Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set

K142297 · Xeridiem (Formerly Mri) · PIF · Jan 8, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K142297
• Device Name: Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
• Applicant: Xeridiem (Formerly Mri)
• Product Code: PIF · Gastroenterology, Urology
• Decision Date: Jan 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The EndoVive™ 3S Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive™ 3S Extension Set is intended to connect to a low profile balloon for enteral feeding, medication administration and gastric decompression.

Device Story

EndoVive™ 3S is a low-profile balloon gastrostomy tube system. Device consists of a silicone tube with an inflatable balloon for retention in the stomach, plus various extension sets for feeding/medication delivery. Used in clinical and home settings; operated by healthcare providers or patients/caregivers. The tube is inserted through a stoma tract; balloon is inflated with water to secure position. Extension sets connect to the tube's feeding port to allow enteral administration or gastric decompression. Features male ENFit connectors to prevent misconnections; includes transition adapters for compatibility with legacy enteral accessories. Benefits include secure, long-term gastric access for patients unable to swallow or requiring decompression.

Clinical Evidence

Bench testing only. No clinical data presented. Performance testing included flow rate, balloon performance, leakage, tensile properties, connector performance (fluid leakage, stress cracking, axial load, unscrewing, overriding), biocompatibility, sterilization, shelf life, and human factors/usability testing.

Technological Characteristics

Materials: silicone, thermoplastics, non-DEHP PVC, Pebax. Standards: AAMI/ANSI/ISO 10993-1, ASTM F2528-06, AAMI/ANSI/ISO 80369-1, EN 1615. Principle: balloon-retained gastrostomy tube. Connectivity: ENFit connectors. Sterilization: 100% Ethylene Oxide (EO). Form factor: low-profile balloon tube with various French sizes (12-24 Fr) and stoma lengths (0.8-6.5 cm).

Indications for Use

Indicated for adult and pediatric patients requiring long-term feeding, unable to tolerate oral feeding, at low risk for aspiration, or requiring gastric decompression and/or medication delivery directly into the stomach.

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

• MIC-KEY® Low Profile Gastrostomy Tube (K043114)
• AMT Mini ONE® Balloon Button Low Profile Gastrostomy Device (K971434)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2015

Xeridiem (formerly Mri) Jesus Valencia RA Specialist 4700 S. Overland Dr. Tucson, AZ 85714

Re: K142297

> Trade/Device Name: EndoVive™ 3s Low Profile Balloon Kit EndoVive™ 3s Bolus Extension Sets EndoVive™ 3s Continuous Extension Sets EndoVive™ 3s Medication Extension Set Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: PIF, PIO Dated: December 4, 2014 Received: December 5, 2014

Dear Jesus Valencia,

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, listing of devices, good manufacturing practice, labeling, and prohibitions 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 Federal Register.

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. You must comply

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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 devicerelated 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 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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 -A

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | K142297 | |
| Device Name | EndoVive 3S Low Profile Balloon Kit and Extension Sets | |
| Indications for Use (Describe) | The EndoVive 3S Low Profile Balloon is indicated for use in adult and pediatric patients who require long term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach. | |
| | The EndoVive 3S Extension Set is indicated for the delivery of nutrition, hydration and/or medication into the stomach through a low profile balloon and also provides a mechanism for gastric decompression. | |
| Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |
| 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) | | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>[e-mail] | | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | |
| FORM FDA 3881 (1/14) | Page 1 of 1 | PSC Publishing Services [phone] EF |

(End of Section)

Xeridiem

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## 510(k) Summary

As required by 21 CFR 807.92, this "510(k) Summary" provides a basis for the substantial equivalence determination of the subject device listed below. This "510(k) Summary" was prepared in adherence to the guidelines provided in FDA Guidance - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].

