(43 days)
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No
The description details a manual surgical instrument (trocar and sleeve) with no mention of AI or ML capabilities, image processing, or data analysis.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is a manual surgical instrument (trocar and sleeve) used for access during endoscopic surgery, which is an interventional tool, not a therapeutic one.
No
The device is described as a surgical instrument (trocar and sleeve) used for creating access during endoscopic surgery, not for diagnosing medical conditions.
No
The device description explicitly states it consists of "Reusable Trocars and Sleeves" which are physical, manual surgical instruments. There is no mention of software as the primary or sole component of the 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 manual surgical instrument used for creating access points during endoscopic surgery (abdominal and thoracic). 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 (trocar, sleeve, cap) and their function in facilitating surgical access and maintaining pneumoperitoneum. This aligns with surgical instruments, not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal 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
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Device Description
The device consists of Reusable Trocars and Sleeves, 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 Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style.
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Abdominal and Thoracic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The Pilling Weck Trocar and Sleeve is substantially equivalent to the Core Dynamics Entree II. Apple Medical Hunt Reich Secondary Trocar, and the Access Surgical Access Single Use Trocar and Sleeve.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 Pilling Weck logo and the words "510(k) Summary" underneath. The logo is a stylized "W" with a diamond shape above it. The text is in a bold, sans-serif font. The image is likely from a document related to a medical device or product.
963815
1. Submitter Name, Address, and Date of Submission:
NOV - 5 1996
Miss Karenann J. Brozowski Group Requlatory 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 Trocar with Sleeve
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Pilling Weck Trocar and Sleeve is substantially equivalent to the Core Dynamics Entree II. Apple Medical Hunt Reich Secondary Trocar, and the Access Surgical Access Single Use Trocar and Sleeve.
4. Description of the Device:
The device consists of Reusable Trocars and Sleeves, 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 Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style.
The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
A Teleflex Company
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5. Intended Use of the Device:
The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal 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 Trocar, consisting of a hub with a stainless steel shaft is equivalent to the predicates.
The sleeve 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.
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sum5mm