SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE

K023843 · Opus Medical, Inc. · OCW · Feb 14, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K023843
• Device Name: SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE
• Applicant: Opus Medical, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Feb 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SmartStitch Suture Device: The Opus SmartStitch M-Connector (Model #OM-8005) is indicated for use with a Actuation Handle (Model #OM-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures. SmartStitch Sutures: The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

Device Story

The Opus SmartStitch Suture Device is a mechanical surgical instrument used for soft tissue approximation and ligation. It consists of an actuation handle, an M-connector, and suture cartridges containing #2 braided polyester suture. The device is designed for use in endoscopic and other limited access surgical procedures. The surgeon operates the handle to deploy the suture through soft tissue. The device facilitates tissue repair by enabling suture placement in confined spaces where traditional suturing may be difficult. It is intended for use by trained healthcare professionals in a clinical or surgical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design characteristics.

Technological Characteristics

Mechanical suture delivery system comprising an actuation handle, M-connector, and suture cartridges. Utilizes #2 braided polyester suture. Designed for endoscopic and limited access surgical use. No electronic, software, or energy-based components.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, ophthalmic, orthopedic, and neurological procedures, and for suture placement in endoscopic or limited access procedures. No specific age or gender restrictions noted.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

·JUL 2 7 2015

Opus Medical, Inc. James W. Hart President/CEO 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, CA 92675

Re: K023843

> Trade/Device Name: Opus SmartStitch® Suture Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCW Dated (Date on orig SE ltr): November 14, 2002 Received (Date on orig SE ltr): November 18, 2002

Dear Mr. Hart,

This letter corrects our substantially equivalent letter of February 14, 2003.

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 (OS) 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): k023843

Device Name:

SmartStitch® Suture Device

Indications for Use:

SmartStitch Suture Device:

The Opus SmartStitch M-Connector (Model #OM-8005) is indicated for use with a Actuation Handle (Model #OM-8500) and Suture Cartridges (Models #OM-8051, -8052, -8053) for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

SmartStitch Sutures:

The Opus Polyester Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, orthopedic, and neurological procedures.

Miriam L. Provost

vision Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023843

(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 _