(88 days)
No
The device description and performance studies focus on electrical stimulation and its clinical outcomes, with no mention of AI or ML algorithms for data analysis, treatment personalization, or other functions.
Yes
The device is intended for the “acute treatment of pain associated with migraine headache in adult patients,” and its performance studies discuss a "therapeutic gain," indicating its use in treating a medical condition.
No
Explanation: The device description and intended use indicate that the gammaCore Sapphire provides non-invasive vagus nerve stimulation for the treatment of various headache types, not for diagnosing conditions.
No
The device description explicitly states it is a "multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "non-invasive vagus nerve stimulation (nVNS) on the side of the neck" for the treatment of cluster and migraine headaches. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation. It does not mention any components or functions related to analyzing biological samples (like blood, urine, or tissue) which is the core function of an IVD.
- No mention of biological sample analysis: The entire document focuses on the delivery of stimulation and its effects on headache symptoms. There is no mention of collecting, processing, or analyzing any biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- · Adjunctive use for the preventive treatment of cluster headache in adult patients.
- · The acute treatment of pain associated with episodic cluster headache in adult patients.
- · The acute treatment of pain associated with migraine headache in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
PKR, QAK
Device Description
The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:
- . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
- . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status.
- . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
- . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
- Indicates on the display the number of remaining doses available in a 24-hour period. ●
The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the healthcare provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her healthcare provider. The refill/reload RFID cards will be programmed using the gammaCore Dispensing and Ordering Terminal (gammaCore DOT) by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy.
When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a healthcare provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The encoded RFID card is matched to a specific gammaCore device serial number residing in a database maintained by electroCore. The gammaCore DOT application, running on a Sony Xperia® tablet, uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication (NFC) protocols.
The encoding algorithm is based on a seed-value pair of numbers specific to a device ID (unique device serial number) that is registered in the gammaCore DOT database. The gammaCore DOT application ensures that only legitimate seed values allow refilling/reloading of the device through validation of the prescription and seed values in the gammaCore DOT database using the unique device and patient IDs.
The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with one to six additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "rd" and the "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload; upon completion of the device refill/reload, the card can be thrown away.
In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses, as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user: it is accessible only to the device manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
side of the neck
Indicated Patient Age Range
adult patients
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)
Clinical data demonstrating the safety and effectiveness of the gammaCore Sapphire for the prophylactic/preventive treatment of cluster headache were collected from a multicenter, randomized, controlled study that took place across 10 sites in Europe from November 23, 2012, to April 30, 2014. The study was designed to compare two parallel groups, standard of care (SoC) plus nVNS (active treatment) versus SoC alone (control). The study began with a 2-week run-in period, followed by a 4week comparative period when the subjects were randomized 1:1 to either active treatment or control. The comparative period was followed by an open-label period during which all subjects received active treatment with gammaCore in addition to the SOC for 4 weeks. Subject demographics were similar among the SoC plus nVNS (n=48) and control (n=49) groups. The primary endpoint of the study was the change in mean number of CH attacks per week. The mean number of CH attacks per week was calculated as the sum of all attacks during the 2-week run-in period divided by 2 and as the sum of all attacks during the last 14 days of the randomized period divided by 2. The change in mean number of attacks was calculated as the number of CH attacks per week during the randomized period (last 14 days) minus the number of CH attacks per week during the run-in period. Subjects treated with SoC plus nVNS had a significantly greater reduction in the number of cluster attacks per week versus the control arm (5.9 vs 2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; P=0.02).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Higher 50% responder rates were also observed among subjects using SoC plus nVNS (40%) versus controls (8.3%) (P
§ 882.5892 External vagal nerve stimulator for headache.
(a)
Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.(2) Software verification, validation, and hazard analysis shall be performed.
(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.
(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).
(5) The labeling must include:
(i) Instructions for proper use of the device, including placement of the device on the patient; and
(ii) Instructions on care and cleaning of the device.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2018
Electrocore, Inc. Mike Romaniw VP. Quality Assurance & Regulatory Affairs 150 Allen Road, Suite 201 Basking Ridge, New Jersey 07920
Re: K182369
Trade/Device Name: gammaCore Sapphire Regulation Number: 21 CFR 882.8592 Regulation Name: External Vagal Nerve Stimulator For Headache Regulatory Class: Class II Product Code: PKR, QAK Dated: August 30, 2018 Received: August 31, 2018
Dear Mike Romaniw:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Timothy A. Marjenin -S
Carlos L. Peña, PhD, MS For Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182369
Device Name gammaCore Sapphire
gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- · Adjunctive use for the preventive treatment of cluster headache in adult patients.
- · The acute treatment of pain associated with episodic cluster headache in adult patients.
