(145 days)
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.
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.
{
"1. A table of acceptance criteria and the reported device performance": "| Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Notes on Comparison | Status |\n|----------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|\n| **Temperature Accuracy Range:** | | | |\n| ± 0.1°C from 25°- 45°C | ± 0.1°C from 32°- 43°C | The thermistor type is identical. The minor difference in range is due to different testing standards (EN 12470-4 for predicate, ISO 80601-2-56 for proposed). The proposed device meets the clinical accuracy range of ISO 80601-2-56, applicable to the indicated patient population, and is considered substantially equivalent. | Met |\n| **Feeding Connector Materials:** | | | |\n| Polyvinyl Chloride (PVC)-Orange colorant | Polyurethane-Orange colorant; Polyurethane-Purple colorant | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met |\n| **Catheter Materials:** | | | |\n| Clear Polyurethane-Orange colorant + ink | Clear Polyurethane-White (TiO2) + ink | Tested in accordance with ISO 10993. Biocompatibility testing proved the patient-contacting materials for the proposed device have the same toxicological, sensitization, irritation, implantation, and acute toxicity profile as the previously cleared device, deemed substantially equivalent. | Met |\n| **Distal Tip:** | | | |\n| One lateral eye, one end eye in catheter tip | 2 offset lateral eyes, closed catheter tip | Tested in accordance with EN 1615 and ISO 80601-2-56. Results showed equivalent tensile strength properties to the predicate device and equivalent performance. All tests passed, deemed substantially equivalent. | Met |",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document describes bench testing and verification, not clinical studies with a test set of patient data. Therefore, this information is not applicable in this context. The testing involved materials and performance criteria based on ISO and EN standards.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The ground truth for the performance testing was established by adherence to recognized international standards (e.g., ISO, EN) for medical device evaluation, rather than expert consensus on a test set of cases.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The device's performance was evaluated through bench testing against established standards, not through clinical adjudication by experts on a test set.",
"5. 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": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (esophageal temperature probe/feeding tube), not an AI diagnostic or assistance tool that would involve human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This device is a physical medical device and does not involve an algorithm for standalone performance evaluation.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the device's performance was established through adherence to recognized international standards for medical devices, specifically: \n- **ISO 80601-2-56:2009** for clinical thermometers.\n- **EN1615: 2000** for enteral feeding catheters.\n- **ISO 80369-1-1: 2010** for small-bore connectors.\n- **ISO 11607-1-1: 2006** for packaging.\n- **ISO 10993 series** for biological evaluation (cytotoxicity, local effects, residuals, irritation, systemic toxicity, chemical characterization).",
"8. The sample size for the training set": "Not applicable. This device is a physical medical device, not a machine learning or AI model that requires a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This device is a physical medical device and does not involve a training set."
}
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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 RoadAndover, 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
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| Classification Panel: | Gastroenterology/Urology |
|---|---|
| Classification Name: | Gastrointestinal tube and accessories |
Predicate Device Details
| 510(k) Number | K120815 |
|---|---|
| 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 |
| 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:
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| Specification | PhillipsInnerSense EsophagealTemperature / FeedingTube(Predicate Device) | PhillipsInnerSense EsophagealTemperature Probe/Feeding Tube(Proposed Device) | Comparison |
|---|---|---|---|
| Indications forUse | Dual function, single-usesterile device whichsimultaneously providescontinuous monitoring ofesophageal temperature anddelivers oral medicationsand/or enteral nutrition inneonatal and pediatricpatients oro/nasogastrically,as directed by a physician forup to 30 days. TheInnerSense device can beused solely for the purpose ofmonitoring esophagealtemperature in situationswhere invasive monitoring isindicated. | Dual function, single-usesterile device whichsimultaneously providescontinuous monitoring ofesophageal temperature anddelivers oral medicationsand/or enteral nutrition inneonatal and pediatricpatients oro/nasogastrically,as directed by a physicianfor up to 30 days. TheInnerSense device can beused solely for the purposeof monitoring esophagealtemperature in situationswhere invasive monitoring isindicated. | Same |
| LumenConstruction | 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 |
| FeedingConnectorMaterials | Polyvinyl Chloride (PVC)-Orange colorant | Polyurethane-OrangecolorantPolyurethane-Purplecolorant | The feeding connectormaterials were tested inaccordance with ISO10993.The results of the 10993biocompatibility testingproved that the patientcontacting materials forthe proposed device havethe same toxicological,sensitization, irritation,and acute toxicity profileas the previously cleareddevice.Thus, the feedingconnector materials aresubstantially equivalent tothe feeding connectormaterials used in thepredicate device. |
| Specification | PhilipsInnerSense EsophagealTemperature / FeedingTube(Predicate Device) | PhilipsInnerSense EsophagealTemperature Probe/Feeding Tube(Proposed Device) | Comparison |
| CatheterMaterials | Clear Polyurethane-Orangecolorant+ ink | Clear Polyurethane-White(TiO2)+ ink | The feeding connectormaterials were tested inaccordance with ISO10993.The results of the 10993biocompatibility testingproved that the patientcontacting materials forthe proposed device havethe same toxicological,sensitization, irritation,implantation, and acutetoxicity profile as thepreviously cleared device.Thus, the feedingconnector materials aresubstantially equivalent tothe feeding connectormaterials used in thepredicate device. |
| Distal tip | One lateral eye, one end eyein catheter tip | 2 offset lateral eyes, closedcatheter tip | The distal tip was testedin accordance with EN1615 and ISO 80601-2-56.The results of EN 1615testing proved that thedistal tip attributes of theproposed deviceexhibited equivalenttensile strength propertiesto that of the predicatedevice.Performance testingresults proved that theproposed deviceperformance wasequivalent to that of thepredicate device.All tests passed, thus therevised distal tip issubstantially equivalent tothe predicate device. |
·
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| Specification | PhilipsInnerSense EsophagealTemperature / FeedingTube(Predicate Device) | PhilipsInnerSense EsophagealTemperature 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 isidentical between theproposed device and thepredicate device.The minor difference intemperature accuracyrange is due to the factthat the predicate devicewas tested in accordancewith EN 12470-4 and theproposed device wastested in accordance withISO 80601-2-56.The proposed device wastested and meets theclinical accuracy range ofISO 80601-2-56,applicable to theindicated patientpopulation, thus therevised temperatureaccuracy range issubstantially equivalent tothat of the predicatedevice. |
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 thermometersfor 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: GeneralRequirements |
Philips Medical Systems InnerSense Esophageal Temperature Probe / Feeding Tube 510(k) September 16, 2013 Page 5 of 6
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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
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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.
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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
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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
§ 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.