ENDOFLIP GASTRIC TUBE

K110529 · Crospon, Ltd. · KNT · Jul 22, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110529
• Device Name: ENDOFLIP GASTRIC TUBE
• Applicant: Crospon, Ltd.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jul 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

Device Story

EndoFLIP® Gastric Tube EF-900 is a single-lumen, 43 Fr, 75 cm disposable tube used during bariatric surgery. Functions as a support bougie; facilitates stomach decompression, gastric fluid drainage, and removal via distal side-holes. Aids deployment of specific EndoFLIP® catheters (EF-620, EF-325, BF-325). Used in hospitals and surgery centers by clinicians. Supplied non-sterile with a suction connector and depth markings at 20 cm and 70 cm. Provides mechanical support and fluid management during surgical procedures.

Clinical Evidence

Bench testing only. Testing included age testing, kink testing, and biocompatibility testing per ISO 10993-1. No clinical data presented.

Technological Characteristics

43 Fr single-lumen tube, 75 cm length. Materials: PVC with Duraglide/PTFE coating. Features distal side-holes for suction and proximal connector. Biocompatibility per ISO 10993-1. Non-sterile, single-patient use.

Indications for Use

Indicated for patients undergoing gastric and bariatric surgery requiring a bougie or suctioning capabilities. No contraindications.

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

• BioEnterics® Gastric Balloon Suction Catheter (K002838)

Reference Devices

• EndoFLIP® catheter (K092850)
• EndoFLIP® catheter (K102214)

Submission Summary (Full Text)

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K110529
PAGE 1 OF 3

510(k) Summary Page 1 of 3 17-Jun-11

JUL 222 2011

| Company | Crospon Ltd.<br>Galway Business Park<br>Dangan<br>Galway, Ireland<br><br>Tel - 011 [353] (91) 519882<br>Fax - 011 [353] (91) 519873 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea, Ph.D. |
| Proprietary or Trade Name: | EndoFLIP® Gastric Tube EF-900 |
| Common/Usual Name: | Gastrointestinal motility monitoring system |
| Classification / CFR: | KNT - CFR 876.1500 |
| Device: | EndoFLIP® Gastric Tube EF-900 |
| Predicate Devices: | K002838 - BioEnterics® Gastric Balloon Suction<br>Catheter |

#### Device Description:

The EndoFLIP® Gastric Tube is a simple single lumen tube which acts as a support bougie for a 43 Fr lumen and may be used to aid in the EndoFLIP® catheter, K092850 and K 102214, deployment. It may also be used for drainage, suction or irrigation as it is open at both ends and features a number of side-holes at the distal end. A connector is supplied to push-on the proximal end to aid attachment to a suction system. The tube is 75 cm long and markings are provided at 20 cm and 70 cm from the distal end. The EndoFLIP® Gastric Tube is supplied non-sterile and is single patient use, disposable. An alcohol swab is provided to wipe down the tube exterior prior to use.

#### Indications for Use:

The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

| Patient Population: | Patients undergoing gastric and bariatric surgery where a bougie<br>or suctioning capabilities are needed. |
|---------------------|------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Hospitals and Surgery Centers |
| Contraindications: | None |

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# KIIO529
PAGE 2 OF 3

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## 510(k) Summary

| | EndoFLIP® Gastric Tube<br>EF-900 | BioEnterics® Gastric Balloon<br>Suction Catheter<br>K002838 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attributes | | |
| Indications for Use | The EndoFLIP® EF-900 Gastric<br>Tube is intended for use in bariatric<br>surgical procedures to provide a sized<br>support bougie, and to permit<br>stomach decompression, gastric fluid<br>drainage and removal. It is also<br>intended for use to aid deployment of<br>EndoFLIP® EF-620, EF-325, and<br>BF-325 catheters. | Indicated for use in gastric and<br>bariatric surgical procedures to<br>provide visible and tactile delineation<br>of the antrum of the stomach along<br>with the ability to decompress and<br>remove gastric fluid and size a gastric<br>pouch. |
| Typical Use | Use in gastric and bariatric<br>surgical procedures | Use in gastric and bariatric<br>surgical procedures |
| Environments of use | Hospital and surgery centers | Hospital and surgery centers |
| Patient Population | All individuals undergoing gastric<br>and bariatric procedures | All individuals undergoing gastric<br>and bariatric procedures |
| Contraindications | None | None |
| Prescription | Prescription use | Prescription use |
| Functions | Suction<br>Drainage | Suction<br>Drainage |
| Intraoperative use | Yes | Yes |
| French Size | 43 Fr | 40 - 56 Fr |
| Design | | |
| Tube | Length -750 mm<br>14.3 mm OD | Length - 685 mm<br>13.3 mm OD |
| Side holes at distal end<br>for suctioning | Yes | Yes |
| Depth markings | Yes | Yes |
| Connector for suction | Yes | Yes |
| Sterility | Supplied non-sterile, and are<br>single patient use, disposable | Supplied non-sterile, and are<br>single patient use, disposable |
| Performance | Age testing | N/A |
| Materials used | Tube -- PVC with<br>Duraglide/PTFE coating | Not identified |
| Biocompatibility | Tested according to ISO 10993-1 | ISO 10993-1 |

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#### 510(k) Summary Page 3 of 3 17-Jun-11

#### Substantial Equivalence:

The EndoFLIP® Gastric Tube is viewed as substantially equivalent to the predicate device because:

#### Indications -

Similar to predicate - K002838 - BioEnterics® Gastric Balloon Suction Catheter - Indicated for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. In both cases the intended use is to assist the clinician in gastric and bariatric procedures.

It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

#### Technology -

Similar to predicate - K002838 - BioEnterics® Gastric Balloon Suction Catheter except the proposed device does not have a balloon which is unnecessary for the intended use i.e. the balloon is specifically purposed for sizing the pouch created during a gastric band placement, whereas the EF-900 is not used for the creation of such pouches.

#### Materials -

The materials in contact with the patient have been tested per ISO 10993.

#### Environment of Use -

Identical to predicate -K002838 - BioEnterics® Gastric Balloon Suction Catheter.

#### Patient Population -

Identical to predicate - K002838 - BioEnterics® Gastric Balloon Suction Catheter.

#### Performance Testing -

We did perform age testing, ISO 10993 testing for material biocompatibility, and a kink test. The proposed device meets its performance specifications and does not raise any new safety or efficacy issues.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three stylized wings or feathers.

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

Crospon, Ltd. % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL .34134-2958

JUL 2 2 2011

Re: K110529

Trade/Device Name: EndoFLIP® EF-900 Gastric Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 17, 2011 Received: June 20, 2011

Dear Mr. Dryden:

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 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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default:htm.

Sincerely yours,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) 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 Statement

Page 1 of 1

510(k) Number:

Device Name:

K110529

EndoFLIP® EF-900 Gastric Tube

Indications for Use:

The EndoFLIP® EF-900 Gastric Tube is intended for use in bariatric surgical procedures to provide a sized support bougie, and to permit stomach decompression, gastric fluid drainage and removal. It is also intended for use to aid deployment of EndoFLIP® EF-620, EF-325, and BF-325 catheters.

Prescription Use (Part 21 CFR 801 Subpart D)

or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sigh-Off of Reproductive, Gastro-Rena 10(k) Numbe

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