(150 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and study summaries do not mention any AI/ML capabilities.
Yes.
The device is described as a neurostimulation device that delivers electrical stimulation for the purpose of improving swallowing in patients with severe dysphagia post-stroke. Its "Intended Use / Indications for Use" explicitly states its function as an "aid to improve swallowing," which clearly indicates a therapeutic purpose.
No
The Phagenyx System is described as a neurostimulation device that delivers electrical stimulation to improve swallowing in patients with severe dysphagia post-stroke. Its purpose is therapeutic intervention, not diagnosis.
No
The device description explicitly states that the Phagenyx System comprises a sterile single-patient use catheter and a Base Station, which are hardware components.
Based on the provided text, the Phagenyx System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke." This describes a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device description details a catheter with electrodes for electrical stimulation and a feeding tube. It also mentions a Base Station for controlling stimulation and storing information. This aligns with a therapeutic device, not a device used to examine specimens.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The Phagenyx System is a therapeutic device used to treat a condition (dysphagia) through electrical stimulation.
N/A
Intended Use / Indications for Use
The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.
Product codes (comma separated list FDA assigned to the subject device)
QQG
Device Description
The Phagenyx System comprises; a sterile single-patient use catheter (PNX-1000) and a Base Station (EPSB3). The catheter is a two-part fine bore that is introduced nasally and extends down as far as the patients' stomach. It incorporates two bipolar ring electrodes on its outer surface to deliver the electrical stimulation. It also incorporates a feeding tube to facilitate delivery of nutrition or hydration. The Base Station has a touch screen user interface that facilitates the optimization of stimulation levels for treatment and stores patient and treatment information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oropharynx
Indicated Patient Age Range
18 years old. No upper age limit.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data from three studies, STEPS, PHAST-TRAC and PHADER involving a total of 298 subjects in 38 hospital sites and 7 countries are provided to evaluate the safety of the Phagenyx System. Five studies involving a total of 317 subjects in 26 hospital sites and 5 countries are provided in support of Phagenyx treatment effectiveness.
Clinical Studies Overview:
- PHAST TRAC: RCT, 9 sites/3 countries (DE, AT, IT), n=69 dysphagic tracheotomized post stroke patients. Warnecke primary endpoint, DSRS secondary endpoint.
- PHADER: Single arm PM registry, 14 sites/3 countries (DE, AT, UK), n=177 post stroke dysphagia. DSRS primary endpoint.
- STEPS: RCT, 16 sites/5 countries (UK, DE, FR, ES, DK), n=52 dysphagia post stroke.
- YOUSSEF: Independent RCT, Single site (UAE), n=18 dysphagic acute stroke. PAS, FOIS endpoints.
- SUNTRUP: Independent RCT, Single site (DE), n=30 dysphagic tracheotomized post stroke patients. Warnecke primary endpoint.
- MUHLE: Independent Single arm observational, Single site (DE), n=23 dysphagic tracheotomized post stroke patients. Warnecke primary endpoint.
SUNTRUP:
- Study Type: Independent sham controlled single blinded randomized controlled trial (RCT).
- Sample Size: 51 subjects screened, 30 randomized (2:1 treatment/sham), 30 assessed, 7 in unblinded crossover.
- Key Results: For the primary endpoint 75% of treated subjects passed the Warnecke assessment by comparison with 20% of the sham subjects (p
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR PHAGENYX SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Oropharyngeal Electrical Stimulator. An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.
NEW REGULATION NUMBER: 21 CFR 874.5950
CLASSIFICATION: Class II
PRODUCT CODE: QQG
BACKGROUND
DEVICE NAME: Phagenyx System
SUBMISSION NUMBER: DEN220025
DATE DE NOVO RECEIVED: April 19, 2022
SPONSOR INFORMATION:
Phagenesis Limited Enterprise House Manchester Science Park Manchester, UK, M15 65E
INDICATIONS FOR USE
The Phagenyx System is indicated as follows:
The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.
