(352 days)
Not Found
Not Found
No
The summary describes a physical device for temperature monitoring and feeding, with no mention of AI or ML in its function or performance studies.
Yes
The device provides continuous monitoring of esophageal temperature, which is a diagnostic function, and delivers oral medications and/or enteral nutrition, which are therapeutic functions.
No
The device is primarily a monitoring and delivery device, providing continuous esophageal temperature monitoring and delivering oral medications or enteral nutrition. While monitoring can be part of diagnostics, the core function described doesn't involve diagnosing a specific condition or disease, but rather observing a physiological parameter (temperature) and facilitating treatment (medication/nutrition delivery).
No
The device description clearly states it is a "dual function, single-use sterile device" and a "disposable, single-use, sterile device" designed for physical placement, indicating it is a hardware device with a temperature sensor and feeding tube.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, disease, or congenital abnormality.
- This device is placed within the patient's body (esophagus) to monitor temperature and deliver substances. It is not analyzing a sample taken from the patient.
The device's function is primarily therapeutic (feeding, medication delivery) and monitoring (temperature), which falls under the category of medical devices used in vivo (within the living body), not in vitro (in glass, referring to laboratory testing).
N/A
Intended Use / Indications for Use
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.
Product codes
FPD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, oro/nasogastrically
Indicated Patient Age Range
neonatal and pediatric patients
Intended User / Care Setting
licensed physician or healthcare provider, according to the hospital standard of care.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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 Road |
Andover, MA 01810 | |
Establishment Registration No. | 1218950 |
New Device Details
| 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 |
1
K120815
Page 3 of 4
Indication for Use
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.
Product 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.
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: General |
Requirements for Safety |
IEC 60601-1-2: 2001+ A1:2004- Medical Electrical Equipment - Part 1-2: General Requirements for |
Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests |
ISO 10993-4: 2002- Biological evaluation of medical devices- Part 4: Selection of Tests for |
Interactions 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 After |
Implantation |
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 10993-17: 2002- Biological evaluation of medical devices- Part 17: Establishment of allowable |
Limits for Leachable Substances |
ISO 10993-18: 2005- Biological evaluation of medical devices- Part 18: Chemical Characterization of |
Materials |
EN 12470-4: 2000+ A1:2009- Clinical Thermometers- Part 4: Performance of Electrical |
Thermometers for Continuous Measurement |
ISO 80369-1:2010- Small-bore Connectors for Liquids and Gases in Healthcare Applications - Part 1: |
General requirements |
2
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
3
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
4
4.0 Indications for Use Statement
DHILIDS
510(k) Number: K120815 ---
Device Name: InnerSense Esophageal Temperature / Feeding Tube
Indications for Use:
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.
. 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