(112 days)
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No
The device description and intended use are purely mechanical, describing a surgical trocar for creating entry points. There is no mention of any computational or analytical functions that would involve AI/ML.
No
This device, a surgical trocar, is used to establish an entry path for instruments during surgery, not to treat a disease or condition itself.
No
The device description indicates that it is a surgical trocar used to create a path of entry for instruments during minimally invasive surgical procedures. Its purpose is to facilitate surgery, not to diagnose a condition.
No
The device description clearly outlines physical components (obturator sub-assembly, sleeve sub-assembly, protective sheath, gaskets, threads) and their mechanical functions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a path of entry for minimally invasive instruments" and for "creating secondary ports under direct visualization." This describes a surgical tool used to access the body for other surgical instruments.
- Device Description: The description details the physical components of a surgical trocar (obturator, sleeve, gaskets, threads) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
This device is clearly a surgical instrument used during a surgical procedure, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.
The (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve has application in thoracic, general, gynecologic, or other minimally invasive surgical procedures to establish a path of entry for minimally invasive instruments. The instrument is intended for insertion under direct visualization for secondary port locations.
Product codes
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Device Description
The (TRADE NAME) Non-shielded Surgical Trocar consists of two main subassemblies: a non-shielded obturator sub-assembly and the sleeve sub-assembly.
The non-shielded obturator sub-assembly is designed with a protective sheath to cover the flat blade. This protective sheath protects the gaskets on the sleeve assembly when the obturator and sleeve are mated together for insertion into the operative cavity. When the sleeve and obturator are properly engaged, the protective sheath is retracted so that the blade is exposed when it extends from the trocar sleeve.
An inner and outer gasket seals to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue
The (TRADE NAME) Non-shielded Surgical Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 75mm to 150mm in length.
This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.
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
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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)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance to the Predicate Device in mating the obturator with the sleeve, insertion into the operative cavity. removal of the obturator from the sleeve, security of the sleeve in tissue, and maintenance of pneumoperitoneum of the operative space.
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
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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 a logo that features a black circle with a design inside. The design consists of four white lines that are angled and converge towards a point, resembling a stylized representation of light rays or a comet. The lines are positioned on the right side of the circle, creating a dynamic and directional feel.
ETHICON ENDO-SURGERY, INC. a Johnson Johnson company
4545 CREEK ROAD CINCINNATI, OH 45242-2839 K 963760
510(k) Summary of Safety and Effectiveness
Statement
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR $807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
Device description The (TRADE NAME) Non-shielded Surgical Trocar consists of two main subassemblies: a non-shielded obturator sub-assembly and the sleeve sub-assembly.
The non-shielded obturator sub-assembly is designed with a protective sheath to cover the flat blade. This protective sheath protects the gaskets on the sleeve assembly when the obturator and sleeve are mated together for insertion into the operative cavity. When the sleeve and obturator are properly engaged, the protective sheath is retracted so that the blade is exposed when it extends from the trocar sleeve.
An inner and outer gasket seals to maintain pneumoperitoneum when instrumentation is inserted and withdrawn through cannula during a surgical procedure. Integral threads along the outside diameter of the cannula portion of the sleeve provide a retention mechanism to stabilize the sleeve in tissue
The (TRADE NAME) Non-shielded Surgical Trocar shall be provided in a variety of sizes from 3mm to 12mm in diameter and 75mm to 150mm in length.
This device is designed to create secondary trocar sites and is labeled to be used only under direct visualization of the insertion site.
Intended use
To establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization.
Continued on next page
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510(k) Summary of Safety and Effectiveness, Continued
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| Indications
statement | The (TRADE NAME) Non-shielded Surgical Trocar with Threaded Sleeve
has application in thoracic, general, gynecologic, or other minimally invasive
surgical procedures to establish a path of entry for minimally invasive
instruments. The instrument is intended for insertion under direct visualization
for secondary port locations. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The technological characteristics of the New Device are the same as the Predicate
Device. |
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device can be
used as designed. The studies demonstrated acceptable performance to the Predicate
Device in mating the obturator with the sleeve, insertion into the operative cavity.
removal of the obturator from the sleeve, security of the sleeve in tissue, and
maintenance of pneumoperitoneum of the operative space. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the
information provided herein, we conclude that the New Device is substantially
equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act. |
| Contact | Ivan S. Placko
Regulatory Affairs Project Manager
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | December 9, 1996 |
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