(91 days)
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.
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.
This FDA premarket notification (510(k)) K960046 describes a device that is substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Such studies are typically required for novel devices or significant modifications to existing devices where performance claims need to be substantiated.
For this 510(k), the submission focuses on establishing substantial equivalence based on design, materials, energy source, and intended use being identical or very similar to predicate devices. The only difference noted for the probes is an increase in length.
Therefore, I cannot provide the requested information from the provided text as it is not present in the document.
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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.
§ 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.