CURVILINEAR SUTURE PLACEMENT SYSTEM

K973415 · Laurus Medical Corp. · GCJ · Dec 2, 1997 · Gastroenterology, Urology

Device Facts

Record IDK973415
Device NameCURVILINEAR SUTURE PLACEMENT SYSTEM
ApplicantLaurus Medical Corp.
Product CodeGCJ · Gastroenterology, Urology
Decision DateDec 2, 1997
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 876.1500
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Laurus Medical Curvilinear Suture Placement System is indicated for the placement of suture in a variety of Transvaginal procedures such as prolapse repair, cystourethropexy, and bladder neck stabilization; through Cooper's Ligament alone and/or in conjunction with non-device suturing procedures for the correction of urinary stress incontinence: for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Story

The Curvilinear Suture Placement Device is a surgical instrument used by physicians in a clinical or OR setting to facilitate suture placement during transvaginal procedures. The device assists in navigating anatomical structures, specifically Cooper's Ligament, to anchor sutures for prolapse repair or bladder neck stabilization. By providing a curvilinear path for the needle/suture, the device enables precise placement in difficult-to-access pelvic areas. This aids the surgeon in correcting urinary stress incontinence and urethral hypermobility. The device is a mechanical tool; it does not utilize electronic processing, software, or AI. It functions as a manual surgical aid to improve the efficiency and accuracy of suture delivery, potentially reducing procedure time and improving patient outcomes in incontinence repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical surgical instrument designed for curvilinear suture delivery. No electronic components, software, or energy sources. Materials and sterilization methods are consistent with standard surgical instrumentation for transvaginal use.

Indications for Use

Indicated for female patients undergoing transvaginal procedures including prolapse repair, cystourethropexy, and bladder neck stabilization, or correction of urinary stress incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.

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.

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Lorraine M. Hanley Microvasive Urology Division Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 DEC - 2 1997 Re: K973415 Trade Name: Curvilinear Suture Placement Device Regulatory Class: II Product Code: GCJ Dated: September 4, 1997 Received: September 9, 1997 Dear Ms. Hanley: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ Page 2 - Ms. Lorraine M. Hanley This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, tco.eele 2 Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 1 1 : 4 : 4 : Image /page/2/Picture/3 description: The image shows a series of bold, black brushstrokes against a white background. The strokes appear to form abstract shapes, possibly resembling characters or symbols. The overall impression is one of dynamic energy and expressive mark-making. 510(k) Submission Curvilinear Suture Placement System 09/94/97 Page 33 > Page of ## 510(k) Number (if known): K973415 Curvilinear Suture Placement Device Device Name: The Laurus Medical Curvilinear Suture Placement System Indications For Use: is indicated for the placement of suture in a variety of Transvaginal procedures such as prolapse repair, cystourethropexy, and bladder neck stabilization; through Cooper's Ligament alone and/or in conjunction with non-device suturing procedures for the correction of urinary stress incontinence: for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Or Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use ccell (Optional Format 1-2-96) (Division Sign-Off) Division of General Restorative Devices, 510(k) Number. K-973415
Innolitics
510(k) Summary
Decision Summary
Classification Order
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