(99 days)
This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region.
The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.
This submission will add 4 stimulation contact options to the predicate Nalu Neurostimulation System (also referred to as the "Nalu PNS System"). The Nalu PNS System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The Nalu PNS System incorporates a miniature implanted neurostimulator, powered by an externally worn Therapy Disc device. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on the peripheral nerves to inhibit the transmission of pain signals to the brain. The Nalu PNS System may be implanted following a successful trial period using the Nalu PNS trial system.
The leads that were cleared with the Nalu PNS System featured 8 stimulation contacts. This submission will provide an optional use of leads with 4 stimulation contacts.
This document is a 510(k) premarket notification for a medical device called the "Nalu Neurostimulation System for PNS" (specifically, the 4-contact version). The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This document does NOT present a study that proves the device meets specific acceptance criteria through clinical performance data. Instead, it argues for substantial equivalence based on non-clinical performance testing because the changes are considered minor.
Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this submission. The "acceptance criteria" here are demonstrating substantial equivalence through non-clinical testing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, primarily the Nalu Neurostimulation System (K183579). This is achieved by showing that the new device (4 Contact PNS System) has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document demonstrates this through comparative tables and statements rather than a traditional pass/fail clinical study.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (4 Contact PNS System) |
|---|---|
| Intended Use: Same as predicate. | Same: Indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin. Not for craniofacial region. Trial devices for stimulation (max 30 days). |
| Technological Characteristics: Similar to predicate, with differences not affecting safety/effectiveness. | Differences: |
- Number of Electrodes: 4 (vs. 8 in primary predicate).
- Lead Length: 25 cm, 40 cm (vs. 40 cm, 60 cm in primary predicate).
- Electrode Array Length: 21 mm (vs. 52 mm in primary predicate).
- Electrode Spacing: 3.0 mm (vs. 4.0 mm in primary predicate).
- Cable Features: Coiled Wires (vs. Multilumen tube in primary predicate).
- Lead Anchor: Integrated Lead Tines (vs. Separate molded silicone anchor with Ti locking mechanism in primary predicate).
Performance: All differences are stated to "not affect safety and effectiveness of intended use" and are within parameters of other reference devices. Tested through non-clinical means. |
| Therapeutic Attributes: Same as predicate. | Same: All parameters like pulse frequency, pulse width, current/voltage regulation, output current/voltage, waveform, pulse shape, maximum phase charge/density, net charge, average phase power/density, pulse delivery mode, current path options, software level of concern, program cycle, pulse pattern, dosage time, transmit frequency are identical to the predicate (K183579). |
| Biocompatibility: Meet standards. | Met: Same biocompatibility reports as predicate supported this device. Materials and processes previously assessed. |
| Sterilization: Meet standards. | Met: Ethylene Oxide sterilization, same as predicate. |
| Electrical & Mechanical Performance: Meet specifications, safe, and effective. | Met: Verification testing included electrical and mechanical tests. Validation, performance, and usability testing demonstrated device meets user needs. Conforms to applicable standards (ISO 14708-1, ISO 14708-3, IEC 62366-1, EN ISO 14971, ISO 11607, ISO 11135-1, CISPR 11). |
| Software Level of Concern: Moderate. | Met: Same as predicate (moderate). |
| Human Factors and Usability: Tested and met. | Met: Testing performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on non-clinical performance testing (bench testing, verification, validation, biocompatibility) and a comparative analysis to a predicate device, as opposed to a clinical test set with a specific sample size of patients/cases.
- Data Provenance: Not applicable. There is no clinical data from patients/cases mentioned. The testing is internal (Nalu Medical) and presumably took place in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. As there is no clinical test set requiring ground truth establishment by experts (e.g., for disease diagnosis or outcome evaluation), this information is not provided nor needed for this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or human interpretation requiring adjudication.
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 an implanted neurostimulator, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not a standalone algorithm.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" implicitly used for non-clinical testing (electrical, mechanical, biocompatibility, sterilization) is based on established engineering principles, international standards (e.g., ISO, IEC, CISPR), and pre-defined specifications/tolerances for the device's performance. For biocompatibility, it's compliance with ISO 10993-1. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning/AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 882.5870 Implanted peripheral nerve stimulator for pain relief.
(a)
Identification. An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).