(145 days)
Not Found
No
The document describes a physical device for temperature monitoring and feeding, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device's primary functions are monitoring (temperature) and delivering substances (medications/nutrition), not directly treating a disease or condition. While delivering medication or nutrition can be part of therapy, the device itself is a delivery/monitoring tool, not a therapeutic agent.
Yes
The device continuously monitors esophageal temperature, which is a diagnostic function, as it provides information about a patient's physiological state.
No
The device description clearly states it is a "single-use, disposable, sterile device" and a "probe/feeding tube," indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The InnerSense Esophageal Temperature Probe/Feeding Tube is a device that is inserted into the body (esophagus) to directly measure temperature and deliver substances. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its functions are continuous monitoring of esophageal temperature and delivery of oral medications/enteral nutrition. These are not diagnostic tests performed on in vitro samples.
Therefore, this device falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.
Product codes
FPD
Device Description
The InnerSense Esophageal Temperature Probe/ Feeding Tube is a single- use, disposable, sterile device designed for nasogastric or orogastric placement in neonatal or pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications and/or provide enteral feeding to a patient for up to 30 days. The InnerSense Esophageal Temperature Probe/ Feeding Tube can be used in neonates or children solely for temperature monitoring; it is not intended to be exclusively used for children who require enteral feeding. The device should be applied only under direct supervision of a licensed physician or healthcare provider and be safely connected only to an enteral giving set or syringe and the compatible patient monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal, nasogastric, orogastric
Indicated Patient Age Range
neonatal and pediatric patients
Intended User / Care Setting
licensed physician or healthcare provider
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed in accordance with the following standards in order to support the substantial equivalence determination:
- ISO 80601-2-56:2009 - Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- EN1615: 2000- Enteral feeding catheters and giving sets for single use and their connectors- Design and Testing
- ISO 80369-1-1: 2010- Small-bore connectors for liquid and gases in healthcare applications- Part 1: General Requirements
- ISO 11607-1-1: 2006- Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 10993-5: 2009- Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-6:2007 - Biological evaluation of medical devices- Part 6: Tests for local effects after implantation
- ISO 10993-7: 2008- Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010- Biological evaluation of medical devices--- Part 10: Tests for irritation and delayed-type hypersensitivity
- ISO 10993-11: 2006- Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
- ISO 10993-18: 2005- Biological evaluation of medical devices-- Part 18: Chemical characterization of materials.
All performance tests demonstrated that the InnerSense Esophageal Temperature Probe / Feeding Tube performed as per its intended use and is substantially equivalent to the predicate device.
The feeding connector materials were tested in accordance with ISO 10993. The results of the 10993 biocompatibility testing proved that the patient contacting materials for the proposed device have the same toxicological, sensitization, irritation, and acute toxicity profile as the previously cleared device.
The distal tip was tested in accordance with EN 1615 and ISO 80601-2-56. The results of EN 1615 testing proved that the distal tip attributes of the proposed device exhibited equivalent tensile strength properties to that of the predicate device. Performance testing results proved that the proposed device performance was equivalent to that of the predicate device. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Temperature Accuracy Range: +/- 0.1°C from 32°- 43°C, and +/- 0.2°C from 25°- 45°C. The proposed device was tested and meets the clinical accuracy range of ISO 80601-2-56.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
InnerSense Esophageal Temperature Probe/ Feeding Tube
Submitter's Name and Address
| Submitter's Name: | |
|---|---|
| Division: | |
| Address: | |
| City, State, and Zip: |
Philips Medical Systems PCCI - Medical Consumables and Sensors 3000 Minuteman Road Andover, MA 01810
Contact Person / Submission Correspondent
Name: Christine Trefethen Regulatory Specialist Title: Telephone: ( 978 ) 659-3890 Facsimile: ( 978 ) 659-7712 E-mail: christine.trefethen@philips.com OCT 2 3 2013
Date of Summary
Date:
September 16, 2013
Manufacturers' Information
| Establishment name: | Philips Medical Systems |
|---|---|
| Address: | 3000 Minuteman Road |
| Andover, MA 01810 | |
| Establishment Registration No. | 1218950 |
New Device Details
| Proprietary or Trade Name: | InnerSense Esophageal Temperature Probe /
Feeding Tube |
|----------------------------|-----------------------------------------------------------|
| Common Name: | Temperature Probe/ Feeding Tube |
| Device Class: | Class II |
| Device Procode: | FPD |
| Device CFR: | 21 CFR 876.5980 |
Philips Medical Systems InnerSense Esophageal Temperature Probe / Feeding Tube 510(k) September 16, 2013 Page 1 of 6
1
| Classification Panel: | Gastroenterology/Urology |
|---|---|
| Classification Name: | Gastrointestinal tube and accessories |
Predicate Device Details
| 510(k) Number | K120815 |
|---|---|
| Proprietary or Trade Name: | InnerSense Esophageal Temperature / Feeding |
| Tube | |
| Common Name: | Feeding Tube/Temperature Probe |
| Device Class: | Class II |
| Device Procode: | FPD |
| Device CFR: | 21 CFR 876.5980 |
| Classification Panel: | Gastroenterology/Urology |
| Classification Name: | Gastrointestinal tube and accessories |
Device Description
The InnerSense Esophageal Temperature Probe/ Feeding Tube is a single- use, disposable, sterile device designed for nasogastric or orogastric placement in neonatal or pediatric patients. It is used to continuously monitor esophageal temperature, deliver oral medications and/or provide enteral feeding to a patient for up to 30 days. The InnerSense Esophageal Temperature Probe/ Feeding Tube can be used in neonates or children solely for temperature monitoring; it is not intended to be exclusively used for children who require enteral feeding. The device should be applied only under direct supervision of a licensed physician or healthcare provider and be safely connected only to an enteral giving set or syringe and the compatible patient monitor.
