BARD ENDOSCOPIC SUTURING SYSTEM

K994290 · C.R. Bard, Inc. · ODE · Mar 20, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994290
• Device Name: BARD ENDOSCOPIC SUTURING SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: ODE · Gastroenterology, Urology
• Decision Date: Mar 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® Endoscopic Suturing System is used for endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for the approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

Device Story

Bard® Endoscopic Suturing System; endoscopic device for placing sutures in esophagus/stomach soft tissue. Components: capsule assembly with suction tubing, fixed head knot pusher, needle assembly, pusher wire, guidewire, suture cutter, suture loader, syringe, and detachable knot pusher handle. Operates via flexible endoscope; needle assembly/accessories pass through biopsy channel. Physician manually actuates needle via handle mechanism under endoscopic visualization to place stitches and tie sutures. Enables multiple stitch delivery. Used in clinical setting for tissue approximation to treat symptomatic GERD. Benefits patient by providing minimally invasive endoscopic alternative to traditional surgery for reflux management.

Clinical Evidence

Supported by biocompatibility testing, in vitro bench testing, animal studies, and human clinical experience. Biocompatibility confirmed non-toxic/non-reactive materials. Bench testing confirmed performance against specifications. Animal studies demonstrated safe, consistent suture placement without complications. Clinical evidence includes a 64-patient prospective randomized investigation and non-U.S. patient experience, supporting safety and effectiveness for the intended use.

Technological Characteristics

Materials: medical grade stainless steel and plastics. Principle: manual needle actuation via handle mechanism. Form factor: capsule assembly with suction tubing, needle assembly, pusher wire, guidewire, suture cutter, and knot pusher. Connectivity: none (manual). Sterilization: sterile. Software: none.

Indications for Use

Indicated for endoscopic placement of sutures in esophageal and stomach soft tissue and tissue approximation for treatment of symptomatic Gastroesophageal Reflux Disease.

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

• Auto Suture™ ENDO STITCH™ Suturing Device (K934738)
• ENDOPATH® Endoscopic Suturing System (K980022)

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

C. R. Bard, Inc. Bard Interventional Products Division Ms. Beth A. Zis Regulatory Affairs Manager 129 Concord Road, Building #3 P.O. Box 7031 Billerica, MA 01821-7031

JUL 2 7 2015

Re: K994290

> Trade/Device Name: Endoscopic Suturing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated (Date on orig SE ltr): December 20, 1999 Received (Date on orig SE ltr): December 21, 1999

Dear Ms. Zis,

This letter corrects our substantially equivalent letter of March 20, 2000.

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

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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 (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 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. 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/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 Radiological Health

Enclosure

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# K994290

# 510(k) Number (if known): Not Known

Device Name: Bard® Endoscopic Suturing System

- For endoscopic placement of suture(s) in the soft tissue of the Indications for Use: esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.
## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** X
(Per 21 CFR 801.109)

OR

Over-the-Counter Use __

NPS (Optional Format 1-2-96)
(Division Sign-Off)

| Division of General Restorative Devices | K 994290 |
|-----------------------------------------|----------|
| 510(k) Number | |

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**MAR 20 2000**

# K994290 (P.10F3)

Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road, Bldg #3 P.O. Box 7031 Billerica, MA 01821-7031 978-663-8989

Image /page/3/Picture/3 description: The image shows the word "BARD" in a stylized, bold font. The letters are outlined in black, giving them a distinct and prominent appearance. The font style is unique, with the "A" resembling an upside-down "V" with a horizontal line through it.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION VI.

As required under Section 513(i)(3)(A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting the safety and effectiveness follows:

### General Information A.

| Name and Address of Submitter: | | Bard Interventional Products<br>Division, C. R. Bard, Inc.<br>129 Concord Road, Building #3<br>Billerica, MA 01821-7031 | | |
|-------------------------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|--|----------|
| Contact: | | Beth A. Zis, R.A.C.<br>Manager of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | |
| Date of Summary: | | December 6, 1999 | | |
| Name of Device:<br>Trade Name/Proprietary Name: | | Bard® Endoscopic Suturing System | | |
| Common Usual Name: | | Endoscopic Suture Device | | |
| Classification Name: | | 78KOG - Endoscopic Suture Device | | |
| B. | Predicate Devices: | | | |
| | Company | Trade Name | | 510(k)# |
| | 1. U. S. Surgical Corp. | Auto Suture™<br>ENDO STITCH™<br>Suturing Device | | #K934738 |
| | 2. Ethicon Endo-Surgery, Inc. | ENDOPATH® Endoscopic<br>Suturing System | | #K980022 |
| C. | Description | | | |

The Bard® Endoscopic Suturing System consists of a capsule assembly with suction tubing and a fixed head knotpusher that attaches to the distal end of a

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994290 (P.2 of 3)

flexible endoscope or a through-the-scope knot pusher, plus a needle assembly, pusher wire, guidewire and suture cutter that all pass through an endoscope's biopsy channel. Also, included is a suture loader to facilitate loading suture tags into the needle, a syringe for flushing the suction tubing, and an detachable knot pusher handle. Only Bard® Suture Tags and the Bard® Endoscopic Handle may be used with the Bard® Endosocpic Suturing System.

### D. Intended Use:

The Bard® Endoscopic Suturing System is used for endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for the approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

### E. Technological Characteristics Summary:

The technological characteristics of the Bard® Endoscopic Suturing System is the same or similar to the predicate devices, in that the materials used to manufacture these products are the same type of medical grade stainless steels and plastics. The products all share common features such as a sterile, stainless steel needle housed in a capsule or suture loading unit at the distal end of the device. They all suture soft tissue by manually actuating the needle with a handle mechanism. They all are designed to allow reloading of sutures to deliver multiple stitches under endoscopic visualization. Further, the Bard® Endoscopic Suturing System and the predicated devices have the same or similar intended use, that is to place stitches and tie suture material to approximate soft tissue under endoscopic visualization.

#### F. Performance Data:

Biocompatibility, in vitro bench testing, animal and clinical testing has been completed and supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use.

The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-reactive to biologic tissues consistent with their intended use.

Bench test results show that the materials chosen and the design utilized in manufacturing the Bard® Endoscopic Suturing System, meet the established specifications necessary for consistent performance during their intended use.

The animal studies support the safety and effectiveness of the Bard® Endoscopic Suturing System. The studies document there were no complications/adverse reactions reported, and that the system is capable of safely and consistently placing sutures in the soft tissues within the stomach and esophagus.

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K994294 (P.3 of 3)

Finally, the summary of human clinical experience under a 64 patient prospective randomized investigation and the non-U. S. patient experience supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use.

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