MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR

K110956 · Medivance, Inc. · FLL · Jul 18, 2011 · General Hospital

Device Facts

• Record ID: K110956
• Device Name: MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
• Applicant: Medivance, Inc.
• Product Code: FLL · General Hospital
• Decision Date: Jul 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.

Device Story

Sterile, single-use YSI400 series thermistor temperature probe; designed for insertion into vent lumen of 16 Fr or 18 Fr nasogastric sump tubes. Device measures patient core esophageal temperature continuously. Operated by clinicians in clinical settings. Output is electrical signal compatible with standard temperature monitors; provides real-time core temperature data to assist healthcare providers in patient thermal management.

Clinical Evidence

Bench testing only. Performance testing demonstrated compliance with BS EN 12470-4 (electrical thermometers for continuous measurement) and ISO 80601-2-56 (clinical thermometers). Biocompatibility testing per ISO 10993-1 confirmed materials are non-cytotoxic, non-irritating, and non-sensitizing.

Technological Characteristics

YSI 400 series thermistor; sterile, single-use, disposable probe; dimensions compatible with 16 Fr/18 Fr nasogastric tube vent lumens; passive electrical sensing; compliant with BS EN 12470-4 and ISO 80601-2-56.

Indications for Use

Indicated for continuous core esophageal temperature measurement in patients requiring nasogastric intubation using 16 Fr or 18 Fr sump tubes.

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

• Level 1 Esophageal Temperature Probe (K935603)
• Therma-Temp Esophageal Stethoscope with Temperature Sensor (K072621)
• Steri-Temp Esophageal Temperature Probe (K072621)

Submission Summary (Full Text)

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K110956
PAGE 1 of 2

# 510(K) SUMMARY Premarket Notification [510(K)] Summary (per 21 CFR 807.92)

JUL 18 2011

#### Company Name

Medivance, Inc. 321 South Taylor Avenue, Suite 200 Louisville, Colorado 80027

| Contact Person: | Lynne Aronson |
|-----------------|----------------------------------------------------|
| | Director, Regulatory Affairs and Quality Assurance |
| Telephone: | 303-926-1917 |
| Facsimile: | 303-926-1924 |

#### Device Name

| Proprietary Name: | Nasogastric Tube Temperature Sensor |
|----------------------|----------------------------------------------------|
| Common Name: | esophageal temperature probe |
| Classification Name: | esophageal stethoscope with electrical conductors; |
| | electronic clinical thermometer |

#### Predicate Devices

The Medivance Nasogastric Tube (NGT) Temperature Sensor is substantially equivalent in intended use, design, technological characteristics, and system features and functions to the following predicate devices in commercial distribution:

| Device Name | Manufacturer | 510(k) |
|---------------------------------------------------------------------------------------------------------------|---------------------|---------|
| Level 1 Esophageal Temperature Probe | Smiths | K935603 |
| Therma-Temp Esophageal Stethoscope with<br>Temperature Sensor, and<br>Steri-Temp Esophageal Temperature Probe | Cincinnati Sub-Zero | K072621 |

#### Indications for Use

The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.

#### Description of the Device

The Medivance Nasogastric Tube (NGT) Temperature Sensor is a sterile, single use, disposable YSI400 series thermistor temperature probe that is designed for placement in the vent lumen of a 16 or 18 Fr Bard Nasogastric Sump or Argyle Salem Sump® nasogastric tube (or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen) for measurement of esophageal temperature.

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#### Substantial Equivalence Summary

The Medivance NGT Temperature Sensor and the predicate Smiths Level 1 and Cincinnati Sub-Zero esophageal temperature sensors are substantially equivalent with respect to the following:

| Indications for Use: | Continuous core patient temperature measurement<br>(esophageal) |
|----------------------------|-----------------------------------------------------------------|
| Technical Characteristics: | YSI 400 series thermistor |
| Accuracy Specifications: | ± 0.2°C within the physiologic temperature range |
| Labeling: | Sterile, Single Use Only |
| Compliance with Standards: | Applicable sections of BS EN 12470-4 and/or ISO<br>80601-2-56 |

### Test Summary

Testing demonstrated that the Medivance NGT Temperature Sensor performance meets the applicable requirements of BS EN 12470-4 (Clinical thermometers-Part 4: Performance of electrical thermometers for continuous measurement) and ISO 80601-2-56 (Medical electrical equipment – Particular requirements for basic and safety and essential performance of clinical thermometers for body temperature measurement).

Biocompatibility testing in accordance with ISO 10993-1 demonstrated that the Medivance NGT Temperature Sensor patient contact materials are non-cytotoxic, non-irritating and non-sensitizing.

#### Conclusions

The Medivance NGT Temperature Sensor has the same intended use and technological characteristic as the commercially-available predicate devices. The performance testing has demonstrated that the Medivance NGT Temperature Sensor meets the applicable requirements of BS EN 12470-4 and ISO 80601-2-56, and therefore provides substantially equivalent performance and safety as the predicate devices.

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

Ms. Lynne Aronson Director, Regulatory Affairs and Quality Assurance Medivance, Inc. 321 South Taylor Avenue, Suite 200 LOUISVILLE CO 80027

JUL 18 2011

Re: K110956

Trade/Device Name: Nasogastric Tube Temperature Probe Regulation Number: 21 CFR§ 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: II Product Code: FLL Dated: July 11, 2011 Received: July 12, 2011

Dear Ms. Aronson:

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 Ameridae, or to conninered prior to May 2019, 2019, in accordance with the provisions of the Federal Food, DNA 1 de necs that have boon require approval of a premarket approval approval application (PMA). and Costictle (rice) that ao new requent to the general controls provisions of the Act. The I ou may, therefore, manieve 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 addition. Thease note: SDATE Det, 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.

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 that ITDA has made a decemblations administered by other Federal agencies. You must comply of or any I cochar statutes and regalaries, but not limited to: registration and listing (21 CFR Part willi an the Ale 3 requirements, areasing, seporting (reporting of medical device-related

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#### Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the auality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quarty by Bectins (Sections (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 n 1 ou active sportion 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,

Hichal Hemer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

## Enclosure

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## STATEMENT OF INDICATIONS FOR USE (FDA FORM)

510(k):

K110956

Device:

Nasogastric Tube Temperature Probe

Indications for Use:

The NGT Temperature Sensor is indicated for continuous measurement of patient core (esophageal) temperature in patients using Bard® or Argyle® 16 Fr or 18 Fr nasogastric sump tubes or other 16 Fr or 18 FR nasogastric tubes with a vent lumen of sufficient diameter to allow easy movement of the sensor within the lumen.

Prescription Use × Use

OR

Over-the-Counter

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aozm M. Diaz

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110956

(Optional Format 1-2-96)