LIMITATIONS
The sale, distribution, and use of the Phagenyx System are restricted to prescription use in accordance with 21 CFR 801.109.
The device is intended to be used in addition to standard dysphagia care.
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PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Phagenyx System comprises; a sterile single-patient use catheter (PNX-1000) and a Base Station (EPSB3). The catheter is a two-part fine bore that is introduced nasally and extends down as far as the patients' stomach. It incorporates two bipolar ring electrodes on its outer surface to deliver the electrical stimulation. It also incorporates a feeding tube to facilitate delivery of nutrition or hydration. The Base Station has a touch screen user interface that facilitates the optimization of stimulation levels for treatment and stores patient and treatment information.
Image /page/1/Picture/3 description: The image shows a medical device and its accessories. On the left is a tablet-like device with a screen displaying a user interface. The device has a white casing and a cable connected to its top. To the right of the device is a thin, flexible tube with markings and a connector at one end. The tube is coiled and appears to be a catheter or similar medical instrument.
Figure 1. Phagenyx System
Output parameters and other electrical specifications for the Phagenyx System are presented below in Table 1.
Table 1. Phagenyx System Specification
| Parameter | Specification |
|---|---|
| Stimulation output (mA) | 1 mA – 50 mA variable, controlled by user |
| Frequency | 5 Hz fixed |
| Pulse width | 200 $μ$ S fixed |
| Waveform | Monophasic square fixed |
| Current density at maximum output | 4.4 mA/cm² |
| Peak stimulation voltage | 240V |
| Peak energy per pulse | 2.4 mJ |
| Stimulation duration | 10 minutes fixed |
| Indication Display | - Power button LED |
| - On/Off |
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| - Active electrical output | - Yellow LED hardware driven |
|---|---|
| - Access control | - Secure password access for authorized users |
| - Data input | - Touchscreen display/full qwerty keyboard |
| - Simulation optimization | - Stepwise graphic illustration/guide |
| - Current level | - mA display on screen |
| - Treatment timer | - 10 minute countdown timer |
| - Electrode contact quality | - Good/poor contact real time icon display |
| - Patient records | - Patient ID and treatment information searchable database |
| Wireless connectivity | No |
| Data transfer | Via USB port in encrypted password controlled zipped files |
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical/bench studies were conducted on the Phagenyx System to demonstrate a reasonable assurance of safety and effectiveness.
BIOCOMPATIBILITY/MATERIALS
The Phagenyx System has been assessed and tested for biocompatibility as per FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process" and ISO 10993 standards. The catheter part of the Phagenyx System is in contact with patient tissues for up to a maximum of 30 days and testing performed reflects this and the fact that the device is placed in a non-sterile environment via a natural bodily orifice. The materials in contact with internal patient tissues are known to be safe (stainless steel electrodes and polyurethane tubing) and have been used in the same types of body areas in other medical device products (e.g., fine bore nasogastric feeding tubes). Biocompatibility testing carried out on the PNX-1000 catheter is summarized in Table 2.
| Tests performed | Acceptance criteria | Outcome |
|---|---|---|
| Cytotoxicity | ||
| (ISO 10993-5) | A reactivity score of 2 or less using the MEM | |
| Elution test | Pass | |
| Sensitization | ||
| (ISO 10993-10) | No macroscopic cutaneous reactions attributed to | |
| allergy on inspection post challenge | Pass | |
| Irritation | ||
| (ISO 10993-10) | Levels of irritation/edema within standard specified | |
| limits | Pass | |
| Acute Systemic Toxicity | ||
| (ISO 10993-11) | Equivalent biological reactivity levels in test and | |
| control sample animals | Pass | |
| Ethylene Oxide (EO) residual | ||
| (ISO 10993-7) | EO residuals within allowable limits | Pass |
Table 2. Biocompatibility testing on the Phagenyx System catheter
SHELF LIFE/STERILITY
The shelf life for the catheter component of the Phagenyx System is 3 years.
