(83 days)
The Clarus Model 1100 Laser Endoscopic Decompression Kit is intended to be used on patients with contained lumbar or cervical disc herniations or bulges. This is a identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)
The Clarus Model 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.
This 510(k) submission is a modification of the existing Clarus Model 1100 Laser Endoscopic Decompression Kit, previously filed as K922881, and found to be substantially equivalent by the FDA on November 16, 1992. The K922881 510(k) device is intended for lumbar disc decompression in the spine. The modifications, represented by this submission, is the addition of cervical indications.
The Clarus Model 1100 Laser Endoscopic Decompression Kit intended use is to be endoscopic laser decompression of discs in the spine (lumbar and cervical). The kit consists of components necessary for endoscopic laser surgery where visualization and laser surgical techniques are required. The Model 1100 consists of a deflectable endoscope with a fixed laser fiber, a flexible trocar, straight and curved cannulas with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. The cervical LASE is identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber. The fixed laser fiber is identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610).
The Clarus Model 1100 Laser Endoscopic Decompression Kit, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the device which have been previously filed with FDA under 510(k) application K922881 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device
As with the previous kits, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected by Clarus to offer the user a comprehensive set of instruments for endoscopic laser disc decompression.
The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.
This document is a 510(k) summary for a medical device and describes a modification to an existing device rather than a new device that requires a comprehensive new study proving its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) is not available or applicable in the provided text.
The submission focuses on establishing substantial equivalence to a predicate device for an expanded indication (cervical) based on previous clearances for its components.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance:
The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific quantitative outcomes for the device's function). Instead, the "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices for the expanded indication.
The "device performance" is described by its intended use and consistency with previously cleared components.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as described for substantial equivalence) |
|---|---|
| Expanded Indication Safety & Effectiveness: | The device is "identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)" for use on patients with contained lumbar or cervical disc herniations or bulges. The cervical endoscope is "identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber." The fixed laser fiber is "identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610)." The kits are manufactured, packaged, and sterilized identically, with the exception of a shortened working length for cervical applications. |
| Material/Design Equivalence: | The device contains the same items and materials (e.g., stainless steel, molded plastic) as previous 510(k) devices. The main components (endoscope, cannulas, dilators) are manufactured by Clarus, and other components are selected to offer a comprehensive set. |
Study Information (or lack thereof):
- Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical kit, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical kit, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this 510(k). The "ground truth" for the device's predicate history and component clearances would have been associated with their original submissions.
- The sample size for the training set: Not applicable. This is not an AI/algorithmic device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.