(104 days)
Not Found
No
The description focuses on a simple thermistor temperature probe and its performance against standard temperature measurement requirements, with no mention of AI or ML.
No
This device is a temperature sensor designed for measurement purposes, not for treating or preventing disease or affecting the structure or function of the body.
No
The device is a temperature sensor that measures patient core temperature. While temperature can be a diagnostic indicator, the device itself is solely for measurement and not for diagnosing a condition or disease.
No
The device description explicitly states it is a "sterile, single use, disposable YSI400 series thermistor temperature probe," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the continuous measurement of patient core (esophageal) temperature. This is a direct measurement of a physiological parameter within the body.
- Device Description: The device is a temperature probe designed for placement within a nasogastric tube to measure temperature. This is a physical sensor interacting with the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Accuracy Specifications: ± 0.2°C within the physiologic temperature range
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 | ||
| Temperature Sensor, and | ||
| 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.
1
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 ISO
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.
2
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
3
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
4
STATEMENT OF INDICATIONS FOR USE (FDA FORM)
510(k):
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)