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The catheter and catheter packaging have been tested for function and integrity (seal integrity per ASTM F1886, gross leaks per ASTM F2096 and seal strength per ASTM F88) after accelerated aging (ASTM F1980), real time aging and transportation simulation (ASTM D7386). All requirements were met.
The catheter is provided sterile for single patient use. It is sterilized with ethylene oxide (EO). The sterilization vas performed to achieve a sterility assurance level (SAL) of 10 " in accordance with ISO 11135-1:2014 Sterilization of health care products - Ethylene Oxide Requirements for development, validation, and routine control of a sterilization process for medical devices.
The base station of the Phagenyx System does not make direct patient contact and is provided non-sterile. Cleaning and disinfection instructions are included in the labeline.
ELECTRICAL SAFETY & ELECTROMAGNETIC COMPATIBILITY (EMC)
The Base Station and the integrated use of Base Station and PNX-1000 catheter as the Phagenyx System have been independently tested to demonstrate compliance with the following standards. All requirements were met.
- IEC 60601-1:2005 + COR1:2006 + COR2:2007 + A1:2012, Medical electrical equipment . - Part 1: General requirements for basic safety and essential performance
- . EN 60601-1-2:2015 Medical electrical equipment. Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- EN60601-2-10:2015+A1:2016. Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
SOFTWARE
The software used in the Phagenyx Base Station was developed in accordance with IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes. The software is considered to be a moderate level of concern. The submission contains all the elements of software documentation as recommended in the FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity information for the USB flash drive was provided in accordance with the FDA Guidance Document, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
USABILITY
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Critical tasks associated with the correct insertion, positioning and use of the catheter for feeding and stimulation were identified through the usability hazard analysis and a US usability study was conducted per the FDA's guidance "Applying Human Factors and Usability Engineering to Medical Devices." Following the training and competency assessment the representative users demonstrated correct and safe use of the device at the intended environment.
PERFORMANCE TESTING - BENCH
Design verification testing were performed for the PNX-1000 Catheter and EPSB3 Base Station component of the system and summarized below.
| Category | Description |
|---|---|
| Mechanical | A range of tensile and actuation tests were performed to assess physical |
| integrity of materials and robustness of manufacturing processes to | |
| produce finished parts. These tests were repeated after transport | |
| conditioning and 3-year real time aging to ensure integrity was not | |
| compromised under a range of environmental conditions or due to the | |
| passage of time. All tests were passed. | |
| Nutritional | Tensile, pressure, flow, and corrosion tests were performed to ensure the |
| nasogastric tubing part of the catheter met obligatory performance | |
| requirements for feeding tubes. A subset of these tests were repeated | |
| after transport conditioning and 3-year real time aging to ensure integrity | |
| was not compromised under a range of environmental conditions or due | |
| to the passage of time. All tests were passed. | |
| Electrical | Functional tests to ensure pulse characteristics were within specification |
| and temperature change testing to ensure safe performance at maximum | |
| output over time. Electrical integrity and continued function were | |
| assessed post transport conditioning and aging. All tests were passed. | |
| Visual/dimensional | Measurements and inspections to verify design output drawings match |
| physical parts. Visual appearance/integrity was repeated after aging | |
| studies to ensure no degradation over time. All tests were passed. |
Table 3. Design Verification of the PNX-1000 Catheter
| Table 4. Design Verification of the EPSB3 Base Station | |||
|---|---|---|---|
| -- | -------------------------------------------------------- | -- | -- |
| Category | Description |
|---|---|
| Electronics Tests | These tests verified the electronic design of the EPSB3 Base Station by |
| checking that the electronics operate correctly. All tests were passed. | |
| System Tests | These tests verified the overall design of the EPSB3 Base Station by |
| checking that the complete Base Station operates correctly. All tests were | |
| passed. |
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| User Interface (UI)
Software Tests | These tests verify the UI software design of the EPSB3 Base Station.
