(95 days)
Not Found
No
The summary does not mention AI, ML, DNN, or any related concepts. The device description focuses on electrical stimulation and hardware components.
Yes
The device description clearly states it is used to "provide therapeutic relief for chronic, intractable pain" and uses pulsed electrical current for "therapy."
No
The device is a spinal cord stimulator system intended for therapeutic relief of chronic, intractable pain, not for diagnosing conditions.
No
The device description explicitly states the system is comprised of an implantable stimulator and an externally worn transmitter, which are hardware components. The performance studies also detail testing of physical characteristics and compliance with hardware-related standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Freedom Spinal Cord Stimulator System is an implantable device that delivers electrical stimulation to nerves near the spine to manage chronic pain. It directly interacts with the patient's body and does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "chronic, intractable pain of the trunk and/or lower limbs" and is an "implantable stimulator." This is a therapeutic device, not a diagnostic one.
- Device Description: The description details an "implantable stimulator" and an "externally worn transmitter" that "acts on nerves near the dorsal column of the spine." This confirms its function as a direct treatment device.
Therefore, the Freedom Spinal Cord Stimulator System falls under the category of an implantable therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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.
Product codes (comma separated list FDA assigned to the subject device)
GZB
Device Description
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
Freedom-8A and Freedom-4A Stimulator (Receiver Kit): A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed in the patient's epidural space. The Freedom-8A Stimulator has eight (8) electrodes, and the Freedom-4A Stimulator has four (4) electrodes.
Stylet(s): A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Receiver Kit, one straight and one bent, each with diameter of 0.25 mm.
Needle and Cannula Assembly: An assembly that includes a 16-gauge stainless steel needle that is packaged inserted in the fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for passage of the Stimulator into the epidural space.
Guidewire: A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Stimulator to pass through more easily.
Suture Sleeve Cap: A polyurethane (Pellethane 55D) cap that is placed over the proximal end of the Stimulator. The Suture Sleeve Cap is attached to the Freedom-8A/4A Stimulator and can be sutured to tissue to reduce the possibility of device migration.
Wearable Antenna Assembly (WAA Kit):
WAA: The WAA housing includes the following components:
i. Transmitting (Tx) Antenna - Antenna used to transmit microwave energy to the implanted Stimulator;
ii. Microwave Field Stimulator (MFS) – A printed circuit board (PCB) that generates 915 MHz RF power with embedded waveform parameter settings and switches for changing parameter settings as needed by the user;
iii. Button Cover – A silicon pad that corresponds to switches on the MFS that allows the user to turn the device on/off or increase or decrease power amplitude as well as interpret device power status (On, Off, Charging, Transmitting, and Bluetooth® Connection);
iv. Battery Assembly – A battery and wire assembly coupled with the Wireless Charging Coil Assembly for charging and the MFS for power delivery;
v. Wireless Charging Coil Assembly - Consists of an inductive charging coil and battery that receives energy from the Wireless Battery Charging Pad. The battery charger components on the MFS are used to transfer charge into the 3.7V lithium ion battery by facilitating power transfer and warns the system when battery power is low.
Wireless Battery Charging Pad: An off-the-shelf Qi-compliant charging pad (RP-WCN7, RP-WCN12, or RP-WCN13) that uses inductive charging technology to recharge the encased lithium ion battery of the WAA.
Athletic Pouch Belt: An off-the-shelf assembly constructed of lightweight nylon mesh with an adjustable belt, and a zipper pouch for housing the WAA.
Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit):
Freedom-8A Trial Lead, Freedom-4A Trial Lead: A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed percutaneously in the patient's epidural space. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes.
Stylet(s): A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Trial Lead Kit, one straight and one bent with a diameter of 0.25 mm.
Needle and Cannula Assembly: An assembly that includes a 16-gauge stainless steel needle that is packaged inserted in the fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for passage of the stimulator into the epidural space.
Guidewire: A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Trial Lead to pass through more easily.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dorsal column of the spine, epidural space, L5 to T5
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
Intended User: Layperson
Environmental Use: Hospital, Home
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)
Non-Clinical Performance Data: The Freedom SCS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The Freedom-8A/4A SCS System complies with all design requirements and applicable voluntary standards. AAMI ANSI ISO 14708-3:2008 standards were tested for temperature change, atmospheric pressure change, external defibrillation exposure, thermal shock, leakage current, and insertion/withdrawal force of the stimulator within the stylet. Mechanical testing included tensile testing and torsion testing. IEC 60601-1 standards were tested for the external unit for protection from temperature change, atmospheric pressure change, push, drop, impact and mold stress relief. IEC 60529 standards were tested for ingress of water and particulate matter. IEC 60601-1-2 standards were tested for electromagnetic compatibility. The software of the Freedom SCS System passed all verification tests. The device passed all the testing in accordance with national and international standards.
