(222 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to a predicate device, with no mention of AI or ML.
No
The device is described as a surgical instrument used for grasping, holding, and manipulating soft tissues during surgery, which are interventional actions, not therapeutic ones.
No
The device description indicates that the Miret surgical instruments are used to "grasp, hold and manipulate soft tissues" during surgery. This is an interventional or surgical function, not a diagnostic one. While they may access "certain areas of the human anatomy," their purpose is manipulation, which is not diagnostic.
No
The device description explicitly states it is fabricated from a stainless steel alloy and consists of physical components like a shaft, working instrument, handle, and locking mechanism. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Miret Surgical Instruments Function: The description clearly states that these instruments are used to "penetrate soft tissue to access certain areas of the human anatomy" and "grasp, hold and manipulate soft tissues" within the body during surgical procedures.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimens with this device.
The Miret Surgical Instruments are surgical tools used for direct manipulation of tissue in vivo, not for diagnostic testing of samples in vitro.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OCW
Device Description
Fabricated from a stainless steel alloy, Miret Surgical Instruments are single-use disposable devices designed for grasping, holding and manipulating tissue. They consist of an integrated needle/cannula shaft that attaches to a working instrument. The shaft can be introduced percutaneously to the surgical site, after which the working instrument can be operated. The working instrument is controlled through a handle and locking mechanism on the proximal end of the device. The Miret Surgical Instruments can be used in a variety of surgical applications, including laparoscopic surgery after insufflation, and are available in either a Maryland or Alligator grasper configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Results:
- Ability of grasper to grip tissue: Equivalent or better
- Ability to actuate grasper after navigation to surgical site: Equivalent or better
- Simulated use: Equivalent or better
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
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
1
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 (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" (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 (800) 638-2041 or (301) 796-7100 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 | |
| CEO, Miret Surgical | ||
| 205 E. Butterfield Road, Suite 457 | ||
| Elmhurst, IL 60126 | ||
| 650-867-2820 | ||
| roop@miretsurgical.com | ||
| 510(k) Consultant Contact: | Jerzy Wojcik | |
| Sr. Director RA/QA, EdgeOne Medical | ||
| 455 N Campbell Ave, Suite 2N | ||
| Chicago, IL 60612 | ||
| 312-300-6643 | ||
| jerzy.wojcik@edgeonemdical.com | ||
| Device Name: | Device Name: | Miret Surgical Instruments |
| Trade Name: | Miret Surgical Instruments | |
| Common Name: | Endoscopic tissue approximation | |
| 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 | |
| Instruments are single-use disposable devices designed for | ||
| grasping, holding and manipulating tissue. They consist of an | ||
| integrated needle/cannula shaft that attaches to a working | ||
| instrument. | ||
| The shaft can be introduced percutaneously to the surgical | ||
| site, after which the working instrument can be operated. The | ||
| working instrument is controlled through a handle and | ||
| locking mechanism on the proximal end of the device. The | ||
| Miret Surgical Instruments can be used in a variety of | ||
| 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 | |
| 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.