### Submitter Information

| Date Prepared: | January 6th, 2015 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Xeridiem<br>4700 S. Overland Dr.<br>Tucson, AZ 85714<br>Contact: Jesus Valencia, RA Specialist<br>[phone] ext. 135<br>[e-mail] |
| 510(k) Correspondent: | Same as above |

### Subject (Proposed) Device Information

| Trade Name: | EndoVive™ 3S Low Profile Balloon Kit and<br>EndoVive™ 3S Extension Sets |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Low Profile Balloon Gastrostomy Tube and<br>Feeding/Medication Extension Sets |
| Classification Name: | Gastrointestinal Tubes with Enteral Specific Connectors and Enteral<br>Specific Transition Connectors<br>[21 CFR 876.5980, Product Code PIF and PIO] |
| Classification Panel: | Gastroenterology/Urology |
| Class: | Class II |

### Primary Predicate Device Information

| Trade Name: | MIC-KEY® Low Profile Gastrostomy Tube |
|-----------------------|-------------------------------------------|
| Common Name: | Low Profile Balloon Gastrostomy Tube |
| Classification Name: | Tubes, gastrointestinal (and accessories) |
| | [21 CFR 876.5980, Product Code KNT] |
| Classification Panel: | Gastroenterology/Urology |
| Class: | Class II |
| 510(k) Number: | K043114 |

### Secondary Predicate Device Information

| Trade Name: | AMT Mini ONE® Balloon Button Low Profile Gastrostomy Device |
|-----------------------|-------------------------------------------------------------|
| Common Name: | Low Profile Balloon Gastrostomy Tube |
| Classification Name: | Tubes, gastrointestinal (and accessories) |
| | [21 CFR 876.5980, Product Code KNT] |
| Classification Panel: | Gastroenterology/Urology |
| Class: | Class II |
| 510(k) Number: | K971434 |

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### Device Description

### Device Identification:

The following is a list and brief description of the components and model variations of the proposed devices.

### EndoVive™ 3S Low Profile Balloon Kit: >

The EndoVive™ 3S Low Profile Balloon Kit contains an EndoVive™ 3S Low Profile Balloon which is a sterile, low profile balloon gastrostomy tube. Table 5.1 lists the varying size offerings for the EndoVive™ 3S Low Profile Balloon. The kit also contains the following accessories which are intended to facilitate placement and use of the EndoVive™ 3S Low Profile Balloon: Continuous and Bolus feeding extension sets, a stiffener, transition adapters, syringes, lubricating jelly, gauze pads and a patient care bag.

| Description | | | EndoVive 3S Low Profile Balloon Configurations | | | | |
|-----------------------------------------|-------|-------|------------------------------------------------|-------|-------|-------|-------|
| | 12 Fr | 14 Fr | 16 Fr | 18 Fr | 20 Fr | 22 Fr | 24 Fr |
| Stoma Lengths (cm) | 0.8 | 0.8 | | | | | |
| | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | |
| | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | 1.2 | |
| | 1.5 | 1:5 | 1:5 | 1:5 | 1:5 | 1 5 | 1.5 |
| | 1.7 | 1.7 | 1.7 | 1.7 | 1.7 | 1.7 | 1.7 |
| | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 |
| | 2.3 | 2.3 | 2.3 | 2.3 | 2.3 | 2.3 | 2.3 |
| | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 | 2.5 |
| | 2.7 | 2.7 | 2.7 | 2.7 | 2.7 | 2.7 | 2.7 |
| | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 |
| | 3.5 | 3.5 | 3.5 | 3.5 | 3.5 | 3.5 | 3.5 |
| | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
| | | 4.5 | 4.5 | 4.5 | 4.5 | 4.5 | 4.5 |
| | | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 | 5.0 |
| | | ર્ટ 5 | 5:5 | 5.5 | 5.5 | 5.5 | 5.5 |
| | | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 | 6.0 |
| | | 6:5 | 6.5 | 6.5 | 6.5 | 6.5 | 6.5 |
| Recommended Balloon<br>Fill Volume (mL) | 4 | 4.5 | 5 | ട | 7 | 8 | 10 |

Table 5.1 – EndoVive™ 3S Low Profile Balloon Device Offerings

### > EndoVive™ 3S Extension Sets:

The following extension sets will be sold separately in a non-sterile 5-pack configuration.