Clinical Performance Data: There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K141399, K934065, K883780, K000852
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Elizabeth Greene Director of Quality Assurance and Regulatory Affairs Stimwave Technologies Incorporated 420 Lincoln Road, Suite 365 Miami Beach, FL 33139
Re: K150517
Trade/Device Name: Freedom Spinal Cord Stimulator (SCS) System Regulation Number: 21 CFR 882.5880 Regulation Name: Stimulator, Spinal-Cord, Implanted (Pain Relief) Regulatory Class: Class II Product Code: GZB Dated: February 27, 2015 Received: March 2, 2015
Dear Ms. Greene:
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. The general controls provisions of the Act include requirements for annual registration. Isting 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known):
Device Name: Freedom Spinal Cord Stimulator (SCS) System
Indications For Use:
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, "wave" is in green, and "TECHNOLOGIES" is in blue with a blue line above it. To the right of the words is a graphic of concentric circles in blue.
510(k) Summary
for
Freedom Spinal Cord Stimulator (SCS) System
1. Submission Sponsor
Stimwave Technologies Incorporated 901 East Las Olas Boulevard Suite 201 Fort Lauderdale Florida 33301 USA Phone: 800.965.5134 Fax: 800.965.5134 Contact: Elizabeth Greene, Director of Quality Assurance and Regulatory Affairs
2. Date Prepared
February 27, 2015, updated June 1, 2015
3. Device Identification
| Trade/Proprietary Name: | Freedom Spinal Cord Stimulator (SCS) System |
|---|---|
| Common/Usual Name: | Spinal Cord Stimulator |
| Classification Name: | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Classification Regulation: | 882.5880 |
| Product Code: | GZB |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4. Legally Marketed Predicate Device(s)
Stimwave Freedom SCS System FRE4-A001, WAA-A012 (K141399) Medtronic Mattrix 3271/3272 Neuromodulation System (K934065) Medtronic Xtrel, Model Number 3425 Receiver (K883780) ANS Renew Neurostimulation System Transmitter, Model 2508, Receiver Model 3408, Antennae Models 1220 and 1230, Lead Models 3143, 3146, 3153, 3156, 3183 and 3186, Extension Models 3382, 3383, 3341, 3342 and 3343 (K000852)
5. Device Description
The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column neural stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral or bilateral
4
Image /page/4/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words is the word "TECHNOLOGIES" in blue. To the right of the words are three curved lines that look like sound waves.
pain. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on nerves near the dorsal column of the spine. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator) and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.
Freedom-8A and Freedom-4A Stimulator (Receiver Kit)
| Freedom-8A
Stimulator,
Freedom-4A
Stimulator | A polyurethane (Pellethane 55D) casing with an embedded receiver,
flexible circuit board and electrodes (Platinum Iridium 90:10) that is
placed in the patient's epidural space. The Freedom-8A Stimulator
has eight (8) electrodes, and the Freedom-4A Stimulator has four (4)
electrodes. |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted
into the open central lumen of the stimulator to provide rigidity
during implantation. Two (2) stylets are provided in the Receiver Kit,
one straight and one bent, each with diameter of 0.25 mm. |
| Needle and
Cannula
Assembly | An assembly that includes a 16-gauge stainless steel needle that is
packaged inserted in the fluorinated ethylene propylene (FEP)
Cannula that acts as a conduit for passage of the Stimulator into the
epidural space. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow
pathway in the epidural space for the Stimulator to pass through more
easily. |
| Suture Sleeve Cap | A polyurethane (Pellethane 55D) cap that is placed over the proximal
end of the Stimulator. The Suture Sleeve Cap is attached to the
Freedom-8A/4A Stimulator and can be sutured to tissue to reduce the
possibility of device migration. |
Wearable Antenna Assembly (WAA Kit)
| WAA | The WAA housing includes the following components: |
|---|---|
| i. Transmitting (Tx) Antenna - Antenna used to transmit | |
| microwave energy to the implanted Stimulator; | |
| ii. Microwave Field Stimulator (MFS) – A printed circuit board | |
| (PCB) that generates 915 MHz RF power with embedded | |
| waveform parameter settings and switches for changing | |
| parameter settings as needed by the user; | |
| iii. Button Cover – A silicon pad that corresponds to switches on the | |
| MFS that allows the user to turn the device on/off or increase or | |
| decrease power amplitude as well as interpret device power status | |
| (On, Off, Charging, Transmitting, and Bluetooth® Connection); | |
| iv. Battery Assembly – A battery and wire assembly coupled with the | |
| Wireless Charging Coil Assembly for charging and the MFS for | |
| power delivery; | |
| v. Wireless Charging Coil Assembly - Consists of an inductive |
5
Image /page/5/Picture/0 description: The image is a logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words "stim wave" is the word "TECHNOLOGIES" in blue, inside of a blue rounded rectangle. To the right of the words "stim wave" is a blue circular wave graphic.
