(243 days)
Not Found
No
The summary describes a nerve stimulator that uses electrical stimulation and transillumination for electrode placement. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended to aid in the reduction of opioid withdrawal symptoms, which is a therapeutic purpose.
No
Explanation: The device is described as a percutaneous nerve field stimulator (PNFS) system intended to reduce the symptoms of opioid withdrawal through electrical stimulation. It treats symptoms rather than diagnosing a condition.
No
The device description explicitly states it consists of hardware components: a percutaneous nerve field stimulator, a multi-pin wire harness percutaneous electrode array, and a pen light.
Based on the provided information, the NSS-2 BRIDGE is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- NSS-2 BRIDGE Function: The NSS-2 BRIDGE is a percutaneous nerve field stimulator. It works by applying electrical stimulation to specific nerves on the head to reduce the symptoms of opioid withdrawal. It does not involve the collection or analysis of any biological specimens from the patient.
- Intended Use: The intended use clearly states it is a "percutaneous nerve field stimulator (PNFS) system... used as an aid to reduce the symptoms of opioid withdrawal." This is a therapeutic intervention, not a diagnostic test.
Therefore, the NSS-2 BRIDGE falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Product codes
PZR
Device Description
NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
branches of Cranial Nerves V, VII, IX and X, and the occipital nerves
Indicated Patient Age Range
18-65 years old
Intended User / Care Setting
Outpatient drug treatment clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A single-arm, open label, multi-center retrospective study was done that included 73 patients (ranging from 18-65 years old; mean age = 32.9 ± 9.4) who met DSM-IV criteria (the classification found in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, published by American Psychiatric Association) for opioid dependence and voluntarily presented to outpatient drug treatment clinics between June 2015. Inclusion criteria included being 18 years of age or older, having a positive urine toxicology screen for opioids, and having a Clinical Opioid Withdrawal Score (COWS) of 5 or greater. Participating clinics located across five states provided data from patients treated with the NSS-2 BRIDGE: St. Louis, MO (27), Liberty, IN (13), Florence, KY (12), Anchorage, AK (9), Rising Sun, IN (6), Richmond, IN (2), Dayton, OH (2), and Indianapolis, IN (2). These scores were extracted from the medical chart. COWS scores were also extracted as recorded in the medical chart at 5 days post BRIDGE placement when available. The use of any rescue medications during the first hour of neurostimulation with the NSS-2 BRIDGE, including anti-psychotics, narcotics or benzodiazepines was monitored.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Single-arm, open label, multi-center retrospective study.
Sample Size: 73 patients.
Key Results:
- The mean COWS score prior to NSS-2 BRIDGE placement was 20.1 (+6.1).
- Twenty minutes after NSS-2 BRIDGE placement, the mean score was reduced by 62.7% to 7.5 (±5.9) (p
§ 882.5896 Percutaneous nerve stimulator for substance use disorders.
(a)
Identification. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Electromagnetic compatibility and electrical, mechanical, and thermal safety testing must be performed.
(3) Electrical performance testing of the device and electrodes must be conducted to validate the specified electrical output and duration of stimulation of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Sterility testing of the percutaneous components of the device must be performed.
(6) Shelf life testing must be performed to demonstrate continued sterility, package integrity, and device functionality over the specified shelf life.
(7) Labeling must include the following:
(i) A detailed summary of the device technical parameters;
(ii) A warning stating that the device is only for use on clean, intact skin;
(iii) Instructions for use, including placement of the device on the patient; and
(iv) A shelf life.
0
DE NOVO CLASSIFICATION REQUEST FOR NSS-2 BRIDGE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Percutaneous nerve stimulator for substance use disorders. A percutaneous nerve stimulator for substance use disorders is a device that stimulates nerves percutaneously to aid in the reduction of withdrawal symptoms associated with substance use disorders.