Table 5.2 – EndoVive™ 3S Extension Set Offerings

| Extension Set (ES) Type | Tubing Diameter (French) | Tubing Length (in) | Connector Profile (ES-to-feeding port of low profile g-tube) | Port Profile (Enteral access devices-to-ES) | Adapters included in packaging | |
|--------------------------------------------------------|--------------------------|--------------------|--------------------------------------------------------------|---------------------------------------------|---------------------------------|------------------------------------|
| | | | | | Feeding Port Transition Adapter | Medication Port Transition Adapter |
| EndoVive™ 3S<br>Continuous<br>Feeding Extension<br>Set | 12 | 12 | Right-angle | Y-port | X | X |
| | 12 | 24 | Right-angle | Y-port | X | X |
| EndoVive™ 3S<br>Bolus Feeding<br>Extension Set | 20 | 12 | Straight | Single Port | | X |
| | 20 | 24 | Straight | Single Port | | X |
| | 20 | 12 | Right-angle | Single Port | | X |
| | 20 | 24 | Right-angle | Single Port | | X |
| EndoVive™ 3S<br>Medication<br>Extension Set | 12 | 2 | Right-angle | Y-port | X | |

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### Device Characteristics:

The following is a brief description of the proposed device characteristics.

- EndoVive™ 3S Low Profile Balloon Kit: >
- Contains no software, biologics, drugs, coatings or additives
- Contains patient contacting materials as described in Section 11 of this 510(k) .
- Is provided sterile for single patient use .
- . ls sterilized using a 100% Ethylene Oxide (EO) sterilization process

### EndoVive™ 3S Extension Sets: >

- Contains no software, biologics, drugs, coatings or additives
- Contains patient contacting materials as described in Section 11 of this 510(k)
- Are provided non-sterile for single patient use 0

### Environment of Use:

As listed in Table 5.3, the proposed devices will be used in healthcare facilities, hospitals and in the home.

### Brief Description of the Device:

The following is a description of the proposed devices' principle of operation and mechanism of action for achieving their intended affect. The following also describes the proposed conditions of use, anatomical location of use and user interface.

The low profile gastrostomy tube is normally placed in a clinical setting and can be replaced and used in both a clinical and home care setting. The extension sets and syringes included with the kit may also be used in both a clinical and home care setting.

Before using the EndoVive™ 3S Low Profile Balloon, the stoma tract must be measured and the tube size appropriate for the patient must be identified by the healthcare provider. The distal end of the tube is inserted through a gastrointestinal stoma tract and into the stomach. Then the balloon is inflated with sterile or distilled water. The fitment of the tube is verified by ensuring that the external bolster is flush against the abdomen.

Extension sets are connected to the feeding port of the low profile gastrostomy tube to begin enteral administration and gastric decompression. The male ENFit connectors attached to the proposed devices are then connected to enteral sets and syringes incorporating female ENFit connectors. If enteral accessories incorporating female ENFit connectors are not available, the feeding port and medication port transition adapters may be connected to the male ENFit connectors to commonly available enteral administration sets and syringes. The male ENFit connectors attached to the EndoVive "" 3S Extension Sets were designed to reduce the likelihood of unwanted connections between enteral connectors. Until the ENFit connectors become widely available, the ENFit transition adapters will be provided with the EndoVive™ 3S Low Profile Balloon Kit to mitigate the risk of inaccessibility to care within the use environment.

### Materials of Use:

The general types of materials used for the proposed devices consist of silicones, thermoplastics and non-DEHP PVC materials. The device materials conform to AAMI/ANSI/ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. A more detailed, itemized table of the proposed device materials and associated types of contact and duration is included in Section 11 of this 510(k).

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### Key Performance Specifications/Characteristics of the Device:

Key performance specifications and device characteristics were derived from device-specific functionality and performance standards such as ASTM F2528-06 - Standard Test Methods for Enteral Feeding Devices with a Retention Balloon, AAMI/ANSI/ISO 80369-1 and EN 1615 - Enteral feeding catheters and enteral qiving sets for single use and their connectors: Design and testing. These standards are applicable for gastrostomy tubes and accessories such as those encompassed in the proposed and predicate devices. A more detailed description of device performance testing is included in Section 18 of this 510(k).