Wearable Antenna Assembly (WAA Kit)
| charging coil and battery that receives energy from the Wireless | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Battery Charging Pad. The battery charger components on the | ||||||||||
| MFS are used to transfer charge into the 3.7V lithium ion battery | ||||||||||
| by facilitating power transfer and warns the system when battery | ||||||||||
| power is low. | ||||||||||
| Wireless Battery | ||||||||||
| Charging Pad | An off-the-shelf Qi-compliant charging pad (RP-WCN7, RP- | |||||||||
| WCN12, or RP-WCN13) that uses inductive charging technology to | ||||||||||
| recharge the encased lithium ion battery of the WAA. | ||||||||||
| Athletic Pouch | ||||||||||
| Belt | An off-the-shelf assembly constructed of lightweight nylon mesh | |||||||||
| with an adjustable belt, and a zipper pouch for housing the WAA. |
Freedom-8A and Freedom-4A Trial Lead (Trial Lead Kit)
| Freedom-8A Trial Lead,
| Freedom-4A Trial Lead | A polyurethane (Pellethane 55D) casing with an embedded receiver, flexible circuit board and electrodes (Platinum Iridium 90:10) that is placed percutaneously in the patient's epidural space. The Freedom-8A Trial Lead has eight (8) electrodes, and the Freedom-4A Trial Lead has four (4) electrodes. |
|---|---|
| Stylet(s) | A stainless steel wire with a polypropylene handle that is inserted into the open central lumen of the stimulator to provide rigidity during implantation. Two (2) stylets are provided in the Trial Lead Kit, one straight and one bent with a diameter of 0.25 mm. |
| Needle and | |
| Cannula | |
| Assembly | An assembly that includes a 16-gauge stainless steel needle that is packaged inserted in the fluorinated ethylene propylene (FEP) Cannula that acts as a conduit for passage of the stimulator into the epidural space. |
| Guidewire | A stainless steel, rigid, solid core guidewire used to create a hollow pathway in the epidural space for the Trial Lead to pass through more easily. |
6. Indication for Use Statement
The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. 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.
6
7. Substantial Equivalence Discussion
The following table compares the Stimwave Freedom SCS System to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence. Stimwave physically measured Medtronic and ANS predicate devices to obtain the values listed in Table 5A.
