(250 days)
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
The Nutrisafe 2 Feeding Tube's acceptance criteria and the study proving its performance are detailed below. It's important to note that this device is a medical device, and the provided text from a 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing, rather than a clinical study with human subjects, AI systems, or extensive statistical performance metrics typically found for diagnostic or AI-driven medical devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain material specifications after formulation change | Meets all specifications |
| Maintain intended use after material formulation change | Meets intended use |
| Reduce risk of inadvertent connection to IV administration sets or other medical delivery systems due to unique connection system | Unique connection reduces the risk of inadvertent connection |
| Reduce risk of involuntary disconnection | Voluntary disconnection achieved by simply unscrewing hub connections |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size in terms of the number of feeding tubes or components used for the non-clinical bench testing. It broadly states that "Non-Clinical verification... was conducted through in-vitro bench testing."
- Data Provenance: The data is from in-vitro bench testing, meaning it was conducted in a laboratory setting. The country of origin for the data is not explicitly stated, but the submission is to the US FDA, implying the tests were conducted either by the applicant (Vygon Corp. in Montgomeryville, PA, USA) or a certified laboratory for the purpose of US market approval. The testing is retrospective in the sense that it evaluates the performance of the manufactured device in a controlled environment as part of the market submission process, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the provided information describes non-clinical bench testing of a physical medical device, not a diagnostic or AI-driven system requiring expert-established ground truth from images or clinical data. The "ground truth" here is determined by engineering specifications and physical measurements, and the conformity to these is assessed by technical personnel.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on a diagnosis or interpretation, which is not relevant to the described non-clinical bench testing.
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 section is not applicable. The provided document is for a physical medical device (feeding tube) and does not involve AI assistance, human readers, or image interpretation. Therefore, an MRMC study or effect size calculation with AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical feeding tube, not an algorithm or software. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The ground truth used for this premarket notification is based on engineering specifications and intended use requirements. The non-clinical bench testing verified that the Nutrisafe 2 Feeding Tube, despite a change in silicone material formulation, continued to meet these established specifications and its intended use, which includes safety features related to connection types.
8. The Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of this device's non-clinical verification. Training sets are relevant for machine learning algorithms, which are not part of this submission. Device manufacturers conduct design and development activities where prototypes might be tested, but this is distinct from an "AI training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for this device.
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Nutrisafe 2 Feeding Tubes Premarket Notification 510(k) Submission
510(k) SUMMARY DEC 1 8 2012 (As Required By 21 CFR §807.92) -K121105 510k number: Vygon Applicant: 103A Park Dr Montgomeryville, PA 18936 Jillian Mikovich Contact Name: Regulatory Affairs Specialist Phone: 800-473-5414 Fax: 215-672-6740 Nutrisafe 2 Feeding Tube Trade Name: Tubes, Feeding Common Name: 876.5980 Regulation Number: FPD Product Code: Gastrointestinal tube and accessories devices, 21 CFR §876.5980 Classification Name: Class II Regulatory Class: Nutrisafe 2 Feeding Tubes, K060944 Predicate Devices: Nutrisafe 2 Feeding Tubes, K100163 June 14, 2012 Date Prepared:
Device Description:
Device Description.
The Nutrisafe 2 silicone feeding tubes are utilizing a different formulation of silicone material I he Nutrisate 2 silicone feeding tubes. The feeding tubes. The feeding tubes are available in several than the catisting Nutrioure is a unique connection does not incorporate a luer, reducing SIZCS, and the leveling system connains an IV administration set or other medical delivery the fisk of madvertenity connection reduces the risk of involuntary disconnection; voluntary systems: "The is achieved by simply unscrewing the hub connections.
Intended Use:
For nasogastric oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Technology Characteristics:
The subject Nutrisafe 2 feeding tubes have the same technological characteristics of the predicate I he subject Natible = 100cmg asteristics are substantially equivalent to the predicate devices.
Non-Clinical Summary:
Non-Clinical verification of Nutrisafe 2 Feeding Tubes was conducted through in-vitro bench testing. Results of this testing indicate that the Nutrisafe 2 Feeding Tube material change meets all specifications and intended use.
14 June 2012
PREMARKET NOTIFICATION
14 June 201
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with healthcare and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2012
Vygon Corp. % Ms. Jillian Mikovich Regulatory Affairs Specialist . 103A Park Drive MONTGOMERYVILLE PA 18936
Re: K121105
Trade/Device Name: Nurisafe 2 Feeding Tube Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: December 12, 2012 Received: December 13, 2012
Dear Ms. Mikovich:
We have reviewed vour 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 - Ms. Jillian Mikovich
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/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,
Benjamin R. Fisher -S
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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Nutrisafe 2 Feeding Tubes Premarket Notification 510(k) Submission 14 June 2012
Indications for Use
510(k) Number (if known):
Device Name:
Indications For Use:
Nutrisafe 2 Feeding Tube
For nasogastric/oralgastric enteral feeding, incorporating safety connectors which reduce the risk of misconnections between feeding tubes and intravenous connectors.
Prescription Use _ X
AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fjisher -S 2012.12.18 1/3:56:49 -05'00'
Division Sign-Off) Division of Reproductive, Gastro-Renal, a urological Devices 510(k) Number
Page 1 of
§ 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.