(127 days)
K 771080
Not Found
No
The device description and performance studies indicate a chemical indicator that changes color based on physical parameters (steam, time, temperature). There is no mention of AI or ML in the text.
No.
This device is a chemical indicator used to monitor sterilization processes, not to provide therapeutic treatment.
No
Explanation: The device is a chemical integrator designed to monitor the effectiveness of steam sterilization cycles for medical instruments, not to diagnose medical conditions in patients. It indicates whether sterilization parameters (temperature, time, steam) have been met.
No
The device is a physical chemical indicator consisting of a paper wick, chemical pellet, and laminate, designed to monitor steam sterilization cycles. It is not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The intended use is for "pack control monitoring" of steam sterilization cycles. This is a quality control measure for the sterilization process itself, not a test performed on a biological sample to diagnose a condition or provide information about a patient's health.
- Device Description: The device is a chemical indicator that changes color based on exposure to steam, time, and temperature. It does not interact with biological samples or provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient
- Analyzing biomarkers or other biological markers
- Use in a laboratory or clinical setting for patient testing
The device is clearly designed to monitor the effectiveness of a sterilization process, which is a critical step in healthcare but is not an IVD function.
N/A
Intended Use / Indications for Use
The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped) ≥ 3 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped) ≥ 3.5 minutes (unwrapped) |
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |
The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.
Minimum Stated Values for SteriGage
| 250° F 121° C | 270° F 132° C | 273° F 134° C | 275° F 135° C |
|---|---|---|---|
| 16.5 minutes | 2.0 minutes | 1.4 minutes | 1.1 minute |
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
3M Comply SteriGage 1243RA, 1243RB, and 1243RE Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or REJECT; the extent of migration depends on steam, time, and temperature.
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)
Testing on multiple lots confirmed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam complies with the chemical integrator performance requirements of FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005 Sterilization of health care products - Chemical indicators, Part 1: General Requirements (for Class 5). Stated values were obtained using a test vessel compliant to ANSVAAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Stated Values in Resistometer | See Minimum Stated Values | Passed |
| Dry Heat | Shows 'Reject' at 137 – 138 °C, 30 min | Passed |
| Comparison to BI | Shows 'Reject' at conditions where BI fails, Shows 'Accept' only at conditions where BI passes | Passed |
| Endpoint Stability | An 'Accept' result or a 'Reject' result does not change after storage for 6 months | Passed |
The testing summarized above showed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam is substantially equivalent to the predicate device, the current 3MTM ComplyTM SteriGage™ Chemical Integrator, cleared under K 771080 in terms of design, intended use, indications for use, composition, physical properties and technological characteristics. The only difference between the predicate and the new integrators is the change in the shape of the product from trapezoidal to rectangular. There are no new questions of safety or effectiveness.
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.
K 771080
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
510(k) Summary
SEP 0 8 2010
SM
Sponsor Information:
3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000
Contact Person:
Phone Number:
FAX Number:
Suzanne Leung Regulatory Affairs (651) 575-8052 (651) 736-0897
Date of Summary:
August 16, 2010
Device Name and Classification:
| Common or Usual Name: | Sterilization Process Indicators for Steam |
|---|---|
| Proprietary Name: | 3MTM ComplyTM SteriGageTM 1243RA, 1243RB, and |
| 1243RE Chemical Integrators for Steam | |
| Classification Name: | Indicator, Physical/Chemical Sterilization Process |
| (21 CFR § 880.2800(b)) | |
| Performance Standards: | There are no mandatory performance standards |
Predicate Device:
3M™ Comply™ SteriGage™ Chemical Integrator (formerly InfoChem SteriGage™ Chemical Integrator)
1
Description of Device:
3M Comply SteriGage 1243RA, 1243RB, and 1243RE Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked ACCEPT or REJECT; the extent of migration depends on steam, time, and temperature.
Indications for Use:
The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped) |
| ≥ 3 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped) |
| ≥ 3.5 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |
The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.
Minimum Stated Values for SteriGage
| 250° F | 270° F | 273° F | 275° F |
|---|---|---|---|
| 121° C | 132° C | 134° C | 135°C |
| 16.5 | 2.0 | 1.4 | 1.1 |
| minutes | minutes | minutes | minute |
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
Testing on multiple lots confirmed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam complies with the chemical integrator performance requirements of FDA's Premarket Notification [510(k)] Submissions for Chemical Indicators: Guidance for Industry and FDA Staff, December 19, 2003 and ANSI/AAMI/ISO 11140-1:2005 Sterilization of health care products - Chemical indicators, Part 1: General Requirements (for Class 5). Stated values were obtained
3M Confidential
2
using a test vessel compliant to ANSVAAMI/ISO 18472:2006 Sterilization of Health Care Product-Biological and Chemical Indicators: Test Equipment.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Stated Values in | ||
| Resistometer | See Minimum Stated Values | Passed |
| Dry Heat | Shows 'Reject' at | |
| 137 – 138 °C, 30 min | Passed | |
| Comparison to BI | Shows 'Reject' at conditions | |
| where BI fails, | ||
| Shows 'Accept' only at | ||
| conditions where BI passes | Passed | |
| Endpoint Stability | An 'Accept' result or a 'Reject' | |
| result does not change after | ||
| storage for 6 months | Passed |
Summary of Nonclinical Testing
The testing summarized above showed that the new model of 3M™ Comply™ SteriGage™ Chemical Integrator for Steam is substantially equivalent to the predicate device, the current 3MTM ComplyTM SteriGage™ Chemical Integrator, cleared under K 771080 in terms of design, intended use, indications for use, composition, physical properties and technological characteristics. The only difference between the predicate and the new integrators is the change in the shape of the product from trapezoidal to rectangular. There are no new questions of safety or effectiveness.
.
Page 15 of 15
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suzanne Leung, Ph.D Regulatory Affairs 3M Company 3M Center, Building 275-05-W-06 Saint Paul, Minnesota 55144-1000
SEP 0 g 2010
Re: K101249
Trade/Device Name: 3M™ Comply" SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: August 30, 2010 Received: August 31, 2010
Dear Dr. Leung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2- Dr. Leung
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or àt its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh foc
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
. Indications for Use
SEP 0 g 2010
510(k) Number (if known): K101249
Device Name:
3MTM ComplyTM SteriGage™ 1243RA, 1243RB, and 1243RE Chemical Integrators for Steam
Indications For Use:
The 3M™ Comply™ SteriGage™ 1243RA, 1243RB, 1243RE Chemical Integrators for Steam are designed for pack control monitoring of the following cycles.
| Cycle Type | Temperature | Exposure Time |
|---|---|---|
| Gravity | 250 °F/121 °C | ≥ 30 minutes |
| Gravity | 270 °F/132 °C | ≥ 3 minutes |
| Vacuum-assisted (prevacuum) | 270 °F/132 °C | ≥ 4 minutes (wrapped) |
| ≥ 3 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 273 °F/134 °C | ≥ 4 minutes (wrapped) |
| ≥ 3.5 minutes (unwrapped) | ||
| Vacuum-assisted (prevacuum) | 275 °F/135 °C | ≥ 3 minutes |
The Minimum Stated Values for SteriGage as determined using a resistometer are shown below.
Minimum Stated Values for SteriGage
| 250° F
121° C | 270° F
132° C | 273° F
134° C | 275° F
135° C |
|------------------|------------------|------------------|------------------|
| 16.5
minutes | 2.0
minutes | 1.4
minutes | 1.1
minute |
Prescription Use (Part 21 CFR 801 Subpart D) -
AND/OR
Over-The-Counter Use · X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K101249