(301 days)
No
The device description and performance studies focus on the mechanical function and compatibility of enteral feeding sets, with no mention of AI or ML technologies.
No.
The device is intended to dispense liquid nutrients and is used with feeding tubes and pumps, which are supportive functions for feeding, not direct therapeutic treatment of a disease or condition.
No
Explanation: The device is an enteral feeding set, intended to dispense liquid nutrients. Its function is to deliver nutrition, not to diagnose a medical condition.
No
The device description clearly outlines physical components such as bags, spikes, and tubing, which are hardware. The performance studies also focus on the accuracy and compatibility of these physical components with enteral feeding pumps.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "dispensing liquid nutrients (feeding solutions)" and interfaces with a "feeding tube." This describes a device used for delivering nutrition directly into the body, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details bags, spikes, and tubing designed for holding and delivering liquid formula. This aligns with an enteral feeding system, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information
- Reagents or test kits
The device described is an enteral feeding set, which is a medical device used for delivering nutrition, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Enteral Feeding Sets are intended 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 enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.
Product codes
KNT, FPD
Device Description
The Generica Medical International's line of Enteral Feeding Sets consists of the following: Generica Medical Enteral Delivery Pump Bag Set, Generica Medical Enteral Delivery Pump Spike Set, and Generica Medical Enteral Delivery Gravity Bag Set. The Generica Medical Enteral Delivery Pump Spike Set with the Cross Spike Connector is compatible with SpikeRight® and SpikeRight® enteral feeding systems. The Generica Medical Enteral Delivery Pump Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. The 1000 mL formula vinyl bag has 50 mL graduations to make it easier for reading and better accuracy when filling. The Generica Medical Enteral Delivery Gravity Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. Bag graduations are in 50 mL increments for easier readings and allow for better accuracy when filling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Generica Medical Enteral Feedings Sets were tested for compatibility and accuracy with the Nestle Compat and Alcor Sentinel Enteral Feeding Pumps. In addition, the accuracy of the Generica Medical Enteral Feeding Sets was compared to the predicate device at various flow rates. Performance testing has demonstrated the product's efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow rate variance:
§ 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
JUL 2 8 2014
510(k) Summary (As required by 21 CFR 807.92(a))
Applicant and Correspondent
| Name: | Generica Medical International |
|---|---|
| Address: | 1910 D Street |
| La Verne, CA 91750 | |
| Contact Person: | Len Hoffstetter |
| President | |
| Phone: | (909) 596-6785 (Office) |
| Date of Preparation: | July 25, 2014 |
Manufacturer
Conod Medical Co., Limited No. 38 Hongfeng Road Changshu City, Jiangsu, China
.Registration#: 3006673317
Name of Device
| Trade/Proprietary/Model Name: | Generica Medical Enteral Delivery Pump Bag Set,
Generica Medical Enteral Delivery Pump Spike Set,
Generica Medical Enteral Delivery Gravity Bag Set |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Enteral Feeding Sets |
| Classification Name: | Gastrointestinal tube and accessories |
| Classification Regulation: | 876.5980 |
| Panel: | Gastroenterology/Urology |
| Product Code: | KNT
FPD |
| Recognized Performance Std: | None |
Device to Which New Device is Substantially Equivalent
| Device Name: | Dynarex Enteral Feeding Sets for Gravity & Pump |
|---|---|
| Use | |
| Manufacturer: | Dynarex |
| Reference: | K082863 |
1
510(k) SUMMARY (Continued)
Device Description
The Generica Medical International's line of Enteral Feeding Sets consists of the following:
- Generica Medical Enteral Delivery Pump Bag Set, 1.
- Generica Medical Enteral Delivery Pump Spike Set, 2.
- ે. Generica Medical Enteral Delivery Gravity Bag Set
The Generica Medical Enteral Delivery Pump Spike Set with the Cross Spike Connector is compatible with SpikeRight® and SpikeRight® enteral feeding systems.
