(162 days)
Not Found
No
The description focuses on the mechanical design and safety features of the feeding tube system, with no mention of AI or ML.
No
The device is described as an enteral feeding system, which delivers nutrients rather than providing therapy for a disease or condition.
No
The device description indicates it is a feeding system for enteral feeding, not for diagnosing medical conditions.
No
The device description clearly states it is a "complete system of feeding tubes and accessories" made of physical materials like PVC, Polyurethane, and Silicone, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "nasogastric/oralgastric enteral feeding." This is a process of delivering nutrition directly into the stomach or small intestine, which is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on the physical components of a feeding tube system (tubes, connectors) and their function in delivering substances into the body. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In summary, the Nutrisafe 2 system is designed for delivering substances into the body for nutritional support, which falls under the category of a medical device for therapeutic use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
Product codes
FPD
Device Description
The Nutrisafe 2 is a complete system of feeding tubes and accessories. The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the Nutrisafe 2 is that it does not change the technique of the end-user, and therefore it does not require any special training.
The Nutrisafe 2 consists of the following:
Feeding Tubes (Reference: 361.xxx, 362.xxx, 363.xxx, 1361.xxx, 1362.xxx, 1363.xxx, 2332.xxx2395.xxx)
Syringes and Syringe Accessories (Reference: 1015.xxx, 818.xxx, 828.xxx)
Accessories (Reference: 368.xxx, 5802.xx)
Sampling Devices (Reference: 821.xxx, 817.xxx)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasogastric/Oralgastric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nutrisafe (K991918/ K003311), Vygon Enteral Nutrition Tube (K820176)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510K Summary
SEP 1 5 2006
Date of Preparation: March 28, 2006
| Applicant: | Vygon Corporation
2495 General Armistead Ave.
Norristown, PA 19403 |
|------------------------|--------------------------------------------------------------------------|
| Contact Individual: | Courtney Smith, Regulatory Affairs Manager
610-539-9300 Ext. 110 |
| Trade Name: | Nutrisafe 2 |
| Common Name: | Feeding tube |
| Regulation Number: | 876.5980 |
| Product Code: | FPD |
| Classification Name: | Gastrointestinal tube and accessories devices |
| Classification: | Class II |
| Predicate Device Name: | Nutrisafe (K991918/ K003311), Vygon Enteral Nutrition Tube (K820176) |
The Nutrisafe 2 is a complete system of feeding tubes and accessories. Device Description: The feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. A recent report in the FDA Patient Safety News: Show #46, December 2005, discussed the risks associated with health care personnel mistakenly connecting the wrong devices to the wrong luer connection. Often, this kind of error can result in fatal results. One of the benefits of the Nutrisafe 2 is that the connection does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system. The Nutrisafe 2 feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the Nutrisafe 2 is that it does not change the technique of the end-user, and therefore it does not require any special training.
1
K060944
page 2 of 2
The Nutrisafe 2 consists of the following:
| Description | Reference |
|---|---|
| Feeding Tubes | 361.xxx, 362.xxx, 363.xxx, 1361.xxx, 1362.xxx, |
| 1363.xxx, 2332.xxx2395.xxx | |
| Syringes and Syringe | |
| Accessories | 1015.xxx, 818.xxx, 828.xxx |
| Accessories | 368.xxx, 5802.xx |
| Sampling Devices | 821.xxx, 817.xxx |
For nasogastric/oralgastric enteral feeding, incorporating safety connectors Intended Use: which eliminates the risk of IV administration through the feeding tube
Technology Characteristics: The Nutrisafe 2 feeding tubes are available in several configurations and in three materials: DEHP-free PVC, Polyurethane, and Silicone. Additional the feeding system contains a unique connection does not incorporate a luer. The locking connection eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections.
Summary of Design Control Activities:
Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic. Performance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.
Conclusion:
The only changes between the predicate device (Nutrisafe K003311 / K991918) and the Nutrisafe 2 is the use of DEHP-free PVC and the unique non-luer connection. The only difference between the predicate device (Enteral Nutrition Tube K820176) is the additional sizes and the unique non-luer connection. Biocompatibility testing, performance testing and risk assessment demonstrate that the Nutrisafe 2 meets manufacturers specifications.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue NORRISTOWN PA 19403
SEP 1 6 2006
Re: K060944
Trade/Device Name: Nutrisafe 2 Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Dated: September 8, 2006 Received: September 8, 2006
Dear Ms. Smith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in the center. The text is written in a decorative font.
3
Page 2 –
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
1f you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.
Sincerely yours.
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Nutrisafe 2
Indications For Use:
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rat. A. Pearson
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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