These tests verify that the software can successfully perform the user
interface functional operations as specified in the User Requirements
Specification. All tests were passed and requirements met. |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unit Tests | These tests verify the design of key software functions/modules/units by
checking that they work independently and correctly for EPSB3. All tests
were passed. |
| Mechanical/
dimensional | These tests ensure that design outputs in the form of drawings,
dimensions and physical features match the physical aspects of the
finished product. All tests were passed and requirements met. |
SUMMARY OF CLINICAL INFORMATION
Data from three studies, STEPS, PHAST-TRAC and PHADER involving a total of 298 subjects in 38 hospital sites and 7 countries are provided to evaluate the safety of the Phagenyx System. Five studies involving a total of 317 subjects in 26 hospital sites and 5 countries are provided in support of Phagenyx treatment effectiveness.
All of the studies relevant to the use of the device in severe dysphagia post-stroke are summarized below.
A. Clinical Studies Overview
| Company Sponsored | Independent | ||
|---|---|---|---|
| Name | Type and Design | Name | Type and Design |
| PHAST | |||
| TRAC | • RCT | ||
| • 9 sites/3 countries (DE, AT, IT) | |||
| • Dysphagic tracheotomized post | |||
| stroke patients | |||
| • Warnecke primary endpoint | |||
| • DSRS secondary endpoint | |||
| • (n=69) | YOUSSEF | • Independent | |
| • RCT | |||
| • Single site (UAE) | |||
| • Dysphagic acute stroke | |||
| • PAS, FOIS endpoints | |||
| • (n=18) | |||
| PHADER | • Single arm PM registry | ||
| • 14 sites/3 countries (DE, AT, UK) | |||
| • Post stroke dysphagia | |||
| • DSRS primary endpoint | |||
| • (n=177) | SUNTRUP | • Independent | |
| • RCT | |||
| • Single site (DE) | |||
| • Dysphagic tracheotomized post | |||
| stroke patients | |||
| • Warnecke primary endpoint | |||
| • (n=30) | |||
| STEPS* | • RCT | ||
| • 16 sites/5 countries (UK, DE, FR, | |||
| ES, DK) | |||
| • Dysphagia post stroke | |||
| • (n=52) | MUHLE | • Independent | |
| • Single arm observational | |||
| • Single site (DE) | |||
| • Dysphagic tracheotomized post | |||
| stroke patients | |||
| • Warnecke primary endpoint |
Table 5. Clinical Studies Overview
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| (n=23) | |
|---|---|
| * | The STEPS study had a neutral outcome. The primary reason for this is that overall the patients in STEPS were |
| undertreated. The key metric in identifying whether a patient has been given sufficient optimized stimulation, is not | |
| the absolute value of the stimulation level but the delta between the Threshold mA and the Stimulation mA (i.e., the |
the absolute value of the stimulation level but the detween the Threshold mA and the Stimulation mA (i.e., the intensity of stimulation above the sensory threshold for that patient). This must be individually determined for each patient and for every treatment. Only 5% of the STEPS subgroup with severe dysphagia received delta stimulation levels comparable to those used in PHAST TRAC. In PHAST TRAC, the deta between the Stimulation Level and Threshold had a mean value of 18mA. In PHADER the mean of the delta was over 13mA. By contrast, in STEPS the mean delta was 40-66% lower, at less than 6mA, with many of the patients receiving stimulation at, or just above, the sensory threshold.