| Comparator | Stimwave | Stimwave | Medtronic | Medtronic | ANS Renew |
|---|---|---|---|---|---|
| Freedom SCS | Freedom SCS | Mattrix | Xtrel, Model | (K000852) | |
| System | System | 3271/3272 | Number 3425 | ||
| (K141399) | (K934065) | (K883780) | |||
| Product Code | GZB | GZB | GZB and GZF | GZB | GZB |
| Regulation No. | 882.5880 | 882.5880 | 882.5880 | 882.5880 | 882.5880 |
| Regulation Name | Stimulator, Spinal- | ||||
| Cord, Implanted | |||||
| (Pain Relief) | Stimulator, | ||||
| Spinal-Cord, | |||||
| Implanted (Pain | |||||
| Relief) | Stimulator, | ||||
| Spinal-Cord, | |||||
| Implanted | |||||
| (Pain Relief) | Stimulator, | ||||
| Spinal-Cord, | |||||
| Implanted | |||||
| (Pain Relief) | Stimulator, | ||||
| Spinal-Cord, | |||||
| Implanted | |||||
| (Pain Relief) | |||||
| Intended Use | Stimulation of | ||||
| spinal cord for | |||||
| chronic, intractable | |||||
| pain of trunk and | |||||
| lower limbs | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Implant Site | Epidural space, L5 | ||||
| to T5 | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Environmental Use | Hospital, Home | Same as | |||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Intended Clinician | Orthopedic, | ||||
| Neurosurgeon, | |||||
| Anesthesiologist | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Intended User | Layperson | Same as | |||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Electrode Material | Platinum-iridium | ||||
| 90:10 | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Stimulator Body | |||||
| Material | Polyurethane | ||||
| 2363-55D | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Cable Features | Multi-lumen Tube | Multi-lumen | |||
| Tube | Coiled Wires | Coiled Wires | Braided Wire | ||
| Stimulator Length | 45 centimeters | 45 centimeters | 30 to 110 | ||
| centimeters | 30 to 110 | ||||
| centimeters | 30 and 60 | ||||
| centimeters | |||||
| Diameter | 1.35 millimeters | 1.35 millimeters | 1.3 millimeters | 1.3 millimeters | 1.37 |
| millimeters | |||||
| Electrode Array | |||||
| Length | 24.0 millimeters | ||||
| 52.0 millimeters | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| No. of Electrodes | 4 or 8 | 4 | 4 | 4 | 4 or 8 |
| Electrode Length | 3.0 millimeters | Same as | |||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Electrode Spacing | 4.0 millimeters | Same as | |||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Electrode Surface | |||||
| Area | 12.72 mm² | 12.72 mm² | 12.25 mm² | 12.25 mm² | "Approx. 13 |
| mm²" | |||||
| Method of | |||||
| Introduction | Percutaneous and | ||||
| Anchor Incision | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | |||||
| Tissue Contact | Yes | Same as | |||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom | Same as | ||||
| Freedom |
| Table 5A. Comparison of Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ----------------------------------------- |
7
| Comparator | Stimwave
Freedom SCS
System | Stimwave
Freedom SCS
System
(K141399) | Medtronic
Mattrix
3271/3272
(K934065) | Medtronic
Xtrel, Model
Number 3425
(K883780) | ANS Renew
(K000852) |
|-------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------|
| Sterilization | Ethylene Oxide
(EO) | Same as
Freedom | Same as
Freedom | Same as
Freedom | Same as
Freedom |
| Labeling | Labeled as Sterile,
Single Use,
Prescription
Device | Same as
Freedom | Same as
Freedom | Same as
Freedom | Same as
Freedom |
| Package | Backer card and
two sterile pouches | Blister
Tray/Tyvek Lid | Same as
Freedom | Same as
Freedom | Same as
Freedom |
| Pulse Frequency | 5 to 1500 Hertz | 2 to 1500 Hertz | 5 to 240 Hertz | 5 to 1400 Hertz | 10 to 1500
Hertz |
| Pulse Width | 50 to 500
microseconds | 50 to 500
microseconds | 50 to 500
microseconds | 50 to 1000
microseconds | 50 to 500
microseconds |
| Current/Voltage
Regulated | Current | Current | Voltage | Voltage | Current |
| Output Voltage
(300 Ω) | 0 to 4.1 V | 0 to 6.3 V | 0 to 7 V | 0 to 5.4 V | 0 to 5.7 V |
| Output Voltage
(500 Ω) | 0 to 6.4 V | 0 to 7.2 V | 0 to 10.8 V | 0 to 7.1 V | 0 to 7.6 V |
| Output Voltage
(800 Ω) | 0 to 7.5 V | 0 to 8.0 V | 0 to 11.6 V | 0 to 8.4 V | 0 to 9.6 V |
| Output Current
(300 Ω) | 0 to 13.5 mA | 0 to 21 mA | 0 to 23.3 mA | 0 to 18.0 mA | 0 to 19.0 mA |
