(87 days)
Not Found
No
The device is a chemical indicator that changes color based on exposure to steam sterilization conditions, which is a purely chemical and physical process, not involving AI/ML.
No
The device is described as a chemical indicator to monitor sterilization conditions, not a device used to treat or diagnose a medical condition.
No
The device is a chemical indicator used to monitor exposure to steam sterilization conditions. It confirms whether the sterilization process has occurred, rather than diagnosing a disease or condition in a patient.
No
The device description clearly states it is a physical indicator consisting of ink printed on vellum, which changes color. This is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for monitoring exposure to steam sterilization conditions. 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 description details a chemical indicator that changes color based on exposure to steam, temperature, and time. This is a physical/chemical reaction, not a biological or biochemical assay typically associated with IVDs.
- Lack of Biological Sample Interaction: IVDs are designed to be used in vitro (outside the body) to examine biological samples like blood, urine, tissue, etc. This device interacts with the sterilization environment, not a biological sample.
- Performance Studies: The performance studies focus on the indicator's response to different sterilization parameters (time, temperature, steam) and its adherence to sterilization indicator standards (11140-1:2005). This is consistent with a sterilization process indicator, not an IVD.
In summary, this device is a sterilization process indicator, used to verify that sterilization conditions have been met, not a diagnostic tool for medical conditions.
N/A
Intended Use / Indications for Use
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.
Product codes (comma separated list FDA assigned to the subject device)
JOJ
Device Description
The INDISTRIP Green Process Indicator for sterilization consists of a metal free indicator ink printed onto white vellum. The indicator changes color from yellow to black when exposed to steam sterilization conditions. Unprocessed indiryclife to stable for atleast 6 months when stored at 30°C or less. The postprocessed indicator color is stable for at least 6 months after exposurer to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilize cycles of
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)
The device was tested in a Saturated Steam environment for various times and temperatures.
Test Environment: Saturated Steam
Test Times: 3.0 min ± 5 s, 10.0 min ± 5 s, 0.5 min ± 5 s, 2.0 min ± 5 s
Test Temperatures: 121 °C (+3/0 °C), 134 °C (+3/0 °C)
Results: All tests for both the Indistrip and Indistrip Green resulted in "Pass", meeting the requirements for both acceptable and unacceptable results regarding color change.
The device was also tested for Dry Heat:
Test Environment: Dry Heat
Test Time: 30 min ± 1 s
Test Temperature: 140 °C (+2/0 °C)
Result: "Pass" for both Indistrip and Indistrip Green for acceptable result (no change or markedly different from visible color change).
The device meets the requirements defined in 11140-1:2005 (AAMI ANSI ISO) Class 1 Table 5-TII Test Performance Characteristics Class 1 Process Indicators.
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
510(k) Summary Statement (as required by 807.92 (c))
Date of Submission: Submitter:
January 14, 2011 Robert Gavrick President Indilab, Inc. 10367 Franklin Avenue Franklin Park, IL 60131 Phone: (847) 928-1050 Fax: (847) 928-1052 MAY - 6 2011
Establishment Registration NO: 1450962
Official Contact:
Mark Espenscheid Business Unit Director / Quality Indilab, Inc. 10367 Franklin Avenue Franklin Park, IL 60131 Phone: (847) 928-1050 Fax: (847) 928-1052
Trade Name:
Indistrip Green
Common Name:
Process Indicator for Steam Sterilization
Device Classification:
Device indicator, physical/chemical sterilization process
Regulation Description Sterilization process indicator.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product Code JOJ
Submission Type 510(k)
Regulation Number 880.2800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report GMP Exempt? No
Predicate Device: Indistrip 400S; 510(k) No. K875193
Section 5 - 510(k) Summary Statement Page 2 of 5 Revision Date 04/28/2011
1
Indications for Use:
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.
