DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)

K082863 · Dynarex Corporation · KNT · Jan 9, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K082863
• Device Name: DYNAREX ENTERAL DELIVERY PUMP SET WITH SPIKE (1000ML), DYNAREX ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE (1000ML)
• Applicant: Dynarex Corporation
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

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 a spike to connect to a pre-filled container. These devices are food contacting.

Device Story

Enteral feeding sets designed to deliver liquid nutrients to patients via feeding tubes. System components include tubing, bag assemblies (1000ml), spikes for pre-filled containers, and flow control clamps. Operation involves connecting the set to a nutrient source and the patient's feeding tube, utilizing either gravity or an external enteral feeding pump to regulate flow. Used in clinical or home settings to provide nutritional support. Device output is the controlled delivery of liquid nutrition. Benefits include reliable, user-controlled enteral feeding administration.

Clinical Evidence

Bench testing only. Testing included Intracutaneous Reactivity, Systemic Injection, and Muscle Implantation tests per USP Class VI, and Luer Taper Inspection per AAMI/ANSI ID54:1996/(R)2005. All tests passed.

Technological Characteristics

Materials: PVC (tubing, bags), Silicone (pump tubing), ABS (clamps, spike adapters), PE (caps). All fluid pathway materials are USP Class VI compliant. Connectivity: Standalone, manual or pump-assisted. Form factor: Tubing sets with bag/spike options. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring enteral nutrition delivery via feeding tube; compatible with gravity or pump-assisted administration of liquid nutrients.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Zevex, Inc. Enteral Feeding Sets for Gravity and Pump Use (K012147)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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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K082863.

# 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<br>parameters | Zevex, Inc.<br>(Predicate Device) | Dynarex Corporation<br>(New Device) |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Product Code | KNT | KNT |
| Intended Use<br>(Referring to entire<br>set) | "The devices in this product family are used to dispense liquid<br>nutrients (feeding solutions) at a user controlled rate. These<br>enteral feeding sets interface with the patients feeding tube and<br>may use gravity or an enteral feeding pump to dispense<br>feeding solution. The devices may include a bag to contain the<br>feeding solution and/or spike to connect to a per-filled<br>container." | Same |
| Luer Adapter | Slip Loc design, PVC<br>USP Class VI Material | Standard Adapter<br>USP Class VI Material |
| Luer Cap | Designed to fit Slip Loc, PE | Standard design fit<br>Same Material |
| Feed Tubing (All) | PVC, USP Class VI Material | Same |
| Pump Tubing<br>(Pump and Spike Set) | Silicone, USP Class VI Material | Same |
| Bag Assembly<br>(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<br>Pathway (All) | USP Class VI Material | Same |
| Spike Adapter<br>(Spike Set Only) | ABS, USP Class VI Material | Same |
| Spike Adapter Cap<br>(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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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