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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medivance Nasogastric Tube Temperature Sensor:

Acceptance Criteria and Device Performance

The provided text only explicitly states one accuracy specification. The other "acceptance criteria" are implied through compliance with standards.

Acceptance Criteria	Reported Device Performance
Accuracy (Physiologic Temp Range)	± 0.2°C
Compliance with BS EN 12470-4	Meets applicable requirements
Compliance with ISO 80601-2-56	Meets applicable requirements
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993-1)

Study Details

Based on the provided text, the study focused on technical and performance testing against recognized standards rather than a clinical trial with human subjects.

Sample size used for the test set and the data provenance: Not specified. The document states "Testing demonstrated that the Medivance NGT Temperature Sensor performance meets the applicable requirements...", implying lab-based performance testing rather than human patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for performance standards is defined by the standards themselves, not by expert consensus on specific cases.
Adjudication method for the test set: Not applicable. The testing seems to be objective measurement against predefined technical specifications within the standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a sensor, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the testing described appears to be standalone performance testing of the device itself against technical specifications and safety standards.
The type of ground truth used: Technical specifications and safety requirements outlined in the international standards BS EN 12470-4 and ISO 80601-2-56, and biocompatibility standards in ISO 10993-1.
The sample size for the training set: Not applicable. This technical testing does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established: Not applicable.

Summary

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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 withTemperature Sensor, andSteri-Temp Esophageal Temperature Probe	Cincinnati Sub-Zero	K072621

Indications for Use

Description of the Device

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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(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 ISO80601-2-56

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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to protect and promote the health of all Americans.

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 (800) 638-2041 or (301) 796-7100 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:

Prescription Use × Use

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)

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.