### Intended Use

The EndoVive" 3S Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression.

The EndoVive™ 3S Extension Set is intended to connect to a low profile balloon for enteral feeding, medication administration and gastric decompression.

### Indications for Use

The EndoVive™ 3S Low Profile Balloon is indicated for use in adult and pediatric patients who require long term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

The EndoVive™ 3S Extension Set is indicated for the delivery of nutrition, hydration and/or medication into the stomach through a low profile balloon and also provides a mechanism for gastric decompression.

### Comparison of Technological Characteristics with the Predicate Device

The device comparison table below provides a general summary of the technological characteristics of the proposed device compared to the predicate device. The proposed device is most similar to the device identified as the primary predicate. The secondary predicate device was chosen to demonstrate substantial equivalence for a few select features are identified with the subscript "(1)" in Table 5.3.

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# Table 5.3 – Device Comparison Table

| Table 5.3 – Device Comparison Table | | | |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed Device | Primary Predicate Device | Secondary Predicate Device |
| | EndoVive™ 3S Low Profile Balloon Kit and<br>Extension Sets | MIC-KEY Low Profile Gastrostomy Tube<br>K043114 | AMT Mini One Balloon Button Low<br>Profile Gastrostomy Tube<br>K971434 |
| Class (FDA) | II | II | II |
| FDA Product Code | PIF / PIO | KNT | KNT |
| FDA Regulation | 876.5980 | 876.5980 | 876.5980 |
| Indications for Use | The EndoVive™ 3S Low Profile Balloon is<br>indicated for use in adult and pediatric patients<br>who require long term feeding, are unable to<br>tolerate oral feeding, are at low risk for<br>aspiration or require gastric decompression<br>and/or medication delivery directly into the<br>stomach. The EndoVive™ 3S Extension Set is<br>indicated for the delivery of nutrition, hydration<br>and/or medication into the stomach through a<br>low profile balloon and also provides a<br>mechanism for gastric decompression. | The MIC-KEY® Low Profile Gastrostomy<br>Tube is designed as a replacement<br>gastrostomy tube for use in a mature<br>gastric stoma when a low profile device<br>would benefit the patient. Gastrostomy<br>tubes are indicated for patients with<br>inability to swallow, other neurological<br>disorders, and other conditions for<br>which tube feeding would benefit the<br>patient in the judgment of the physician. | The AMT Mini ONE® Balloon Button Low<br>Profile Gastrostomy Device is indicated<br>for providing nutrition directly into the<br>stomach through an established stoma in<br>a patient who is unable to consume<br>nutrition by conventional means. |
| Operating Principle | Low profile gastrostomy tube tip enters though<br>the stoma tract and into the stomach, then the<br>device is secured in place by inflating the<br>balloon. Extension sets are connected to the<br>low profile gastrostomy tube and then enteral<br>accessories connected to the extension sets to<br>allow for administration of nutrients and<br>medication into the stomach and for gastric<br>decompression. | Low profile gastrostomy tube tip enters<br>though the stoma tract and into the<br>stomach, then the device is secured in<br>place by inflating the balloon. Extension<br>sets are connected to the low profile<br>gastrostomy tube and then enteral<br>accessories connected to the extension<br>sets to allow for administration of<br>nutrients and medication into the<br>stomach and for gastric decompression. | Low profile gastrostomy tube tip enters<br>though the stoma tract and into the<br>stomach, then the device is secured in<br>place by inflating the balloon. Extension<br>sets are connected to the low profile<br>gastrostomy tube and then enteral<br>accessories connected to the extension<br>sets to allow for administration of<br>nutrients and medication into the<br>stomach and for gastric decompression. |
| Clinical Conditions of Use | | | |
| For Use in Adult Patients | Yes | Yes | Yes |
| For Use in Pediatric<br>Patients | Yes | Yes | Yes |
| For Use During Initial<br>Placement Procedures | Yes | Yes(2) | No |
| For Use During<br>Replacement Procedures | Yes | Yes | Yes |
| Environment of Use | Healthcare Facility<br>Hospital<br>Home | Healthcare Facility<br>Hospital<br>Home | Healthcare Facility<br>Hospital<br>Home |