Consensus Standards: Utilized as part of our Statement of Conformity
Recognition Number: 14-195 Product Area: Sterility
Title of Standard: Sterilization of health care products - Chemical indicators - Part 1: General requirements, 2ed (Revision of ANSI/AAMI ST60:1996)
Reference Number: 11140-1:2005 Publication Date: 09/08/2009
Standards Development Organization: AAMI ANSI ISO
Device Description:
The INDISTRIP Green Process Indicator for sterilization consists of a metal free indicator ink printed onto white vellum. The indicator changes color from yellow to black when exposed to steam sterilization conditions. Unprocessed indiryclife to stable for atleast 6 months when stored at 30℃ or less. The postprocessed indicator color is stable for at least 6 months after exposurer to steam sterilization conditions for: 121°C (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134°C (273°F) for 4 minutes in gravity or vacuum assisted steam sterilize cycles of
The indicator does not respond to dry heat or ethylene oxide. The process requirements, in comparison to the predicate device are presented in Table 5-11
Section 5 – 510(k) Summary Statement Page 3 of 5 Revision Date 04/28/2011
2
Comparison with Predicate Device (Table 5-TI):
| Item
| Name | Predicate Device | Subject Device |
|---|---|---|
| Indistrip (K875193) | Indistrip Green | |
| Intended Use | For use as an internal or | |
| external chemical indicator | ||
| to monitor exposure to | ||
| steam sterilization | ||
| conditions for 121-141°C | ||
| (250 - 285°F) gravity and | ||
| vacuum assisted steam | ||
| sterilizer cycles. | For use as an internal or | |
| external chemical indicator | ||
| to monitor exposure to | ||
| steam sterilization | ||
| conditions for: 121°C | ||
| (250°F) @ 30 minutes in | ||
| gravity steam sterilizer | ||
| cycles or @ 134°C (273°F) | ||
| for 4 minutes in gravity or | ||
| vacuum assisted steam | ||
| sterilizer cycles. | ||
| Material | Lead Based Ink Printed | |
| onto White Vellum | Organic Based Ink, Metal | |
| Free, Printed onto White | ||
| Vellum | ||
| Color Change | Off-White/tan to Black | Yellow to Black |
| Sterilization Method | Steam | Steam |
| Color Change Timing | 8 minutes 250°F | |
| 3 minutes 273°F | 8 minutes 250°F | |
| 3 minutes 273°F | ||
| Size | 9/16" x 4" | 9/16" x 4" |
| Precautions | Do not use the Indistrip to | |
| monitor dry heat, ethylene | ||
| oxide, or other low | ||
| temperature sterilization | ||
| processes | Do not use the Indistrip | |
| Green to monitor dry heat, | ||
| ethylene oxide, or other | ||
| low temperature | ||
| sterilization processes | ||
| General Instructions | Utilize on and/or in each | |
| pack to be steam | ||
| sterilized. Process | ||
| according to established | ||
| procedures. After | ||
| processing remove the | ||
| indicator and observe the | ||
| color change. If the | ||
| indicator bar is not black, | ||
| inadequate exposure is | ||
| indicated. Return for | ||
| processing. | Utilize on and/or in each | |
| pack to be steam | ||
| sterilized. Process | ||
| according to established | ||
| procedures. After | ||
| processing remove the | ||
| indicator and observe the | ||
| color change. If the | ||
| indicator bar is not black, | ||
| inadequate exposure is | ||
| indicated. Return for | ||
| processing. |
Section 5 – 510(k) Summary Statement Page 4 of 5 Revision Date 04/28/2011
· · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·
·
:**,* ****
3
Performance Data:
| Test
Environment | Test Time | Test Temperature | No Change or a
change that is
markedly different
from the visible color
change as specified
by the manufacturer | Visible color
change as
specified by the
manufacturer | Indistrip
Results | Indistrip
Green
Results |
|---------------------|----------------|------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------|-------------------------------|
| Saturated
Steam | 3.0 min ± 5 s | 121 °C (+3/0 °C) | Acceptable result | Unacceptable
result | Pass | Pass |
| Saturated
Steam | 10.0 min ± 5 s | 121 °C (+3/0 °C) | Unacceptable result | Acceptable result | Pass | Pass |
| Saturated
Steam | 0.5 min ± 5 s | 134 °C (+3/0 °C) | Acceptable result | Unacceptable
result | Pass | Pass |
| Saturated
Steam | 2.0 min ± 5 s | 134 °C (+3/0 °C) | Unacceptable result | Acceptable result | Pass | Pass |
| Dry Heat | 30 min ± 1 s | 140 °C (+2/0 °C) | Acceptable result | Unacceptable
result | Pass | Pass |
Meats the requirements defined in 11140-1:2005 (AAMI ANSI ISO) Class 1 Table 5-TII Test Performance Characteristics Class 1 Process Indicators
Conclusion:
The Indistrip Green, Heavy Metal free Steam Sterilization indicator is in accordance with 21 CFR 807 has the same intended use, provides substantially equivalent process color change timing, and color change stability as the Indistrip steam sterilization predicate device 510(k) K875193. The main difference is the indistrip
the Indistrin Groon, Product Cards IND (1933) The main difference is that the Indistrip Green, Product Code INDA00G indicator ink is developed with a metal free organic indicator as compared to the standard lead based steam indicator utilized in the Indistrip 400S steam indicator strip. The two devices are substantially equivalent.
Section 5 – 510(k) Summary Statement Page 5 of 5 Revision Date 04/28/2011
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Mr. Mark Espenscheid Director of Quality Indilab, Incorporated 10367 Franklin Avenue Franklin Park, Illinois 60131
Re: K110369
Trade/Device Name: Indistrip Green Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: January 15, 2011 Received: February 8, 2011
Dear Mr. Espenscheid:
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.
5
Page 2- Mr. Espenscheid
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 (2) 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 at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
dams
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
6
Section 4 - Indications for Use Statement.
510(k) Number (if known): N/A
Device Name: Indistrip Green
Indications for Use:
Indications for Use:
For use as an internal or external chemical indicator to monitor exposure to steam sterilization conditions for: 121℃ (250°F) @ 30 minutes in gravity steam sterilizer cycles or @ 134℃ (273ºF) for 4 minutes in gravity or vacuum assisted steam sterilizer cycles.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANTOHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabetk B. Clamin-Will
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital intection Control, Dental Devices
:10(k) Number: K110369
Section 4 - Indications for Use Statement Page 2 of 2 Revision 04-28-2011