- · The acute treatment of pain associated with migraine headache in adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
5 510(K) SUMMARY
The following information is provided as required by 21 CFR §807.87 for the electroCore gammaCore Sapphire 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Applicant: | electroCore, Inc.
150 Allen Road, Suite 201
Basking Ridge, New Jersey 07920
Ph: 973-290-0097
Fax: 973-290-9171 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 3009060963 |
| Contact: | Mike Romaniw
VP, Quality Assurance & Regulatory Affairs
Office: 973-355-6702
Fax: 973-290-9171
Mike.Romaniw@electroCore.com |
| Alternate Contact: | Eric J. Liebler
SVP, Neurology
Mobile: 908-938-9780
Eric.Liebler@electroCore.com |
| Alternate Contact: | Deborah Lavoie Grayeski
Sr. Project Manager
M Squared Associates, Inc.
Office: 347-954-0418
Fax: 703-562-9797
dgrayeski@MSquaredAssociates.com |
| Alternate Contact: | Janice M. Hogan, Esq.
Partner
Hogan Lovells US LLP
Direct: 267-675-4611
Janice.Hogan@HoganLovells.com |
4
| Date of Submission: | August 30, 2018 |
|---|---|
| Proprietary Name: | gammaCore Sapphire |
| Common Name: | External vagal nerve stimulator for headache |
| Classification Status: | Class II |
| Product Codes: | PKR, QAK |
| Primary Predicate Device: | gammaCore Sapphire, K180538 |
| Reference Device: | gammaCore-S, K173442 |
Indication for Use: The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for:
- . Adjunctive use for the preventive treatment of cluster headache in adult patients.
- . The acute treatment of pain associated with episodic cluster headache in adult patients.
- . The acute treatment of pain associated with migraine headache in adult patients.
Device Description: The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:
- . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
- . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status.
- . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
- . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
- Indicates on the display the number of remaining doses available in a 24-hour period. ●
5
The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the healthcare provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her healthcare provider. The refill/reload RFID cards will be programmed using the gammaCore Dispensing and Ordering Terminal (gammaCore DOT) by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy.
When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a healthcare provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The encoded RFID card is matched to a specific gammaCore device serial number residing in a database maintained by electroCore. The gammaCore DOT application, running on a Sony Xperia® tablet, uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication (NFC) protocols.
The encoding algorithm is based on a seed-value pair of numbers specific to a device ID (unique device serial number) that is registered in the gammaCore DOT database. The gammaCore DOT application ensures that only legitimate seed values allow refilling/reloading of the device through validation of the prescription and seed values in the gammaCore DOT database using the unique device and patient IDs.
The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with one to six additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "rd" and the "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload; upon completion of the device refill/reload, the card can be thrown away.
In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses, as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user: it is accessible only to the device manufacturer.
6
Summary of Technological Characteristics:
There are no changes to the technological characteristics of the gammaCore Sapphire for this expanded indication.
Summary of Non-clinical Testing:
There are no changes to the technological characteristics of the gammaCore Sapphire for this expanded indication; no additional non-clinical or performance testing is required.
Summary of Clinical Data:
Clinical data demonstrating the safety and effectiveness of the gammaCore Sapphire for the prophylactic/preventive treatment of cluster headache were collected from a multicenter, randomized, controlled study that took place across 10 sites in Europe from November 23, 2012, to April 30, 2014. The study was designed to compare two parallel groups, standard of care (SoC) plus nVNS (active treatment) versus SoC alone (control). The study began with a 2-week run-in period, followed by a 4week comparative period when the subjects were randomized 1:1 to either active treatment or control. The comparative period was followed by an open-label period during which all subjects received active treatment with gammaCore in addition to the SOC for 4 weeks.
Subject demographics were similar among the SoC plus nVNS and control groups that comprised the study population (Table 3).
| Characteristic | nVNS plus SoC (n=48) | Control (n=49) |
|---|---|---|
| Age, y, mean (SD) | 45.4 (1.0) | 42.3 (11.0) |
| Sex, no. (%) | ||
| Male | 34 (71) | 33 (67) |
| Race, no. (%) | ||
| Caucasian | 48 (100) | 49 (100) |
Table 3. Subject Demographic Characteristics (safety population)
Abbreviations: nVNS, non-invasive vagus nerve stimulation; SD, standard deviation; SoC, standard of care.
Consistent with previous studies of nVNS for the treatment of primary headache, nVNS was safe and well tolerated. The primary endpoint of the study was the change in mean number of CH attacks per week. The mean number of CH attacks per week was calculated as the sum of all attacks during the 2-week run-in period divided by 2 and as the sum of all attacks during the last 14 days of the randomized period divided
7
by 2. The change in mean number of attacks was calculated as the number of CH attacks per week during the randomized period (last 14 days) minus the number of CH attacks per week during the run-in period. Subjects treated with SoC plus nVNS had a significantly greater reduction in the number of cluster attacks per week versus the control arm (5.9 vs 2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; P=0.02). Higher 50% responder rates were also observed among subjects using SoC plus nVNS (40%) versus controls (8.3%) (P90%) were mild, transient, and self-limiting.
