(91 days)
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No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on mechanical components and direct visualization.
No
While it is used in a medical procedure to alleviate a condition, its primary function is to provide visualization and manipulate instruments during surgery, not to directly treat or cure the disease itself. Its components are primarily tools for removal (Nucleotome probes, grasping forceps) rather than therapeutic agents.
No
The device is described as a working channel scope used for direct visualization during a laparoscopic procedure to decompress a herniated lumbar disc, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components, including a scope, probes, cannula, and grasping forceps. It also mentions a "Nucleotome console" which is likely a hardware component.
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.
- Device Function: The description clearly states the device is used for "decompressing a herniated lumbar disc using direct visualization during a laparoscopic procedure." This is a surgical procedure performed inside the body, not a diagnostic test on a sample.
- Components: The components listed (scope, probes, cannula, forceps) are surgical instruments used for visualization and tissue removal during a procedure. They are not reagents, test kits, or analyzers used for laboratory testing.
- Intended Use: The intended use is a surgical intervention, not a diagnostic assessment.
Therefore, the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is a surgical device, not an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct visualization during a laparoscopic procedure.
Product codes
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Device Description
The Surgical Dynamics 30K Working Channel Scope and Instrument Kit for Laparoscopic Discectomy are comprised of the following components:
30K Working Channel Scope Nucleotome 2.5 mm Laparoscopic Probe Nucleotome 3.5 mm Laparoscopic Probe Nucleotome 4.7 mm Laparoscopic Probe IA Cannula Grasping Forceps with Teeth for Laparoscopic Discectomy
The Nucleotome probes are used in conjunction with the Nucleotome console.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
direct visualization
Anatomical Site
lumbar disc
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)
Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy, Argus Medical Company Laparoscopic Discectomy Instrument System, Nucleotome System and Probe Kits
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with CFR 807.92 (April 26, 1992), the following information is submitted:
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- Name: Surgical Dynamics, Inc. Address: 2575 Stanwell Drive Concord, CA 94520 Telephone: 510 687 2192 extension 509 Contact: Charmaine Henderson Date of Summary Preparation: August 1995
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- Surgical Dynamics, Inc. 30K Working Channel Scope Name of Device: and Instrument Kit for Automated Laparoscopic Discectomy
Generic Name: Rigid Endoscope and Instrument Set
- ന് Predicate device:
Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy
Argus Medical Company Laparoscopic Discectomy Instrument System
Nucleotome System and Probe Kits
- ধ: Device Description:
The Surgical Dynamics 30K Working Channel Scope and Instrument Kit for Laparoscopic Discectomy are comprised of the following components:
30K Working Channel Scope Nucleotome 2.5 mm Laparoscopic Probe Nucleotome 3.5 mm Laparoscopic Probe Nucleotome 4.7 mm Laparoscopic Probe IA Cannula Grasping Forceps with Teeth for Laparoscopic Discectomy
The Nucleotome probes are used in conjunction with the Nucleotome console.
- ട. Intended Use:
The intended use of the Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is to decompress a herniated lumbar disc using direct
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visualization during a laparoscopic procedure.
- ୍. Technological Characteristics of the Device:
The Surgical Dynamics Working Channel Scope for Automated Laparoscopic Discectomy is identical in design, materials and energy source as the predicate device, the Surgical Dynamics 30K Working Channel Scope for Automated Percutaneous Lumbar Discectomy. The intended use is the same as the predicate device; Argus Medical Company Laparoscopic Discectomy Instrument System. The Surgical Dynamics 2.5 mm Laparoscopic Probe, Surgical Dynamics 3.5 mm Laparoscopic Probe and the Surgical Dynamics 4.7 mm Laparoscopic Probe are identical in design, materials and energy source to the predicate Surgical Dynamics probes and kits with one exception; the new devices are longer in length.