(87 days)
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector is intended to deliver liquid nutrition formula to an enteral access device (a feeding tube).
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end and a hanging ring at the other. A silicone valve is mounted in the inner lumen of the connector to reduce the risk of formula leakage. The outer lumen (spout) of the ENFit® connector is covered with a foil tamperevidence seal. The pouch is designed such that it can be provided pre-filled with Trovita Health Science acidified liquid nutrition formula for tube feeding.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically the Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector.
The request asks for information typically found in studies for AI/machine learning diagnostic devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance). However, the provided document does not describe an AI/machine learning device. Instead, it concerns a physical medical device used for delivering liquid nutrition.
Therefore, the requested information (acceptance criteria for an AI device, study design, expert involvement, etc.) cannot be extracted from this document as it pertains to a different type of medical device and regulatory process.
The document discusses "performance data" (Section 6.6) for the physical device, including:
- Risk Analysis (FMEA)
- ENFit® Connector Dimensional Analysis
- Flow Rate Analysis
- Valve Performance Testing
- Performance Testing per ISO 80369-3:2016 (e.g., Falling Drop Positive Pressure Liquid Leakage, Stress Cracking, Resistance to Separation)
- Biocompatibility Testing per ISO 10993-1:2009 (Cytotoxicity, Irritation/Intracutaneous Reactivity, Sensitization)
- Human Factors and Usability Validation
- Packaging and Shipping Testing
These are engineering and material performance tests for a physical product, not clinical validation or AI model performance studies.
Therefore, I cannot fulfill your request based on the provided input. The information you are asking for (acceptance criteria and study details for an AI-powered diagnostic device) is not present in this regulatory document about a medical nutrition delivery pouch.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
TrovRx, Inc. dba Trovita Health Science % Julie Bodmer Regulatory Consultant Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K163586
Trade/Device Name: Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PIF Dated: December 29, 2016 Received: December 30, 2016
Dear Julie Bodmer:
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
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -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
510(k) Number (if known)
Device Name
Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector
Indications for Use (Describe)
The Trovita Health Science Safe-T Feed Pouch with ENFit® Connector is intended to deliver liquid nutrition formula to an enteral access device (a feeding tube).
| Type of Use (Select one or both, as applicable) |
|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) |
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Trovita Health Science. The word "TROVITA" is in large, bold, blue letters. Below that, in smaller letters, is the phrase "HEALTH SCIENCE". Below that is an orange rectangle with the words "REDEFINING NUTRITION" in white letters. To the right of the word "TROVITA" is a circular design made up of orange dots.
510(K) SUMMARY 6.0
6.1 ADMINISTRATIVE INFORMATION
Date of Summary Preparation: 16 March 2016
6.1.1 CONTACT INFORMATION
| Submitter/Manufacturer: | TrovRx, Inc. dba Trovita Health Science230 South Broad Street17th FloorPhiladelphia, PA 19102Tel: 908-938-7534Email: info@trovitahealth.com |
|---|---|
| Primary Submission Contact: | Julie BodmerRegulatory Consultant, Libra Medical Inc.8401 73rd Ave North, Suite 63Minneapolis, MN 55428Phone: 612-910-3412Fax: 763-477-6357Email: jbodmer@libramed.com |
| Secondary Submission Contact: | Sara PetrieRegulatory Consultant, Libra Medical Inc. |
8401 73rd Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-396-9849 Fax: 763-477-6357 Email: spetrie@libramed.com
6.1.2 DEVICE INFORMATION
| Trade Name: | Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouchwith ENFit® Connector |
|---|---|
| Common Name: | Gastrointestinal Tubes with Enteral Specific Connectors |
| Classification Name: | Gastrointestinal tubes and accessories |
| Classification Regulation: | 21 CFR 876.5980 |
| Class: | II |
| Panel: | Gastroenterology and Urology |
| Product Code: | PIF |
| Prior FDA SubmissionsRelated to Subject Device: | None |
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Image /page/4/Picture/1 description: The image shows the logo for Trovita Health Science. The word "Trovita" is in large, bold, blue letters. Below that, the words "Health Science" are in smaller, gray letters. Below that, the words "Redefining Nutrition" are in a yellow box. To the right of the word "Trovita" is a cluster of orange circles.
