(157 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is an accessory to a stimulator component, intended to secure tissue, not to provide therapy itself.
No
The device is an accessory to a spinal cord stimulator system, intended to secure the stimulator to surrounding tissue. Its purpose is mechanical fixation, not diagnosis.
No
The device description clearly states it is comprised of physical components: a carbothane anchor, a deployment handle, a loading rod, and a loading base. It is a physical medical device used for fixation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure a component of a spinal cord stimulator system to tissue (fascia or ligament). This is a surgical/implantable device function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an anchor and a deployment system used to physically attach the stimulator. This aligns with a surgical accessory, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
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 fit that description.
N/A
Intended Use / Indications for Use
The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the fascia or interspinous/supraspinous ligament.
Product codes
GZB
Device Description
The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.
Injectroducer: An acrylonitrile butadiene styrene (ABS) handle and cannula (stainless steel 304V, KR01 Phillips K-Resin) anchor deployment device that is used to secure the SandShark Anchor onto the stimulator to the fascia or interspinous/supra-spinous ligament. Identical to K172644.
SandShark Anchor: A carbothane (80A) anchor that is deployed by the Injectroducer onto the stimulator securing the device to the fascia or interspinous/supra-spinous ligament. Four (4) SandShark Anchors are provided in the SIA System, pre-loaded onto the Loading Rod. Identical to K172644.
Loading Rod: An assembly that is used with the Loading Base to transfer the SandShark Anchor onto the cannula of the Injectroducer. The handle is constructed of ABS and the rod is stainless steel 304V. Identical to K172644.
Loading Base: An ABS base that holds the Loading Rod in place while transferring the SandShark Anchor onto the cannula of the Injectroducer. The design has been updated to be hand-held; no change in material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fascia or interspinous/supraspinous ligament
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital or Ambulatory Surgical Center Only
Intended Clinician: Orthopedic, Neurosurgeon, Anesthesiologist
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)
The SIA System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The SIA 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 SIA System 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 SIA System was functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008. The testing is leveraged from K172644 and is directly applicable for demonstration of device safety and efficacy as the packaging, mode of action, and materials remain the same. The design modification to the Loader Base does not impact the outcome of the leveraged tests for safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2019
Stimwave Technologies Inc. Elizabeth Greene Chief Compliance Officer 1310 Park Central Boulevard South Pompano Beach, Florida 33064
Re: K191466
Trade/Device Name: SandShark Injectable Anchor (SIA) System Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZB Dated: August 9, 2019 Received: August 9, 2019
Dear Elizabeth 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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191466
Device Name SandShark Injectable Anchor (SIA) System
Indications for Use (Describe)
The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the fascia or interspinous/supraspinous ligament.
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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Image /page/3/Picture/0 description: The image contains the logo for Stimwave Technologies. The word "stim" is in dark blue, and the word "wave" is in green. Below the words "stim" and "wave" is the word "TECHNOLOGIES" in dark blue. To the right of the word "wave" is a graphic of three curved lines that resemble radio waves.
510(k) Summary
for
SandShark Injectable Anchor (SIA) System
1. Submission Sponsor
Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach FL, 33064 USA Phone: 800.965.5134 Fax: 800.965.5134 Contact: Elizabeth Greene, Chief Compliance Officer
2. Date Prepared
May 31, 2019
3. Device Identification
| Trade/Proprietary Name: | SandShark Injectable Anchor System |
|---|---|
| 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)
SandShark Injectable Anchor (SIA) System (K172644)
5. Device Description
The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.
4
Image /page/4/Picture/0 description: The image contains the logo for Stimwave Technologies. The logo features the word "stim" in blue, followed by "wave" in green. To the right of "wave" are three concentric arcs in blue, resembling radio waves. Below the words is the word "TECHNOLOGIES" in blue, enclosed in a blue rounded rectangle.
SandShark Injectable Anchor (SIA) System
| Injectroducer | An acrylonitrile butadiene styrene (ABS) handle and cannula
(stainless steel 304V, KR01 Phillips K-Resin) anchor deployment
device that is used to secure the SandShark Anchor onto the
stimulator to the fascia or interspinous/supra-spinous ligament.
Identical to K172644. |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SandShark
Anchor | A carbothane (80A) anchor that is deployed by the Injectroducer onto
the stimulator securing the device to the fascia or interspinous/supra-
spinous ligament. Four (4) SandShark Anchors are provided in the
SIA System, pre-loaded onto the Loading Rod. Identical to K172644. |
| Loading Rod | An assembly that is used with the Loading Base to transfer the
SandShark Anchor onto the cannula of the Injectroducer. The handle
is constructed of ABS and the rod is stainless steel 304V. Identical to
K172644. |
| Loading Base | An ABS base that holds the Loading Rod in place while transferring
the SandShark Anchor onto the cannula of the Injectroducer. The
design has been updated to be hand-held; no change in material. |
6. Indication for Use Statement
The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the stimulator to the fascia or interspinous/supra-spinous ligament.
