(171 days)
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.
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.
The provided document is a 510(k) Summary for a medical device (Kangaroo® Enteral Extension Set for Syringe Pumps). This type of document is for regulatory submission to demonstrate substantial equivalence to a predicate device, not typically a research study proving efficacy or diagnostic accuracy. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Biological Reactivity, In-Vitro, (USP XXIII <87>): Deemed acceptable. |
| Dermal Sensitization (ISO 10993-10.2 (draft)): Deemed acceptable. | |
| Primary Mucosal Irritation (FDA Good Laboratory Practice guidelines, 19, revision 5; GCPT-19.(5)): Deemed acceptable. | |
| Substantial Equivalence | The device is considered substantially equivalent to a family of 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, and Pediatric Feeding Tubes K822875) based on: |
| - Both proposed and predicate extensions sets are used for administering enteral feedings. | |
| - Both are made of PVC material. | |
| - Both are EtO sterilized. | |
| - Both have a non-IV compatible connector. | |
| Device Material | PVC material |
| Sterilization Method | EtO sterilized |
| Distal Connector Compatibility | Non-IV compatible distal connector |
| Packaging | Tyvek/polyethylene tray (differs from predicate's low-density polyethylene bag) |
| Length | Varies in length from the predicate device |
2. Sample size used for the test set and the data provenance
This document does not describe a "test set" in the context of an algorithm or diagnostic study. The tests performed are for biocompatibility. The sample sizes for these biological reactivity tests are not specified in the summary. The provenance is internal testing performed by the manufacturer, Sherwood-Davis & Geck.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth. The "ground truth" for the biocompatibility tests would be established through standardized laboratory procedures and measurements.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions.
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 a medical device (enteral extension set), not an AI-driven diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the ground truth is based on the established standards and methodologies outlined in the referenced guidelines (USP XXIII <87>, ISO 10993-10.2 (draft), FDA Good Laboratory Practice guidelines). "Acceptable" is determined by meeting the specified criteria within these standards.
8. The sample size for the training set
Not applicable. This is a medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an algorithm.
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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 & Geck444 McDonnell Blvd.Hazelwood, MO 63042-2516 |
|---|---|
| Contact: | Vanada JohnsonRegulatory 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 (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known) | |
| Device Name: | Sherwood-Davis & GeckKangaroo® Enteral Feeding Extension Set for Syringe Pumps |
| Indications for Use: | The Kangaroo® Enteral Feeding Extension Set for Syringe Pumps isintended for enteral feeding, on the order of a physician, to provide ameans of delivering feeding formula from a filled syringe through to anyfeeding 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(Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices510(k) Number K973409 | |
|---|---|
| Prescription Use(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
í
§ 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.