(102 days)
No
The document describes a simple enteral feeding set that dispenses liquid nutrients and does not mention any AI or ML capabilities.
No
The device dispenses liquid nutrients, which is a supportive function for patient health, but it does not directly treat or cure a medical condition, nor does it affect the structure or function of the body as defined for a therapeutic device.
No
Explanation: The device is described as an enteral feeding set utilizado to dispense liquid nutrients, not to diagnose a medical condition.
No
The device description clearly states it is an "enteral feeding set" which is a physical medical device used to dispense liquid nutrients. It mentions components like bags, spikes, and interfaces with feeding tubes, all of which are hardware. The performance studies also focus on material biocompatibility and physical properties (Luer taper), further indicating a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "dispense liquid nutrients (feeding solutions)" and interfaces with a "patients feeding tube." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical function of dispensing liquid and its equivalence to a predicate device used for the same purpose.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely in vivo (within the body) for nutritional support.
N/A
Intended Use / Indications for Use
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.
Product codes
KNT
Device Description
Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Results
- Intracutaneous Reactivity Test - Class VI USP Passes
- Systemic Injection Test - Class VI USP Passes
- Muscle Implantation Test - Class VI USP Passes
- Luer Taper Inspection - AAMI/ ANSI ID54.1996/(R)2005 Sect. 4.1 & 4.2 Passes
The standards used by Dynarex Corporation to determine substantial equivalence are based on AAMI/ ANSI ID54.1996/(R)2005 and Class VI USP Methods. All testing meets requirements for erythema and edema scores, physical specifications and dimensions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
K082863
510(K) SUMMARY
JAN - 9 2009
Page 1 of 2
THIS SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF THE SAFE MEDICAL DEVICES ACT OF 1990.
Submitter
Dynarex Corporation 10 Glenshaw Street Orangeburg, NY 10962 USA Phone: 845-365-8200 Fax: 845-365-8238
Contact Person
Date of Summary
Trade Name
Common Name
Classification Name
Predicate Device
Device Description/ Comparison
Intended Use
James Hurlman
09/24/2008
Dynarex Enteral Feeding Sets for Gravity and Pump Use
Enteral Feeding Sets for Gravity and Pump Use
Gastrointestinal tube and accessories.
Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use ( K012147)
Dynarex is substantially equivalent in safety and effectiveness to the Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use in that both products have the same principles of operation, form and function and meet the same safety requirements under Class VI testing and functional Luer taper testing as required by the referenced standard.
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container.
1
510(K) SUMMARY
Page 2 of 2
Substantial Equivalence Discussion:
The Dynarex Enteral Feed Sets are substantially equivalent to the predicate devices EnteralLite line of products.
| Characteristic and
parameters | Zevex, Inc.
(Predicate Device) | Dynarex Corporation
(New Device) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Product Code | KNT | KNT |
| Intended Use
(Referring to entire
set) | "The devices in this product family are used to dispense liquid
nutrients (feeding solutions) at a user controlled rate. These
enteral feeding sets interface with the patients feeding tube and
may use gravity or an enteral feeding pump to dispense
feeding solution. The devices may include a bag to contain the
feeding solution and/or spike to connect to a per-filled
container." | Same |
| Luer Adapter | Slip Loc design, PVC
USP Class VI Material | Standard Adapter
USP Class VI Material |
| Luer Cap | Designed to fit Slip Loc, PE | Standard design fit
Same Material |
| Feed Tubing (All) | PVC, USP Class VI Material | Same |
| Pump Tubing
(Pump and Spike Set) | Silicone, USP Class VI Material | Same |
| Bag Assembly
(Gravity & Pump Set) | 500 ml, PVC, USP Class VI Material | 1000ml, PVC |
| | 1200 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Clamp (All) | ABS | Same |
| Materials in Fluid
Pathway (All) | USP Class VI Material | Same |
| Spike Adapter
(Spike Set Only) | ABS, USP Class VI Material | Same |
| Spike Adapter Cap
(Spike Set Only) | PE | Same |
Summary of Testing:
Test Results 1. Intracutaneous Reactivity Test - Class VI USP Passes 2. Systemic Injection Test - Class VI USP Passes 3. Muscle Implantation Test - Class VI USP Passes 4. Luer Taper Inspection - AAMI/ ANSI ID54.1996/(R)2005 Sect. 4.1 & 4.2 Passes
The standards used by Dynarex Corporation to determine substantial equivalence are based on AAMI/ ANSI ID54.1996/(R)2005 and Class VI USP Methods. All testing meets requirements for erythema and edema scores, physical specifications and dimensions. .
Conclusion:
Our evaluation concluded that the Dynarex family of Enteral Feeding Sets for Gravity and Pump Use are substantially equivalent to the predicate device and raise no new issues of Safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized symbol to the right and text arranged in a circle around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The symbol appears to be an abstract representation of a human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 9 2009
Mr. James Hurlman Manager, Quality Assurance & Regulatory Affairs Dynarex Corporation 10 Glenshaw Street ORANGEBURG NY 10962
K082863 Re:
Trade/Device Name: Enteral Feeding Sets for Gravity and Pump Use Regulation Number: 21 CFR §876.5980
Regulation Name: Gastrointestinal tube and accessories
Regulatory Class: II
Product Code: KNT Dated: December 23, 2008
Received: December 24, 2008
Dear Mr. Hurlman:
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 (PMA). 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.
3
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 os 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.
If 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures. 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/cdrb/industry.suppot/index.html.
Sincerely yours,
Launne D. Morris
anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
K082863 510(k) Number (if known):
Device Name(s): Enteral Feeding Sets for Gravity and Pump Use
Indications For Use:
The devices in this product family are used to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a pre-filled container. These devices are food contacting.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR .
Over-The-Counter Use (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)
Helin Rem
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number