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 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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Bard® Endoscopic Suturing System, indicating its substantial equivalence to predicate devices. It does not contain the specific acceptance criteria or a detailed study justifying how the device meets those criteria, largely because 510(k) submissions typically focus on demonstrating equivalence rather than establishing new safety and effectiveness through extensive performance studies against pre-defined acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred regarding performance data:

The document states: "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."

Here's an attempt to structure the answer based on the prompt's requirements, noting significant limitations due to the nature of the provided text:

Acceptance Criteria and Device Performance Study for Bard® Endoscopic Suturing System

1. Table of Acceptance Criteria and Reported Device Performance

Performance Criterion	Acceptance Criteria	Reported Device Performance
Biocompatibility	Not explicitly stated (implied to meet relevant biocompatibility standards)	"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 Testing	Established specifications for consistent performance	"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."
Animal Studies	Safety and effectiveness in placing sutures in soft tissues without complications/adverse reactions	"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."
Human Clinical Experience	Safety and effectiveness for its intended use	"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."

2. Sample Size Used for the Test Set and Data Provenance

Human Clinical Experience (Test Set): 64 patients.
Data Provenance: "64 patient prospective randomized investigation" (likely multi-center or within a specific region, though not explicitly stated as US or international for this specific 64-patient cohort). There was also "non-U. S. patient experience" mentioned, indicating some international data. The study type is explicitly prospective and randomized.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The document describes a clinical investigation but does not detail how the clinical outcomes (ground truth) were adjudicated or by whom.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. The device is an endoscopic suturing system, not an imaging AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The clinical study mentioned is for the device's performance, not an AI component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Bard® Endoscopic Suturing System is a medical device used by a human operator, not an autonomous algorithm.

7. Type of Ground Truth Used

Clinical Outcomes/Safety and Effectiveness: For the human clinical experience and animal studies, the "ground truth" would be related to clinical endpoints such as:
- Absence of complications/adverse events.
- Successful placement of sutures.
- Approximation of tissue.
- Treatment of symptomatic Gastroesophageal Reflux Disease.
- These are based on observations, clinical assessments, and potentially follow-up data from the patients and animals.

8. Sample Size for the Training Set

This information is not provided and is not applicable in the context of this device. "Training set" refers to data used to train machine learning models. This device is a mechanical/manual instrument, not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the reasons stated above.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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 ProductsDivision, C. R. Bard, Inc.129 Concord Road, Building #3Billerica, MA 01821-7031
Contact:		Beth A. Zis, R.A.C.Manager of Regulatory AffairsPhone: (978) 262-4866Fax: (978) 262-4878
Date of Summary:		December 6, 1999
Name of Device: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™ENDO STITCH™Suturing Device	#K934738
	2. Ethicon Endo-Surgery, Inc.	ENDOPATH® EndoscopicSuturing 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:

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.

. ·

. . .

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.