6.2 PREDICATE DEVICE
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector is substantially equivalent to the following devices:
- K150286 Medline Enteral Feeding Sets ●
- K152857 NeoMed NeoConnect™ Enteral Syringes with ENFit® Connector ●
DEVICE DESCRIPTION 6.3
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector consists of a foil pouch with an integrated female ENFit® connector at one end and a hanging ring at the other. A silicone valve is mounted in the inner lumen of the connector to reduce the risk of formula leakage. The outer lumen (spout) of the ENFit® connector is covered with a foil tamperevidence seal. The pouch is designed such that it can be provided pre-filled with Trovita Health Science acidified liquid nutrition formula for tube feeding.
INDICATIONS FOR USE / INTENDED USE 6.4
The Trovita Health Science Safe-T Feed" Ready-to-Feed Pouch with ENFit® Connector is intended to deliver liquid nutrition formula to an enteral access device (a feeding tube).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATES 6.5
The Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector is intended to connect to male ENFit® connectors, including temporary transition sets and feeding tube administration sets. The disposable pouch is for single-patient use and is designed such that the user can connect the pouch directly to a feeding tube.
Because the device will be pre-filled with acidified liquid nutrition formula, there is no need to transfer the liquid nutrition to a syringe or feeding bag prior to feeding. The potential for spills during transfer to these intermediate devices is eliminated. The integrated valve in the connector is designed to eliminate the risk of leakage during connection to the feeding tube. The valve does not open until breached by the male ENFit® connector of the feeding tube when connected. Liquid nutrition can be administered by hanging the pouch for gravity feeding or by gently squeezing the pouch to perform a bolus feeding.
The intended use of the subject device and predicate devices are similar in that they each are single-use, disposable devices intended to provide liquid nutrition to a patient via a feeding tube. The subject device is provided non-sterile just as the Medline predicate (K150286) while the NeoMed predicate (K152857) is provided sterile. The principles of operation are the same. Each device employs a female ENFit® connector to connect directly to a male ENFit® connector on a feeding tube or extension set. The subject device differs in that the need to pre-fill the device prior to feeding is eliminated, thus reducing the risk of spills and food contamination.
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Image /page/5/Picture/1 description: The image shows the logo for Trovita Health Science. The word "TROVITA" is in large, bold, blue letters. Below that, in smaller letters, are the words "HEALTH SCIENCE". Below that is a yellow rectangle with the words "REDEFINING NUTRITION" in white letters. To the right of the word "TROVITA" is a circle made of orange dots.
6.6 PERFORMANCE DATA
The following performance testing was conducted on the Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Safety:
- Risk Analysis (FMEA) including Misconnection Assessment ●
- User Risk Analysis O
- o Risk Management Report
- ENFit® Connector Dimensional Analysis ●
- Flow Rate Analysis using commercially available enteral feed ●
- Valve Performance Testing ●
- Performance Testing per ISO 80369-3:2016 ●
- Falling Drop Positive Pressure Liquid Leakage O
- Stress Cracking O
- Resistance to Separation from Axial Load O
- Resistance to Separation from Unscrewing O
- Resistance to Overriding o
- Disconnection by Unscrewing o
- Biocompatibility Testing per ISO 10993-1:2009 ●
- Cytotoxicity o
- O Irritation / Intracutaneous Reactivity
- Sensitization o
- Human Factors and Usability Validation ●
- Packaging and Shipping Testing
6.7 SUBSTANTIAL EQUIVALENCE
The results of the performance testing listed above show that the subject device meets its specifications. Similar performance testing was conducted on the predicate devices. The subject device and predicate devices have similar intended use, technological characteristics, principles of operation, and treat a similar target population. This information along with the supporting documentation provided in this submission indicates that the subject device is substantially equivalent to the predicate devices.
6.8 CONCLUSION
The subject device and predicate devices have similar intended use and technological characteristics. The noted differences do not raise new or different questions of safety and effectiveness. Therefore, the Trovita Health Science Safe-T Feed™ Ready-to-Feed Pouch with ENFit® Connector and predicates, K150286 and K152857, are substantially equivalent.
§ 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.