KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS

K973409 · Davis & Geck, Inc. · KNT · Feb 27, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K973409
• Device Name: KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
• Applicant: Davis & Geck, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Feb 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kangaroo® Enteral Feeding Extension Set for Syringe Pumps is intended for enteral feeding, on the order of a physician, to provide a means of delivering feeding formula from a filled syringe through to any feeding tube which will accept its non-I.V. compatible connector.

Device Story

Kangaroo® Enteral Feeding Extension Set is a single-use PVC tubing assembly; connects filled syringe to enteral feeding tube; features non-IV compatible distal connector to prevent accidental intravenous administration. Used in clinical settings; operated by healthcare professionals. Device facilitates delivery of enteral formula from syringe to patient feeding tube. Benefits include safe, dedicated enteral delivery path; prevents medication/nutrition errors via incompatible connectors.

Clinical Evidence

Bench testing only. Testing included Biological Reactivity (USP XXIII <87>), Dermal Sensitization (ISO 10993-10.2), and Primary Mucosal Irritation (FDA GLP guidelines). No clinical data provided.

Technological Characteristics

Material: PVC. Sterilization: EtO. Features: Non-IV compatible distal connector. Form factor: Extension tubing set of varying lengths. Packaging: Tyvek/polyethylene tray.

Indications for Use

Indicated for single use enteral feedings in patients requiring enteral nutrition delivered via syringe pump.

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

• Kangaroo® Enteral Extension Set for Pumps (K914375)
• Entri-Flex® Feeding Tubes (K833621)
• Dobbhoff® Feeding Tubes (K833188)
• Entri-Flex® Feeding Tubes w/flexible weight (K801558)
• Pediatric Feeding Tubes (K822875)

Submission Summary (Full Text)

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FEB 2 7 1998

## 510k SUMMARY OF SAFETY AND EFFECTIVENESS

## Kangaroo® Enteral Extension Set for Syringe Pumps

| Submitted by: | Sherwood-Davis & Geck<br>444 McDonnell Blvd.<br>Hazelwood, MO 63042-2516 |
|---------------|--------------------------------------------------------------------------|
| Contact: | Vanada Johnson<br>Regulatory Affairs Specialist |

Date of Summary: September 5, 1997

The Kangaroo® Enteral Extension Set for Syringe Pumps is an Enteral Feeding Administration Set composed of a PVC material and is a class II device per 21 CFR Section 876.5980. Procode: 80FRN.

The Kangaroo® Enteral Extension Set for Syringe Pumps has a non-IV compatible distal connector which when connected to a syringe allows enteral formula to be administered through an enteral feeding tube. The Kangaroo® Enteral Extension Set for Syringe Pumps is indicated for single use enteral feedings .

Similarities between the proposed Kangaroo® Enteral Extension Set for Syringe Pumps and the currently marketed Kangaroo® Pump Sets are 1) both extension sets are used for administering enteral feedings, 2) both extension sets are made of PVC material, 3) both extension sets are EtO sterilized and 4) both extension sets have a non-IV compatible connector.

The differences between the proposed vs. the predicate device is 1) the proposed extension set will vary in length from the predicate device and 2) the proposed device will be packaged in a tyvek/polyethlene tray vs. a low density polyethylene bag.

The following battery of tests were performed in accordance to respective guidelines and deemed acceptable - Biological Reactivity, In-Vitro, (USP XXIII <87>), Dermal Sensitization (ISO 10993-10.2 (draft)) and Primary Mucosal Irritation (FDA Good Laboratory Practice guidelines, 19, revision 5; GCPT-19.(5).

Sherwood-Davis & Geck considers the Kangaroo® Enteral Extension Set for Syringe Pumps substantially equivalent to a family of predicate devices, the Kangaroo® Enteral Extension Set for Pumps covered under 510k K914375, Entri-Flex® Feeding Tubes covered under K833621, Dobbhoff ® Feeding Tubes covered under K833188, Entri-Flex® Feeding Tubes w/flexible weight covered under 510k K801558 and Pediatric Feeding Tubes covered under 510k K822875.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 2 7 1998

Ms. Vanada Johnson Regulatory Affairs Specialist Sherwood, Davis & Geck 444 McDonnell Blvd. Hazelwood, MO 63042-2516 Re: K973409

Kangaroo® Enteral Feeding Extension Set for Syringe Pumps Dated: January 12, 1998 Received: January 13, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT

Dear Ms. Johnson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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| 510(k) Number (if known) | |
| Device Name: | Sherwood-Davis & Geck<br>Kangaroo® Enteral Feeding Extension Set for Syringe Pumps |
| Indications for Use: | The Kangaroo® Enteral Feeding Extension Set for Syringe Pumps is<br>intended for enteral feeding, on the order of a physician, to provide a<br>means of delivering feeding formula from a filled syringe through to any<br>feeding tube which will accept its non-I.V. compatible connector. |

(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrenc of CDRH, Office of Device Evaluation (ODE)

| | Rober D Satling<br>(Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices<br>510(k) Number K973409 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-the-Counter Use |
| (Division Sign-off) | |
| 510(k) Number | |
| Sherwood-Davis & Geck | |

Sherwood-Davis & Geck
Kangaroo Enteral Feeding Extension Set Fory Syringe Pumps

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