EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES

K071651 · Endogastric Solutions, Inc. · ODE · Sep 14, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071651
• Device Name: EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIES
• Applicant: Endogastric Solutions, Inc.
• Product Code: ODE · Gastroenterology, Urology
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Device Story

EsophyX System with SerosaFuse fasteners is an endoscopic tissue approximation/plication system. Device uses stainless steel helix or suction to grasp GI tract tissue; operator manually actuates handle to deploy sterile polypropylene fasteners via a stylet, pusher, and lumen delivery subsystem. Used transorally by physicians to perform full-thickness plication and ligation. Enables narrowing of gastroesophageal junction and reduction of hiatal hernias ≤ 2cm. System provides mechanical tissue fixation to treat symptomatic chronic GERD in patients responsive to pharmacological therapy. Single-use, sterile device.

Clinical Evidence

No clinical data provided; substantial equivalence based on intended use, descriptive information, and performance evaluation.

Technological Characteristics

System consists of sterile polypropylene fasteners and a flexible delivery device. Delivery mechanism utilizes stainless steel helix or suction for tissue grasping. Fastener delivery subsystem includes a stylet, pusher, and lumen. Device is single-use and provided sterile. No software or electronic components.

Indications for Use

Indicated for patients with symptomatic chronic gastroesophageal reflux disease (GERD) who require and respond to pharmacological therapy. Used for endoluminal, transoral tissue approximation, full thickness plication, and ligation in the GI tract; narrowing the gastroesophageal junction; and reducing hiatal hernia ≤ 2cm.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• NDO Surgical Endoscopic Plication System (K023234)
• Bard Endoscope Suturing System (K994290)
• Bard EndoCinch (K003956)
• EGS StomaphyX endoluminal fastener and delivery system (K062875)

Submission Summary (Full Text)

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#### 510(k) SUMMARY 3

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

> SEP 1 4 2007 510(k) Number: K071651

## Applicant Information:

| Date Prepared: | June 14, 2007 |
|-------------------|-----------------------------------------------------------------------------------------|
| Date Revised | September 12, 2007 |
| Name: | EndoGastric Solutions, Inc. |
| Address: | 8210 154th Avenue N.E.<br>Redmond, WA 98052<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Michael A. Daniel |
| Phone Number: | Office: 925-254-5228 / Cell 415-407-0223 |
| Facsimile Number: | [phone] |

#### Device Information:

| Classification: | Class II |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™<br>Fastener and accessories |
| Common Name: | Endoscopic tissue approximation/plication system |
| Classification Name: | Nonabsorbable Polypropylene Surgical Suture GAW / 21 CFR 878.5010<br>Endoscopic Suture/Plication System, (GERD) ODE / 21 CFR 876.1500<br>Endoscopic Tissue Approximation Device OCW / 21 CFR 876.1500 |

#### Predicate Devices:

The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener and accessories is substantially equivalent in intended use and method of operation to a combination of the following predicate devices:

| NDO Surgical Endoscopic Plication System | K023234 |
|--------------------------------------------------------------|-------------------|
| Bard Endoscope Suturing System / Bard EndoCinch | K994290 / K003956 |
| EGS StomaphyX TM endoluminal fastener and delivery system | K062875 |

EndoGastric Solutions, Inc. 510(k) Submission.

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## Device Description:

The EndoGastric Solutions SerosaFuse™ implantable fasteners, and associated EsophyX delivery device and accessories consist of sterile polypropylene fastener implants and an ergonomic, flexible fastener delivery device. The fasteners and delivery devices are provided sterile and are for single use. The polypropylene fasteners are proprietary and function only with the EGS delivery devices. The delivery devices use either a stainless steel helix or suction to grasp tissue and fasten it using the SerosaFuse polypropylene fasteners. The fastener delivery subsystem comprises 3 elements: stylet, pusher, and a lumen. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

## Intended Use:

The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

## Comparison to Predicate Device(s):

The design of the EndoGastric Solutions SerosaFuse™ implantable fasteners, associated delivery devices and accessories is similar to the predicates listed in that they are all devices designed to reach the desired suture location under endoscopic visualization, grasp tissue and place sutures/clips in a desired location. All products are re-loadable for repeat fastener/suture/clip placement. The products all share common features such as a sterile, stainless steel needle (called a stylet in the EGS delivery devices) housed in a suture loading unit (the delivery device), They all deliver fastener/suture/clips through soft tissue by manually actuating the needle with a handle mechanism. All devices are packaged sterile and are for single patient use. Further, the EndoGastric Solutions SerosaFuse™ implantable fasteners, associated delivery devices and accessories and the predicate devices have the same or similar intended use.

#### Summary:

Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the EndoGastric Solutions SerosaFuse™ implantable fasteners, associated delivery devices and accessories have been shown to be substantially equivalent to currently marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# SEP 1 4 2007

Mr. Michael A. Daniel Vice President, Regulatory and Clinical Affairs EndoGastric Solutions™, Inc. 8210 154th Avenue, N.E. REDMOND WA 98052

Re: K071651

Trade/Device Name: EsophyX™System with EGS SerosaFuse™ Fasteners and accessories Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: June 15, 2007 Received: June 18, 2007

Dear Mr. Daniel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a black and white seal for the FDA Centennial 1906-2006. The seal is circular with text around the perimeter. The center of the seal has the letters FDA in a stylized font with the word Centennial underneath. There are three stars below the word Centennial.

Protecting and Promoting Public Health

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#### Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K07/65/

EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Device Name: Fastener and accessories

#### Indications For Use:

The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/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)

Herbert Lehman

(Division Sign-Off Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

Page 1 of 1

EndoGastric Solutions, Inc. 510(k) Submission. June 15, 2007.