BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595

K003956 · C.R. Bard, Inc. · ODE · Jan 5, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K003956
• Device Name: BARD ENDOCINCH SUTURING SYSTEM # 000452; 000454; 000595
• Applicant: C.R. Bard, Inc.
• Product Code: ODE · Gastroenterology, Urology
• Decision Date: Jan 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

For endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

Device Story

The Bard® EndoCinch™ Suturing System is a multi-component endoscopic device used by physicians to place sutures in esophageal and gastric soft tissue for tissue approximation. The system comprises a reusable handle, disposable capsule assembly, needle assembly, guidewire, pusher wire, clip delivery device, and suture components. The physician operates the device endoscopically; manual actuation of the handle deploys a suture clip that secures the suture ends and cuts the suture, replacing traditional knot-tying methods. This mechanism reduces the number of endoscope intubations required compared to previous methods. By approximating tissue, the device aims to treat symptomatic Gastroesophageal Reflux Disease, potentially providing a minimally invasive alternative to surgical intervention.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated the suture clips against the predicate polypropylene knot. Testing confirmed suture security under simulated conditions of food swallowing, lower esophageal sphincter forces, and gastric environment. Mechanical testing included tensile testing of critical joints in the clip delivery device. Procedural efficiency testing demonstrated that the clip delivery system requires three endoscope intubations compared to nine for the predicate knot-tying method.

Technological Characteristics

Multi-component system including reusable handle and disposable assemblies (capsule, needle, clip delivery). Fixation mechanism uses a mated ring and plug suture clip to secure suture ends. Manual actuation of the handle performs both clip fixation and suture cutting. Replaces traditional knot-tying. Materials include polypropylene suture components. System is designed for use with an endoscope.

Indications for Use

Indicated for patients with symptomatic Gastroesophageal Reflux Disease requiring endoscopic tissue approximation in the esophagus and stomach.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Bard® Endoscopic Suturing System
• Y-Knot Suture Clip (Innovasive Devices, Inc.)
• SutureLok (Smith & Nephew, Inc., Endoscopy Division)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

C. R. Bard, Inc. % Mr. Peter N. Ruys N. V. Kema Utrechtseweg 310 NL-6812 AR Arnhem The Netherlands

JUL 2 7 2015

K003956 Re:

> Trade/Device Name: Bard® EndoCinch™ 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): November 27, 2000 Received (Date on orig SE ltr): December 21, 2000

Dear Mr. Ruys,

This letter corrects our substantially equivalent letter of January 5, 2001.

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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510(k) Number (if known):

Bard® EndoCinch™ Suturing System Device Name:

(003956

For endoscopic placement of suture(s) in the soft Indications For Use: tissue of the 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---------------------------------------|----|--------------------------|
| | | (Optional Format 1-2-96) |

Miriam C. Provost for

| (Division Sign-Off) | C. Witten |
|---------------------------------|-----------|
| Division of Restorative Devices | |
| (510(k)) Number | K003956 |

016

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K003956 (1 of 3)

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

BARD

# VI 510(k) SUMMARY SAFETY AND EFFECTIVENESS INFORMATION

JAN - 5 2001

As required by the Safe Medical Devices Act of 1990, codified under Section 513, Part (i)(3)(A) of the Food Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based follows.

# A. Submitter Information Submitter's Name:

Address:

- Phone: Fax: Contact Person: Date of Preparation:
Common/Usual Name:

Classification Name:

B. Device Name Trade Name:

Bard Interventional Products C.R. Bard, Inc. 129 Concord Road, Bldg. #3 Billerica. MA 01821 [phone] [phone] Beth A. Zis. R.A.C. November 17, 2000

Bard® EndoCinch™ Suturing System Suturing Device Endoscopes and accessories

082

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- C. Predicate Device Name(s) Trade Name:
Bard® Endoscopic Suturing System Bard Interventional Products, Division of C. R. Bard, Inc.

Y-Knot Suture Clip Innovasive Devices, Inc.

SutureLok Smith & Nephew, Inc., Endoscopy Division

- D. Device Description:
The Bard® EndoCinch™ Suturing System is a multi-component system consisting of a reusable handle, disposable capsule assembly, needle assembly, guidewire, pusher wire, clip delivery device, suture clip loader, suture clips, suture loader, suture loop tools and suture tag assemblies. Only the Bard® Endoscopic Handle and Bard® Suture Tags may be used with the Bard® EndoCinch™ Suturing System.

## E. Intended Use:

For endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.

## F. Technological Characteristics Summary:

The Bard EndoCinch Suturing System is substantially equivalent to the Bard Endoscopic Suturing System. The system will now contain a clip delivery device and suture clips to secure the suture. The ring and plug of the suture clip are mated together to secure the two ends of the suture through manual actuation of the handle. This fixation, like the predicate devices, replaces

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K003956 (3 of 3)

the knot component of the suture tag assembly. The clip delivery device also will cut the suture once the suture clip is secured by manually actuating the handle. The suture clips and delivery device will replace the current suture cutter and knot pushing devices contained in the kit. The remaining components of the current suture kit and the reusable handle are not changing.

G. Performance Data

Comparative performance testing was done, where appropriate, between the proposed EndoCinch™ suture clips and the current polypropylene knot. The clip delivery device was tested to assure that the suture clips can be delivered to cinch and cut the suture and the critical joints of the clip delivery device underwent tensile testing.

Comparative testing of the suture clips to the current knot demonstrated that the suture remains secure when exposed to the simulated conditions of food swallowing, lower esophaged sphincter forces and the gastric environment without degradation or loss of integrity.

Testing also demonstrated that the suture clip can be delivered to the intended location, and can secure and cut the suture in three versus nine intubations of the endoscope as compared to the current knot tying method used.