxide. The stated critical values for the 3MTM Attest™ CI 1348/1348E are contained in Table 1.
Table 1: Stated Values of 3M™ Attest™ CI 1348/1348E
| Attribute | Measurement |
|---|---|
| VH2O2 | 5.1 mg/L |
| Exposure Time | 1 minute |
| Temperature | 50 C |
6
5. Summary of Technological Characteristics compared to Predicate Device
| | Submission Device: 3MTM AttestTM
Vaporized Hydrogen Peroxide Tri- | Predicate Device:
3MTM ComplyTM | |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Metric Chemical Indicator (K193110) | Hydrogen Peroxide
Chemical Indicator
1248 (K183211) | Comparison |
| Device
Models | 1348, 1348E | 1248 | Different |
| Device Design | The 3MTM AttestTM 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 AttestTM CI 1348/1348E verifies that
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 ComplyTM
Hydrogen Peroxide
Chemical Indicator
1248 consists of a
non-cellulosic plastic
material onto which a
chemical indicator
bar is printed. A
comparison color
match is also printed
on the product to aid
in color
interpretation.
Upon exposure to
vaporized hydrogen
peroxide, the
chemical indicator
bar turns from blue
toward pink. | Similar |
| Sterilizers in
which Color
Change
Performance
was
Demonstrated
(Blue toward
Pink) | STERRAD® 100S
STERRAD® NX (Standard and Advanced
cycles)
STERRAD® NX with ALLClearTM Technology
(Standard and Advanced cycles)
STERRAD® 100NX (Standard, Flex, Express,
and Duo cycles)
STERRAD® 100NX with ALLClearTM
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) | STERRAD® 100
STERRAD® 100S
STERRAD® NX
(Standard and
Advanced cycles)
STERRAD® NX with
ALLClearTM
Technology
(Standard and
Advanced cycles)
STERRAD® 100NX
(Standard, Flex,
Express, and Duo
cycles)
STERRAD® 100NX
with ALLClearTM
Technology
(Standard, Flex, | Similar. The Tri-
Metric CI is not
indicated to be used
with the
STERRAD® 100
sterilizer. Testing
with the STERIS®
V-PRO® maX is
equivalent to V-
PRO® 1 and V-
PRO® 1 Plus
cycles. |
Table 2: Comparison of Submission Device and Predicate Device
7
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
| | | | | Indicator
Agent | | | | | | | |
|------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--|--|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Express, and Duo
cycles) | | | Proprietary | | Identical | | | | |
| | | AMSCO® V-PRO™
1 (Lumen cycle) | | Stability of the
endpoint
reaction | At least one month (4 weeks) | At least one month (4 weeks) | Identical | | | | |
| | | AMSCO® V-PRO™
1 Plus (Lumen and
Non Lumen cycles) | | Shelf life | 6 months | Two (2) years | Similar | | | | |
| | | AMSCO® V-PRO™
maX Low
Temperature
Sterilization System
(Lumen, Non Lumen
and Flexible cycles) | | Endpoint
Specifications
(Minimum
Stated Values) | VH2O2
Concentration | Exposure
Time | Temperature | | | | |
| | | AMSCO® V-PRO™
60 (Lumen, Non
Lumen and Flexible
cycles) | | | 5.1 mg/L | 1 minute | 50 degrees C | | | | |
| 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, 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). | | Use the 3M™
Comply™ Hydrogen
Peroxide Chemical
Indicator 1248 as an
internal pack process
indicator to verify
exposure to
vaporized hydrogen
peroxide in the
STERRAD® 100,
STERRAD® 100S,
STERRAD® NX
(Standard and
Advanced cycles),
STERRAD® 100NX
(Standard, Flex,
Express and Duo
cycles), STERRAD®
NX with
ALLClear™
Technology
(Standard and
Advanced cycles),
STERRAD® 100NX
with ALLClear™
Technology
(Standard, Flex,
Express and Duo
cycles), AMSCO®
V-PRO® 1 (Lumen
cycle), AMSCO® V-
PRO® 1 Plus
(Lumen and Non
Lumen cycles),
AMSCO® V-PRO®
maX Low
Temperature
Sterilization System
(Lumen, Non Lumen
and Flexible cycles)
AMSCO® V-PRO®
60 (Lumen, Non
Lumen and Flexible
cycles) | Sterilization System
(Lumen, Non Lumen, | Similar. Tri-Metric
removes
STERRAD® 100
and updates brand
names associated
with the former
AMSCO® V-PRO
sterilizers. Tri-
Metric notes color
change in the device
description portion
of the instructions
for use rather than
in the indications
for use portion of
the instructions for
use. | | | | | Different. The predicate is sensitive to VH2O2 exposure only, while the submission device is sensitive to VH2O2 concentration, exposure time, and temperature. |
| | | | | | | | Not applicable. The CI turns from blue toward pink after exposure to vaporized hydrogen peroxide. | | | | |
| | | | and Flexible cycles)
and AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. | | | | | | | | |
8
TRADITIONAL PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
6. Nonclinical Comparison to the Predicate Device
The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E has similar design, fundamental technology, and performance specification to the predicate device sold under the tradename 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 (K183211). The key difference between the Tri-Metric CI 1348/1348E and the Hydrogen Peroxide CI 1248 is that Tri-Metric is sensitive to three critical process variables (sterilant exposure duration, concentration, and temperature), while the predicate is sensitive to sterilant exposure.
Given differences in device construction and performance specifications between the predicate and new device, nonclinical testing was performed in accordance with the FDA Guidance for Industry and Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003.
9
Table 3: Summary of Nonclinical Testing
| Test | Result |
|---|---|
| Health Care Facility Simulated Use Testing: | |
| Color change of the indicator was assessed after exposure to | |
| representative complete and incomplete cycles for the STERRAD® 100S, | |
| STERRAD® NX® (Standard and Advanced cycles), STERRAD® NX® | |
| with AllClear™ (Standard and Advanced cycles), STERRAD® 100NX® | |
| (Standard, Flex, Express and Duo cycles) STERRAD® 100NX® System | |
| with AllClear™ (Standard, Flex, Express and Duo cycles), STERIS ® V- | |
| PRO® maX (Lumen, Non-Lumen and Flexible cycles), STERIS® V- | |
| PRO® maX 2 (Lumen, Non-Lumen, Flexible, and Fast Non-lumen | |
| cycles), and STERIS® V-PRO® 60 (Lumen, Non-Lumen, Flexible and | |
| Fast Non-Lumen cycles) sterilizers. | Pass |
| Worst Case Sterilant Exposure Testing: | |
| Testing was conducted using overexposure conditions in a commercial | |
| sterilizer to ensure color change in overexposure conditions was similar to | |
| color change observed for in-pack monitoring of the same cycle. | Pass |
| Endpoint Color Stability: | |
| Following VH2O2 processing, chemical indicator samples were placed in | |
| a shelf life study to confirm the chemical indicator samples conserved | |
| their color change reading over time. | Pass |
| Shelf Life Testing: | |
| 6 months of shelf life testing assessing endpoint and non-endpoint | |
| conditions was conducted. | Pass |
7. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248, cleared under K183211.