(295 days)
Not Found
No
The device description and performance studies focus on a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide, not on any computational or learning-based technology.
No
This device is a chemical indicator used to monitor sterilization processes, not to treat a disease or condition.
No
This device is a chemical indicator used for monitoring sterilization processes, not for diagnosing medical conditions in patients. It verifies that sterilization parameters have been met.
No
The device description clearly states it is a chemical indicator consisting of a coated indicator strip and film laminate, which are physical components, 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 sterilization cycles in various sterilizers. This is a quality control function for a sterilization process, not a diagnostic test performed on a biological sample from a patient.
- Device Description: The device is a chemical indicator that changes color based on exposure to vaporized hydrogen peroxide, temperature, and time. It is used to verify the effectiveness of a sterilization process, not to diagnose a disease or condition in a patient.
- Lack of Biological Sample: IVD devices are designed to be used in vitro (outside the body) on biological specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with any biological sample.
- Focus on Sterilization Parameters: The device measures parameters of the sterilization process (time, temperature, hydrogen peroxide concentration), not biological markers or indicators 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 sterilizers and cycles:
- STERRAD 100S® Sterilization System
- STERRAD NX® Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
- STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
- V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
- V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
- V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
- V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
- V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
- V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
- STERIZONE® VP4 Sterilizer (Cycle 1)
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 to 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 (Simulated Use Testing)
Study Name: Health Care Facility Simulated Use Testing on STERIZONE VP4 Sterilizer (Cycle 1)
Purpose: Assess color change of indicator after exposure to representative complete and incomplete cycles for the STERIZONE VP4 Sterilizer (Cycle 1)
Acceptance Criteria:
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 cycle in the STERIZONE VP4 Sterilizer (Cycle 1).
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 cycle in the STERIZONE VP4 Sterilizer (Cycle 1).
Result:
All Tri-Metric CIs tested met acceptance criteria.
All Tri-Metric CIs tested met acceptance criteria.
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
April 20, 2022
3M Company Mary Fretland Regulatory Affairs Specialist 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144
Re: K212022
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: March 24, 2022 Received: March 25, 2022
Dear Mary Fretland:
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 Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212022
Device Name
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 sterilizers and cycles:
- STERRAD 100S® Sterilization System
- STERRAD NX® Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles)
- STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
- STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles)
- V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
- V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
- V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
- V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles)
- V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
- V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
- STERIZONE® VP4 Sterilizer (Cycle 1)
| 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. The logo is red and consists of the number "3" and the letter "M" in a bold, sans-serif font. The number and letter are connected to each other.
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: Mary Fretland Regulatory Affairs Specialist Phone Number: (651) 461-2734
Date of Summary: 19 April 2022
510(k): K212022
4
PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
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 |
1. Predicate Device:
K203284, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
2. Description of Device:
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 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 to 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.
3. Indications for Use
Use the 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following sterilizers and cycles:
| STERRAD 100S® Sterilization System |
|---|
| STERRAD NX® Sterilization System (Standard and Advanced cycles) |
| STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) |
| STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) |
5
PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
| STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) |
|---|
| V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) |
| V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) |
| V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) |
| V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen and Flexible cycles) |
