(301 days)
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.
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
Here's a breakdown of the requested information based on the provided document:
This document describes a 510(k) submission for Enteral Feeding Sets, which are devices intended to dispense liquid nutrients. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than undergoing extensive clinical trials for de novo approval. Therefore, the "study" proving the device meets acceptance criteria is primarily non-clinical performance testing to demonstrate equivalence to the predicate, not a clinical study involving human patients or complex AI model evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating substantial equivalence to the predicate device (Dynarex Enteral Feeding Sets) through similar technological characteristics and comparable performance in specific tests.
| Parameter Description | Predicate Device Acceptance Criteria | Subject Device (Generica Medical Enteral Feeding Set) Reported Performance | Comparison Result |
|---|---|---|---|
| Description | Similar to Dynarex Enteral Delivery Pump Spike Set & Gravity Bag Set | Generica Medical Enteral Delivery Pump Bag Set, Pump Spike Set, and Gravity Bag Set descriptions provided. | Similar and Slightly Different (due to bag volume, but overall function similar) |
| Port: Bag Volume | 1200 mL | 1000 mL | Substantially Equivalent (SE) - While different, implies it's acceptable for similar use. |
| Port: Spike | Spike Right | Spike Right | Same |
| Port: Drip Chamber | Clear | Clear | Same |
| Port: Distal Tip Connector | 4 Step Adapter | 4 Step Adapter | Same |
| Style: Pump Bag Set | Yes | Yes | Same |
| Style: Spike Set | Yes | Yes | Same |
| Style: Gravity Bag Set | Yes | Yes | Same |
| Flow Rate Variance | <10% | <10% | Same |
| Other Features: Non-Sterile | Yes | Yes | Same |
| Other Features: Single Patient Use | Yes | Yes | Same |
| Other Features: Disposable | Yes | Yes | Same |
| Compatibility | Compatible with enteral feeding pumps | Tested with Nestle Compat and Alcor Sentinel Enteral Feeding Pumps | Demonstrated Compatibility |
| Accuracy | Accurate dispensing of formula | Accuracy compared to predicate at various flow rates | Demonstrated Efficacy / Same as Predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size (e.g., number of bags, spikes, sets tested) for the non-clinical performance tests. It states that the "Generica Medical Enteral Feedings Sets were tested." This implies an adequate number were tested to support the claims of compatibility and accuracy, but the precise count is not provided.
- Data Provenance: The testing was conducted by or on behalf of Generica Medical International (located in La Verne, CA, USA) and their manufacturer Conod Medical Co., Limited (located in Jiangsu, China). The testing is implicitly prospective in the sense that it was conducted specifically for this premarket notification rather than being a retrospective analysis of existing data. It's a non-clinical, in-vitro/benchtop type of testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable (N/A).
For a non-clinical device like an enteral feeding set, the "ground truth" is defined by the objective performance parameters (e.g., flow rate variance, compatibility) measured against engineering specifications or the predicate device's performance. There are no human "experts" establishing a "ground truth" in the way one would for image interpretation or diagnosis. It's about engineering and performance validation.
4. Adjudication Method for the Test Set
This section is Not Applicable (N/A).
Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting complex data (e.g., medical images) and need a consensus mechanism to establish ground truth or handle disagreements. Since this is a non-clinical device performance test, no human adjudication was involved.
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
This section is Not Applicable (N/A).
This submission is for a basic medical device (enteral feeding sets), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A).
This device is not an algorithm; it's a physical medical device. Performance was evaluated as a standalone product (i.e., the feeding set itself), but not as an "algorithm only".
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing was established by:
- Engineering Specifications / Predicate Device Performance: The primary ground truth was defined by meeting the performance characteristics (e.g., flow rate variance <10%, "Spike Right" compatibility) demonstrated by the predicate device and the inherent functional requirements of an enteral feeding set.