01/06/15

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|-------------|----------|
| 0(k) | 11 1 |
| 51 | ( |
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# Section 5 - 510(k) Summary

| Single Patient Use | Yes | Yes | Yes |
|------------------------------------------------------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|
| Sterile | Yes | Yes | Yes |
| Sterilization Method | ETO | ETO | ETO |
| | Low Profile Gastrostomy Tube | | |
| Balloon Material | Silicone | Silicone | Silicone |
| Shaft Material | Silicone | Silicone | Silicone |
| Balloon-to-Shaft<br>Adhesive | Silicone Adhesive | Silicone Adhesive | Silicone Adhesive |
| Radiopaque Marker<br>Materials | Barium/Silicone | Barium/Silicone | Barium/Silicone |
| External Bolster Material | Silicone | Silicone | Silicone |
| Feeding Valve Material | Thermoplastics/Silicone | Thermoplastics/Silicone | Thermoplastics/Silicone |
| Balloon Inflation Valve<br>Material | Thermoplastics/Silicone/Metal Spring | Thermoplastics/Silicone/Metal Spring | Thermoplastics/Silicone/Metal Spring |
| Active (Functional) Tube<br>Length Offerings | 0.8-6.5 cm(1) | 0.8-5.0 cm | 0.8-6.5 cm(1) |
| French Size Offerings | 12-24 FR | 12-24 FR | 12-24 FR |
| Packaging Configuration | PETG Tray w/ Tyvek lid | PETG Tray w/ Tyvek lid | PETG Tray w/ Tyvek lid |
| | Kit Components | | |
| Low Profile Gastrostomy<br>Tube | Yes | Yes | Yes |
| Gauze Pads | Yes | Yes | Yes |
| Lubricating Jelly | Yes | No | No |
| Extension Sets | Yes | Yes | Yes |
| Inflation Syringe | Yes | Yes | Yes |
| Bolus Feeding Syringe | Yes | Yes | Yes |
| Stiffener (for shaft of low<br>profile G-tube) | Yes(1) | No | Yes(1) |
| Feeding Port Transition<br>Adapter<br>(Female ENFit-to-Christmas<br>tree-type connector) | Yes | No | No |
| Medication Port<br>Transition Adapter<br>(Female ENFit-to-luer<br>connector) | Yes | No | No |
| | Extension Sets | | |
| Tubing Materials | Non-DEHP PVC | Non-DEHP PVC | Non-DEHP PVC |

01/06/15

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| Connector Materials | Thermoplastic | Thermoplastic | |
|------------------------------------------------------------------------------------------------------------------|------------------|---------------------------|---------------------------|
| Pinch Clamp Materials | Thermoplastic | Thermoplastic | |
| Feeding Port Materials | Thermoplastic | Non-DEHP PVC | Non-DEHP PVC & Silicone |
| Medication Port Materials | Thermoplastic | Non-DEHP PVC | Non-DEHP PVC & Silicone |
| Feeding/Medication Port Tether | Pebax | Non-DEHP PVC | Non-DEHP PVC |
| Feeding/Medication Port Cap | Thermoplastic | Non-DEHP PVC | Non-DEHP PVC |
| Feeding Port Compatibility | ENFit Connectors | Christmas Tree Connectors | Christmas Tree Connectors |
| | | Catheter Tip Connectors | Catheter Tip Connectors |
| Medication Port Compatibility | ENFit Connectors | Luer Slip/Lock Connectors | Luer Slip/Lock Connectors |
| Offered in Separately Packaged Configurations | Yes | Yes | Yes |
| 1) Note: Indicates proposed device features relying on substantial equivalence to the secondary predicate device | | | |

Note: Indicates proposed device features relying on substantial equivalence to the secondary predicate device.