Clinical data demonstrating the safety and effectiveness of acute treatment of pain associated with migraine headache were provided in the gammaCore-S submission (K173442) and are applicable to the
9
gammaCore Sapphire. The gammaCore-S and gammaCore Sapphire have the same fundamental scientific technology and intended use. The devices do not differ in output, waveform, or treatment protocol.
Substantial Equivalence Discussion:
gammaCore Sapphire technology is identical to the device technology cleared under K180538. There have been no changes in the technological characteristics or intended use of the gammaCore Sapphire in the proposed Indications for Use Statement. The instructions for the device associated with acute treatment of episodic cluster headache do differ from those for preventive treatment of cluster headache and those for migraine headache; however, for all indications, use of more than 24 stimulations per day has not been formally evaluated and continues to be listed as a precaution in the labeling.
Summary:
Table 5 establishes the substantial equivalence of the subject device to that of the predicate device.
10
| Table 5. Substantial Equivalence Comparison Table | |||
|---|---|---|---|
| --------------------------------------------------- | -- | -- | -- |
| | gammaCore Sapphire
(Subject Device) | gammaCore Sapphire
(Primary Predicate) | gammaCore-S
(Reference Device) | Substantial Equivalence |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K180538 | K173442 | |
| Intended use | The gammaCore Sapphire is a
device that provides non-
invasive vagus nerve
stimulation (nVNS) when
applied to the side of the neck.
This is a mild electrical
stimulation of the vagus nerve,
which runs through the neck
and carries information to the
central nervous system. Each
stimulation with gammaCore
lasts 2 minutes. The patient
controls the stimulation
strength. | The gammaCore Sapphire is a
device that provides nVNS
when applied to the side of the
neck. This is a mild electrical
stimulation of the vagus nerve,
which runs through the neck
and carries information to the
central nervous system. Each
stimulation with gammaCore
lasts 2 minutes. The patient
controls the stimulation
strength. | The gammaCore-S is a device
that provides nVNS when
applied to the side of the neck.
This is a mild electrical
stimulation of the vagus nerve,
which runs through the neck
and carries information to the
central nervous system. Each
stimulation with gammaCore
lasts 2 minutes. The patient
controls the stimulation
strength. | No change in intended use |
| Indication for
use | The gammaCore Sapphire is
indicated for:
• Adjunctive use for the
preventive treatment of cluster
headache (CH) in adult
patients
• The acute treatment of pain
associated with episodic
cluster headache (eCH) in
adult patients
• The acute treatment of pain
associated with migraine
headache in adult patients | The gammaCore Sapphire is
indicated for the acute treatment
of pain associated with eCH in
adult patients | The gammaCore-S
device is indicated for the acute
treatment of pain associated
with eCH and migraine
headache in adult patients | The expansion of the indication
does not alter the intended
therapeutic effect or otherwise
create a new intended use, as
explained previously. Supported
by clinical data in Section 20 of
this submission. |
| Rx vs OTC | Prescription use only | Prescription use only | Prescription use only | No change |
| | gammaCore Sapphire
(Subject Device) | gammaCore Sapphire
(Primary Predicate) | gammaCore-S
(Reference Device) | Substantial Equivalence |
| Treatment
recommendation | Preventive treatment of CH:
120-second stimulation cycle,
3 consecutive stimulations- on
either side of the neck as follows:
o First daily treatment: within
1 hour of waking
o Second daily treatment: at
least 7-10 hours after the
first daily treatment
Acute treatment of eCH:
120-second stimulation cycle,
3 consecutive stimulations up to
8 times a day
Acute treatment of migraine:
120-second stimulation cycle, 2
bilateral stimulations up to 3
times a day | Acute treatment of eCH:
120-second stimulation cycle,
3 consecutive stimulations up to
8 times a day | Acute treatment of eCH:
120-second stimulation cycle,
3 consecutive stimulations up to
8 times a day
Acute treatment of migraine:
120-second stimulation cycle, 2
bilateral stimulations up to 3
times a day | Change in treatment protocol to
reflect different forms of
primary headache |
| Patient-
contacting
materials | SS, ABS-PC, SignaGel®
electrode gel | SS, ABS-PC, SignaGel
electrode gel | SS, ABS-PC, SignaGel
electrode gel | No change in materials |
| Electrical
classification | UL 60601-1 Class III Type BF
Applied Part | UL 60601-1 Class III Type BF
Applied Part | UL 60601-1 Class III Type BF
Applied Part | No change in classification |
| Waveform/
