(70 days)
The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.
I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies or acceptance criteria for the new device.
The document mainly describes:
- The submitter's information.
- The device's name and classification.
- The predicate device.
- A description of the Pilling Weck 2-Piece Take-Apart Instruments.
- The intended use of the device.
- A comparison of the technological characteristics of the new device to the predicate device to establish substantial equivalence.
Therefore, I cannot fill out the requested table or answer the questions related to studies, sample sizes, expert qualifications, or ground truth.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Pilling Weck, along with the text "510(k) Summary" below it. The logo consists of a stylized "W" shape with a diamond above it. The text is in a bold, sans-serif font. The image is in black and white.
MAR - 4 1997
K65176
1/3
- Submitter's Name, Address and Telephone Number, and Contact Person:
Miss Karenann J. Brozowski Pilling Weck Group Tall Pines Park Jaffrey, NH 03452
Telephone Number: (603)532-7706
Contact Person: Miss Karenann J. Brozowski
- Name of the Device, including the trade or proprietary name if applicable, and the common name, and the classification name, if known;
Trade Name: Pilling Weck 2-Piece Take-Apart Instruments
Common Name: Endoscopic Forceps/Graspers/Scissors
Classification Name: Endoscopic and Accessories
3. Identification of the legally marketed device that the submitter claims equivalence.
The devices in consideration are substantially equivalent to the devices currently marketed by Karl Storz Endoscopy America, Inc. Under 510(k) K952149.
A Telefiex Compan
{1}------------------------------------------------
- A description of the device that is the subject of the premarket notification submission, such as might be found in the labeling or the promotional material of the device.
The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.
5. A statement of the intended use of the device that this the subject of the premarket notification submission:
The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
- If the device has the same technological characteristics as the predicate device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of the new device in comparison to those of the predicate device. If the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to the legally marketed device.
The intended uses of the Pilling Weck 2-Piece Take-Apart Instrumentation and the Karl Storz Endoscopy America, Inc. Devices under K952149 have the same intended use, and that is for endoscopy procedures though cannulae for cutting, grasping, dissecting, retracting, and manipulating.
{2}------------------------------------------------
Page 3
The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use.
Both devices include insulated and noninsulated handles, and accommodating shafts.
In the Pilling Weck device there is included a flushing port to facilitate cleaning. This port is not present on the Karl Storz devices.
All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button. In some of the Storz instruments, security is achieved by a one-quarter turn into the outer tube and then connecting into the outer tube handle. The rest of the Storz instruments are the same as Pilling Weck.
§ 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.