(162 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.
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.
The provided 510(k) summary for the Nutrisafe 2 describes a medical device, not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria, ground truth, and studies for AI/algorithm performance are not applicable.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritant and non-toxic | "Biocompatibility testing of the material demonstrates that it is non-irritant and non-toxic." |
| Performance: No adverse effect on safety/efficacy due to changes | "Performance testing demonstrates that the changes do not affect safety or efficacy." |
| Risk Assessment (ISO 14971 compliance) | "Risk Assessment was conducted in compliance with ISO 14971." |
| Elimination of risk of IV administration through feeding tube | The device's design "does not incorporate a luer, and thus eliminating the risk of inadvertently connecting the system to an IV system." This is a fundamental design characteristic and the basis for its intended use and a key benefit over predicate devices. |
| Elimination of risk of involuntary disconnection | The device features "a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections." This is a fundamental design characteristic. |
| No change in end-user technique; no special training required | "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." This is a claim made about user interaction with the device. |
| Meets manufacturers specifications | "Biocompatibility testing, performance testing and risk assessment demonstrate that the Nutrisafe 2 meets manufacturers specifications." While this is a general statement, it implies various internal specifications were met. This is a common umbrella acceptance criterion for medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as the device is a physical feeding tube system, not an algorithm or AI device that relies on a test set of data. The studies conducted were physical materials and performance tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable for a physical medical device. "Ground truth" in the context of AI refers to verified labels on data. For the Nutrisafe 2, evaluations would involve standard engineering and biological testing methods.
4. Adjudication Method for the Test Set
This information is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are used in studies involving expert review of data, typically for AI performance evaluation.
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
This information is not applicable as the device is a physical feeding tube system, not an AI-assisted diagnostic or therapeutic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This information is not applicable as the device is a physical feeding tube system, not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Nutrisafe 2 is derived from physical and biological testing standards and requirements, interpreted as meeting manufacturer specifications and safety/efficacy goals. This includes:
- Biocompatibility standards: Demonstrating non-irritant and non-toxic properties.
- Performance standards: Verifying the functional aspects like the locking connection and prevention of incorrect luer connections.
- Risk assessment standards: Compliance with ISO 14971.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical feeding tube system, not an AI algorithm that requires a training set. Material and design choices are based on engineering principles and existing medical knowledge, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
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510K Summary
SEP 1 5 2006
Date of Preparation: March 28, 2006
| Applicant: | Vygon Corporation2495 General Armistead Ave.Norristown, PA 19403 |
|---|---|
| Contact Individual: | Courtney Smith, Regulatory Affairs Manager610-539-9300 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.
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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 SyringeAccessories | 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.
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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.
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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
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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
Page 1 of _ 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.