(139 days)
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No
The device description focuses on mechanical components and their function in creating a surgical port. There is no mention of data processing, algorithms, or learning capabilities.
No
The device, a trocar, is used to create a path of entry for surgical instruments and maintain pneumoperitoneum, not to treat a disease or condition.
No
The device is a surgical instrument (trocar) intended to create a path of entry for other minimally invasive instruments during surgical procedures. Its purpose is mechanical access, not diagnosis.
No
The device description clearly outlines physical components (obturator, sleeve, tip, shield, seals, 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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The TRISTAR TM LP Trocar with Low Profile Threaded Sleeve is a surgical instrument designed to create a path of entry into the body for other surgical instruments. It is used during a surgical procedure, inside the body.
- Intended Use: The intended use clearly states it's for establishing a path of entry for minimally invasive instruments during surgical procedures. It does not mention any testing of biological samples.
- Device Description: The description details the physical components of a surgical trocar (obturator, sleeve, seals, threads) and its function in creating an access port. It does not describe any components related to sample collection, analysis, or testing.
Therefore, the TRISTAR TM LP Trocar with Low Profile Threaded Sleeve is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the New Device is to establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization. The TRISTAR TM LP Trocar with Low Profile 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 TRISTAR TM LP Trocar with Low Profile Threaded Sleeve consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly. The obturator consists of a sharp pyramidal tip and a spring loaded safety shield. The safety shield is designed to cover the pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The sleeve subassembly has an inner gasket seal and an outer gasket seal 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 TRISTAR TM LP Trocar with Low Profile Threaded Sleeve shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm 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
thoracic, general, gynecologic, or other minimally invasive surgical procedures
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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§ 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
MAY - 5 1997
11
4102
Appendix A 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 TRISTAR TM LP Trocar with Low Profile Threaded Sleeve consists of two main sub-assemblies: an obturator sub-assembly and a sleeve sub-assembly. |
| The obturator consists of a sharp pyramidal tip and a spring loaded safety shield. The safety shield is designed to cover the pyramidal tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. | |
| The sleeve subassembly has an inner gasket seal and an outer gasket seal 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 TRISTAR TM LP Trocar with Low Profile Threaded Sleeve shall be provided in a variety of sizes from 3mm to 12mm in diameter and 65mm 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 | The intended use of the New Device is to establish a path of entry for minimally invasive instruments. The instrument is intended for creating secondary ports under direct visualization. |
| Indications statement | The TRISTAR TM LP Trocar with Low Profile 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. |
| Continued on next page |
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K 965045 820亿
Appendix A 510(k) Summary of Safety and Effectiveness,
Continued
1
| 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
Project Manager
Regulatory Affairs Department
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | December 16, 1996 |