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### Discussion of Similarities and Differences

As outlined in Table 5.3, the proposed device and primary predicate device are similar in the following:

- . Same intended use, in as far as that both are used for administration of enteral nutrition and gastric decompression, anatomical locations of use,
- ... Same environment and conditions of use,
- . Similar indications for use, technological characteristics, general material types, principles of operation and mechanism of action,
- .............................................................................................................................................................................. Both are provided in sterile, single patient use kits for facilitating placement and use of the low profile gastrostomy tube, and
- Both offer non-sterile, single patient use and separately packaged extension sets for user convenience.

As outlined in Table 5.3, the following are the differences between the proposed and primary predicate devices.

- The proposed device has a more comprehensive range of active length offerings for the low profile gastrostomy tube to better accommodate differing stoma tract lengths across the entire user profile of the device. The range of length offerings for the proposed device are identical to those of the secondary predicate device
- The proposed device kit includes a stiffener for select French size kits to facilitate insertion of the low profile gastrostomy tube through the stoma tract as does the secondary predicate device
- = The proposed device kit includes water-soluble lubricating jelly for tube lubrication and to facilitate insertion of the low profile gastrostomy tube through the stoma tract
- The proposed device has male ENFit connectors attached to the extension set ports to reduce the likelihood of enteral misconnections and to fulfill the requirements of FDA Draft Guidance: Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications and AAMI/ANSI/ISO 80369-1. The male ENFit connectors were designed in accordance to the enteral connector specifications included in FDA Device Master File (MAF # F2258) Related to Small Bore Connectors Intended for Enteral Applications.
- . The proposed device kit includes two additional transition adapters incorporating female ENFit connectors to ensure the proposed devices can be connected with enteral accessories commonly used across the spectrum of care as the market transitions to the new ENFit connector system for addressing enteral misconnections.

The differences identified in the technological characteristics of the proposed devices do not raise new questions of safety or efficacy. Performance (bench) testing as well as usability evaluations demonstrate that the proposed device is as safe and effective as its primary predicate device.

### Performance Data

Nonclinical device performance testing was conducted for supporting substantial equivalence between the proposed and predicate devices. The bench tests addressed device performance characteristics such as:

- lumen/connector flow rate,
- balloon performance,
- internal leakage,
- tensile properties,
- connector performance which included the following tests,
- fluid leakage, о
- o stress cracking,
- resistance to separation from axial load, O

{11}------------------------------------------------

- O resistance to separation from unscrewing,
- O resistance to overriding, and
- disconnection from unscrewing o
- biocompatibility, ●
- sterilization,
- packaging,
- shelf life,
- dimensional analysis,
- enteral connector misconnection assessment,
- enteral connector risk management report,
- . human factors/usability testing,
- failure modes and effects analysis (FMEA), and ●
- risk analysis

A more detailed description of the device performance testing is included in Section 18 of this 510(k). In conclusion, the proposed device performed equivalent to or better than the primary predicate device.

### Conclusions Regarding Substantial Equivalence

In order to support substantial equivalence of the proposed device to its predicate, the following are provided among the information and summary tables included throughout this 510(k) submission: 1.) device description, 2.) indications for use, 3.) device comparison tables, 4.) material information, 5.) nonclinical (bench) test results, and 6.) product labeling. In particular, device performance test results demonstrate that there were no differences that are critical to the intended use of the proposed device or that affect the safety and effectiveness of the proposed device when used as labeled.

The proposed and predicate devices have the same intended use, in as far as that both are used for administration of enteral nutrition and gastric decompression, the same anatomical locations of use and the same environment and conditions of use. Further, the proposed and predicate devices have similar indications for use, technological characteristics, general material types, principles of operation and mechanism of action. The differences in technological characteristics of the proposed device have been identified and do not present any new issues of safety or effectiveness. Thus, the EndoVive™ 3S Low Profile Balloon and Extension Sets are substantially equivalent to the MIC-KEY® Low Profile Gastrostomy Tubes (K043114).

(End of Section)