GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE

K121999 · Draeger Medical GmbH · FLL · Feb 28, 2013 · General Hospital

Device Facts

• Record ID: K121999
• Device Name: GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE
• Applicant: Draeger Medical GmbH
• Product Code: FLL · General Hospital
• Decision Date: Feb 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

General Purpose Temperature Probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.

Device Story

Disposable temperature probes consisting of NTC (Negative Temperature Coefficient) thermistor sensor and plug connector; interfaces with Dräger and Siemens patient monitors. General purpose probes inserted into esophagus or rectum for core temperature; skin probes applied to skin surface via adhesive. Thermistor resistance changes with temperature; monitor converts resistance to temperature reading. Used by clinicians in hospital settings for patient temperature management. Provides continuous temperature data to assist clinical decision-making regarding patient thermal status.

Clinical Evidence

Bench testing only. Verification and validation included shock/vibration, storage/transport, device compatibility, accuracy testing, electrical safety, biocompatibility, mechanical testing (bending, connection cycles, pull-off forces), labeling review, resistance to fluids/disinfectants, and shelf life.

Technological Characteristics

NTC (Negative Temperature Coefficient) thermistor (YS1400). Disposable, single-patient-use. General purpose (esophageal/rectal) and skin probe form factors. Connects to Dräger/Siemens patient monitors. Non-sterile. Biocompatible materials.

Indications for Use

Indicated for patients requiring core body or skin temperature monitoring in clinical settings using Dräger or Siemens patient monitoring systems. General purpose probes for esophageal or rectal insertion; skin probes for surface application via adhesive cover.

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

• SC 9000 Bedside Monitor, SC 9015 Bedside Monitoring System (K946306)
• Reusable temperature probes (Skin Temperature Probe, reusable; General Purpose Temperature Probe, reusable) (K050837)
• Disposable temperature, Skin and Oesophageal probes (K051873)
• Disposable temperature probes/ sensors and instrument cables (K070339)

Submission Summary (Full Text)

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# 510(k) Summary acc. to 21 CFR 807.92

## Applicants Name and Address:

FEB 2 8 2013

Dräger Medical GmbH Moislinger Allee 53-55 23542 Lübeck Germany

## Manufacturer Name and Address:

Dräger Medical GmbH Moislinger Allee 53-55 23542 Lübeck Germany

#### Establishment Registration Number :

9611500

### Contact Person:

Ulrich Schröder Director Regulatory Affairs & Clinical Affairs

Tel. No.: 011 49 [phone] Fax No.: 011 49 [phone]

## Applicants US Contact Person

Beth Zis Director Regulatory Affairs

Tel. No.: [phone] Fax No.: [phone]

#### Date submission was prepared:

## 2012/07/06

#### Device Name:

Common Name: Classification Name: Regulation Number: Class:

Temperature Probes (General Purpose/ Skin) Clinical electronic thermometer, FLL 21 CFR 880.2910 ll

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## Legally Marketed Devices to which Substantial Equivalence is claimed:

| 510(k) number | Trade name | Company |
|---------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| K946306 | SC 9000 Bedside Monitor, SC 9015 Bedside<br>Monitoring System | Dräger (former Siemens) |
| K050837 | Reusable temperature probes (Skin<br>Temperature Probe, reusable; General<br>Purpose Temperature Probe, reusable | GE HEALTHCARE |
| K051873 | Disposable temperature, Skin and<br>Oesophageal probes | GE HEALTHCARE |
| K070339 | Disposable temperature probes/ sensors<br>and instrument cables | CINCINNATI SUB-ZERO<br>PRODUCTS, INC |

## Device Description:

Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes.

The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.

## Intended Use:

## General Purpose Temperature Probes

Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum.

## Skin Temperature Probes

Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.

Verification & validation measures include but are not limited to the following key tests: Shock & Vibration, Storage and Transport, Compatibility to devices, Accuracy Test, Electrical Safety, Biocompatibility, Mechanical tests (bending, connection cycles, pull-off forces) Labelling review, Resistance to fluids and disinfectants, Shelf Life.

## Differences, Similarities and Conclusion:

The Dräger temperature probes are identical in fit, form and function to the predicates. The intended use and general construction as the predicate devices remain the same. The function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal.

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The Dräger temperature probes are non-sterile and are intended for single patient use instead of some predicates. The Dräger temperature probes use different materials but the devices are made from biocompatible materials and all verification and validation data provided indicate product performance is given within the range the device can be used by clinicians. In summary, the disposable temperature probes described in this submission are substantially equivalent to the predicate devices.

NTC-Negative Temperature Coefficient Thermistor

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2013

Draeger Medical GmbH C/O Ms. Beth Zis Director, Regulatory Affairs Draeger Medical Systems, Incorporated 6 Tech Drive ANDOVER MA 01810

Re: K121999

Trade/Device Name: General Purpose Temperature Probes, Skin Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 31, 2013 Received: February 4, 2013

Dear Ms. Zis:

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.

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Page 2 - Ms. Zis

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 devicerelated adverse events) (21 CFR 803); 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.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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 (if known) | K 121999 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | General Purpose Temperature Probes Skin Temperature Probes |
| Indications for Use | General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover. |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use

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Richard C. Chapman 2013.02.19 16:39:46 -05'00'

(Division Sign-Off) (Division of Anastheslology, General Hospital Division of Antrol, Dental Devices

510(k) Number:

K121999