The InnerSense Esophageal Temperature/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 Description

Philips' InnerSense Esophageal Temperature/Feeding Tube is a disposable, single-use, sterile device designed for nasogastric placement in neonatal and 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. It should be used only under direct supervision of a licensed physician or healthcare provider, according to the hospital standard of care. Note: the temperature probe is auto-located in the distal esophagus when device is placed in accordance with the Insertion steps provided in the Application section of the IFU.

AI/ML Overview

The provided 510(k) summary for the InnerSense Esophageal Temperature / Feeding Tube ([K120815](https://www.accessdata.fda.gov/cdrh_docs/reviews/[K120815](https://510k.innolitics.com/search/K120815).pdf)) describes extensive verification of functional performance. However, it does not explicitly define specific numerical acceptance criteria with pass/fail thresholds in the same way one might find for a diagnostic algorithm's sensitivity or specificity. Instead, the document outlines categories of tests performed and attests to their successful completion.

Here's an interpretation of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of various performance tests, aligned with established medical device standards. The "reported device performance" is the statement that these tests were successfully completed.

Acceptance Criteria Category	Description (Implicit)	Reported Device Performance
Feeding Tube Attributes
Tensile Strength / Pull Cycle Testing	Device must withstand specified tensile forces and cyclic pulling without failure.	Successfully completed
Resistance to Liquid Leakage	Device must prevent liquid leakage under specified pressure.	Successfully completed
Fluid Extraction	Device must allow for appropriate fluid extraction.	Successfully completed
Temperature Sensor Attributes
Temperature Accuracy	Device must measure temperature within a specified deviation from a true value.	Successfully completed
Temperature Stability	Device's temperature measurements must remain stable over time and under conditions.	Successfully completed
General Safety and Biocompatibility
Biocompatibility (various ISO 10993)	Device materials must be biologically safe (no cytotoxicity, irritation, systemic toxicity, etc.).	Successfully completed
Electrical Safety (IEC 60601-1)	Device must meet general electrical safety requirements.	Successfully completed
Electromagnetic Compatibility (IEC 60601-1-2)	Device must operate safely in its electromagnetic environment without interference.	Successfully completed
Clinical Thermometer Performance (EN 12470-4)	Device must meet performance standards for electrical thermometers for continuous measurement.	Successfully completed
Small-bore Connectors (ISO 80369-1)	Device's connectors must meet specifications for small-bore connectors.	Successfully completed

The study that proves the device meets the acceptance criteria is the "Extensive verification of functional performance" which was "successfully completed." This verification involved subjecting the device to numerous tests as outlined above and by the listed international standards (IEC 60601-1, IEC 60601-1-2, ISO 10993 series, EN 12470-4, ISO 80369-1).

Additional Information Not Found in the Provided Text:

The provided 510(k) summary focuses on device design and in vitro performance testing against engineering standards. It does not contain information related to human user studies or AI/algorithm performance. Therefore, the following points cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable in the context of in vitro device performance verification against engineering standards. The "test set" would refer to the physical units of the device that underwent testing. The document does not specify the number of devices tested, nor does it refer to data provenance in terms of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for in vitro engineering tests is established by calibrated instrumentation and adherence to standard protocols, not by expert human interpretation in the clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for clinical endpoints or image interpretation, not for in vitro device performance tests.
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 physical medical device (temperature/feeding tube), not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnosis or interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the in vitro performance tests, the "ground truth" would be established by the reference standards and calibrated equipment used during testing (e.g., a reference thermometer for temperature accuracy, a force gauge for tensile strength).
The sample size for the training set: Not applicable. This device does not involve machine learning or a "training set."
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the engineering and biocompatibility testing of a physical medical device, not a software algorithm or AI system. As such, many of the requested criteria related to AI/algorithm evaluation are not relevant or addressed in this submission.

Summary

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K120815
Page 1 of 4

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR 0 6 2013

InnerSense Esophageal Temperature / Feeding Tube

Submitter's Name and Address

Submitter's Name:	Philips Medical Systems
Division:	PCCI - Medical Consumables and Sensors
Address:	3000 Minuteman Road
City, State, and Zip:	Andover, MA 01810

Contact Person / Submission Correspondent

Name:	Peter Schipelliti
Title:	Sr. Quality and Regulatory Manager
Telephone:	(978) 659-4744
Facsimile:	(978) 659-7712
E-mail:	peter.schipelliti@philips.com

Date of Summary

Date:

March 5, 2013

Manufacturers' Information; Establishment Registration Number.

Establishment name:	Philips Medical Systems
Address:	3000 Minuteman RoadAndover, MA 01810
Establishment Registration No.	1218950

New Device Details

Proprietary or Trade Name:	InnerSense Esophageal Temperature / FeedingTube
Common Name:	Feeding Tube / Temperature Probe
Device Class:	Class II
Device Procode:	FPD
Device CFR:	21 CFR 876.5980
Classification Panel:	Gastroenterology/Urology

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K120815
Page 3 of 4

Indication for Use

Product Description

Device Testing / Performance Data

Extensive verification of functional performance has been performed and successfully completed. The proposed device was subjected to numerous verification tests for both the feeding tube attributes and the temperature sensor attributes. Feeding tube related performance tests included tensile strength / pull cycle testing, resistance to liquid leakage under pressure and fluid extraction. Temperature sensor related tests included temperature accuracy and stability. Testing included the standards identified below:

Standards
IEC 60601-1: 1988 + A1:1991 + A2:1995- Medical Electrical Equipment Part 1: GeneralRequirements for Safety
IEC 60601-1-2: 2001+ A1:2004- Medical Electrical Equipment - Part 1-2: General Requirements forSafety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
ISO 10993-4: 2002- Biological evaluation of medical devices- Part 4: Selection of Tests forInteractions with Blood
ISO 10993-5: 2009- Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 19003-6:2007- Biological evaluation of medical devices – Part 6: Tests for Local Effects AfterImplantation
ISO 10993-10:2010- Biological evaluation of medical devices - Part 10: Tests for Irritation andDelayed-Type Hypersensitivity
ISO 10993-11: 2006- Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity
ISO 10993-17: 2002- Biological evaluation of medical devices- Part 17: Establishment of allowableLimits for Leachable Substances
ISO 10993-18: 2005- Biological evaluation of medical devices- Part 18: Chemical Characterization ofMaterials
EN 12470-4: 2000+ A1:2009- Clinical Thermometers- Part 4: Performance of ElectricalThermometers for Continuous Measurement
ISO 80369-1:2010- Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1:General requirements

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread.

Public Health Service

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

March 6, 2013

Philips Medical Systems % Mr. Peter Schipelliti Senior Quality and Regulatory Manager 3000 Minuteman Road ANDOVER MA 01810

Re: K120815

Trade/Device Name: InnerSense Esophageal Temperature / Feeding Tube Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: February 19, 2013 Received: February 22, 2013

Dear Mr. Schipelliti:

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. 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

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Page 2 - Mr. Peter Schipelliti

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The letters "P" and "L" are stylized and appear to be part of a logo or emblem. The text is horizontally oriented and appears to be a signature or title.

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

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4.0 Indications for Use Statement

DHILIDS

510(k) Number: K120815 ---

Device Name: InnerSense Esophageal Temperature / Feeding Tube

Indications for Use:

. X Prescription Use (21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

HerbertPLerner-S

vision Sign-Off) n of Reproductive. Gastro-Renal, and k) Number

Regulation Number and Section

§ 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.