DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES

K111282 · Starboard Medical, LLC · FLL · Aug 11, 2011 · General Hospital

Device Facts

• Record ID: K111282
• Device Name: DISPOSABLE TEMPERATURE PROBES / SENSORS AND INTERCONNECT INSTRUMENT CABLES
• Applicant: Starboard Medical, LLC
• Product Code: FLL · General Hospital
• Decision Date: Aug 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Skin Temperature Sensor: The Starboard Medical Skin Temperature sensor is intended for continuous monitoring of skin temperature. Tympanic Temperature Sensor: The Starboard Medical Tympanic Temperature sensor is intended for use in routine continuous monitoring of tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated.

Device Story

Disposable temperature sensors (skin and tympanic) and interconnect cables; compatible with YSI 400 series monitoring instrumentation. Sensors detect thermal signals from patient skin or ear canal; transmit data via interconnect cables to standard clinical monitors. Used in clinical settings for continuous body temperature monitoring. Provides real-time temperature data to healthcare providers to assist in clinical decision-making and patient management. Single-use, sterile devices.

Clinical Evidence

Bench testing only. Evidence includes materials biocompatibility testing, accuracy testing, and electrical testing/comparison to predicate devices.

Technological Characteristics

Disposable temperature sensors and interconnect cables. Compatible with YSI 400 series monitoring systems. Sterile, single-use. Materials biocompatibility verified. Electrical performance tested for compatibility with standard clinical electronic thermometers.

Indications for Use

Indicated for continuous patient temperature monitoring via skin surface or ear canal (tympanic membrane proximity) in clinical settings. Includes adult and pediatric populations. Prescription use 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 Skin Temperature Sensor (K864195)
• SMITHS LEVEL 1 Tympanic Temperature Sensor (K873205)

Submission Summary (Full Text)

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### 510(k) Summarv 5.

AUG 1 1 2011

... Date.prepared: July_7,.20111______________________________________________________________________________________________________________________________________________

This 510(k) is being submitted by Anthony Beran on behalf of Starboard Medical, LLC.

## Contact:

Anthony Beran President Starboard Medical, LLC 22845 Savi Ranch Parkway Suite H Yorba Linda, CA 92887 Tel: [phone] or 714 730 0845 Fax: [phone] Email: [e-mail] FDA Establishment Registration #: 3006845683

## Contract Manufacturer:

Starboard Medical Jiangsu Tel: [phone] FDA Establishment Registration#: 3006845687

### Trade Name:

The device trade name is Disposable Temperature probes/ sensors and Interconnect Instrument Cables.

### Device common, usual, or classification names:

Skin temperature sensor Tympanic temperature sensor Interconnect Instrument Cables

## Device Regulation:

21CFR880.2910, Clinical Electronic Thermometers

### Classification:

Class II, product code FLL Classification Panel: General Hospital

### Predicate Device:

The following devices have been identified as predicate devices: SMITHS LEVEL 1 Skin Temperature Sensor - K864195 SMITHS LEVEL 1 Tympanic Temperature Sensor - K873205

## Description of device:

The Starboard Medical temperature sensors are intended for use in clinical situations where continuous monitoring of patient's body temperatures is required. The sensors are compatible with all monitoring instrumentation designed to accept YSI 400 series temperature sensors or

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equivalent. The Interconnect Instrument cables are used to interconnect the disposable temperature probe / sensor with the patient monitor.

# This 510(k) includes the following probes:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------400-SK (Skin Temperature Sensor) 400-TY (Tympanic Temperature Sensor - Adult) 400-TYP (Tympanic Temperature Sensor - Pediatric) C400MP-M (Interconnect Instrument Cable) C400MP-MJ (Interconnect Instrument Cable) C400P-M (Interconnect Instrument Cable) C400P-MJ (Interconnect Instrument Cable)

The probes / sensors are single use, and they are sterile.

# Intended Use:

Skin Temperature Sensor: The Starboard Medical Skin Temperature sensor is intended for continuous monitoring of skin temperature.

Tympanic Temperature Sensor: The Starboard Medical Tympanic Temperature sensor is intended for use in routine continuous monitoring of tympanic temperature as an indicator of core body temperature when this type of measurement is clinically indicated.

# Technology Characteristics:

Both devices are substantially equivalent to the predicate devices based on material, technology, manufacturing processes, and performance.

# Performance Data:

Both devices have been subjected to materials bio-compatibility testing, accuracy testing, and electrical testing and comparison.

# Conclusion:

We believe the differences between the Starboard Medical devices and the predicate devices are minor, and conclude that the subject devices are as safe and effective as the predicate devices, therefore substantially equivalent to the predicate devices.

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

Mr. Anthony Beran President Starboard Medical, LLC 22845 Savi Ranch Pkwy, Suite H Yorba Linda, California 92887

AUG 1 1 2011

Re: K111282

Trade/Device Name: Disposable Temperature Probes/ Sensors and Interconnect Instruments Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 8, 2011 Received: July 15, 2011

Dear Mr. Beran:

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- Mr. Beran

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 (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. nist

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

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#### Indications for Use Statement 4.

510(k) Number (if known): Unknown. ___________________________________________________________________________________________________________________________________________

K111282

### Device Name(s):

.

Skin Temperature Sensor, Catalog Numbers 400-STS Tympanic Temperature Sensor, Catalog Numbers 400-TY, 400-TYP Interconnect Instrument Cables Catalog Numbers C400MP-M, C400MP-MJ, C400P-M, C400P-MJ

## Indications for Use:

Skin Temperature Sensor (400-STS)

The Starboard Medical Skin temperature sensor is indicated for continuous patient temperature monitoring when the skin placement site is clinically recommended. The sensor is designed for placement on the surface of the skin.

Tympanic Temperature Sensor (400-TY, 400-TYP)

The Starboard Medical Tympanic Temperature sensor is indicated for continuous monitoring of patient temperature when the ear canal placement site is clinically recommended. The probe is designed for insertion into the ear canal in the proximity of the Tympanic membrane.

Interconnect Instrument Cables (C400MP-M, C400MP-MJ, C400P-M, and C400M-MJ)

The instrument cables are indicated for interconnecting the disposable temperature sensor or probe with the monitoring instrument.

Prescription Use: XXXXX (Part 21CFR801 Subpart D)

and/or

Over-the-Counter Use: (Part 21CFR801 Subpart C)

Rld C. Chaye 8/10/4

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

510(k) Number: K.111282