(27 days)
The HydroCision Spinelet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.
The HydroCision SpineJet System comprises of (i) sterile disposable tubing assembly- SpineJet device and (ii) reusable console unit- HydroCision Console. The components of SpineJet device consists of a pump cartridge, handpiece and tubing assembly (also known as disposable hose). The SpineJet device is provided sterile, via ethylene oxide sterilization. The reusable HydroCision Console are packaged and sold separately. The SpineJet device is designed to be used in combination with the HydroCision console as a SpineJet system. The SpineJet system is connected with a foot pedal, a sterile bag of saline, and a waste container prior to operation.
The SpineJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the SpineJet device and pressurizes the saline to deliver to the tip of the SpineJet handpiece through high pressure saline tube. The SpineJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The SpineJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline from saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of Spinelet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility.
The Hydrocision Console (K190804) is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the SpineJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface.
To perform an open or minimally invasive spinal procedure, the SpineJet handpiece needle is inserted into the spine through cannula access set and guided toward the targeted diseased tissue under fluoroscopic guidance. Once the Spinelet handpiece needle is in position, the surgeon activates the high-pressure saline of Spinelet device using the Hydrocision console and foot pedal. Using fluoroscopic guidance, the surgeon uses the Spinelet handpiece to cut and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn, and the incision is closed using steri-strips for a closed, minimally invasive procedure.
The Spinelet device is provided sterile, via ethylene oxide sterilization.
This is a medical device 510(k) summary for the HydroCision SpineJet System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study of the device's clinical performance against acceptance criteria in the way a novel AI/software medical device might.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, type of ground truth) are not applicable or not provided in this type of submission.
Here's a breakdown of the information provided, tailored to your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria and corresponding performance metrics for the HydroCision SpineJet System in the context of a clinical study. Instead, the submission focuses on validating that the modified device maintains the safety, functionality, and performance characteristics substantially equivalent to its predicate device.
The "acceptance criteria" are implied to be adherence to various engineering standards and confirmation that the design changes do not negatively impact the device's function or safety.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Performance Bench Testing | The modified SpineJet device's safety, functionality, and performance characteristics were verified to be substantially equivalent to the predicate device. The SpineJet device will perform as intended. |
| Human Factors / Usability | Found to be in conformance with IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices. |
| Electromagnetic Compatibility & Electrical Safety | Tested and found to comply with applicable parts of IEC 60601-1 and IEC 60601-1-2. |
| Risk Analysis | A risk analysis according to ISO 14971 was carried out, systematically identifying and evaluating hazards and consequences using "Failure Mode and Effect Analysis." |
| Overall Conclusion | The modified HydroCision SpineJet system met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents, and internal test protocols. No safety and efficacy issues were raised. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no clinical test set in the sense of patient data for evaluating a diagnostic or predictive algorithm. The testing described is primarily engineering bench testing and compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of submission.
4. Adjudication Method for the Test Set
Not applicable.
5. 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-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, safety standards, and functional equivalence to its predicate device through bench testing rather than clinical outcomes or diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.