| Output Current
(500 Ω) | 0 to 12.8 mA | 0 to 15 mA | 0 to 21.6 mA | 0 to 14.2 mA | 0 to 15.2 mA |
| Output Current
(800 Ω) | 0 to 9.4 mA | 0 to 10 mA | 0 to 14.5 mA | 0 to 10.5 mA | 0 to 12.0 mA |
| Waveform | Charge Balanced
(delayed) Biphasic
asymmetrical | Charge
Balanced
(delayed)
Biphasic
asymmetrical | Charge
Balanced
Biphasic
asymmetrical | Charge
Balanced
Biphasic
asymmetrical | Charge
Balanced
(delayed)
Biphasic
asymmetrical |
| Pulse Shape | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential | Decaying
Exponential |
| Average Current
Density (300 Ω) | 105.0 mA/cm2 | 111.6 mA/cm2 | 175.0 mA/cm2 | 125.8 mA/cm2 | 117.7 mA/cm2 |
| Average Current
Density (500 Ω) | 95.1 mA/cm2 | 96.7 mA/cm2 | 151.7 mA/cm2 | 101.7 mA/cm2 | 103.1 mA/cm2 |
| Average Current
Density (800 Ω) | 69.0 mA/cm2 | 77.0 mA/cm2 | 106.7 mA/cm2 | 75.8 mA/cm2 | 86.2 mA/cm2 |
| Maximum Phase
Charge* (300 Ω) | 6.8 µC/pulse | 10.5 µC/pulse | 11.7 µC/pulse | 18.0 µC/pulse | 9.5 µC/pulse |
| Maximum Phase
Charge* (500 Ω) | 6.4 µC/pulse | 7.2 µC/pulse | 10.8 µC/pulse | 14.2 µC/pulse | 7.6 µC/pulse |
| Maximum Phase
Charge* (800 Ω) | 4.7 µC/pulse | 5.0 µC/pulse | 7.3 µC/pulse | 10.5 µC/pulse | 6.0 µC/pulse |
| Maximum Charge
Density* (300 Ω) | 53.1 µC/cm2 | 82.5 µC/cm2 | 97.2 µC/cm2 | 150.0 µC/cm2 | 73.1 µC/cm2 |
| Maximum Charge
Density* (500 Ω) | 50.3 µC/cm2 | 56.6 µC/cm2 | 90.0 µC/cm2 | 118.3 µC/cm2 | 58.5 µC/cm2 |
| Maximum Charge
Density* (800 Ω) | 36.9 µC/cm2 | 39.3 µC/cm2 | 60.4 µC/cm2 | 87.5 µC/cm2 | 46.2 µC/cm2 |
| Maximum Current
Density* (300 Ω) | 106.1 mA/cm2 | 165.1 mA/cm2 | 194.4 mA/cm2 | 150.0 mA/cm2 | 146.2 mA/cm2 |
| Maximum Current
Density* (500 Ω) | 100.6 mA/cm2 | 113.2 mA/cm2 | 180.0 mA/cm2 | 118.3 mA/cm2 | 116.9 mA/cm2 |
| Comparator | Stimwave | Stimwave | Medtronic | Medtronic | ANS Renew |
| | Freedom SCS | Freedom SCS | Mattrix | Xtrel, Model | (K000852) |
| | System | System | 3271/3272 | Number 3425 | |
| Maximum Current | | (K141399) | (K934065) | (K883780) | |
| Density* (800 Ω) | 73.9 mA/cm² | 78.6 mA/cm² | 120.8 mA/cm² | 87.5 mA/cm² | 92.3 mA/cm² |
| Net Charge | 0 µC | 0 µC | 0 µC | 0 µC | 0 µC |
| Average Phase
Power (300 Ω) | 0.053 W/phase | 0.060 W/phase | 0.132 W/phase | 0.068 W/phase | 0.070 W/phase |
| Average Phase
Power (500 Ω) | 0.073 W/phase | 0.076 W/phase | 0.166 W/phase | 0.074 W/phase | 0.090 W/phase |
| Average Phase
Power (800 Ω) | 0.062 W/phase | 0.060 W/phase | 0.131 W/phase | 0.066 W/phase | 0.100 W/phase |
| Average Phase
Power Density
(300 Ω) | 0.42 W/cm²/phase | 0.48
W/cm²/phase | 1.10
W/cm²/phase | 0.57
W/cm²/phase | 0.54
W/cm²/phase |
| Average Phase
Power Density
(500 Ω) | 0.58 W/cm²/phase | 0.59
W/cm²/phase | 1.38
W/cm²/phase | 0.62
W/cm²/phase | 0.69
W/cm²/phase |
| Average Phase
Power Density
(800 Ω) | 0.48 W/cm²/phase | 0.60
W/cm²/phase | 1.09
W/cm²/phase | 0.55
W/cm²/phase | 0.77
W/cm²/phase |
| Pulse Delivery
Mode | Continuous | Continuous | Continuous | Continuous | Continuous |
| ON/OFF Times | No Cycling | No Cycling | ON/OFF
Cycling Option | ON/OFF
Cycling Option | No Cycling |
| Current Path
Options | Bipolar | Bipolar | Bipolar | Bipolar | Bipolar |
| Power Delivery | Coupled receiver,
built into
Stimulator body | Coupled
receiver, built
into Stimulator
body | Coupled
receiver, Radio
Frequency
transmission | Coupling
receiver, Radio
Frequency
transmission | Coupled
receiver,
hardwired with
connector |
| Transmit
Frequency | 915 MHz | 915 MHz | 2 MHz | 1.60 MHz | 2 MHz |
| Material | Platinum-iridium
90:10,
Polyurethane
2363-55D | Same as
Freedom | Same as
Freedom | Same as
Freedom | Same as
Freedom |
| Sterile | Yes - ethylene
oxide | Same as
Freedom | Same as
Freedom | Same as
Freedom | Same as
Freedom |
| Single-Use | Yes | Yes | Yes | Yes | Yes |
| Shelf Life | 2 year | 1 year | 1 year | 1 year | 2 years |
| Complies with ISO
10993-1 | Yes | Yes | Yes | Yes | Yes |
| Safety Testing
Passed | Yes | Yes | Yes | Yes | Yes |
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Image /page/8/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, "wave" is in green, and "TECHNOLOGIES" is in blue. To the right of the words is a graphic of three curved lines that resemble sound waves, also in blue.