The Generica Medical Enteral Delivery Pump Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easv and helps prevent spills and waste. The 1000 mL formula vinvi bag has 50 mL graduations to make it easier for reading and better accuracy when filling.
The Generica Medical Enteral Delivery Gravity Bag Set has a twist cap. The vinyl bag features a rigid wide-mouth angled funnel opening that makes pouring easy and helps prevent spills and waste. Bag graduations are in 50 mL increments for easier readings and allow for better accuracy when filling
Statement of Intended Use
The Enteral Feeding Sets are intended 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 enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.
Summary of Technological Characteristics
The Intended Use statement of the Generica Medical Enteral Feeding Sets is identical to that of the predicate. The materials of construction used in the Generica Medical Enteral Feeding Sets are identical to those of the predicate device. Performance testing has demonstrated that the products' efficacy and effectiveness is the same as the predicate device.
2
:
| Parameter
Description | Predicate Device:
Dynarex Enteral Feeding
Sets | Subject Device:
Generica Medical Enteral
Feeding Set | Comparison of
Subject Device
to Predicate | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------|
| Description | Dynarex Enteral Delivery
Pump Spike Set is the ideal
Enteral Feeding Set if you do
not need the feeding bag.
Dynarex Enteral Delivery
Pump Spike Set includes the
components needed to open
the nutritional bag, connect
the tubing to the pump and
the feeding set adapter to the
feeding tube.
The Dynarex Enteral
Feeding Gravity Bag Set is
an effective method to
deliver liquid nutrition to
patients. This enteral
feeding set features a
feeding set adapter with a
protective cap, a locking tip,
and gravity forced formula
flow. | The Generica Medical
Enteral Delivery Pump Bag
Set has a twist cap. The
vinyl bag features a rigid
wide-mouth angled funnel
opening that makes pouring
easy and helps prevent spills
and waste. The 1000 mL
formula vinyl bag has 50 mL
graduations to make it easier
for reading and better
accuracy when filling.
The Generica Medical
Enteral Delivery Pump
Spike Set with the Cross
Spike Connector is
compatible with
SpikeRight™ and
SpikeRight® enteral feeding
systems.
The Generica Medical
Enteral Delivery Gravity
Bag Set has a twist cap. The
vinyl bag features a rigid
wide-mouth angled funnel
opening that makes pouring
easy and helps prevent spills
and waste. Bag graduations
are in 50 mL increments for
easier readings and allow for
better accuracy when filling | Similar and Slightly | |
| | Parameter
Description | Predicate Device:
Dynarex Enteral Feeding Sets | Subject Device:
Generica Medical Enteral
Feeding Set | Comparison of
Subject Device
to Predicate |
| Port | Bag | 1200 ml | 1000 ml | SE |
| | Spike | Spike Right | Spike Right | Same |
| | Drip Chamber | Clear | Clear | Same |
| | Distal Tip
Connector | 4 Step Adapter | 4 Step Adapter | Same |
| Style | Pump Bag Set | Yes | Yes | Same |
| | Spike Set | Yes | Yes | Same |
| | Gravity Bag
Set | Yes | Yes | Same |
| Pe | Flow rate
variance | Trade/Device Name: Generica Medical Enteral Feeding Sets Regulation Number: 21 CFRS 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Codes: KNT. FPS Dated: June 30. 2014 Received: July 9, 2014
Dear Jim Barley.
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. Ilisting of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eegleral Registers
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.
6
Page 2 - Jim Barley
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): 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 331-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher. Ph.D. Director . Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Kadiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133077
Device Name
Generica Medical Enteral Feeding Sets
Indications for Use (Describe)
The Enteral Feeding Sets are intended to dispense liguid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the passess feeding tube and may asse gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a hag to contain the feeding solution and/or spike to a pre-filled container.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Benjamin R. Fisher -S 2014.07.28 16:51:45 -04'00'
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