(34 days)
The Stimulus-Dissection Instruments are indicated for tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, forceps, retractors, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are noninsulated stainless steel to provide for mechanical, manually actuated dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
This 510(k) submission (K014163) for the Stimulation/Dissection Instruments does not contain explicit acceptance criteria or a dedicated study section detailing performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to existing predicate devices.
Summary of Device Performance and Substantial Equivalence:
The core of this submission is a comparison table outlining the characteristics of the Stimulus - Dissection Instruments and the predicate device, Ball-Tip Monopolar Stimulating Probe [K992869]. The "reported device performance" is essentially that the new device shares the same fundamental characteristics and intended use as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not stated, I will infer them from the characteristics listed for substantial equivalence. The "Reported Device Performance" will reflect that the new device meets these inferred criteria by being "Yes" where applicable.
| Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Stimulus - Dissection Instruments) |
|---|---|
| Indications For Use: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | Yes (Shares same Indications For Use) |
| Construction: Stainless steel construction | Yes |
| Electrical Insulation: Electrical insulation on all surfaces not intended to provide electrical contact with the patient | Yes |
| Patient Contact Surface: Distal stainless steel patient contact surface | Yes |
| Stimulator Connector: Proximal stimulator connector | Yes |
| Safety Standard Compliance: IEC 60601-1 Protected Pin design (21 CFR 898.12) | Yes |
| Biocompatibility: Biocompatible materials | Yes |
| Sterilization: Steam autoclavable | Yes |
2. Sample Size for Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable (N/A) for this type of submission. This submission does not include a dedicated clinical or performance study with a test set. The substantial equivalence argument relies on the comparison of design features and intended use with a predicate device.
- Data Provenance: N/A. There is no new data from a test set presented. The "data" here is descriptive of the device's design and functions, and a comparison to an existing, legally marketed device.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: N/A. No ground truth was established by experts for a test set, as no performance study was conducted.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set:
- Adjudication Method: N/A. No test set requiring ground truth adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. This submission does not describe an MRMC study or any comparative effectiveness study with human readers. The device is a surgical instrument with a stimulation function, not an AI-powered diagnostic tool. The focus is on the safety and effectiveness of the instrument itself, not on improving human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No. This device is a physical surgical instrument; it is not an algorithm, and therefore, a standalone algorithm performance study is not relevant or included.
7. Type of Ground Truth Used:
- Type of Ground Truth: N/A. No ground truth in the context of a performance study (e.g., pathology, outcomes data, expert consensus on diagnostic findings) was used. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device and relevant standards (e.g., IEC 60601-1).
8. Sample Size for the Training Set:
- Sample Size for Training Set: N/A. This device does not involve machine learning or AI, so there is no "training set."
9. How Ground Truth for Training Set Was Established:
- How Ground Truth Was Established: N/A. As there is no training set, this is not applicable.
Conclusion:
This 510(k) submission for the Stimulation/Dissection Instruments is a substantial equivalence submission, a common pathway for medical devices. It does not present a performance study with explicit acceptance criteria or a test set. Instead, it successfully argues that the new device is as safe and effective as a legally marketed predicate device by demonstrating that its design, technology, features, function, and intended use are substantially equivalent. The "acceptance criteria" are effectively the characteristics of the predicate device that define its safety and effectiveness, which the new device is shown to share.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.