(239 days)
Not Found
Not Found
No
The device is a passive chemical indicator that changes color based on time and temperature exposure, not through computational analysis or learning.
No.
The device's purpose is to monitor the temperature history of other medical devices, not to provide therapy itself.
No.
The device indicates whether a medical device has exceeded a specific time-temperature profile, but it does not diagnose a medical condition or disease in a patient. It assesses the history of a separate medical device.
No
The device is described as a physical label with color-changing ink, indicating it is a 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 to indicate whether a medical device has exceeded a specific time-temperature profile. This is a measure of the storage or environmental conditions of the medical device itself, not a test performed on a biological specimen from a patient.
- Device Description: The device is a label affixed to a medical device or its packaging. It monitors temperature history over time. This is a physical indicator of environmental exposure, not a diagnostic test.
- Lack of Biological Specimen: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimen.
The HEATmarker™ TTI is a time-temperature indicator, a type of device used to monitor the environmental conditions of other products, in this case, medical devices. It provides information about the history of the medical device's exposure to heat, which can be relevant to its efficacy or safety, but it is not a diagnostic test performed on a patient.
N/A
Intended Use / Indications for Use
The HEATmarker™ Time-Temperature Indicator is intended to be used by a health care provider to distinguish between medical devices that have been or have not been exposed to a specific time and temperature profile of interest.
When affixed to a medical device by a health care provider (user), the HEATmarker™ Time-Temperature Indicator (TTI) is indicated, via a permanent color change, for the purpose of distinguishing between medical devices that have exceeded a selected timetemperature profile of interest to the user from devices that have not exceeded that profile.
Product codes
OCI
Device Description
The HEATmarker™ TTI monitors the temperature history over time for any medical device to which it is affixed. The TTI can be used to monitor the heat exposure of devices at the unit package level. The TTI is constructed similar to a label that allows it to be permanently affixed to a medical device, or to the medical device packaging.
The visible surface of the TTI contains an area of color-changing ink surrounded by an area of fixed color. The TTI varies in color from start point (light) to end point (dark), defined as the time when the inner, active area reaches the same color as the fixed reference area. TTIs are categorized by the length of time at a specified temperature until end point is reached, for example, 3 months at 5°C.
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
health care provider
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)
Non-clinical Studies:
Emergency Medical personnel have used HEATmarker™ TTIs in a number of studies addressing the possibility of heat abuse to medical devices carried in emergency vehicles. The TTIs changed color in accordance with the Mean Kinetic Temperature recorded on the vehicles using electronic temperature recorders.
HEATmarker™ TTIs have been shown to react according to the Arrhenius relationship with regard to time and temperature. Studies of the polymerization of the substituted diacetylene monomers support this relationship as do more recent studies involving inks made from these monomers.
The HEATmarker™ TTI changes color in a predictable manner when exposed to a given temperature for a specified period of time. As with the predicate device, this allows the TTI to demonstrate that the medical device to which it is affixed has been exposed to a quantity of heat characterized by a specified time-temperature profile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510K SUMMARY FOR PUBLIC DISCLOSURE
| Applicant: | TEMPTIME Corporation
116 American Rd.
Morris Plains, NJ 07950 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Chris Caufield
Director, Sales and Sales Administration |
| Date Summary Prepared: | 21 November 2006 |
| Device Name: | HEATmarker™ Time Temperature Indicator |
| Common Name: | Time Temperature Indicator (TTI) |
| Classification Name: | Physical/Chemical Process Indicator |
| Equivalent Device: | SteriTec Dry Heat Indicator Labels |
| Device Description: | The HEATmarker™ TTI monitors the temperature
history over time for any medical device to which it
is affixed. The TTI can be used to monitor the heat
exposure of devices at the unit package level. The
TTI is constructed similar to a label that allows it to
be permanently affixed to a medical device, or to
the medical device packaging.
The visible surface of the TTI contains an area of
color-changing ink surrounded by an area of fixed
color. The TTI varies in color from start point
(light) to end point (dark), defined as the time when
the inner, active area reaches the same color as the
fixed reference area. TTIs are categorized by the
length of time at a specified temperature until end
point is reached, for example, 3 months at 5°C. |
| Intended Use: | The HEATmarker™ Time-Temperature Indicator
is intended to be used by a health care provider to
distinguish between medical devices that have been
or have not been exposed to a specific time and
temperature profile of interest. |
| Technological Characteristics: | Both the HEATmarker™ TTI and the predicate
device are manufactured utilizing inks that change
color in response to exposure to a given temperature |
:
. . . . . . . . .
1
for a specified time. The HEATmarker™ TTI uses a static reference color as a comparison to determine when end point is reached while the predicate device undergoes a color change from green to black.
Non-clinical Studies:
Emergency Medical personnel have used HEATmarker™ TTIs in a number of studies addressing the possibility of heat abuse to medical devices carried in emergency vehicles. The TTIs changed color in accordance with the Mean Kinetic Temperature recorded on the vehicles using electronic temperature recorders.
HEATmarker™ TTIs have been shown to react according to the Arrhenius relationship with regard to time and temperature. Studies of the polymerization of the substituted diacetylene monomers support this relationship as do more recent studies involving inks made from these monomers.
The HEATmarker™ TTI changes color in a predictable manner when exposed to a given temperature for a specified period of time. As with the predicate device, this allows the TTI to demonstrate that the medical device to which it is affixed has been exposed to a quantity of heat characterized by a specified time-temperature profile.
Conclusion:
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
AUG 15 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Steve Feldman Vice President, Quality and Regulatory Affairs TEMPTIME Corporation 116 American Road Morris Plains, New Jersey 07950
Re: K063759
Trade/Device Name: HEATmarker™ Time Temperature Indicator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: OCI Dated: June 7, 2007 Received: June 7, 2007
Dear Mr. Feldman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Feldman
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
HEATmarker™ Time Temperature Indicator
Indications for Use:
When affixed to a medical device by a health care provider (user), the HEATmarker™ Time-Temperature Indicator (TTI) is indicated, via a permanent color change, for the purpose of distinguishing between medical devices that have exceeded a selected timetemperature profile of interest to the user from devices that have not exceeded that profile.
Prescription Use X (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 ANOTHER PAGE IF NEEDED)
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(Division Sign-Utf) Oivision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: __大生も3つS9