(65 days)
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No
The device description and intended use clearly describe a manual surgical instrument (trocar and sleeve) with no mention of computational or data-driven capabilities.
No
Explanation: The device is described as a "manual surgical instrument" used for incision and access during endoscopic surgery, not for treating a disease or condition. It facilitates a surgical procedure rather than providing therapy itself.
No
This device is described as a surgical instrument used for incision and providing access for other instruments, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of stainless steel and polymer, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "manual surgical instrument" used for "incision and peritoneal access" during "Endoscopic Surgery (Abdominal and Thoracic)". This describes a surgical tool used directly on a patient for access and manipulation, not for testing samples in vitro (outside the body).
- Device Description: The description details the physical components of a surgical trocar and sleeve, including a stainless steel tip, polymer handle, sleeve, and insufflation port. These are all components of a surgical instrument, not a diagnostic test kit or analyzer.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, diagnostic assays, or any other elements typically associated with in vitro diagnostics.
In summary, the device is a surgical instrument used for accessing body cavities during endoscopic procedures, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary 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 a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft.
The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port . There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.
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): 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.
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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.
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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).
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§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
P 1 9 2
Image /page/0/Picture/2 description: The image shows the logo for Pilling Weck, along with the text "510(k) Summary" below the logo. The logo consists of a stylized "W" shape on the left, followed by the words "Pilling Weck" in a bold, sans-serif font. The text "510(k) Summary" is in a smaller font size and is centered below the company name. The overall design is simple and professional, with a focus on the company name and the type of document being presented.
1. Submitter Name, Address, and Date of Submission:
Miss Karenann J. Brozowski Group Requlatory Affairs Director Pilling Weck Group Tall Pines Park Jaffrev. NH 03452
JAN | 0 1997
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: Secondary Trocar and Sleeve with Insufflation Port
3. Identification of the legally marketed device to which the submitter claims equivalence.
The Pilling Weck Secondary Trocar and Sleeve with Insufflation Port are substantially equivalent to the Core Dynamics Entree II. Access Surgical Access Single Use Trocar and Sleeve. United States Surgical Acute Suture Surgiport™ Disposable Surgical Trocar and Cannula with Insufflation Port, and Karl Stortz Trocars and Cannula with Insufflation Ports.
4. Description of the Device:
The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.
The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft.
4 Telefiex Compan
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, threaded and contains an insufflation port . There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.
5. Intended Use of the Device:
The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary 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 Trocar, consisting of a hub with a stainless steel tip are equivalent to the predicates.
The sleeve with insufflation port and cap assembly. which has the port of entry for the surgical instrument and has a threaded shaft, is used with the Trocar, 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.
sum11mm