(158 days)
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No
The device description focuses on a mechanical shielding mechanism and does not mention any computational or learning capabilities.
No
The device is a surgical instrument (trocar) for gaining access to the abdominal cavity, focusing on safety features (shielding) rather than directly treating a disease or condition. While used in therapeutic procedures, it is not therapeutic itself.
No
Explanation: The device description clearly states its purpose is to gain surgical access by pushing through the abdominal wall and then automatically shielding the cutting edge. It is a surgical tool designed for access, not for diagnosing conditions.
No
The device description clearly describes a physical surgical instrument (Trocar) with mechanical components (springloaded, blunt Obturator) and does not mention any software functionality.
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.
- Device Description: The description clearly states the device is a surgical instrument (a trocar) used to gain surgical access to the abdominal cavity. It is used on the patient's body, not to test samples from the patient's body.
- Intended Use: The intended use is for surgical access, not for diagnostic testing of biological samples.
- Anatomical Site: The anatomical sites mentioned (intra-abdominal cavity, abdominal wall) are where the device is used on the patient, not where samples are collected for testing.
Therefore, the SHIELDED Trocar is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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- The Intended Use and the Indications for Use are identical for our SHIELDED Trocar and the other, older Trocar versions.
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- ()ur SHELDED Trocar establishes and maintains surgical access to the intra-abdominal cavity. It allows CO2 insufflation and surgical Endoscopy identically to other, older trocars, with no difference in Effectiveness.
Product codes
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Device Description
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- Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immedeately re-entors it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator. While assembled this new Trocar never allows accidental cutting of a patient or operating room personel. Disassembly of this instrument is only required for cleaning and sterilization.
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- Our SHIELDED Trocar represents a combination between common old Trocars and the SHECRNA function of Veress needles: A springloaded blunt Obturator devic· always covers the sharp cutting edge.
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
intra-abdominal cavity
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
Comparative Bench testing with animal tissue enabled us to conclude that the performance and effectiveness of our SHELDED Trocar is identical to older Trocar models.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Subject: SHIELDED Trocar with springloaded Obturator
510(k) # K960347
$$\mathbf{u} \cdot \mathbf{u}$$
A. Summary of Safety and Effectiveness:
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- Our "SHIELDED Trocar" was in detail compared to other, older 'Trocars and we concluded that our device provides safety for patients and operating room personnel. The cutting edge of our trocar is never exposed at any time.
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- ()ur SHELDED Trocar establishes and maintains surgical access to the intra-abdominal cavity. It allows CO2 insufflation and surgical Endoscopy identically to other, older trocars, with no difference in Effectiveness.
B. Parts of finding Substantial Equivalence:
- l. The Intended Use and the Indications for Use are identical for our SHIELDED Trocar and the other, older Trocar versions.
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- The Design Engineering of our Trocar and older versions is identical in almost all components:
They a11 have: 1. A sharp cutting odge
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- A Trocar Sheath
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- Trocar Housing
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- A valve to minimize CO2 loss
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- A Stopcock for C()2 insufflation
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- A Sealing Cap
1
C. Descriptive Information
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- Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immedeately re-entors it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator.
While assembled this new Trocar never allows accidental cutting of a patient or operating room personel. Disassembly of this instrument is only required for cleaning and sterilization.
- Our SHIELDED Trocar adds one feature to the old commonly known Trocar: It does not expose any sharp edges, except when it is pushed through the abdominal wall to gain surgical access. Then, inside of the body cavity, it automatically and immedeately re-entors it's SHIELDING MODE by covering the cutting edge with a springloaded, blunt Obturator.
-
- Our SHIELDED Trocar represents a combination between common old Trocars and the SHECRNA function of Veress needles: A springloaded blunt Obturator devic· always covers the sharp cutting edge.
D . Performance Testing
Comparative Bench testing with animal tissue enabled us to conclude that the performance and effectiveness of our SHELDED Trocar is identical to older Trocar models.
E . Adverse Health Effects
We were not able to determine any adverse health effects with our SHIELDED Trocar and we cannot imagine any possibility of this kind.
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