frequency | Sinusoidal wave, symmetrical
biphasic
5000-Hz pulses at a rate of 25
Hz | Sinusoidal wave, symmetrical
biphasic
5000-Hz pulses at a rate of 25
Hz | Sinusoidal wave, symmetrical
biphasic
5000-Hz pulses at a rate of 25
Hz | No change in waveform or
frequency |
| Maximum
output | 30V (peak), 60 mA(peak) | 30V (peak), 60 mA(peak) | 30V (peak), 60 mA(peak) | No change in outputs |
| Load impedance | 450-550 ohms | 450-550 ohms | 450-550 ohms | No change in impedance |
| Power supply | 3V LiFePo4 battery | 3V LiFePo4 battery | 3V LiFePo4 battery | No change in power supply
voltage |
| | gammaCore Sapphire
(Subject Device) | gammaCore Sapphire
(Primary Predicate) | gammaCore-S
(Reference Device) | Substantial Equivalence |
| Service life | 3 Years from date of
manufacture | 3 Years from date of
manufacture | 3 Years from date of
manufacture | No change in service life |
| Device circuitry | | | | |
| Controls | Control slide
Increase slide up/decrease slide
down | Control slide
Increase slide up/decrease slide
down | Increase (+) and decrease (-)
push buttons | No change in circuitry or
controls of the subject and
predicate devices.
Differences between the subject
device and reference device
represent changes in the user
interface. These changes do not
impact the safety or
effectiveness of the device. |
| Output
regulation | Device software and control
slide | Device software and control
slide | Device software and push
buttons | |
| Device status
display | LED screen | LED screen | LCD screen | |
| Battery charger | Qi-compatible wireless charger
in clam shell storage case | Qi-compatible wireless charger
in clam shell storage case | Not applicable | |
| RFID
refill/reload
capability | Allows refilling/reloading of the
number of days/doses for which
the device can provide
treatment; allows for continued
use of same device for extended
periods of time | Allows refilling/reloading of the
number of days/doses for which
the device can provide
treatment; allows for continued
use of same device for extended
periods of time | Not applicable | |
| Device
diagnostics,
Bluetooth | Provides for diagnostics by
manufacturer of returned
devices, including number of
days device was used, number
of doses delivered, and
remaining days/doses | Provides for diagnostics by
manufacturer of returned
devices, including number of
days device was used, number
of doses delivered, and
remaining days/doses | Not applicable | |
| | gammaCore Sapphire
(Subject Device) | gammaCore Sapphire
(Primary Predicate) | gammaCore-S
(Reference Device) | Substantial Equivalence |
| Audible signals/alarms | | | | |
| Start-up | Yes | Yes | Yes | No change in available alarm
signals |
| Session
complete | Yes | Yes | Yes | |
| Errors/depleted
battery | Yes | Yes | Yes | |
| No doses left | Yes | Yes | Yes | |
| Expired/no
days left | Yes | Yes | Yes | |
| Visual indicators/status | | | | |
| Start-up
(powered on) | Light on | Light on | Light on | No change to display/message in
the subject and predicate
devices.
Differences between the subject
device and reference device
represent changes in the user
interface. These changes do not
impact the safety or
effectiveness of the device. |
| Unit ready
(powered on) | LED doses remaining for 24-hr
period | LED doses remaining for 24-hr
period | Light on/LCD amplitude "0" | |
| Dose complete | LED days and doses remaining
and last amplitude | LED days, doses remaining, and
last amplitude | Light off/LCD days, doses
remaining, and last amplitude | |
| Errors/depleted
battery | E# display | E# display | LCD "Err"/flashing light | |
| No doses
remaining | LED doses 00 | LED doses 00 | Flashing light/LCD number of
doses remaining | |
| Expired/no
days left | LED doses/days remaining | LED doses/days remaining | Flashing light/LCD days
remaining | |
| Low battery | LED display battery charge
indicator | LED display battery charge
indicator | No light/LCD display "Lo" | |
| Reloading error | LED display if refill process
fails | LED display if refill process
fails | Not applicable | |
| Card error | LED display if refill card fails | LED display if refill card fails | Not applicable | |
11
12
13
14
Conclusion:
There have been no changes in the technological characteristics or intended use of the gammaCore Sapphire. Clinical data demonstrating the safety and effectiveness of acute treatment of pain associated with migraine headache were provided previously for gammaCore-S in submission K173442 and are applicable to the gammaCore Sapphire. The addition of the preventive treatment of cluster headache to the Indications for Use does not raise new or different questions of safety or effectiveness compared to those raised with the predicate device. Therefore, the presented information demonstrates that the subject device is substantially equivalent to the predicate device.