(54 days)
The Clarus Model 21200 Nucleotome Discectomy Probe is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
The Clarus Model 21200 Nucleotome Probe Set is indicated for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
This 510(k) submission is a modification of the existing Nucleotome devices. previously filed as K844131, K902778, K913145, K914282, K923525, K931109, K942987 and respectively found to be substantially equivalent by the FDA on November 29, 1984; October 30, 1990; December 19, 1991; December 19, 1991; February 9, 1993; March 29, 1994; and October 30, 1995. The modifications represented by this submission, is the addition of thoracic and cervical indications.
The Nucleotome Discectomy Probe is intended to be used for decompression of the discs in the spine (lumbar, thoracic and cervical). The set consists of components necessary, as required for percutaneous surgical techniques. The Model 21200 consists of a Discectomy Probe, a guide needle, a straight cannula, with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. A syringe with a union connector is also included to help maintain the openness of the aspiration tubing.
The Clarus Model 21200 Nucleotome Discectomy Probe, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the devices which have been previously filed with FDA under 510(k) applications K844131, K902778, K913145, K914282, K923525, K931109, K942987 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical and/or thoracic applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device.
As with the previous sets, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected to offer the user a comprehensive set of instruments for 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.
The provided document is a 510(k) Summary for the Clarus Medical Model 21200 Nucleotome Probe Set. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study.
The document indicates that the device is a modification of existing Nucleotome devices and that the modification is primarily the addition of thoracic and cervical indications. The existing design was already found to be substantially equivalent to other devices for lumbar applications. Therefore, the "study" demonstrating this device meets acceptance criteria is primarily a comparison to predicate devices and a demonstration that the modifications do not raise new questions of safety or effectiveness.
Here's an analysis based on your requested information, acknowledging that a traditional clinical study with acceptance criteria and performance metrics for a new AI/medical device algorithm is not present in this type of submission for this particular device:
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) for a modified existing device, the "acceptance criteria" revolve around demonstrating that the modified device is substantially equivalent to its predicate devices for the expanded indications, and that its performance is consistent with the known performance and safety of those predicates. There are no performance metrics like sensitivity, specificity, or AUC reported in this document.
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices (for expanded indications) | The Clarus Model 21200 Nucleotome Discectomy Probe is "manufactured, packaged, and sterilized identically, with one exception" (shortened working length for cervical/thoracic applications) to previously cleared Nucleotome devices. This establishes substantial equivalence for the design and manufacturing process. The intended use for aspiration of disc material during percutaneous discectomies is consistent with predicate devices, now expanded to include thoracic and cervical regions. |
| Safety and Effectiveness not adversely impacted by modification | The modification (shortened working length) is presented as a minor change to accommodate the expanded indications, implying that the fundamental safety and effectiveness of the existing Nucleotome technology are maintained. No specific safety or effectiveness data beyond this assertion are provided in the summary. |
Study Information (Extracted from 510(k) Summary)
Since this is a 510(k) for a device modification, a traditional clinical study as you might expect for an AI algorithm is not described. The "study" here is more of a technical justification comparing the new device to predicates.
- Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study data is presented in this 510(k) summary. The comparison is made against existing device characteristics and predicate device clearances.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described as there is no test set or clinical evaluation presented.
- 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 instrument, not an AI diagnostic tool involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Safety and Effectiveness Demonstration
The Clarus Medical Model 21200 Nucleotome Probe Set gains its clearance based on substantial equivalence to a series of previously cleared Clarus Medical Nucleotome devices (K844131, K902778, K913145, K914282, K923525, K931109, K942987) and one other predicate device (K032473 Stryker Dekompressor™ Precutaneous Discectomy Probe).
The core argument for substantial equivalence for this particular 510(k) (K040919) is that the device's design, manufacturing, packaging, and sterilization are identical to its predicates, with the single exception of a shortened working length to accommodate its expanded indications for use in the thoracic and cervical regions of the spine. By demonstrating that this modification does not introduce new questions of safety or effectiveness and that the device's intended function (aspiration of disc material during percutaneous discectomies) remains the same, the sponsor is asserting that the device meets the implicit "acceptance criteria" for 510(k) clearance.
§ 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.