(274 days)
No
The device description and performance studies focus on physical attributes and connection mechanisms, with no mention of AI or ML.
No
This device is an adaptor for connecting administration sets and feeding tubes, and its function is limited to enabling fluid transfer for enteral nutrition rather than directly treating or mitigating a disease.
No
The device is an adaptor for connecting enteral feeding tubes and administration sets, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical adaptor for connecting medical tubes, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "enteral use only" and describes its function as a connector between feeding tubes and administration sets. This relates to delivering substances into the digestive tract, not analyzing samples from the body to diagnose conditions.
- Device Description: The description reinforces its role as a connector for enteral feeding.
- Performance Studies: The performance studies focus on physical attributes, device performance (leakage, strength, flow), and biocompatibility. These are typical tests for medical devices that interact with the body or deliver substances, but not for IVDs which analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Nutrisafe 2 – ENFit adaptor does not fit this description.
N/A
Intended Use / Indications for Use
The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.
Product codes
PIO
Device Description
The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Non-clinical verification of Nutrisafe 2 - ENFit Adaptor was conducted through bench testing. Testing confirmed physical attributes and device performance meet the requirements of standards performance and biocompatibility. Nutrisafe 2 - ENFit Adaptor passed biocompatibility testing including cytotoxicity, sensitization and intracutaneous injection, performed in accordance with ISO 10993. Testing also confirmed device performance meets the requirements including dimensional analysis, fluid leakage, stress cracking, resistance to separation from axial load and unscrewing, resistance to overriding, disconnection by unscrewing, flow testing and misconnection risk analysis. Results of this testing indicate that the Nutrisafe 2 – ENFit Adaptor meets all specifications and intended use.
Key Metrics
Not Found
Predicate Device(s)
Cedic Enteral Distal End Transition Connector, K140581
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Vygon Jillian Mikovich Regulatory Affairs Manager 2750 Morris Road, Suite A200 Lansdale, PA 19446
Re: K151237
Trade/Device Name: Nutrisafe 2 - ENFit Adaptor Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIO Dated: January 4, 2016 Received: January 7, 2016
Dear Jillian Mikovich,
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.
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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 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/ResourcesforYou/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 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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Indications for Use
510(k) Number (if known) K151237
Device Name Nutrisafe 2 - ENFit Adaptor
Indications for Use (Describe)
The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.
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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PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR §807.92)
| 510k number: | K151237 |
|---|---|
| Applicant: | Vygon |
| 2750 Morris Road, Suite A200 | |
| Lansdale, PA 19446 | |
| Contact Name: | Jillian Mikovich |
| Manager, Regulatory Affairs | |
| Phone: 800-473-5414 | |
| Fax: 215-672-6740 | |
| Trade Name: | Nutrisafe 2 – ENFit Adaptor |
| Common Name: | Enteral Specific Transition Connector |
| Regulation Number: | 876.5980 |
| Product Code: | PIO |
| Classification Name: | Enteral Specific Transition Connector, 21 CFR §876.5980 |
| Regulatory Class: | Class II |
| Predicate Device: | Cedic Enteral Distal End Transition Connector, K140581 |
| Date Prepared: | May 7, 2015 |
Device Description:
The Nutrisafe 2 – ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end. Vygon has not previously submitted any 510(k)s for the subject device.
Intended Use:
The Nutrisafe 2 - ENFit adaptor is indicated for enteral use only. It enables the connection between an administration set equipped with a female ENFit connector at its distal end and a Nutrisafe 2 feeding tube equipped with a male Nutrisafe 2 connector at its proximal end.
Technology Characteristics:
The subject device allows for connection to the Nutrisafe 2 feeding system while the predicate device will allow connection to a funnel connector. The difference in technological characteristics does not diminish the substantial equivalence to the predicate device.
Non-Clinical Summary:
Non-clinical verification of Nutrisafe 2 - ENFit Adaptor was conducted through bench testing. Testing confirmed physical attributes and device performance meet the requirements of standards performance and biocompatibility. Nutrisafe 2 - ENFit Adaptor passed biocompatibility testing including cytotoxicity, sensitization and intracutaneous injection,
4
performed in accordance with ISO 10993. Testing also confirmed device performance meets the requirements including dimensional analysis, fluid leakage, stress cracking, resistance to separation from axial load and unscrewing, resistance to overriding, disconnection by unscrewing, flow testing and misconnection risk analysis. Results of this testing indicate that the Nutrisafe 2 – ENFit Adaptor meets all specifications and intended use.
Conclusion:
Given the testing mentioned above, the subject device, Nutrisafe 2 – ENFit Adaptor is as safe, as effective and performs as well as the legally marketed predicate device, Cedic Enteral Distal End Transition Connector.