(*) asterisk denotes that formulas were used for the calculations.
Table 5B identifies the differences between the cleared Freedom SCS System (K141399) and the modifications identified by this Special Premarket Notification.
Table 5B. Comparison of the similarities and differences between FDA-cleared Stimwave product (Freedom-4) and the products submitted in this Special Premarket Notification (Freedom-8A/4A).
| Criteria | Freedom-4 | Freedom-4A | Freedom-8A |
|---|---|---|---|
| Product Code | GZB | Same as Freedom-4 | Same as Freedom-4 |
| Regulation No. | 882.5880 | Same as Freedom-4 | Same as Freedom-4 |
| Criteria | Freedom-4 | Freedom-4A | Freedom-8A |
| Regulation Name | Stimulator, Spinal-Cord, | ||
| Implanted (Pain Relief) | Same as Freedom-4 | Same as Freedom-4 | |
| Intended Use | Stimulation of spinal cord for | ||
| chronic, intractable pain of trunk | |||
| and lower limbs | Same as Freedom-4 | Same as Freedom-4 | |
| Mode of Action | RF wireless transmission of | ||
| energy to produce therapeutic | |||
| stimulation at the Stimulator. | |||
| The external unit of the system, | |||
| the WAA, sends a pulsed RF | |||
| signal on a carrier frequency of | |||
| 915 MHz to a passive, implanted | |||
| receiver within the Stimulator | Same as Freedom-4 | Same as Freedom-4 | |
| No. of Electrodes | 4 | 4 | 8 |
| MRI Conditional | 1.5 and 3T | ||
| (Receiver Only) | No, MR Unsafe | No, MR Unsafe | |
| Electrode Material | Platinum-Iridium | ||
| 90:10 | Same as Freedom-4 | Same as Freedom-4 | |
| Stimulator Body | |||
| Material | Polyurethane | ||
| 2363-55D | Same as Freedom-4 | Same as Freedom-4 | |
| Polarity | Fixed | Programmable | |
| (Anode, Cathode, or | |||
| Off) | Programmable | ||
| (Anode, Cathode, or | |||
| Off) | |||
| Packaging | Blister Tray/Tyvek Lid | Backer card and two | |
| Tyvek sterile pouches | Backer card and two | ||
| Tyvek sterile pouches | |||
| Sterilization | Ethylene Oxide (EO) | Same as Freedom-4 | Same as Freedom-4 |
| Accessories | Guidewire, Stylet(s), Introducer | ||
| Sheath, Tuohy Needle, Suture | |||
| Sleeve Cap | Guidewire, Stylet(s), | ||
| Coude Needle, | |||
| Cannula, Suture | |||
| Sleeve Cap | Guidewire, Stylet(s), | ||
| Coude Needle, | |||
| Cannula, Suture | |||
| Sleeve Cap | |||
| Pulse Frequency | 2 to 1500 Hz | 5 to 1500 Hz | 5 to 1500 Hz |
| Pulse Width | 50 to 500 µs | Same as Freedom-4 | Same as Freedom-4 |
| Output Current | |||
| (500 Ω) | 0 to 15 mA | 0 to 12.8 mA | 0 to 12.8 mA |
| Transmit Frequency | 915 MHz | Same as Freedom-4 | Same as Freedom-4 |
| Power Delivery | Coupled receiver, built into | ||
| Stimulator body | Same as Freedom-4 | Same as Freedom-4 | |
| Wearable Antenna | |||
| Assembly (WAA) | Thermoplastic urethane molded | ||
| wearable transmitter | ABS plastic | ||
| transmitter contained | |||
| in a wearable athletic | |||
| pouch belt | ABS plastic | ||
| transmitter contained | |||
| in a wearable athletic | |||
| pouch belt | |||
| iPad Application | MalibuTM | WaveCrestTM | WaveCrestTM |
| Software Level of | |||
| Concern | Moderate | Same as Freedom-4 | Same as Freedom-4 |
9
Image /page/9/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words is the word "TECHNOLOGIES" in blue, inside of a blue rounded rectangle. To the right of the words are blue concentric circles.