| Study Name | Patient Age | Patient Race/Ethnicity |
|---|---|---|
| PHAST TRAC | Inclusion: > 18 years old. No upper age limit. | |
| Actual recruited | ||
| Mean age years and (SD) Treated: 61.7 (13.0) | ||
| Mean age years and (SD) Sham: 66.8 (10.3) | Not recorded. | |
| PHADER | Inclusion: > 18 years old. No upper age limit. | |
| Actual recruited | ||
| Mean age years and (SD): 68.2 (14.2) | Not recorded. | |
| STEPS | Inclusion: > or = 18 years old. No upper age | |
| limit. | ||
| Actual recruited (whole study) | ||
| Mean age years and (SD): 74.4 (11.2) | ||
| Actual recruited (n=52 subgroup) | ||
| Mean age years: 74.9 | Information on ethnicity was | |
| recorded. | ||
| Distribution as follows: | ||
| Asian (9%), Black (3%), White | ||
| (86%), Other (3%) | ||
| YOUSSEF | Inclusion criteria relating to age unknown | |
| Actual recruited | ||
| Mean age years and (SD) Treated: 64.3 (11.3) | ||
| Mean age years and (SD) Sham: 66.7 (8.5) | 100% Middle Eastern/Non-white | |
| SUNTRUP | Inclusion criteria relating to age unknown | |
| Actual recruited | ||
| Mean age years and (SD) Treated: 63.0 (14.5) | ||
| Mean age years and (SD) Sham: 66.7 (14.5) | Not recorded. | |
| MUHLE | Inclusion criteria relating to age unknown | |
| Actual recruited | ||
| Mean age years and (SD) Treated: 64.4 (11.7) | Not recorded. |
Table 6. Patient Demographics
1. SUNTRUP
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Study summary - The Suntrup study was an independent sham controlled single blinded randomized controlled trial (RCT) in post stroke patients with severe persistent dysphagia that were tracheotomized, where the dysphagia was the only remaining impediment to safe removal of the tracheostomy tube. Patients were considered suitable for inclusion if they were fully weaned from mechanical ventilation and were able to stay alert for at least 15 minutes. Dysphagia severity was assessed both at screening and for the primary endpoint by endoscopic exam using the Warnecke endpoint. This measures management of secretions, spontaneous swallow frequency and laryngeal sensitivity. Patients that passed Warnecke were eligible for decannulation of their tracheostomy tube based on the observed improvement in swallowing, All subjects received standard of care and the treatment group received the standard 3 x 10 minutes of Phagenyx System treatment over 3 consecutive days.
Subject accountability - 51 subjects were screened and 30 randomized 2:1 to the treatment or sham arm. Post intervention or sham all 30 subjects were assessed with 72 hours using the Warnecke endpoint. 8 sham subjects that were Warnecke negative after primary endpoint assessment were offered treatment in an unblinded crossover but one of these was lost to discharge prior to treatment.
Safety Results - The authors reported that there were no device or treatment related adverse events.
Effectiveness Results - For the primary endpoint 75% of treated subjects passed the Warnecke assessment by comparison with 20% of the sham subjects (p4 DSRS at follow up 1. >6 DSRS at follow up 2 and >9 DSRS at follow up 3). This is illustrated in Figure 7.
Image /page/14/Figure/3 description: The image is a bar graph that shows the percentage of subjects who are NPO (nothing by mouth) at different time points after a stroke event. At the beginning of the study, 150 subjects were NPO for a mean of 7 weeks. After Phagenyx treatment, the percentage of subjects who were NPO decreased to 79% at FU1 (2-3 days), 53% at FU2 (14 days), and 26% at FU3 (60-120 days).
Figure 7. DSRS Outcomes for 150 Subjects with Baseline DSRS of 12
Study conclusions - Phagenyx is safe and potentially effective in the treatment of severe dysphagia post stroke in patients that do not respond to standard dysphagia care. Although this was a single arm study, the timing and size of improvement in DSRS seen in a significant % of
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subjects that had not responded to standard dysphagia care for many weeks strongly suggests a treatment effect. The single device related serious adverse event seen in this study was resolved without complication and was only possibly related to catheter insertion and not to treatment.
Publication - Bath et al., Pharvngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: main results from the PHADER cohort study, EClinicalMedicine 28 (2020) 100608.
B. Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
TRAINING
Prior to the usability assessment a standard training program was provided the participants. The training program included three parts:
- . Classroom training 1 - Theory (understand the science and clinical evidence)
- . Classroom training 2 - Practical (understand how to optimally use and care for the Phagenyx System)
- . Hands on training and competency assessment
Training was performed on site with participants and the results of their performance were documented and signed off if appropriate by a qualified Phagenesis trainer. Usability studies conducted in Europe and U.S. validated that the training program is equally effective when delivered to U.S. healthcare users.
LABELING
The labeling is sufficient and meets the requirements of 21 CFR 801.109 Prescription devices.
Labeling includes PNX-1000 instructions for use for adjustment and insertion of the catheter component of the system, its use for feeding purposes and maintenance and care of the device. It also includes a list of contraindications and warnings and shelf life.
Labeling additionally includes the Phagenvx System User Guide which presents detailed information on the use of the overall system for treatment optimization and delivery, contraindications, warnings and anticipated adverse events and cleaning and disinfection instructions. The User Guide also includes a summary of clinical studies.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the oropharyngeal electrical stimulator and measures necessary to mitigate these risks.
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| Identified Risks to Health | Mitigation Measures |
|---|---|
| Incorrect stimulation output leading to | |
| discomfort or delayed treatment, or | |
| incorrect location of stimuli leading to | |
| jaw chattering or facial/ear pain | Non-clinical performance testing |
| Software verification, validation and hazard analysis | |
| Usability testing | |
| Training | |
| Off target neurostimulation due to | |
| patient specific injury resulting in | |
| harmful neurological activity | Usability testing |
| Training | |
| Tissue damage due to mechanical | |
| stress, electrical effects, or heating | |
| effects | Usability testing |
| Training | |
| Electrical safety testing | |
| Electrical shock from electrical | |
| component malfunction | Non-clinical performance testing |
| Electrical safety testing | |
| Interference with other devices | |
| leading to malfunction or injury | Electromagnetic compatibility (EMC) testing |
| Adverse tissue reaction | Biocompatibility evaluation |
| Infection | Sterilization validation |
| Reprocessing validation | |
| Shelf life testing | |
| Labeling | |
| Software failure leading to delayed | |
| treatment or discomfort | Software verification, validation and hazard analysis |
| Fire hazard in the presence of | |
| supplementary oxygen | Non-clinical performance testing |
| Training | |
| For devices with feeding tubes, | |
| leakage and misplacement of feeding | |
| tube leading to feeding-related | |
| complications (e.g., temporary | |
| suboptimal nutrition, reflux aspiration, | |
| respiratory distress) | Non-clinical performance testing |
| Training | |
| Usability testing |
Table 8. Identified Risks to Health and Mitigation Measures
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the oropharyngeal electrical stimulator is subject to the following special controls:
- Non-clinical performance testing must demonstrate the device performs as intended under (1) anticipated conditions of use, including the following:
- Electrical output testing; (i)
- Mechanical integrity testing of electrical components; (ii)
- (iii) Testing to verify safe use of the electrical stimulator component in the presence of supplementary oxygen; and
- If the device incorporates a feeding tube, feeding tube functionality testing, including (iv) mechanical integrity, liquid leakage, flow rate and connector compatibility.
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- (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
- Performance testing must demonstrate the sterility of the components intended to be (3) provided sterile.
- (4) Performance data must validate the reprocessing instructions for any reusable components of the device.
- (5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
- (6) Software verification, validation and hazard analysis must be performed for any software components of the device.
- (7) Performance testing must demonstrate the electromagnetic compatibility (EMC) and electrical safety of any electrical components.
- (8) A training program must be included with sufficient educational elements so that upon completion of the training program, the users can correctly operate the device.
- Usability testing must demonstrate that the device can be correctly used as per training and (9) labeling.
- (10) The labeling must include a shelf life for any sterile components.
