Entuit Start Initial Placement Gastrostomy Set

K170323 · Cook Incorporated · KGC · Sep 14, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K170323
• Device Name: Entuit Start Initial Placement Gastrostomy Set
• Applicant: Cook Incorporated
• Product Code: KGC · Gastroenterology, Urology
• Decision Date: Sep 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Indications for Use

The Entuit™ Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

Device Story

The Entuit Start Initial Placement Gastrostomy Set is a procedural kit used by physicians in clinical settings to facilitate the initial placement of gastrostomy feeding tubes in adult patients. The set includes a heavy-duty stainless steel PTFE-coated Amplatz extra-stiff wire guide, multiple dilators, a Peel-Away introducer, an entry access needle, a scalpel, a syringe, and gauze. During the procedure, the physician uses these components to gain access to the stomach and dilate the tract to the appropriate size for the feeding tube. The device is for one-time use and is sterilized via ethylene oxide. By providing a standardized set of tools, the device assists the clinician in achieving accurate tube placement, thereby supporting the patient's nutritional needs.

Clinical Evidence

Bench testing only. Testing included compatibility, tensile strength (wire guide, dilator, introducer), corrosion, flex, fracture, peel force, radiopacity, and biocompatibility (cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity).

Technological Characteristics

Materials: Stainless steel (wire guide), polyethylene/polyvinyl chloride (dilators), PTFE (introducer sheath), PET/Tyvek (packaging). Components: Wire guide (0.038 inch), dilators (12-24 Fr), Peel-Away introducers (16-26 Fr). Sterilization: Ethylene oxide (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for assisting physicians with initial placement of feeding tubes during gastrostomy procedures in adult patients.

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

• Kimberly-Clark Introducer Kits (K080253)

Reference Devices

• Gastrointestinal Anchor Set (K131201)
• Gastrointestinal Anchor Set (K152524)
• Stoma measuring device (K130674)

Submission Summary (Full Text)

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

September 14, 2017

Cook Incorporated Erum B. Nasir Regulatory Affairs Team Lead 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

K170323 Re:

Trade/Device Name: Entuit Start Initial Placement Gastrostomy Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KGC Dated: August 8, 2017 Received: August 9, 2017

Dear Erum B. Nasir:

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.

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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 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 (DICE) 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Joyce M. Whang-S

for

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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# Indications for Use

510(k) Number (if known) K170323

Device Name

Entuit Start Initial Placement Gastrostomy Set

Indications for Use (Describe)

The Entuit Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| <input type="checkbox"/> | |
| <input type="checkbox"/> | |

X | Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo, and the word "MEDICAL" is written in white, smaller block letters in the lower portion of the logo.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: [phone] TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

# 1.0 510(k) SUMMARY

## Entuit™ Start Initial Placement Gastrostomy Set As required by 21 CFR §807.92 Date Prepared: September 14, 2017

#### Submitted By:

| Submission: | Traditional 510(k) Premarket Notification |
|-----------------------|---------------------------------------------------------------|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact: | Erum B. Nasir |
| Email: | [e-mail] |
| Contact Phone Number: | [phone] x102607 |
| Contact Fax Number: | [phone] |

#### Device Information:

| Trade Name: | Entuit™ Start Initial Placement Gastrostomy Set |
|-----------------------|-------------------------------------------------|
| Common Name: | Gastrointestinal tube and accessories |
| Classification Name: | Tube, Gastro-Enterostomy |
| Regulation: | 21 CFR §876.5980 |
| Product Code: | KGC |
| Device Class: | II |
| Classification Panel: | Gastroenterology/Urology |

## Predicate Device:

The Entuit™ Start Initial Placement Gastrostomy Set is substantially equivalent to the Kimberly-Clark Introducer Kits (K080253), cleared by FDA on February 26, 2008.

# Device Description:

The Entuit™ Start Initial Placement Gastrostomy Set includes a heavy duty stainless steel polytetrafluoroethylene (PTFE) coated Amplatz extra stiff wire guide, dilators, and one or more Peel-Away® Introducers. Depending upon set specifications, two or three dilators

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2

Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017

may be included. The set also includes an entry access needle, scalpel, syringe, and gauze. The Entuit Start Initial Placement Gastrostomy Set is sterilized by ethylene oxide and intended for one-time use.

## Intended Use:

The Entuit™ Start Initial Placement Gastrostomy Set is intended to assist the physician with the initial placement of feeding tubes while performing a gastrostomy in adult patients only.

