Miret Grasper, Alligator, Miret Grasper, Maryland

K160149 · Miret Surgical, Inc. · OCW · Aug 30, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160149
• Device Name: Miret Grasper, Alligator, Miret Grasper, Maryland
• Applicant: Miret Surgical, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: Aug 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Miret Surgical Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.

Device Story

Miret Surgical Instruments are single-use, disposable, minimally invasive surgical tools. They consist of an integrated needle/cannula shaft and a working instrument (Maryland or Alligator grasper) controlled by a proximal handle and locking mechanism. The device is introduced percutaneously to the surgical site. Operated by a surgeon during laparoscopic or other minimally invasive procedures, the device allows for the grasping, holding, and manipulation of soft tissues. The mechanical action of the grasper is controlled manually by the clinician. The device facilitates tissue management during surgery, potentially improving surgical access and control in minimally invasive environments.

Clinical Evidence

Bench testing only. Performance evaluation included testing the ability of the grasper to grip tissue and the ability to actuate the grasper after navigation to the surgical site. Simulated use testing was also conducted. All results demonstrated performance equivalent or superior to the predicate device.

Technological Characteristics

Constructed from stainless steel alloy and plastic handles. Manual mechanical actuation via proximal handle and locking mechanism. Single-use, disposable, sterile. Form factor includes integrated needle/cannula shaft for percutaneous access. No electronic or software components.

Indications for Use

Indicated for use in minimally invasive surgical procedures, including laparoscopic surgery, to grasp, hold, and manipulate soft tissues in patients requiring such intervention.

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.

Predicate Devices

• MINI LAP INSTRUMENTS (K070686)

Submission Summary (Full Text)

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

August 30, 2016

Miret Surgical Inc. % Jerzy Wojcik EdgeOne Medical 455 N Campbell Ave, #2N Chicago. Illinois 60612

Re: K160149

Trade/Device Name: Miret Surgical Instruments (Miret Grasper, Alligator; and Miret Grasper, Maryland) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OCW Dated: August 15, 2016 Received: August 16, 2016

Dear Jerzy Wojcik:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K160149

Device Name Miret Surgical Instruments

Indications for Use (Describe)

The Miret Surgical Instruments are a family of minimally invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------------|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

| Date Summary Prepared: | January 18, 2016 | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| 510(k) Owner: | Miret Surgical Inc | |
| Contact Person: | Avi Roop<br>CEO, Miret Surgical<br>205 E. Butterfield Road, Suite 457<br>Elmhurst, IL 60126<br>650-867-2820<br>[e-mail] | |
| 510(k) Consultant Contact: | Jerzy Wojcik<br>Sr. Director RA/QA, EdgeOne Medical<br>455 N Campbell Ave, Suite 2N<br>Chicago, IL 60612<br>312-300-6643<br>[e-mail] | |
| Device Name: | Device Name: | Miret Surgical Instruments |
| | Trade Name: | Miret Surgical Instruments |
| | Common Name: | Endoscopic tissue approximation<br>device |
| | Classification: | 876.1500 |
| | Class: | 2 |
| | Product Code: | OCW |
| Predicate Device(s): | Primary Predicate | |
| | K070686 | MINI LAP INSTRUMENTS |
| Device Description: | Fabricated from a stainless steel alloy, Miret Surgical<br>Instruments are single-use disposable devices designed for<br>grasping, holding and manipulating tissue. They consist of an<br>integrated needle/cannula shaft that attaches to a working<br>instrument.<br>The shaft can be introduced percutaneously to the surgical<br>site, after which the working instrument can be operated. The<br>working instrument is controlled through a handle and<br>locking mechanism on the proximal end of the device. The<br>Miret Surgical Instruments can be used in a variety of<br>surgical applications, including laparoscopic surgery after | |

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insufflation, and are available in either a Maryland or Alligator grasper configuration.

- The Miret Surgical Instruments are a family of minimally Statement of Intended Use: invasive devices with the means to penetrate soft tissue to access certain areas of the human anatomy. The devices are used to grasp, hold and manipulate soft tissues.
The proposed Miret Surgical Instruments have the same Comparison of Technological Characteristics with Predicate technology, indications and fundamental characteristics as the predicate. Both are intended to be used in minimally invasive Devices: surgeries. Both are composed of patient contact metal with plastic handles and achieve the same function of opening and closing the graspers by hand operation. Both are available in various grasper designs such as Maryland or Alligator, and are sterile, single-use, disposable devices.

Non-Clinical Performance Data: Non-clinical performance testing was performed to verify that the performance of the Miret Surgical Instrument is substantially equivalent to currently marketed laparoscopic instrument, and specifically substantially equivalent to the MINI LAP Instruments (K070686).

| Evaluation | Conclusion |
|-----------------------------------------------------------------|----------------------|
| Ability of grasper to grip tissue | Equivalent or better |
| Ability to actuate grasper after<br>navigation to surgical site | Equivalent or better |
| Simulated use | Equivalent or better |

- Overall Conclusions: Based on the indications for use. technological characteristics, and comparison to predicate devices, the Miret Surgical Instruments have been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.