Indications for Use
The InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.
Comparison of Technological Characteristics:
The proposed device shares the same fundamental scientific technology, indications for use, and operating principles as the predicate device.
A summary comparison of the technological characteristics between the proposed device and the predicate device is as follows:
2
| Specification | Phillips
InnerSense Esophageal
Temperature / Feeding
Tube
(Predicate Device) | Phillips
InnerSense Esophageal
Temperature Probe/
Feeding Tube
(Proposed Device) | Comparison |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Dual function, single-use
sterile device which
simultaneously provides
continuous monitoring of
esophageal temperature and
delivers oral medications
and/or enteral nutrition in
neonatal and pediatric
patients oro/nasogastrically,
as directed by a physician for
up to 30 days. The
InnerSense device can be
used solely for the purpose of
monitoring esophageal
temperature in situations
where invasive monitoring is
indicated. | Dual function, single-use
sterile device which
simultaneously provides
continuous monitoring of
esophageal temperature and
delivers oral medications
and/or enteral nutrition in
neonatal and pediatric
patients oro/nasogastrically,
as directed by a physician
for up to 30 days. The
InnerSense device can be
used solely for the purpose
of monitoring esophageal
temperature in situations
where invasive monitoring is
indicated. | Same |
| Lumen
Construction | Dual Lumen | Dual Lumen | Same |
| Method of Sterility | EtO Sterilization | EtO Sterilization | Same |
| Thermistor type | Series 400 | Series 400 | Same |
| Offered diameters | 5, 6.5 and 8Fr. | 5, 6.5 and 8Fr. | Same |
| Feeding
Connector
Materials | Polyvinyl Chloride (PVC)-
Orange colorant | Polyurethane-Orange
colorant
Polyurethane-Purple
colorant | The feeding connector
materials were tested in
accordance with ISO
10993.
The results of the 10993
biocompatibility testing
proved that the patient
contacting materials for
the proposed device have
the same toxicological,
sensitization, irritation,
and acute toxicity profile
as the previously cleared
device.
Thus, the feeding
connector materials are
substantially equivalent to
the feeding connector
materials used in the
predicate device. |
| Specification | Philips
InnerSense Esophageal
Temperature / Feeding
Tube
(Predicate Device) | Philips
InnerSense Esophageal
Temperature Probe/
Feeding Tube
(Proposed Device) | Comparison |
| Catheter
Materials | Clear Polyurethane-Orange
colorant+ ink | Clear Polyurethane-White
(TiO2)+ ink | The feeding connector
materials were tested in
accordance with ISO
10993.
The results of the 10993
biocompatibility testing
proved that the patient
contacting materials for
the proposed device have
the same toxicological,
sensitization, irritation,
implantation, and acute
toxicity profile as the
previously cleared device.
Thus, the feeding
connector materials are
substantially equivalent to
the feeding connector
materials used in the
predicate device. |
| Distal tip | One lateral eye, one end eye
in catheter tip | 2 offset lateral eyes, closed
catheter tip | The distal tip was tested
in accordance with EN
1615 and ISO 80601-2-
56.
The results of EN 1615
testing proved that the
distal tip attributes of the
proposed device
exhibited equivalent
tensile strength properties
to that of the predicate
device.