8. Biocompatibility Data
The materials of the Freedom SCS System (Freedom-8A/4A) remain unchanged from the Freedom SCS System (K141399) and thus, the biocompatibility tests conducted on representative subassemblies of the Freedom SCS System (Freedom-4, K141399) directly apply to the Freedom SCS System (Freedom-8A/4A). The materials, construction and
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intended use of the Freedom-8A/4A SCS System is comparable to the predicate device, and have a long history of safety with respect to biocompatibility. The biological safety of the Freedom-8A/4A Stimulator (same as the Freedom-4 Stimulator) was evaluated in accordance to ISO 10993-1:2009 and guidance document Blue Book Memorandum G95-1 Use of International Standard ISO-10993, and Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing. Under these, for the stated indications for use, the device was classified as a (C), implant device in contact with tissue/bone. The results for the biocompatible testing for cytotoxicity, sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, genotoxicity, implantation (4, 8, and 13 weeks), and subchronic toxicity demonstrated no negative impacts from the materials that are used in the Freedom SCS System. The Freedom-8A/4A Stimulator materials in direct tissue contact include Pellethane 55D and Pt-Ir (90:10), both having an extensive record (previously cleared and approved) of chronic and carcinogenetic safety. The WAA is intended to be on top of a thin shirt or article of clothing around the midsection of the patient. The User Manual provided to the patient describes that the WAA should always be worn on top of a layer of clothing. The WAA does not come into contact with the patient's skin. The categorization by nature of body contact of the WAA is thus "noncontacting device", and not included in the scope of ISO 10993-1:2009. The Freedom-8A/4A SCS System (same as the Freedom SCS System, K141399) meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
The Freedom SCS System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The Freedom-8A/4A SCS System complies with all design requirements and applicable voluntary standards.
AAMI ANSI ISO 14708-3:2008 - For protection from temperature change including shipping and storage temperature ranges, the Freedom-8A/4A Stimulator was functional, receiving a safe rating following post visual inspection and passed the change of temperature testing performed as specified by AAMI ANSI ISO 14708-3:2008. For atmospheric pressure change, the Freedom-8A/4A Stimulator was functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008.
For testing external defibrillation exposure, the Freedom-8A/4A Stimulator was verified as functional after exposure to external defibrillation. Thus, the Freedom-8A/4A Stimulator complies with testing as specified by AAMI ANSI ISO 14708-3:2008
Following the thermal shock testing, the Freedom-8A/4A Stimulator was found to have "no irreversible damage" and fully functional as specified by the manufacturer, and to have no physical anomalies present at the time of inspection. Thus, the Freedom-8A/4A Stimulator complies with the thermal shock design requirements and the applicable standard.
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Image /page/11/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the words is the word "TECHNOLOGIES" in blue, inside of a blue rounded rectangle. To the right of the words is a blue wave graphic.
For leakage current testing, the Freedom-8A/4A Stimulator produced zero leakage current on all tested paths for all tested samples. Thus, the Freedom-8A/4A Stimulator complies with the leakage design requirements and the applicable standard.
For testing the insertion and withdrawal of the stimulator within the stylet, the Freedom-8A/4A Stimulator was found to require less than 2.5N of insertion or withdrawal force for all tested stylets in all tested stimulator samples. Visual inspection confirmed no damage was present in any stimulator samples. Thus, the Freedom-8A/4A Stimulator complies with design specifications for stylet insertion and withdrawal force.
