GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET

K133077 · Generica Medical International, Inc. · KNT · Jul 28, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133077
• Device Name: GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET
• Applicant: Generica Medical International, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Enteral feeding sets consist of vinyl bags (1000 mL capacity with 50 mL graduations), tubing, and connectors (spike or twist cap). Devices interface between a nutrient source (bag or pre-filled container) and a patient's feeding tube. Operation is either via gravity or an enteral feeding pump. Used in clinical or home settings to deliver liquid nutrition. Healthcare providers or patients set the flow rate via the pump or gravity control. Benefits include controlled, accurate delivery of liquid nutrients to patients unable to ingest food orally. The system includes a rigid wide-mouth angled funnel for filling and a cross-spike connector compatible with SpikeRight systems.

Clinical Evidence

No clinical data. Bench testing only. Testing included compatibility and flow rate accuracy verification with Nestle Compat and Alcor Sentinel enteral feeding pumps, demonstrating performance equivalent to the predicate device.

Technological Characteristics

Vinyl bag construction; 1000 mL capacity; 50 mL graduations; rigid wide-mouth angled funnel; 4-step distal tip adapter; SpikeRight compatible connector. Non-sterile, single-patient use, disposable. Mechanical flow control via gravity or pump. No software or electronic components.

Indications for Use

Indicated for patients requiring enteral nutrition delivery via feeding tube; compatible with gravity or enteral feeding pump systems for dispensing liquid nutrients.

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

• Dynarex Enteral Feeding Sets for Gravity & Pump Use (K082863)

Submission Summary (Full Text)

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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 Street<br>La Verne, CA 91750 |
| Contact Person: | Len Hoffstetter<br>President |
| Phone: | [phone] (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,<br>Generica Medical Enteral Delivery Pump Spike Set,<br>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<br>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 |

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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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:

| Parameter<br>Description | Predicate Device:<br>Dynarex Enteral Feeding<br>Sets | Subject Device:<br>Generica Medical Enteral<br>Feeding Set | Comparison of<br>Subject Device<br>to Predicate | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------|
| Description | Dynarex Enteral Delivery<br>Pump Spike Set is the ideal<br>Enteral Feeding Set if you do<br>not need the feeding bag.<br>Dynarex Enteral Delivery<br>Pump Spike Set includes the<br>components needed to open<br>the nutritional bag, connect<br>the tubing to the pump and<br>the feeding set adapter to the<br>feeding tube.<br>The Dynarex Enteral<br>Feeding Gravity Bag Set is<br>an effective method to<br>deliver liquid nutrition to<br>patients. This enteral<br>feeding set features a<br>feeding set adapter with a<br>protective cap, a locking tip,<br>and gravity forced formula<br>flow. | The Generica Medical<br>Enteral Delivery Pump Bag<br>Set has a twist cap. The<br>vinyl bag features a rigid<br>wide-mouth angled funnel<br>opening that makes pouring<br>easy and helps prevent spills<br>and waste. The 1000 mL<br>formula vinyl bag has 50 mL<br>graduations to make it easier<br>for reading and better<br>accuracy when filling.<br>The Generica Medical<br>Enteral Delivery Pump<br>Spike Set with the Cross<br>Spike Connector is<br>compatible with<br>SpikeRight™ and<br>SpikeRight® enteral feeding<br>systems.<br>The Generica Medical<br>Enteral Delivery Gravity<br>Bag Set has a twist cap. The<br>vinyl bag features a rigid<br>wide-mouth angled funnel<br>opening that makes pouring<br>easy and helps prevent spills<br>and waste. Bag graduations<br>are in 50 mL increments for<br>easier readings and allow for<br>better accuracy when filling | Similar and Slightly | |
| | Parameter<br>Description | Predicate Device:<br>Dynarex Enteral Feeding Sets | Subject Device:<br>Generica Medical Enteral<br>Feeding Set | Comparison of<br>Subject Device<br>to Predicate |
| Port | Bag | 1200 ml | 1000 ml | SE |
| | Spike | Spike Right | Spike Right | Same |
| | Drip Chamber | Clear | Clear | Same |
| | Distal Tip<br>Connector | 4 Step Adapter | 4 Step Adapter | Same |
| Style | Pump Bag Set | Yes | Yes | Same |
| | Spike Set | Yes | Yes | Same |
| | Gravity Bag<br>Set | Yes | Yes | Same |
| Pe | Flow rate<br>variance | <10% | <10% | Same |
| Other Features | Non-Sterile | Yes | Yes | Same |
| | Single Patient<br>Use | 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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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 [phone] or [phone] 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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