NEW REGULATION NUMBER: 21 CFR 882.5896
CLASSIFICATION: Class II
PRODUCT CODE: PZR
BACKGROUND
DEVICE NAME: NSS-2 BRIDGE
SUBMISSION NUMBER: DEN170018
DATE OF DE NOVO: March 17, 2017
CONTACT: Innovative Health Solutions (IHS), Inc. 829 South Adams St. Versailles, IN 47042
INDICATIONS FOR USE
The NSS-2 BRIDGE is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
LIMITATIONS
For prescription use only.
The device is contraindicated for use by patients with cardiac pacemakers, hemophilia, and psoriasis vulgaris.
The device should only be applied to healthy, clean, intact skin.
The device therapy is limited to 120 hours, after which the device is disposable.
1
The appliance is splash-proof but not watertight. When showering, the device must not be allowed to come into direct contact with water.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
NSS-2 BRIDGE is a device that electrically stimulates branches of Cranial Nerves V. VII. IX and X, and the occipital nerves identified by transillumination through percutaneous electrodes to aid in the reduction of opioid withdrawal symptoms. The device consists of (1) a percutaneous nerve field stimulator (PNFS; Figure 1), (2) a multi-pin wire harness percutaneous electrode array (Figure 2), and (3) a pen light for use in the transillumination technique that aids in positioning of the percutaneous electrodes (Figure 3).
Image /page/1/Picture/4 description: The image shows a translucent, curved object, possibly made of plastic or silicone, resting on a solid green surface. The object has a smooth, rounded shape with a slight curve, and its transparency allows a glimpse of the surface beneath. The lighting is soft and even, highlighting the object's texture and form.
Figure 1: Percutaneous nerve field stimulator (PNFS)
The wire harness percutaneous electrode array consists of 4 leads. The 1-1-1-4 configuration consists of three single-needle leads, and one 4-needle array (Figure 2).
Image /page/1/Figure/7 description: The image shows a schematic drawing of a mechanical system with a rectangular block on the left and four circular objects on the right. The rectangular block has a series of vertical lines on its face, suggesting it may be a connector or terminal block. Four cables or rods extend from the block to the circular objects, which appear to be pulleys or tensioners, and the cables are arranged in a parallel fashion, converging towards the block.
Figure 2: 1-1-1-4 Wire Harness configuration
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Image /page/2/Picture/0 description: In the image, a person wearing blue gloves is examining a patient's ear. The ear is illuminated with a bright light, possibly from a medical device. A small electronic device is attached to the patient's ear, which could be a sensor or monitoring device. The image appears to be taken in a medical setting, possibly during a check-up or examination.
Figure 3: Visualization of neurovasculature of the ear using transillumination technique
Image /page/2/Picture/2 description: This image shows a medical device with four leads. The leads are connected to a small, clear, curved device that contains a circuit board. The device is labeled "FIG. 2" in the bottom right corner. The background is a plain white surface.
Figure 4: Full system
The stimulator is placed behind the ear and the percutaneous electrodes are positioned utilizing the transillumination function of the device. The transillumination technique assists in the visualization of the neurovasculature of the ear, specifically the main arterial branches and the concurrent neuro-vascular matrixes, to aid in the placement of the percutaneous electrodes near the nerve branches in the ear. The system specifications are listed in Table 1 and the output waveforms are demonstrated in Figure 5.
| Device Technology Description | |
|---|---|
| General Device | |
| Characteristics | NSS-2 BRIDGE |
| Power supply | 1 x 3V battery (Type CR1220 Li) |
| Output | Max 3.2 V @ 1kΩ -10kΩ |
| Total duration of | |
| treatment | 5 x 24 hrs |
| Duty type | (b) (4) |
| Weight including battery | 5g |
| Dimensions | 36mm x 16mm x 7mm |
| Table 1: System Specifications | V | ||
|---|---|---|---|
| -------------------------------- | --- | -- | -- |
3
Image /page/3/Picture/0 description: The image contains two sets of parentheses with characters inside. The first set of parentheses contains the letter 'b', while the second set contains the number '4'. Both the parentheses and the characters within them are black, contrasting with the gray background.
