(63 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of the embolization plug, with no mention of AI or ML.
Yes
The device is implanted to obstruct or reduce blood flow, which is a therapeutic intervention.
No
Explanation: The device is an embolization plug designed to obstruct or reduce blood flow, which is a therapeutic function, not a diagnostic one. It is used to treat a condition by physically blocking vessels, rather than identifying or characterizing a disease.
No
The device description clearly states it is a permanent implant comprised of physical components like a foam plug, anchor coil, core wire, and marker band, delivered via an introducer sheath. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obstruct or reduce the rate of blood flow in the peripheral vasculature." This is a therapeutic intervention performed within the body (in vivo).
- Device Description: The device is a "permanent implant, blood contacting pushable embolization device." This describes a device that is placed inside the body to perform a physical function.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. They are used outside the body (in vitro).
The description clearly indicates a device used for a therapeutic procedure within the patient's body, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The IMPEDE Embolization Plug is a permanent implant, blood contacting pushable embolization device comprised of a self-expanding porous, degradable polyurethane-based foam plug, a distal pre-shaped helical platinum-iridium alloy anchor coil, an etched passivated superelastic nitinol core wire, and a proximal platinum-iridium alloy marker band. The device is pre-loaded in the IMPEDE Introducer Sheath which is made of a PEEK tube and a polycarbonate luer hub. The assembled unit is supplied e-beam sterile for single use. The device is delivered with the plug in the crimped state to the target vessel using a guidewire through a standard angiographic catheter. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to embolize the target vessel. The anchor coil stabilizes the device within the vessel to allow precise control of placement and to minimize risk of device migration and unintended thromboembolism while the plug expands to embolize and conform to the vessel lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
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)
Biocompatibility testing: The biocompatibility evaluation for the IMPEDE device was conducted in accordance with ISO10993-1 Biological Evaluation of Medical Devices – Part 1: Guidance on Selection of Tests. The implant is considered a permanent implant, blood contacting device, and the introducer is considered an external communicating device, limited (
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).
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June 22, 2018
Shape Memory Medical, Inc. Meghan Reu Quality and Regulatory Manager 807 Aldo Avenue, Suite 109 Santa Clara, California 95054
Re: K181051
Trade/Device Name: IMPEDE Embolization Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: April 17, 2018 Received: April 20, 2018
Dear Meghan Reu:
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, 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 801); medical device 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);
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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 medical devices and radiation-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.
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181051
Device Name IMPEDE Embolization Plug
Indications for Use (Describe)
The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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& SHAPE MEMORY MEDICAL
510(K) SUMMARY
SUBMITTER
Shape Memory Medical Inc 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054
Phone: 408-649-5175 x 711 Fax: 669-230-5932
Contact Person: Meghan Reu, Quality and Regulatory Manager Date Prepared: June 19, 2018
DEVICE
Name of Device: IMPEDE® Embolization Plug Common Name: Vascular Embolization Device Classification Name: Device, embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD
PREDICATE DEVICES
Vascular Solutions Gel-Block Embolization Pledgets (K113266) Reverse Medical Micro Vascular Plug System (K150108) Biomerix Vascular Occlusion Device and Loader (K043371) Amplatzer Vascular Plug 4 (K113658)
DEVICE DESCRIPTION
The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE Embolization Plug consists primarily of two components:
- IMPEDE Embolization Plug
- IMPEDE Introducer Sheath ●
The IMPEDE Embolization Plug is a permanent implant, blood contacting pushable embolization device comprised of a self-expanding porous, degradable polyurethane-based foam plug, a distal pre-shaped helical platinum-iridium alloy anchor coil, an etched passivated superelastic nitinol core wire, and a proximal platinum-iridium alloy marker band.
The IMPEDE polyurethane foam undergoes slow degradation with the majority (>90%) of the foam remaining at 30 days in a swine intravascular model. The amount of foam degradation was also assessed in vivo in 180-day rat subcutaneous implants and 26 week rabbit intramuscular implants. Analysis of the histology slides from both studies revealed near complete degradation of the polymer foam at the majority of the implant sites in each study.
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The device is pre-loaded in the IMPEDE Introducer Sheath which is made of a PEEK tube and a polycarbonate luer hub. The implant is categorized as a permanent implant, blood contacting device, and the introducer is categorized as an external communicating device, limited (