Performance testing
results proved that the
proposed device
performance was
equivalent to that of the
predicate device.
All tests passed, thus the
revised distal tip is
substantially equivalent to
the predicate device. |
·
3
4
| Specification | Philips
InnerSense Esophageal
Temperature / Feeding
Tube
(Predicate Device) | Philips
InnerSense Esophageal
Temperature Probe/
Feeding Tube
(Proposed Device) | Comparison |
|--------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Temperature/
Accuracy Range | $\pm$ 0.1°C from 25°- 45°C | $\pm$ 0.1°C from 32°- 43°C, and
$\pm$ 0.2°C from 25°- 45°C | The thermistor type is
identical between the
proposed device and the
predicate device.
The minor difference in
temperature accuracy
range is due to the fact
that the predicate device
was tested in accordance
with EN 12470-4 and the
proposed device was
tested in accordance with
ISO 80601-2-56.
The proposed device was
tested and meets the
clinical accuracy range of
ISO 80601-2-56,
applicable to the
indicated patient
population, thus the
revised temperature
accuracy range is
substantially equivalent to
that of the predicate
device. |
The proposed device is considered substantially equivalent to the predicate device based on the results of the non-clinical performance tests conducted. All technological differences between the proposed device and the predicate have been evaluated through extensive verification tests (see Non-clinical Performance data section below) which concluded that the modifications to the device do not raise any new issues of safety and effectiveness.
Non-clinical Performance Data:
Extensive verification of the device modifications was conducted and successfully completed. All performance tests demonstrated that the InnerSense Esophageal Temperature Probe / Feeding Tube performed as per its intended use and is substantially equivalent to the predicate device. Bench testing was performed in accordance with the following standards in order to support the substantial equivalence determination:
| Standards |
|---|
| ISO 80601-2-56:2009 - Particular requirements for basic safety and essential performance of clinical thermometers |
| for body temperature measurement |
| EN1615: 2000- Enteral feeding catheters and giving sets for single use and their connectors- Design and Testing |
| ISO 80369-1-1: 2010- Small-bore connectors for liquid and gases in healthcare applications- Part 1: General |
| Requirements |
Philips Medical Systems InnerSense Esophageal Temperature Probe / Feeding Tube 510(k) September 16, 2013 Page 5 of 6
5
galleries and the states of the Standards of the Standards of the Market of the ાદ્ય ISO 11607-1-1: 2006- Packaging for terminally sterilized medical devices. Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 10993-5: 2009- Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
NEW YORK STATE PROGRAM EVALUATION OF MEDICAL SERVICES UNDER TITLE XIX OF THE SOCIAL SECURITY ACT
ISO 10993-6:2007 - Biological evaluation of medical devices- Part 6: Tests for local effects after implantation
ISO 10993-7: 2008- Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals ISO 10993-10:2010- Biological evaluation of medical devices--- Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11: 2006- Biological evaluation of medical devices- Part 11: Tests for systemic toxicity ISO 10993-18: 2005- Biological evaluation of medical devices-- Part 18: Chemical characterization of materials
Substantial Equivalence Conclusion
The Philips InnerSense Esophageal Temperature Probe/ Feeding Tube does not change the indications for use or the fundamental scientific technology, when compared to the legally marketed predicate device. Any differences between the proposed device and the predicate were evaluated to have no impact on the safety or effectiveness of the InnerSense Esophageal Temperature Probe / Feeding Tube and therefore it is considered substantially equivalent to the device cleared under Premarket Notification K120815.
September 16, 2013 Page 6 of 6
6
Image /page/6/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 symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 23, 2013
Philips Medical Systems % Christine Trefethen Regulatory Affairs Specialist 3000 Minuteman Road Andover, MA 01810
Re: K131590
Trade/Device Name: InnerSense Esophageal Temperature Probe/ Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: September 16, 2013 Received: September 17, 2013
Dear Christine Trefethen,
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.
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.
7
Page 2 - Christine Trefethen
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 (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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Herbert - Berner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement 5.0
510(k) Number: K131590
Device Name: InnerSense Esophageal Temperature Probe/ Feeding Tube
Indications for Use:
The InnerSense Esophageal Temperature Probe/Feeding Tube is a dual function, single-use sterile device which simultaneously provides continuous monitoring of esophageal temperature and delivers oral medications and/or enteral nutrition in neonatal and pediatric patients oro/nasogastrically, as directed by a physician for up to 30 days. The InnerSense device can be used solely for the purpose of monitoring esophageal temperature in situations where invasive monitoring is indicated.
Prescription X Use (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Po 2013.10.23 1