DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE

K012147 · Zevex, Inc. · KNT · Nov 2, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012147
• Device Name: DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
• Applicant: Zevex, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Special
• 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 solution) at a controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a spike to connect to a pre-filled container.

Device Story

Enteral feeding sets facilitate delivery of liquid nutrients to patients via feeding tubes; sets connect to pre-filled containers via spike; operation via gravity or external enteral feeding pump. Modifications include 'Slip Loc' enteral adapter design, new USP Class VI base materials, and integrated anti-free-flow fitting for pump models. Anti-free-flow fitting automatically prevents flow when set is removed from pump. Used in clinical or home settings; operated by healthcare professionals or caregivers. Output is controlled flow of nutritional solution to patient. Benefits include accurate nutrient delivery and prevention of free-flow incidents.

Clinical Evidence

Bench testing only. Testing included volumetric accuracy, blow-by pressure of the anti-free-flow fitting, bond strength between components, and cytotoxicity testing for biocompatibility of new materials.

Technological Characteristics

Materials: USP Class VI polymers. Components: 'Slip Loc' enteral adapter, anti-free-flow fitting, tubing, spike. Connectivity: None (mechanical). Sterilization: Non-sterile. Operation: Gravity or pump-assisted flow control.

Indications for Use

Indicated for patients requiring enteral nutrition delivery via feeding tube, utilizing either gravity-fed 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

• Infusion pump, enteral, external (K954735)
• Enteral Feeding Sets for Gravity and Pump Use (K862489)

Submission Summary (Full Text)

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K012147
Page 1 of 2

NOV 2 2001

## 510(K) SUMMARY FOR K012147

ZEVEX
INCORPORATED

10/03/2001

Submitter ZEVEX, Inc. 4314 ZEVEX Park Lane Salt Lake City, UT 84123 [phone] Contact: Susan Schmidt

Trade Name: ZEVEX, Inc, Enteral Feeding Sets for Gravity and Pump Use Common Name: Enteral Feeding Sets for Gravity and Pump Use Classification Name: Tubes, Gastrointestinal (and Accessories)

#### K954735 Infusion pump, enteral, external Predicates: (disposable sets were included as accessories) K862489 Enteral Feeding Sets for Gravity and Pump Use

The devices in this product family are used to dispense liquid nutrients (feeding solution) at a The devices in this product failing sets interface with the patient's feeding tube and may use controlled rate. Theose literal rooms dispense feeding solution. The devices may include a use gravity of an onterarresting paint on a spike to connect to a pre-filled container.

## Summary of Device Comparision:

| New Device Models: | |
|--------------------------------------------------|-----------|
| Spike Pump Set | S0010 |
| Spike Pump Set with Anti Free Flow Fitting | 2L8018-AF |
| 500 ml Bag Pump Set | S0500 |
| 500 ml Bag Pump Set with Anti Free Flow Fitting | 2L0500-AF |
| 1200 ml Bag Pump Set | S1200 |
| 1200 ml Bag Pump Set with Anti Free Flow Fitting | 2L8020-AF |
| 1200 ml Bag Gravity Set | 2L8001 |
| 300 ml Intermittent Feeding Gravity Set | 2L8050 |
| | |

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Image /page/1/Picture/1 description: The image shows the logo for ZEVEX INCORPORATED. The word "ZEVEX" is in large, bold, black letters. Below it, the word "INCORPORATED" is in smaller, black letters.

#### 510(K) SUMMARY FOR K012147 (continued)

| Model | Comparison Criteria | Modified Device | Predicate Device |
|----------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| All | Enteral Adapter | 'Slip Loc' design<br>New Base Material, USP Class VI | Original design<br>Original Base Material,<br>USP Class VI |
| All | Cap, Enteral Adapter | Designed to fit 'slip loc' enteral adapter<br>Same Base Material | Designed to fit original enteral adapter<br>Same Base Material |
| All anti free flow models | Pump Fitting | Anti Free Flow Fitting<br>New Base Material, USP Class VI | Pinch Clip Occluder anti free flow device<br>Original Base Material, USP Class VI |
| 500 ml Bags,<br>300 ml intermittent<br>gravity set | Bag Assembly | Smaller surface area<br>Same material | 1200 ml (larger surface area)<br>Same material |
| All | All other components | Same | Same |
| All | Intended Use | Same | Same |
| All | Biocompatibility of<br>final product | Only material changes are 'slip loc' enteral adapter and anti free flow fitting. Both new materials are USP Class VI and colorants are approved by FDA for food grade applications. | Original materials were USP class VI. |
| All | Sterilization | Not sterile | K954735 disposable sets are<br>not sterile |
| All | Labeling | Added additional pump and gravity set use information<br>Added anti free flow information<br>(where applicable) | Referenced pump procedures |

The anti free flow device, in the new models, consists of a tubing fitting which has been modified to include an anti free flow feature, which automatically prevents flow when the set is removed from the pump. Testing included a volumetric accuracy test, a test to check the blow by pressure of the anti free flow fitting, a bond test to check the bond strength between components, and a cytotoxicity test to check the biocompatibility of the new materials. The test results indicated that the modifications have not reduced the safety or effectiveness of the product or created new issues regarding safety or effectiveness.

44

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three birds in flight, arranged in a stacked formation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 0 2 2001

Ms. Susan P. Schmidt Regulatory Affairs Manager ZEVEX®, Inc. 4314 ZEVEX Park Lane SALT LAKE CITY UT 84123 Re: K012147

Trade/Device Name: ZEVEX® 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: 78 KNT Dated: October 3, 2001 Received: October 4, 2001

Dear Ms. Schmidt:

We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 910(x) premailer is substantially equivalent (for the indications referenced above and nave decembed the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Amendments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been recassified in accordance with as persuisions of the Act. The and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, therefore, market the device, subject to uirements for annual registration, listing of the and general controls provisions of the rict mercise requirement of the management misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (SCC above) and entines regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affectives it may be subject to additional controls. Little 21, Parts 800 to 898. In addition, FDA may found in the Code of Fouch Regarments your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a but cevice complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decommanding and regulations administered by other Federal and light or any Federal Statutes and regulations and limited to: registration and listing comply with all the Act 3 requirements, meaths; good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the ologtrop (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of 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 11 you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012147

Page_12of_23

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Enteral Feeding Sets for Gravity and Pump Use Device Name:_

Indications For Use:

NOV 0 2 2001

The devices in this product family are used to dispense liquid nutrients (feeding solution) at a The devices in this product family are assures with the patient's feeding tube and user controlled rate. These enteral feeding pump to dispense feeding solution. The devices may inay use gravity of an enteral revealing polution and/or a spike to connect to a pre-filled container.

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices K012147
510(k) Number

(Optional Format 3-10-98)

*Prescription Use* ✓