(115 days)
No
The summary describes a mechanical device for dispensing liquid nutrients and does not mention any AI or ML components or functionalities.
No.
The device dispenses liquid nutrients, which is supportive care rather than a direct therapeutic intervention for a disease or condition. Its function is to provide nutrition, which is distinct from treating or curing an illness.
No
The device is described as an enteral feeding set that dispenses liquid nutrients, which is a therapeutic function, not a diagnostic one. The performance studies focus on safety and effectiveness of dispensing, not on diagnosing conditions.
No
The device description clearly states it is an "enteral feeding set" which is a physical device used to dispense liquid nutrients. It mentions components like a spike and interfaces with a feeding tube, indicating hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dispense liquid nutrients (feeding solution) at a user controlled rate." This is a delivery mechanism for nutrition, not a test performed on a biological sample to diagnose a condition.
- Device Description: The description reinforces the function of dispensing feeding solution and interfacing with a feeding tube.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
- Predicate Devices: The predicate devices listed are "Infusion pump, enteral, external" and "Enteral Feeding Sets for Gravity and Pump Use." These are devices used for delivering substances into the body, not for in vitro diagnostic testing.
In summary, the device's function is to deliver nutrition, which falls under the category of medical devices used for treatment or support, not for in vitro diagnosis.
N/A
Intended Use / Indications for 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 pierceable septum and/or a spike to connect to a pre-filled container.
Product codes
KNT
Device Description
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 pierceable septum and/or a spike to connect to a pre-filled container.
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 (801) 264-1001 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 |
1
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 | |
| New Base Material, USP Class VI | Original design | ||
| Original Base Material, | |||
| USP Class VI | |||
| All | Cap, Enteral Adapter | Designed to fit 'slip loc' enteral adapter | |
| Same Base Material | Designed to fit original enteral adapter | ||
| Same Base Material | |||
| All anti free flow models | Pump Fitting | Anti Free Flow Fitting | |
| New Base Material, USP Class VI | Pinch Clip Occluder anti free flow device | ||
| Original Base Material, USP Class VI | |||
| 500 ml Bags, | |||
| 300 ml intermittent | |||
| gravity set | Bag Assembly | Smaller surface area | |
| Same material | 1200 ml (larger surface area) | ||
| Same material | |||
| All | All other components | Same | Same |
| All | Intended Use | Same | Same |
| All | Biocompatibility of | ||
| 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 |
| not sterile | |||
| All | Labeling | Added additional pump and gravity set use information | |
| Added anti free flow information | |||
| (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
2
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
3
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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 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 (800) 638-2041 or (301) 443-6597 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
4
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 ✓