HEATMARKER TIME TEMPERATURE INDICATOR

K063759 · Temptime Corporation · OCI · Aug 15, 2007 · General Hospital

Device Facts

• Record ID: K063759
• Device Name: HEATMARKER TIME TEMPERATURE INDICATOR
• Applicant: Temptime Corporation
• Product Code: OCI · General Hospital
• Decision Date: Aug 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2800
• Device Class: Class 2

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.

Device Story

HEATmarker™ TTI is a physical/chemical process indicator label affixed to medical devices or their packaging. It monitors cumulative heat exposure over time. The device features an active area of color-changing ink and a fixed reference color area. As the device is exposed to heat, the active ink darkens; the end point is reached when the active area color matches the fixed reference color. The TTI follows the Arrhenius relationship for time-temperature kinetics. Healthcare providers use the visual color change to determine if a medical device has been subjected to heat abuse, aiding in decisions regarding device integrity or usability. It is used in clinical or emergency settings where temperature-sensitive medical equipment is stored or transported.

Clinical Evidence

No clinical data. Non-clinical studies conducted by emergency medical personnel evaluated TTI performance in emergency vehicles. Results showed TTI color changes correlated with Mean Kinetic Temperature recorded by electronic temperature recorders. Bench testing confirmed the TTI reacts according to the Arrhenius relationship regarding time and temperature, consistent with the polymerization of substituted diacetylene monomers.

Technological Characteristics

Physical/chemical process indicator label. Construction utilizes substituted diacetylene monomer-based inks that undergo irreversible color change in response to cumulative heat exposure. Operates via passive chemical reaction following the Arrhenius relationship. Form factor is a label for surface application. No energy source required. No software or connectivity.

Indications for Use

Indicated for use by healthcare providers to distinguish between medical devices that have exceeded a specific time-temperature profile and those that have not, via a permanent color change on the indicator affixed to the device.

Regulatory Classification

Identification

Biological sterilization process indicator: 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. Physical/chemical sterilization process indicator: 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.

Predicate Devices

• SteriTec Dry Heat Indicator Labels

Submission Summary (Full Text)

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# 510K SUMMARY FOR PUBLIC DISCLOSURE

K063759

| Applicant: | TEMPTIME Corporation<br>116 American Rd.<br>Morris Plains, NJ 07950 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Chris Caufield<br>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<br>history over time for any medical device to which it<br>is affixed. The TTI can be used to monitor the heat<br>exposure of devices at the unit package level. The<br>TTI is constructed similar to a label that allows it to<br>be permanently affixed to a medical device, or to<br>the medical device packaging.<br><br>The visible surface of the TTI contains an area of<br>color-changing ink surrounded by an area of fixed<br>color. The TTI varies in color from start point<br>(light) to end point (dark), defined as the time when<br>the inner, active area reaches the same color as the<br>fixed reference area. TTIs are categorized by the<br>length of time at a specified temperature until end<br>point is reached, for example, 3 months at 5°C. |
| Intended Use: | The HEATmarker™ Time-Temperature Indicator<br>is intended to be used by a health care provider to<br>distinguish between medical devices that have been<br>or have not been exposed to a specific time and<br>temperature profile of interest. |
| Technological Characteristics: | Both the HEATmarker™ TTI and the predicate<br>device are manufactured utilizing inks that change<br>color in response to exposure to a given temperature |

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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:

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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.

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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 [phone]. 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 [phone] or [phone] 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:

K063759

# 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