(68 days)
HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.
The TenJet device is a single use disposable device intended for use in orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures. The TenJet device is constructed from various biocompatible materials. The TenJet device is designed to be used in combination with HydroCision Console and Foot Pedal, which are sold and package separately. The Accessory Kit, also known as supply kit is packaged along with each HydroCision TenJet Device. The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. The itemized contents of the kit with their manufacturer and regulatory information are provided in section 11.7.3 of this 510(k).
The components of TenJet device consists of a pump cartridge, handpiece and tubing assembly, which is used in combination with HydroCision Console. The TenJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the TenJet device and pressurizes the saline to deliver to the tip of the TenJet handpiece through high pressure saline tube. The TenJet 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 TenJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of TenJet 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 is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the TenJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface. The detailed software description and associated documentation is included in Section 16 of the TenJet 510(k).
To perform an open, arthroscopic or minimally invasive surgical procedure, the TenJet handpiece needle is inserted into the body through a small incision and guided toward the targeted diseased tissue under ultrasound visualization. Once the Tenlet handpiece needle is in position, the surgeon activates the high-pressure saline of TenJet device using the Hydrocision console and foot pedal. Using ultrasound visual guidance, the surgeon uses the TenJet handpiece to cut, debride 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, ultrasound guided procedure.
The TenJet device is provided sterile, via ethylene oxide sterilization.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria.
Based on the provided text, the device in question (HydroCision TenJet Device) is a medical device and not an AI/ML enabled device. Therefore, a significant portion of the requested information, specifically regarding AI/ML related studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance, etc.), is not applicable and cannot be extracted from this document.
The document details a 510(k) premarket notification for a medical device that uses high-pressure saline for tissue debridement. The "acceptance criteria" and "proof" in this context are related to demonstrating substantial equivalence to a previously cleared predicate device, rather than performance metrics of an AI model.
The "studies" are primarily non-clinical bench testing, biocompatibility testing, human factors/usability studies, and electrical/EMC testing, all aimed at confirming the device's safety and effectiveness compared to the predicate and applicable standards.
Breakdown of Applicable Information from the Provided Text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a single, concise table of acceptance criteria with corresponding performance for each. Instead, it describes general conformance to standards and internal test protocols to prove substantial equivalence. The "acceptance criteria" can be inferred from the types of tests conducted and their successful completion.
| Acceptance Criterion (Inferred) | Reported Device Performance / Proof |
|---|---|
| Performance (Substantial Equivalence to Predicate) | |
| TenJet Weldment Burst Strength | Testing verified performance is substantially equivalent to predicate and performs as intended. |
| TenJet Weldment Strength | Testing verified performance is substantially equivalent to predicate and performs as intended. |
| TenJet Sharp Tip Testing | Testing verified performance is substantially equivalent to predicate and performs as intended. |
| TenJet Tissue Differentiation- Safety and Efficacy (Bovine and Cadaver) | Testing verified performance is substantially equivalent to predicate and performs as intended. |
| Biocompatibility (per ISO 10993-1:2009 and FDA guidance) | All tests passed: Cytotoxicity, Sensitization, EO Residual, Irritation / Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity. |
| Sterilization Efficacy (Ethylene Oxide) | Validation performed and passed. |
| Human Factors / Usability (per IEC 62366-1:2015) | Device found in conformance. |
| Electromagnetic Compatibility (EMC) & Electrical Safety (per IEC 60601-1, IEC 60601-1-2) | Device found to comply with applicable parts of the standards. |
| Software Development & Validation | Software developed, verified, tested, and validated to company's documented procedures. |
| Risk Analysis (per ISO 14971) | Carried out, hazards identified and evaluated; no safety and efficacy issues raised. |
| Overall Safety and Effectiveness | Adequately supported by Non-Clinical performance data, substantial equivalence information, materials information, and comparison of design characteristics. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size:
- For TenJet Tissue Differentiation- Safety and Efficacy, the text mentions "Bovine and Cadaver" tissue. It does not specify the number of bovine or cadaver samples used.
- For other bench tests, biocompatibility, human factors, and electrical testing, specific sample sizes are not provided.
- Data Provenance:
- The studies appear to be non-clinical, laboratory-based tests. The country of origin for the data is implied to be the US, as the company (HydroCision, Inc.) and consultants are based in the US, and it's a submission to the US FDA.
- The data is inherently prospective in nature, as it was generated specifically for this 510(k) submission to demonstrate compliance and substantial equivalence before market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable / Not Provided. This type of information is relevant for AI/ML performance studies, not for the types of non-clinical device performance studies described here for a mechanical/fluidic device. The "ground truth" for these tests are objective measurements, pass/fail criteria based on standards, or comparison to the predicate device's established performance.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for image analysis or diagnostic tasks, which are not described here.
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:
- No. This is not an AI-enabled device. Therefore, no MRMC comparative effectiveness study involving AI assistance would have been conducted or is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-enabled device. Software is mentioned for the console's functionality (touch-screen LCD display, graphical user interface), and it states "The HydroCision console software has been developed, verified, tested and validated to the company's documented development and test procedures." This refers to standard medical device software validation, not standalone AI algorithm performance.
7. The Type of Ground Truth Used:
- The "ground truth" for the various tests were:
- Bench Testing: Objective physical measurements, comparison to predicate device characteristics, and observed performance on specific tissue types (bovine and cadaver).
- Biocompatibility: Established ISO standards (ISO 10993-1:2009) and FDA guidance for toxicology and material safety.
- Sterilization: Industry standards for ethylene oxide sterilization validation.
- Human Factors/Usability: Conformance to IEC 62366-1:2015.
- EMC/Electrical Safety: Conformance to IEC 60601-1 and IEC 60601-1-2.
- Software: Conformance to the company's documented development and test procedures.
- The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence." This means that ground truth from patient outcomes or extensive clinical trials was not used for this submission.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device. No training set for an algorithm is mentioned.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no AI/ML training set, this question is not relevant.
§ 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.