Figure 5. Representative output waveforms of the NSS-2 BRIDGE device.
The following components are part of a convenience kit sold with the NSS-2 BRIDGE:
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- Tweezers
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- Transilluminator (pen light)
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- Alcohol swab
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- Surgical marker
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- Fixation plasters
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- Foam adhesive
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- Multi-pin wire harness percutaneous electrode array
The NSS-2 BRIDGE is nearly identical to the Electronic Auricular Device (EAD) previously cleared in K140530 for a different intended use (i.e., in the practice of acupuncture). The NSS-2 BRIDGE incorporated the following technical changes from this previously cleared device:
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- The previously cleared device has a pulse sequence of 2 hours on and 2 hours off over a 120 hour run-time. The NSS-2 BRIDGE has a modified pulse sequence of 2 hours on and 1 minute off with the cycle repeating over the 120 hour run-time.
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- The original wire harness has 4 percutaneous leads: three 4-needle arrays, and one single-needle lead (a "4-4-4-1" harness configuration). An additional wire harness option was added for the NSS-2 BRIDGE with 4 percutaneous leads: three singleneedle leads, and one 4-needle array (a "1-1-1-4" harness configuration).
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- The NSS-2 BRIDGE kit includes sterile adhesive strips and a pen light.
- The material of the PNFS plastic housing changed from (b) (4) 4. is medical grade. Data is on file to support conformance to ISO 10993-1.
4
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- The NSS-2 BRIDGE includes the use of a transillumination technique to place the device.
SUMMARY OF NONCLINICAL/BENCH STUDIES
New biocompatibility, electrical safety, electromagnetic compatibility, shelf life, sterility, and software testing was not required for the NSS-2 BRIDGE device as the device is nearly identical to the EAD device cleared in K140530. In the sections below, the testing provided for the K140530 submission is summarized to support the safety and effectiveness of this device for its intended use (see the 510(k) Summary for K140530 for more information). The technological changes detailed above do not impact any results of the testing. Additional information on these changes and why they do not impact the results of the testing are discussed in the associated sections below.
BIOCOMPATIBILITY/MATERIALS
Biocompatibility information for DEN170018 was leveraged from data previously provided for the EAD device cleared under K140530.
| Table 2: List of Patient-Contacting Materials | ||
|---|---|---|
| Patient Contacting | ||
| Device Component | Nature of Tissue | |
| Contact | Duration of Tissue Contact | |
| Tweezers | No skin contact | No skin contact |
| Transilluminator (pen | ||
| light) | Behind ear | 36). Note that as stated above, patients were required to have a COWS score of 5 or greater in order to be included in this retrospective study. These scores were extracted from the medical chart. COWS scores were also extracted as recorded in the medical chart at 5 days post BRIDGE placement when available. |
The use of any rescue medications during the first hour of neurostimulation with the NSS-2 BRIDGE, including anti-psychotics, narcotics or benzodiazepines was monitored. However, no rescue medications were utilized within the first 60 minutes of NSS-2 BRIDGE use. Patients were instructed to follow-up within 1-5 days, depending on the clinic, and to leave the device on for the entire 5 day period. Patients were also instructed to return the device once removed so that it could be properly disposed. The protocol required monitoring of any adverse events associated with the device during the study. However, no adverse events were observed during the study.
Basic descriptive statistics were used for participant demographics. Non-parametric analysis with repeated measures ANOVA was used to evaluate effectiveness in reducing withdrawal scores across all time periods measured. Missing COWS scores were encountered at 20 min (11/73) and at 60 min (2/73). Imputing of missing data was not performed and analysis was made only with available data since the missing values were considered missing at random. Data were presented as mean (±standard deviation) and p