| V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cycles) |
| V-PRO® s2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast cycles) |
| STERIZONE® VP4 Sterilizer (Cycle 1) |
4. Summary of Technological Characteristics compared to Predicate Device
| Feature | Submission Device: 3MTM AttestTM
Vaporized Hydrogen Peroxide Tri-
Metric Chemical Indicator | Predicate Device:
3MTM Attest™ Vaporized Hydrogen
Peroxide Tri-Metric Chemical
Indicator (K203284) | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Models | 1348, 1348E | 1348, 1348E | Identical |
| Indications
for Use | Use the 3MTM Attest™ Vaporized
Hydrogen Peroxide Tri-Metric
Chemical Indicator 1348/1348E for
pack control monitoring of the
following sterilizers and cycles:
STERRAD 100S® Sterilization
System
STERRAD NX® Sterilization
System (Standard and Advanced
cycles)
STERRAD 100NX® Sterilization
System (Standard, Flex, Express and
Duo cycles)
STERRAD NX® with ALLClear®
Technology Sterilization System
(Standard and Advanced cycles)
STERRAD 100NX® with
ALLClear® Technology Sterilization
System (Standard, Flex, Express and
Duo cycles)
V-PRO® 1 Low Temperature
Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature
Sterilization System (Lumen and
Non Lumen cycles)
V-PRO® maX Low Temperature
Sterilization System (Lumen, Non
Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature
Sterilization System (Lumen, Non
Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature
Sterilization System (Lumen, Non
Lumen, Flexible, and Fast Non
Lumen 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® Sterilization
System
STERRAD NX® Sterilization
System (Standard and Advanced
cycles)
STERRAD 100NX® Sterilization
System (Standard, Flex, Express and
Duo cycles)
STERRAD NX® with ALLClear®
Technology Sterilization System
(Standard and Advanced cycles)
STERRAD 100NX® with
ALLClear® Technology Sterilization
System (Standard, Flex, Express and
Duo cycles)
V-PRO® 1 Low Temperature
Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature
Sterilization System (Lumen and
Non Lumen cycles)
V-PRO® maX Low Temperature
Sterilization System (Lumen, Non
Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature
Sterilization System (Lumen, Non
Lumen and Flexible cycles)
V-PRO® maX 2 Low Temperature
Sterilization System (Lumen, Non | Similar. The
submission
device adds the
STERIZONE®
VP4 Sterilizer
(Cycle 1) to the
indications for
use and
removes the
"hydrogen
peroxide
sterilization" as
a descriptor for
the list of
sterilizers. The
list now
includes both
hydrogen
peroxide and a
dual sterilant
(hydrogen
peroxide/ozone)
sterilizer. |
6
PREMARKET NOTIFICATION [510(k)] 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
| | V-PRO® s2 Low Temperature
Sterilization System (Lumen, Non
Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer
(Cycle 1) | | Lumen, Flexible, and Fast Non
Lumen cycles)
V-PRO® s2 Low Temperature
Sterilization System (Lumen, Non
Lumen, Flexible, and Fast cycles) | | |
|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Indicator
Agent | Proprietary | Proprietary | Identical | | |
| Stability of
the endpoint
reaction | At least six months | At least six months | Identical | | |
| Shelf life | 15 months | 15 months | Identical | | |
| Endpoint
Specifications
(Minimum
Stated
Values) | VH2O2
Concentration
5.1 mg/L
Exposure
Time
1 minute
Temperature
50 degrees
C | VH2O2
Concentration
5.1 mg/L
Exposure
Time
1 minute
Temperature
50 degrees
C | Identical | | |
5. Nonclinical Comparison to the Predicate Device
The submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, has identical design, fundamental technology, and performance specifications to the predicate device under the same name. The key difference between the submission device and the predicate device is that the submission device adds an indication for pack control monitoring of the exposure time, temperature, and amount of vaporized hydrogen peroxide of the dual sterilant vaporized hydrogen peroxide/ozone STERIZONE® VP4 Sterilizer (Cycle 1), last cleared under K203284.
Given the addition of this indication for the STERIZONE® VP4 Sterilizer, 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. Testing was conducted via simulated use testing of the STERIZONE® VP4 Sterilizer in a health care facility and all tests conducted passed.
| Test Name | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Health Care | |||
| Facility | |||
| Simulated Use | |||
| Testing on | |||
| STERIONE | |||
| VP4 Sterilizer | |||
| (Cycle 1) | Assess color change of | ||
| indicator after exposure | |||
| to representative | |||
| complete and incomplete | |||
| cycles for the | |||
| STERIONE VP4 | |||
| Sterilizer (Cycle 1) | The 3MTM 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 cycle in the | |||
| STERIONE VP4 Sterilizer (Cycle 1). |
The 3MTM 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 cycle in the STERIONE VP4
Sterilizer (Cycle 1). | All Tri-Metric
CIs tested met
acceptance
criteria.
All Tri-Metric
CIs tested met
acceptance
criteria. |
Summary of Nonclinical Testing
7
6. Conclusion
The conclusions drawn from the non-clinical performance data demonstrate that the submission device, 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/13485, is as safe, as effective, and performs as well or better than the legally marketed predicate of the same name (K203284), Class II (21 CFR 880.2800), product code QKM.