Who is the manufacturer of INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE?

Philips Medical Systems filed the 510(k) submission for INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE (K131590).

What is the FDA product code for INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE?

FPD. It is classified under 21 CFR 876.5980 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE?

InnerSense Esophageal Temperature / Feeding Tube (K120815).

Who can help prepare an FDA 510(k) submission like INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE

K131590 · Philips Medical Systems · FPD · Oct 23, 2013 · Gastroenterology, Urology

Device Facts

Record ID	K131590
Device Name	INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE
Applicant	Philips Medical Systems
Product Code	FPD · Gastroenterology, Urology
Decision Date	Oct 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5980
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

Single-use, sterile, dual-lumen nasogastric/orogastric tube; integrates Series 400 thermistor for continuous esophageal temperature monitoring with enteral feeding/medication delivery lumen. Used in neonatal and pediatric clinical settings; operated by physicians or healthcare providers. Connects to compatible patient monitors and enteral giving sets/syringes. Provides real-time temperature data to clinicians to support patient thermal management; enables enteral nutrition delivery. Benefits include simultaneous monitoring and feeding, reducing need for multiple invasive devices.

Clinical Evidence

Bench testing only. Verification included biocompatibility (ISO 10993-5, -6, -7, -10, -11, -18), mechanical performance (EN 1615, ISO 80369-1-1), and temperature accuracy (ISO 80601-2-56). All tests met specifications.

Technological Characteristics

Dual-lumen catheter; materials: polyurethane with TiO2 and ink; Series 400 thermistor; diameters: 5, 6.5, 8Fr; EtO sterilization; 2 offset lateral eyes with closed tip; connectivity: wired to patient monitor; temperature accuracy: ±0.1°C (32°-43°C), ±0.2°C (25°-45°C).

Indications for Use

Indicated for neonatal and pediatric patients requiring continuous esophageal temperature monitoring and/or enteral nutrition/medication delivery via oro/nasogastric route for up to 30 days.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

InnerSense Esophageal Temperature / Feeding Tube (K120815)

Related Devices

K120815 — INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE · Philips Medical Systems · Mar 6, 2013
K110956 — MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR · Medivance, Inc. · Jul 18, 2011
K180742 — EnsoETM · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · May 17, 2018
K172029 — EnsoETM · Attune Medical · Jan 5, 2018
K180244 — EnsoETM · Advanced Cooling Therapy, Inc. D/B/A Attune Medical · Feb 28, 2018

Submission Summary (Full Text)

{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

INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

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