#### Comparison to Predicate Device:

The Entuit™ Start Initial Placement Gastrostomy Set and the predicate device, the Kimberly-Clark Introducer Kits (K080253), are substantially equivalent in that these devices are similar in intended use and principles of operation. The differences between the subject device and the predicate device, including the materials, dimensions, and components within the sets, do not raise any new issues of safety and effectiveness. The substantial equivalence comparison of the subject device to the predicate device is provided in the table below.

| | | Kimberly-Clark Introducer Kits<br>(K080253) | Entuit™ Start Initial Placement<br>Gastrostomy Set<br>(Subject of this submission) |
|----------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Regulation Number | 21 CFR §876.5980 | Identical |
| Product Code | | KGC | Identical |
| Classification | | Class II | Identical |
| | Intended Use | The Kimberly-Clark Introducer Kits are<br>intended to facilitate primary placement<br>of Kimberly-Clark, Kimberly-Clark<br>MIC and Kimberly-Clark MIC-KEY<br>brand of gastrostomy feeding tubes. | The Entuit Start Initial Placement<br>Gastrostomy Set is intended to assist<br>the physician with the initial placement<br>of feeding tubes while performing a<br>gastrostomy in adult patients only. |
| | Material | Unknown | Stainless Steel |
| Wire<br>Guide | Diameter<br>(inch) | 0.035 | 0.038 |
| | Length<br>(cm) | Unknown | 100 |
| Dilator | Diameter<br>(Fr) | Not included | 12, 14, 16, 18, 20, 22, 24 |
| | Length (cm) | Not included | 20 |
| | Shaft<br>Material | Not included | Polyethylene (12 Fr Dilator),<br>Polyvinyl chloride (14 - 24 Fr dilators) |
| | Hydrophilic<br>Coating | Unknown | Yes |

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| | | Kimberly-Clark Introducer Kits<br>(K080253) | Entuit™ Start Initial Placement<br>Gastrostomy Set<br>(Subject of this submission) |
|-------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Peel-Away<br>Introducer<br>(Sheath<br>and<br>Dilator) | Diameter<br>(Fr) | 16, 18, 20, 22, 24* | 16, 18, 20, 22, 26 |
| | Sheath<br>Material | NA | Polytetrafluoroethylene (PTFE) |
| | Sheath<br>Length (cm) | N/A | 15.5 (for 16 & 18 Fr)<br>13 (for 20 - 24 Fr) |
| | Dilator Shaft<br>Material | Unknown | Polyvinyl chloride |
| | Dilator<br>Length (cm) | N/A | 20 |
| | Compatible Gastrostomy<br>tube size (Fr) | 12, 14, 16, 18, 20 | 12, 14, 16, 18, 20, 22, 24 |
| Gastrointestinal Anchor<br>Set | | Gastrointestinal Anchor Set with Saf-T-<br>Pexy* T-Fasteners | Not included with set - FDA cleared<br>(K131201and K152524), sold<br>separately |
| Accessory components | | 18 g Safety introducer needle<br>Safety Scalpel No.11 Blade<br>12 ml syringe<br>Hemostat<br>Stoma Measuring Device | 18 g entry access needle<br>Safety Scalpel No.11 Blade<br>6cc syringe<br>Gauze** |
| | Packaging | Unknown | Tray: Polyethylene terephthalate<br>Pouch: Polyethylene, Tyvek<br>Spiral Holder: Polyethylene |
| | Sterilization | Ethylene oxide | Identical |
| | Sterility Assurance Level<br>(SAL) | Unknown | 10-6 |

*Device includes serial dilators with varying size increments.

**Stoma measuring device is cleared under K130674 and is sold separately.

## Technological Characteristics:

The subject Entuit™ Start Initial Placement Gastrostomy Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

- . Compatibility - (Peel away sheath and Gastrostomy Catheter, Dilator and Wire Guide, Needle and Wire Guide)
- Wire Guide Tensile ●
- Wire Guide Corrosion
- Wire Guide Flex ●
- Wire Guide Fracture .
- Dilator Shaft Tensile ●
- . Dilator Hub-to-Shaft Tensile

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Cook Incorporated - Traditional 510(k) Entuit Start Initial Placement Gastrostomy Set 14 SEP 2017

- . Peel-Away Introducer Shaft Tensile
- Peel-Away Introducer Knob-to-Shaft Tensile
- . Peel Force Testing
- Radiopacity Testing
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for ● cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, and acute systemic toxicity were performed to ensure the biocompatibility of the subject device set.

## Conclusion:

The results of these tests show that the Entuit™ Start Initial Placement Gastrostomy Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and support a determination of substantial equivalence.