DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES

K070339 · Cincinnati Sub-Zero Products, Inc. · FLL · Sep 26, 2007 · General Hospital

Device Facts

• Record ID: K070339
• Device Name: DISPOSABLE TEMPERATURE PROBES/SENSORS AND INSTRUMENT CABLES
• Applicant: Cincinnati Sub-Zero Products, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Sep 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Indications for Use

THE CSZ SKIN TEMPERATURE SENSOR is intended for use in routine continuous monitoring of skin temperature when the other sensors which might better reflect core body temperature are not clinically indicated. The sensor is designed for placement on the surface of the skin. THE CSZ TYMPANIC TEMPERATURE SENSOR is intended for use in routine continuous monitoring of the tympanic temperature as an indicator of the core body temperature when this type of measurement is clinically indicated. The probe is designed for placement inside the ear canal. All probes are intended for use by qualified medical professions only.

Device Story

Disposable temperature sensors utilize resistance-based thermistor chips (400 series) to detect temperature changes; sensors encapsulated in PVC cups; skin sensors feature foam enclosures for insulation; tympanic probes feature foam tips for atraumatic insertion and compressible foam cylinders for securement. Probes connect via Molex or phone connectors to instrument cables, which interface with multi-channel patient monitors. Used in clinical settings by medical professionals for continuous monitoring of hypo/hyperthermia. Output is a temperature reading displayed on a compatible monitor, assisting clinicians in patient thermal management.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included thermistor resistance/temperature curve accuracy, current leakage (IEC 60601-1), biocompatibility (ISO 10993), and performance per EN12470-4.

Technological Characteristics

Disposable thermistor-based temperature sensors (400 series). Materials include PVC encapsulation and foam insulation. Connectivity via Molex or phone connectors to standard multi-channel patient monitors. Sterilized via ethylene oxide. Complies with IEC 60601-1, IEC 60601-2-49, and EN12470-4 standards.

Indications for Use

Indicated for routine continuous monitoring of skin or tympanic temperature in patients requiring temperature assessment. Tympanic sensors serve as indicators of core body temperature. Intended for use by qualified medical professionals only.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• SMITHS Level 1 Temperature Probes and Cables (STS-400, TTS-400, C400-10, C400-10HP)

Submission Summary (Full Text)

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#### PRE-MARKET NOTIFICATION 510(k) SUMMARY

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is:

## GENERAL COMPANY INFORMATION AS REQUIRED UNDER 807.92 (A) (1)

Submitter's Name: Cincinnati Sub-Zero Products, Inc 12011 Mosteller Road Cincinnati, Ohio 45241-1528 Phone: [phone] Fax: [phone]

Name of Contact Person: Dan Wittmer, Engineering Manager Date: September 24, 2007

### DEVICE NAME AS REQUIRED UNDER 807.92 (a) (92)

Trade Name: Disposable Temperature Probes Skin Temperature Sensor Tympanic Temperature Sensor

Common name: Temperature Probes

Classification Name: The following class II classifications appear applicable: FLL Clinical Electronic Thermometry 21 CFR 880.2910

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE {807.92(a) (3)}

The CSZ Disposable Temperature Probes/sensors and cables outlined above are substantially equivalent in materials, manufacturing, safety and effectiveness to the Predicate SMITHS Level 1 Temperature Probes and Cables:

SKIN TEMPERATURE SENSOR with the 400 series Thermistor Temperature Sensor (STS400)

TYMPANIC TEMPERATURE SENSOR with 400 series Thermistor Temperature sensor (TT400, TTSP-400, TTS-400J)

CABLES (C400-10, C400-10HP)

KIT-0339

4

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### A DESCRIPTION OF THE DEVICE 807.92 (A) (4)

K070339

Page 2

Undesirable effects of hypothermia and hyperthermia are clinically well documented. Malignant hyperthermia is every doctor's nightmare. To detect hypo/hyperthermia, the body temperature is continuously monitored using disposable temperature sensors or probes. The basic component of these sensors is a resistance chip, which is sensitive to changes in temperature. The chip is in the form of "400" series thermistor connected to a lead wire and encapsulated in a PVC cup. At the end of the lead wires an insert molded connector or standard phone connector provides for the interconnection with the instrument cable.

These sensors are inserted in the structure that fits specific anatomy where the temperature is measured.

The skin sensor is placed on the surface of the skin and is a part of the foam enclosure which provides thermal insulation for more accurate temperature mcasurement.

The tympanic probe is designed for placement in proximity to the tympanic membrane, The probe incorporates a small foam tip for atraumatic insertion and a large compressible foam cylinder for securement and thermal insulation.

The distal end of the skin sensor and the tympanic sensor is terminated with a Molex or phone connector for interconnection with the instrument cable.

The probes are individually packaged in sterilizable bags. There are 20 probes per box and 10 boxes per shipping carton. Probes are ethylene oxide sterilized.

The following probes and cables are included in this 510k application:

Probes:

Skin Temperature Sensor (487M, 499B) Tympanic Temperature Sensor (495M, 495M-P) Cables (4872MS, 4872ML, 4900B)

These probes can be used with Smith's Level 1 TM-200 temperature/monitors or any other multi-channel patient monitor compatible with the "400" series thermistors or equivalent.

