(58 days)
Not Found
Not Found
No
The device description and intended use clearly describe a manual surgical instrument (trocar and cannula) with no mention of any computational or data-driven features that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a surgical instrument used for creating ports of entry during endoscopic surgery, not for treating a disease or condition itself.
No
The device is described as a surgical instrument used for creating a port of entry for other instruments during endoscopic surgery, not for diagnosing a medical condition.
No
The device description clearly outlines physical components such as trocars, cannulas, sleeves, and caps, which are hardware.
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 manual surgical instrument used for creating access ports during endoscopic surgery. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details the physical components of the device (trocars, cannulas, caps) and their function in facilitating surgical access and maintaining pneumoperitoneum. This aligns with surgical instrumentation, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – creating and maintaining surgical access.
N/A
Intended Use / Indications for Use
The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.
Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
Product codes
Not Found
Device Description
The device consists of Reusable Trocars and Cannula with Insufflation Port with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Reusable Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip.
The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
The Pilling Weck Trocars and Cannula with Insufflation Port are substantially equivalent to the Core Dynamics Entree II, Access Surgical Access Single Use Trocar and Sleeve, Mahe Reusable Standard Trocar and Trumpet Valve Cannula, Mahe Safety Trocar.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo for Pilling Weck. To the left of the name is a black abstract symbol. Below the name is the text "510(k) Summary".
1. Submitter Name, Address, and Date of Submission:
DEC 1 2 1996
Miss Karenann J. Brozowski Group Regulatory Affairs Director Pilling Weck Group Tall Pines Park Jaffrey, NH 03452
Telephone: (603)532-7706
Contact: Same as above.
2. Names of the Device, Common, Proprietary(if Known), and Classification.
Classification Name: Secondary Trocar with Sleeve
Common Name: Reusable Trocars and Cannula with Insufflation Port
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Pilling Weck Trocars and Cannula with Insufflation Port are substantially equivalent to the Core Dynamics Entree II, Access Surgical Access Single Use Trocar and Sleeve, Mahe Reusable Standard Trocar and Trumpet Valve Cannula, Mahe Safety Trocar.
4. Description of the Device:
The device consists of Reusable Trocars and Cannula with Insufflation Port with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.
The Reusable Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip.
A Telefiex Company
One Weck Drive, P.O. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000
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The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
5. Intended Use of the Device:
The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve.
Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
The usage of this product is identical to previous devices, which have the same technological characteristics.
6. Summary of Technological Characteristics:
The following technological characteristics are the same or equivalent as predicate devices: '
The Reusable Trocars, consisting of a hub with a stainless steel shaft are equivalent to the predicates.
The cannula with insufflation ports used with the Trocar is treaded, which is equivalent to the predicates.
The Cap Assembly is contains the seal, which is used to minimize the leakage from the pneumoperitoneum, which is equivalent to the predicates.
sum10mm