- Objective Measurements: The tests involved objective measurements of flow rates and physical compatibility with pumps.
8. The Sample Size for the Training Set
This section is Not Applicable (N/A).
This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable (N/A).
As there is no training set, there is no ground truth for it.
In summary: The "study" for this device was a series of non-clinical, benchtop performance tests designed to demonstrate that the Generica Medical Enteral Feeding Sets perform comparably to their predicate device and meet essential functional requirements, thereby establishing substantial equivalence for 510(k) clearance. Clinical trials or complex AI performance evaluations were not applicable to this type of device.
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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 StreetLa Verne, CA 91750 |
| Contact Person: | Len HoffstetterPresident |
| 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: | KNTFPD |
| 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 |
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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.
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:
| ParameterDescription | Predicate Device:Dynarex Enteral FeedingSets | Subject Device:Generica Medical EnteralFeeding Set | Comparison ofSubject Deviceto Predicate | |
|---|---|---|---|---|
| Description | Dynarex Enteral DeliveryPump Spike Set is the idealEnteral Feeding Set if you donot need the feeding bag.Dynarex Enteral DeliveryPump Spike Set includes thecomponents needed to openthe nutritional bag, connectthe tubing to the pump andthe feeding set adapter to thefeeding tube.The Dynarex EnteralFeeding Gravity Bag Set isan effective method todeliver liquid nutrition topatients. This enteralfeeding set features afeeding set adapter with aprotective cap, a locking tip,and gravity forced formulaflow. | The Generica MedicalEnteral Delivery Pump BagSet has a twist cap. Thevinyl bag features a rigidwide-mouth angled funnelopening that makes pouringeasy and helps prevent spillsand waste. The 1000 mLformula vinyl bag has 50 mLgraduations to make it easierfor reading and betteraccuracy when filling.The Generica MedicalEnteral Delivery PumpSpike Set with the CrossSpike Connector iscompatible withSpikeRight™ andSpikeRight® enteral feedingsystems.The Generica MedicalEnteral Delivery GravityBag Set has a twist cap. Thevinyl bag features a rigidwide-mouth angled funnelopening that makes pouringeasy and helps prevent spillsand waste. Bag graduationsare in 50 mL increments foreasier readings and allow forbetter accuracy when filling | Similar and Slightly | |
| ParameterDescription | Predicate Device:Dynarex Enteral Feeding Sets | Subject Device:Generica Medical EnteralFeeding Set | Comparison ofSubject Deviceto Predicate | |
| Port | Bag | 1200 ml | 1000 ml | SE |
| Spike | Spike Right | Spike Right | Same | |
| Drip Chamber | Clear | Clear | Same | |
| Distal TipConnector | 4 Step Adapter | 4 Step Adapter | Same | |
| Style | Pump Bag Set | Yes | Yes | Same |
| Spike Set | Yes | Yes | Same | |
| Gravity BagSet | Yes | Yes | Same | |
| Pe | Flow ratevariance | <10% | <10% | Same |
| Other Features | Non-Sterile | Yes | Yes | Same |
| Single PatientUse | Yes | Yes | Same | |
| Disposable | Yes | Yes | Same |
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Brief description of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.
- · 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.
Brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.
Not applicable.
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Conclusion drawn for the nonclinical and clinical tests
The Generica Medical Enteral Feeding Sets have the same intended use and technological characteristics as the predicate device, Dynarex Enteral Feeding Sets. The materials of construction used in the Generica Medical Enteral Feeding Sets are substantially equivalent to those of the predicate device. Performance testing has demonstrated the product's efficacy. The Generica Medical Enteral Feeding Sets have been demonstrated to be substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that represent the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Central Center - WO66-G609 Silver Spring, MID 20993-0002
July 28, 2014
Generica Medical International. Inc. Jim Barley Director of RA/QA 1910 D Street LaVerne, CA 91750
Re: K133077
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.
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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
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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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§ 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.