The packaging label describes: the product name, catalog number, expiration date, CE mark, legal entity information and the caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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### THE INTENDED USE {807.92 (a) (5)}

Ko70339
pg 3

THE CSZ SKIN TEMPERATURE SENSOR is intended for use in routine continuous monitoring of skin temperature when the other sensors which might better reflect core body temperature are not clinically indicated. The sensor is designed for placement on the surface of the skin.

THE CSZ TYMPANIC TEMPERATURE SENSOR is intended for use in routine continuous monitoring of the tympanic temperature as an indicator of the core body temperature when this type of measurement is clinically indicated. The probe is designed for placement inside the ear canal.

All probes are intended for use by qualified medical professions only.

### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVICE COMPARED TO THE PREDICATE DEVICE 807.92 (a) (6)

The CSZ disposable temperature probes and cables are substantially equivalent in their intended use, accuracy, safety and effectiveness to the predicate Smith's Level 1 disposable temperature probes and cable (STS-400, TTS-400, C400-10 and C400-10HP)

The CSZ disposable temperature probes have the following similarities to the predicate disposable temperature probes:

- -The intended use is the same
- The mechanical design suitable for measurements in different anatomical locations ﺖ on the body is the same
- Mechanical design, materials, dimensions and manufacturing processes are equal "
- * Indications and contraindications are the same
- r Thermistor's temperature/resistance curve and the accuracy within the measurement range are the same
- -Methods of testing are the same
- Sterilization process are equal ત

The CSZ disposable temperature probes have the following differences from the predicated product:

- Labeling, artwork, logo and content of inserts i

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X070339

pg 4

# SUMMARY OF NON-CLINICAL TESTS WHICH SUPPORT A DETERMINATION OF SUBSTANTIAL EQUIVALENCE {807.92 (B) (2)}

In order to support the substantial equivalence status, the CSZ disposable temperature probes have been tested in the laboratory and have also been assessed against the standards as outlined below.

- Thermistor resistance/temperature curve and its accuracy. "400" series thermistor । requirements
- Current leakage test (ICE601-1EN60601-1) m
- Biocompatibility of materials in contact with body fluids (ISO 10993 Biological evaluation of Medical Devices
- IEC 60601-1:1988 & Amdt. 1:1991& Amdt. 2:1995 (part 1 General Requirements for Safety)
- IEC 60601-2-49:2001 (Part 2:-49 Particular requirements for the safety of multi-function patient monitoring equipment)
- EN12470-4:2001 Performance of electrical thermometers =
- 21CFR Part 898, IEC 601-1 sub clause 56,3© Cables and cords 60227-1-7, -7.60245-1-8 60799
- ISO 15223:2000 Medical Devices-Symbols to be used with Medical Devices u labeling and information to be supplied
- EN 980 + A1 + A2 graphical symbols for use in the labeling of medical devices w
- ISO 14971:2000 Medical Devices Application of risk management to medical devices
- 510(k) Sterility Review Guidance K90-1: Guidance for Industry and FDA, August -30, 2002

### CONCLUSION

The above summary presents the evidence that the CSZ Disposable Temperature Probes (outlined above) are substantially equivalent in their design, intended use, accuracy of measurement, safety and effectiveness, to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Mr. Dan Wittmer Engineering Manager Cincinnati Sub-Zero Products, Incorporated 12011 Mosteller Road Cincinnati, Ohio 45241-1528

Re: K070339

Trade/Device Name: Skin Temperature Sensor, Catalog Numbers 487M and 499B Tympanic Temperature Sensor, Catalog Numbers 495M and 495M-P Instrument Cables, Catalog Numbers 4872MS and 4900B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer

SEP 26 2007

Regulatory Class: II Product Code: FLL Dated: August 24, 2007 Received: August 29, 2007

Dear Mr. Wittmer:

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. Wittmer

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 yours.

Clare Jones McWilliams

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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# Attachment C

## Indications for Use

K070339

Device Name(s):

Skin Temperature Sensor, Catalog Numbers 487M and 499B

Tympanic Temperature Sensor, Catalog Numbers 495M and 495M-P

Instrument Cables, Catalog Numbers 4872MS and 4900B

Indications for Use:

Skin Temperature Sensor (487M and 499B): The CSZ skin temperature sensor is intended for use in routine continuous monitoring skin temperature when the other sensors which might better reflect core body temperature are not indicated clinically. The sensor is designed for placement on the surface of the skin.

Tympanic Temperature Sensor (495M and 495M-P): The tympanic temperature sensor is intended for use in routine continuous monitoring tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated.

Instrument Cables (4872MS and 4900B): The intended use of the instrument cable is to interconnect the disposable temperature sensor/probe with the temperature monitoring instrument.

Prescription Use: XXXXX

and/or

Over-the-Counter Use:

(Part 21CFR801 Subpart D)

(Part 21CFR801 Subpart C)

signature

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __ 大�2 Ø334

8/24/2007