(102 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic and Parameters | Acceptance Criteria (Predicate Device) | Reported Device Performance (New Device) |
|---|---|---|
| Product Code | KNT | KNT |
| Intended 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 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 (PE) |
| Feed Tubing (All) | PVC, USP Class VI Material | Same (PVC, USP Class VI Material) |
| Pump Tubing (Pump and Spike Set) | Silicone, USP Class VI Material | Same (Silicone, USP Class VI Material) |
| Bag Assembly (Gravity & Pump Set) | 500 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Bag Assembly (Gravity & Pump Set) | 1200 ml, PVC, USP Class VI Material | 1000ml, PVC |
| Clamp (All) | ABS | Same (ABS) |
| Materials in Fluid Pathway (All) | USP Class VI Material | Same (USP Class VI Material) |
| Spike Adapter (Spike Set Only) | ABS, USP Class VI Material | Same (ABS, USP Class VI Material) |
| Spike Adapter Cap (Spike Set Only) | PE | Same (PE) |
| Performance Tests | ||
| Intracutaneous Reactivity Test | Class VI USP (Pass) | Passes |
| Systemic Injection Test | Class VI USP (Pass) | Passes |
| Muscle Implantation Test | Class VI USP (Pass) | Passes |
| Luer Taper Inspection | AAMI/ANSI ID54.1996/(R)2005 Sect. 4.1 & 4.2 (Pass) | Passes |
| Erythema and Edema Scores | Meets requirements | Meets requirements |
| Physical Specifications and Dimensions | Meets requirements | Meets requirements |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a separate "test set" in the sense of a clinical or image-based dataset. The testing described focuses on material properties and physical conformance.
- Sample Size for testing: Not explicitly stated for each test (e.g., number of devices tested for Luer taper inspection). However, it implies testing was conducted on samples of the Dynarex Enteral Feeding Sets.
- Data Provenance: The testing was conducted by Dynarex Corporation to demonstrate substantial equivalence to the predicate device. The document does not specify a country of origin for the data beyond Dynarex being a US-based company, and the nature of the tests suggests laboratory or bench testing rather than patient data. It is therefore prospective with respect to the device's design and testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a medical device clearance based on substantial equivalence to a predicate device, primarily through material and functional characteristic comparison, and safety testing (biocompatibility, physical standards). It does not involve expert interpretation of medical images or patient outcomes in the way an AI/ML device would.
4. Adjudication Method for the Test Set
Not applicable. See point 3.
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
Not applicable. This is not an AI/ML device, nor does it involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on established industry standards and validated test methods for material biocompatibility (Class VI USP) and physical performance (AAMI/ANSI ID54.1996/(R)2005). The comparison is also made against the specifications and performance of the legally marketed predicate device (Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use K012147), which serves as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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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.
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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 andparameters | Zevex, Inc.(Predicate Device) | Dynarex Corporation(New Device) |
|---|---|---|
| Product Code | KNT | KNT |
| Intended Use(Referring to entireset) | "The devices in this product family are used to dispense liquidnutrients (feeding solutions) at a user controlled rate. Theseenteral feeding sets interface with the patients feeding tube andmay use gravity or an enteral feeding pump to dispensefeeding solution. The devices may include a bag to contain thefeeding solution and/or spike to connect to a per-filledcontainer." | Same |
| Luer Adapter | Slip Loc design, PVCUSP Class VI Material | Standard AdapterUSP Class VI Material |
| Luer Cap | Designed to fit Slip Loc, PE | Standard design fitSame 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 FluidPathway (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.
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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.
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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
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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
§ 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.