For mechanical testing, the Freedom-8A/4A Stimulator passed all criteria of the test, showing no visible damage to the stimulator body or functional damage to the components. Mechanical testing included tensile testing and torsion testing. Thus, the Freedom-8A/4A Stimulator complies with all stimulator mechanical design requirements.
IEC 60601-1 - For testing the external unit for protection from temperature change, including shipping and storage temperature ranges, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the Freedom SCS System satisfies the outlined protection from temperature change design requirements and the applicable standard, IEC 60601-1. For atmospheric pressure change testing, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the external unit of the Freedom SCS System satisfies the outlined atmospheric pressure change design requirements and the applicable standard, IEC 60601-1. For the push, drop, impact and mold stress relief testing of the external unit, it was determined through testing that the external unit is robust to withstand expected damage in accordance with general safety standards. The external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the WAA component of the Freedom-8A/4A SCS System satisfies the outlined push, drop, impact, and mold stress relief design requirements and the applicable standard. IEC 60601-1. For the identification, marking and documents of the external unit it was determined through an analysis of the labeling that the external unit complies with the requirements of the standard. All requirements and markings are clearly identified and viewable either from the external case of the product or from within the accompanying documents. For the means of protection, creepage distances, and air clearances of the external unit it was determined through an analysis of the design that the system satisfies the requirements of the applicable standard, IEC 60601-1.
IEC 60529 - For testing the ingress of water, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the WAA component of the Freedom SCS
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Image /page/12/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in blue, and the word "wave" is in green. Below the two words is the word "TECHNOLOGIES" in red. To the right of the words are blue concentric circles.
System satisfies the outlined Ingress of Water design requirements and the applicable standard IEC 60529. For particulate matter testing, the external unit met the passing criteria of both of the visual and functional inspections following the testing. It showed no physical damage and was fully operational. Thus, the WAA component of the Freedom SCS System satisfies the outlined Particulate Matter design requirements and the applicable standard. IEC 60529.
IEC 60601-1-2 - For testing the external unit for electromagnetic compatibility, the unit met all acceptance criteria for emissions, low-frequency magnetic fields, immunity, electrostatic discharge, radiated RF electromagnetic fields, electrical fast transients and bursts, and magnetic fields. The external unit operated within all test limits and showed no physical damage and was fully operational. Thus, the external unit for the Freedom-8A/4A SCS System satisfies the IEC 60601-1-2 standard.
The Freedom SCS System complies with the applicable standards for neurostimulators, MRI exposure, electrical safety, electromagnetic interference and compatibility, biocompatibility, packaging, and sterilization. The software of the Freedom SCS System passed all verification tests outlined and the design requirements for Software Verification have been met. The device passed all the testing in accordance with national and international standards.
Following performance testing. it has been determined that the Freedom SCS System is substantially equivalent to legally marketed predicate devices for the therapy for chronic, intractable pain of the trunk and/or lower limbs, including unilateral pain.
Stimwave Technologies Incorporated completed a number of tests for the Freedom SCS System that demonstrates substantial equivalence to the legally marketed predicate devices. The Freedom SCS System meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety confirms that the output meets the design inputs and specifications. The Freedom SCS System passed all testing stated above as shown by the acceptable results obtained.
10. Clinical Performance Data
There was no clinical testing required to support the medical device, as the indications for use are equivalent to the legally marketed predicate devices. These types of devices, including the legally marketed predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to legally marketed predicate devices when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The Freedom SCS System has the same intended
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Image /page/13/Picture/0 description: The image is a logo for a company called Stimwave Technologies. The word "stim" is in dark blue, and the word "wave" is in green. Below the words "stim wave" is the word "TECHNOLOGIES" in dark blue. To the right of the words is a graphic of concentric circles in dark blue.
use as the legally marketed predicates devices and is implanted percutaneous into the epidural space ranging from T5 to L5. Performance tested verified that the Freedom SCS System complies with all applicable voluntary standards such as IEC 60601-1, AAMI ANSI ISO 14708-3. and IEC 60529. The Freedom SCS System also meets the design requirements where no applicable standard could be used. This included stimulator body durability testing, programmable parameters, as well as power and performance of the external unit. There were no recognized performance standards for this device. There was no clinical testing performed on this device since performance testing demonstrated similar performance as the legally marketed predicate devices, and materials for the implanted stimulator are the same as the legally marketed predicate devices.
It has been shown in this 510(k) submission that the difference between the Freedom SCS System and the legally marketed predicate devices do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate devices. Freedom SCS System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate devices.