7. Substantial Equivalence Discussion
The following table compares the Stimwave SIA 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.
| Comparator | Stimwave SandShark Injectable Anchor (SIA) System
(K172644) | Stimwave SandShark Injectable Anchor (SIA) System
(This submission) |
|------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------|
| Product Code | GZB | Same as K172644 |
| Regulation No. | 882.5880 | Same as K172644 |
| Regulation Name | Stimulator, Spinal-Cord, Implanted (Pain Relief) | Same as K172644 |
| Intended Use | Accessory for securing a spinal cord stimulator to
surrounding tissue | Same as K172644 |
| Implant Site | Fascia or inter-spinous/supra-spinous ligament | Same as K172644 |
| Environmental Use | Hospital or Ambulatory Surgical Center Only | Same as K172644 |
| Intended Clinician | Orthopedic, Neurosurgeon, Anesthesiologist | Same as K172644 |
| Anchor Material | Carbothane 80A | Same as K172644 |
| Cannula Material | Stainless Steel 304V | Same as K172644 |
| Anchor Length | 1.5 inch | Same as K172644 |
| Anchor Outer Diameter | 0.087 inch | Same as K172644 |
| Loading Base | Table-top design | Hand-held design |
| Method of Introduction | Percutaneous and Anchor Incision | Same as K172644 |
| Table 5A. Comparison of Characteristics | |||
|---|---|---|---|
| -- | ----------------------------------------- | -- | -- |
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Image /page/5/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in purple, and the word "wave" is in green. The word "TECHNOLOGIES" is in blue and is located in a rounded rectangle. To the right of the word "wave" is a blue circular wave pattern.
| Comparator | Stimwave SandShark Injectable Anchor (SIA) System
(K172644) | Stimwave SandShark Injectable Anchor (SIA) System
(This submission) |
|---------------------------|----------------------------------------------------------------|------------------------------------------------------------------------|
| Tissue Contact | Yes | Same as K172644 |
| Sterilization | Ethylene Oxide (EO) | Same as K172644 |
| Labeling | Labeled as Sterile, Single Use, Prescription Device | Same as K172644 |
| Sterile | Yes - ethylene oxide | Same as K172644 |
| Single-Use | Yes | Same as K172644 |
| Shelf Life | 1 year | Same as K172644 |
| Complies with ISO 10993-1 | Yes | Same as K172644 |
| Safety Testing Passed | Yes | Same as K172644 |
(*) asterisk denotes that formulas were used for the calculations.
8. Biocompatibility Data
The materials, construction and intended use of the SIA System are identical to the predicate device, and have a long history of safety with respect to biocompatibility, thus the biological safety testing of the SIA System is leveraged from K172644. The biological safety of the SandShark Anchor was evaluated in accordance to ISO 10993-1:2009, guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and 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, implantation (4, 8, and 13 weeks), subacute and subchronic toxicity, chronic toxicity, carcinogenicity, extractables and leechables demonstrated no negative impacts from the materials that are used in the SIA System. The SIA System meets biological safety and compatibility requirements of ISO 10993-1:2009 and Blue Book Memorandum G95-1.
9. Non-Clinical Performance Data
The SIA System was tested to verify that the performance meets the system design requirements as well as all applicable voluntary standards. The SIA 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 SIA System 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 SIA System was functional following post testing functionality inspection and passed atmospheric pressure change testing as specified by AAMI ANSI ISO 14708-3:2008. The testing is leveraged from K172644 and is directly applicable for demonstration of device safety and efficacy as the packaging, mode of action, and materials remain the same. The design modification to the Loader Base does not impact the outcome of the leveraged tests for safety and effectiveness.
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Image /page/6/Picture/0 description: The image shows the logo for Stimwave Technologies. The word "stim" is in a large, purple, sans-serif font, and the word "wave" is in a large, green, sans-serif font. Below the words "stim wave" is the word "TECHNOLOGIES" in a smaller, purple, sans-serif font. To the right of the words is a graphic of three curved lines that resemble radio waves, also in purple.
Stimwave completed a number of tests for the SIA System that demonstrates substantial equivalence to the legally marketed predicate device. The SIA System meets all the requirements for overall design, sterilization, and biocompatibility confirms that the output meets the design inputs and specifications through leveraged or new testing described in this submission. The SIA System passed all testing stated above as shown by the acceptable results obtained. The updated design of the Loading Base does not impact device performance, and thus, demonstrates continued safety and efficacy compared to the predicate device. The inclusion of secondary contract suppliers for the SIA System demonstrates no impact to established safety and efficacy.
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 device. These types of devices, including the legally marketed predicate device, 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 device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. The SIA System has the same intended use as the legally marketed predicates device. Performance testing data leveraged from K172644 verifies that the SIA System complies with all applicable voluntary standards such as AAMI ANSI ISO 14708-3. The SIA System also meets the design requirements where no applicable standard could be used. This includes leveraged anchor durability testing, as well as biocompatibility and sterilization validation of the SIA System. 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 device, and materials for the SIA System are the same as the legally marketed predicate device. The updated design of the Loading Base does not impact device performance, and thus, demonstrates continued safety and efficacy compared to the predicate. The inclusion of secondary contract suppliers for the SIA System demonstrates no impact to established safety and efficacy.
It has been shown in this 510(k) submission that the difference between the SIA System and the legally marketed predicate device do not raise any questions regarding its safety and effectiveness as compared to legally marketed predicate device. The SIA System, as designed and manufactured, is determined to be substantially equivalent to the referenced legally marketed predicate device.