(120 days)
K150127 Laparoscopic Handles with PEEK Insulation
No
The device description and performance studies focus on mechanical, electrical, and sterilization properties of manual surgical instruments, with no mention of AI or ML.
No.
The device is a surgical instrument used to perform procedures like cutting and grasping, which are surgical actions rather than therapeutic treatments.
No
The device is described as a laparoscopic surgical manual instrument used for cutting, grasping, dissecting, retracting, and manipulating functions during surgery. It is a surgical tool, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components (handle, shaft, inserts) and mentions mechanical and electrical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a laparoscopic surgical manual instrument used for performing surgical functions (cutting, grasping, dissecting, etc.) within the body during endoscopic procedures.
- Device Description: The description details a surgical instrument with a handle, shaft, and inserts for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) outside the body to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
The device described is a surgical tool used directly on the patient during a procedure, which falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.
The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing including biocompatibility, sterilization, cleaning, electrical safety, and mechanical testing was performed in support of the substantial equivalence determination.
Biocompatibility Testing: The Ergonomic handles are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (
§ 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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February 9, 2018
Symmetry Surgical Inc. Christopher Smith Sr. Director of Regulatory Compliance 3034 Owen Drive Antioch, Tennessee 37013
Re: K173272
Trade/Device Name: Ergonomic Handle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: October 9, 2017 Received: October 12, 2017
Dear Christopher Smith:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S3
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) K173272
Device Name Ergonomic Handle
Indications for Use (Describe)
Laparoscopic surgical manual instruments are designed to be used endoscopically through camula to perform cutting, grasping, dissecting, retracting, and manipulating functions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 4: 510(k) SUMMARY
| Submitter's Name: | Symmetry Surgical Inc. |
|---|---|
| Address: | 3034 Owen Drive, Antioch, TN 37013 USA |
| Telephone: | 1-800-251-3000 |
| Fax: | 1-800-342-3272 |
| Submitter: | Christopher Smith |
| Date Prepared: | February 8, 2018 |
| Device Trade Name: | Ergonomic Handle |
| Common Name: | Ergonomic Handle |
| Device Classification: | Class II |
| Classification Name: | Endoscope and Accessories |
| Regulation: | 21 CFR 876.1500 |
| Device Regulation Panel: | General and Plastic Surgery |
| Device Product Code: | GCJ |
| Predicate Device: | K150127 Laparoscopic Handles with PEEK Insulation |
Device Description:
Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.
The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.
Intended Use:
Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.
Indications For Use:
Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions.
Technological Characteristics of the Device Compared to the Predicate Device:
Indications between the predicate and subject device are equivalent. Both devices are intended to be used endoscopically to perform cutting, dissecting, and manipulating functions.
- The subject device has additional ability to adjust the handle position to allow for better ● surgeon comfort but this does not affect the function of the device.
- The subject device allows the devices to be disassembled for easier cleaning and ● sterilization.
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- The subject device is only available in a 5mm option and does not introduce a new worstcase scenario.
- The subject device adjustable grip angle allows the surgeon to use the device in a more comfortable manner depending on the procedure and does not affect the performance of the device for its indicated uses.
There are no technological characteristics that raise new issues of safety or effectiveness. Based upon the similarities of the Ergonomic Handle and the predicate device studied, the safety and effectiveness of the Ergonomic Handle is substantially equivalent to the predicate device referenced.
Assessment of Performance Data:
Design verification and validation testing including biocompatibility, sterilization, cleaning, electrical safety, and mechanical testing was performed in support of the substantial equivalence determination.
Biocompatibility Testing
The Ergonomic handles are considered External Communicating Devices: Tissue/Bone/Dentin with limited contact duration (