(15 days)
Not Found
No
The device description and performance studies focus on mechanical components and suture delivery, with no mention of AI/ML terms or functionalities.
Yes
The device is described as being used for "treatment of symptomatic Gastroesophageal Reflux Disease," which indicates a therapeutic purpose.
No
The device description and intended use clearly indicate that the Bard® EndoCinch™ Suturing System is used for endoscopic placement of sutures and tissue approximation, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components (reusable handle, disposable capsule assembly, needle assembly, guidewire, etc.) and the performance studies describe testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endoscopic placement of sutures in the soft tissue of the esophagus and stomach for the treatment of symptomatic Gastroesophageal Reflux Disease. This is a surgical procedure performed directly on the patient's tissue.
- Device Description: The device is a multi-component system designed for performing a surgical procedure (suturing). It involves physical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health status. This device does not involve the analysis of biological specimens.
Therefore, the Bard® EndoCinch™ Suturing System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
ODE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus and stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
Page 2 -
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
2
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)
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
3
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 (978) 262-4866 (978) 262-4878 Beth A. Zis. R.A.C. November 17, 2000
Bard® EndoCinch™ Suturing System Suturing Device Endoscopes and accessories
082
4
- 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
5
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.