BENEFIT-RISK DETERMINATION
The benefits associated with use of the Phagenyx System have been established through assessment of data derived from 4 randomized controlled trials, a single arm observational study, and a postmarket registry study. These 6 studies included 369 subjects across 8 countries to assess Phagenyx for its intended use.
Benefits were demonstrated in multiple aspects of swallowing function, including spontaneous swallows, secretion management, and larvngeal sensibility. The magnitude of effect compared to controls was generally large in the controlled studies, with meaningful improvements in swallowing function that were demonstrated to correlate with return to oral intake even after prolonged periods of no response to standard of care. Overall, these results demonstrate that device provides a treatment benefit for different aspects of nutritional intake including fluids. diet and level of supervision/independence.
The risks associated with the Phagenyx System are low as evidenced by the safety data gathered in the randomized controlled studies as well as the post-market data gathered. Although there was 1 SAE reported and a number of nonserious device or treatment related events reported across the different studies assessing the device, these events were reported as resolved without
18
complications. Furthermore, the risk of respiratory AEs and SAEs, such as aspiration pneumonia and respiratory infection is consistent with the rates reported in the literature and, overall, there were no significant differences in these AEs and SAEs between the treatment and control groups in the studies assessing the safety the Phagenyx System.
In summary, the Phagenyx System offers a benefit to patients with severe dysphagia post stroke with relatively few risks. The data on safety and effectiveness for the Phagenyx System support a clinically meaningful degree of benefit that outweighs the low risk of serious, device-related adverse events.
PATIENT PERSPECTIVES
Patient reported outcome data were collected in PHADER, STEPS and YOUSSEF clinical studies and summarized below:
| Study Name | Patient Reported Outcomes |
|---|---|
| PHAST TRAC | Patients in the study were critically ill and, in most cases, not suited to partaking in |
| patient reported outcome measures where a baseline data set was needed as a | |
| comparison. As a result these types of endpoints were not included in the study | |
| design. | |
| PHADER | The PHADER post market registry study included EQ5D, Dysphagia Handicap Index |
| and EAT-10 as secondary endpoint patient centric measures. However, for the same | |
| reasons as indicated in PHAST TRAC, SUNTRUP and MUHLE (i.e., inability of the | |
| subjects to comply) less than 20% of these patients could have an EQ5D measure | |
| taken at baseline for example and less than 1% had a full set of EQ5D results over all | |
| the timepoints. Meaningful statistical analysis of the patient reported outcome data | |
| was therefore not possible. |
EQ5D: EuroQol-5D scale for measuring quality of life |
| STEPS | EQ5D, HADS and LOT-R information was gathered in this study, but for reasons
previously explained, this study was neutral overall for both primary and secondary
endpoints. No significant difference was seen therefore between treated and sham
patients using any of these measures.
HADS: Hospital Anxiety and Depression Score
LOT-R: Life Orientation Test-Revised |
| YOUSSEF | 7-point categorical scale. Statistically greater patient satisfaction was shown in the
treated group versus the control group. |
| SUNTRUP | Patients in the study were critically ill and, in most cases, not suited to partaking in
patient reported outcome measures where a baseline data set was needed as a
comparison. As a result these types of endpoints were not included in the study
design. |
| MUHLE | Patients in the study were critically ill and, in most cases, not suited to partaking in
patient reported outcome measures where a baseline data set was needed as a
comparison. As a result these types of endpoints were not included in the study
design. |
Table 9. Patient Reported Outcomes
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BENEFIT/RISK CONCLUSION
In conclusion, given the available information above, for the following indication statement;
The Phagenyx System is a neurostimulation device delivering electrical stimulation to the oropharynx, to be used in addition to standard dysphagia care, as an aid to improve swallowing in patients with severe dysphagia post stroke.
The probable benefits outweigh the probable risks for the Phagenyx System. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the Phagenyx System is granted and the device is classified as follows:
Product Code: OOG Device Type: Oropharyngeal electrical stimulator Regulation Number: 21 CFR.874.5950 Class: II