IMPEDE-FX Embolization Plug

K182390 · Shape Memory Medical · KRD · May 23, 2019 · Cardiovascular

Device Facts

• Record ID: K182390
• Device Name: IMPEDE-FX Embolization Plug
• Applicant: Shape Memory Medical
• Product Code: KRD · Cardiovascular
• Decision Date: May 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Device Story

IMPEDE-FX Embolization Plug is a permanent, pushable, transcatheter embolization implant; consists of porous, degradable polyurethane thermoset foam plug with proximal platinum-iridium marker band. Device pre-loaded in PEEK introducer sheath; delivered via catheter using off-the-shelf guidewire. Upon deployment in aqueous environment at body temperature, plug self-expands to primary shape to obstruct/reduce peripheral blood flow. Used as adjunct to IMPEDE Embolization Plug to enhance or extend vessel occlusion. Operated by physicians in clinical settings. Benefits include controlled vessel occlusion; foam undergoes slow oxidative degradation over time.

Clinical Evidence

No human clinical data. Evidence includes bench testing (simulated use, radial force, dimensional/visual inspection) and an acute (4-hour) porcine large animal study evaluating usability, performance, and vessel response. Biocompatibility and long-term degradation data (swine, rat, rabbit models) were leveraged from the predicate IMPEDE device.

Technological Characteristics

Permanent implant; polyurethane thermoset foam; platinum-iridium marker band. Delivery system: PEEK introducer sheath with polycarbonate luer hub. Pushable, non-detachable. E-beam sterilized. Single-use. Dimensions: 6x10mm, 8x10mm, 12x15mm.

Indications for Use

Indicated for use with the IMPEDE Embolization Plug to obstruct or reduce blood flow in the peripheral vasculature.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• IMPEDE Embolization Plug (K181051)

Reference Devices

• Vascular Solutions Gel Block Embolization Pledgets (K113266)

Submission Summary (Full Text)

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 23, 2019

Shape Memory Medical Meghan Reu Ouality and Regulatory Manager 807 Aldo Avenue, Suite 109 Santa Clara, California 95054

Re: K182390

Trade/Device Name: IMPEDE-FX Embolization Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: April 25, 2019 Received: April 26, 2019

# 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. 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

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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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Kenneth Cavanaugh Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K182390

Device Name IMPEDE-FX Embolization Plug

Indications for Use (Describe)

The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug 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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#### 510(k) SUMMARY

#### SUBMITTER

Shape Memory Medical Inc 807 Aldo Avenue, Suite 109 Santa Clara, CA 95054

Contact Person: Meghan Reu, Quality and Regulatory Sr. Manager Phone: [phone] x 711 Fax: [phone] Date Prepared: March 29, 2019

#### DEVICE

Name of Device: IMPEDE-FX Embolization Plug Common Name: Vascular Embolization Device Classification Name: Device, embolization, arterial Regulatory Class: Class II, 21 CFR 870.3300 Product Code: KRD

PREDICATE DEVICE IMPEDE Embolization Plug (K181051)

REFERENCE DEVICE Vascular Solutions Gel Block Embolization Pledgets (K113266)

#### DEVICE DESCRIPTION

The IMPEDE-FX Embolization Plug is a permanent implant, pushable embolization device comprised of a porous, degradable polyurethane thermoset foam plug and a proximal platinumiridium alloy marker band. The foam plug is crimped into a secondary shape to allow delivery through a catheter to the target vessel using a guidewire. Upon deployment in the target vessel and exposure to an aqueous environment and body temperature, the plug will self-expand to its primary shape to embolize the target vessel. The IMPEDE-FX device may only be used in conjunction with the IMPEDE® Embolization Plug System to further enhance vessel occlusion or increase the length of occlusion within the target vessel. It is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

The IMPEDE-FX polyurethane foam undergoes slow oxidative 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.

The device is pre-loaded into an introducer sheath which is made of a PEEK tube bonded to a polycarbonate luer hub to facilitate the transfer of the device into the catheter. The device implant is categorized as a permanent implant, blood contacting device, and the introducer is categorized as an external communicating device, limited (< 24 hour) circulating blood

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contacting device. The assembled unit is supplied to the user e-beam sterile for single use.

### INDICATIONS FOR USE

The IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature.

### COMPARSON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICE

Transcatheter embolization of the peripheral vasculature is the technological principle for both the subject and predicate devices. It is based on the method of delivering an implant device through a catheter and deploying it into and filling the target site thereby obstructing or reducing blood flow to the vasculature. The following table shows the technological similarities and differences between the subject and predicate device:

| | IMPEDE-FX Embolization Plug | IMPEDE™ Embolization Plug |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K182390 | K181051 |
| Indications for Use | The IMPEDE-FX Embolization Plug is<br>indicated for use with the IMPEDE<br>Embolization Plug to obstruct or reduce<br>the rate of blood flow in the peripheral<br>vasculature | The IMPEDE Embolization Plug is<br>indicated to obstruct or reduce the rate of<br>blood flow in the peripheral vasculature |
| Implant Dimensions<br>OD (mm) x L (mm) | IMP-FX-06: 6 x 10<br>IMP-FX-08: 8 x 10<br>IMP-FX-12: 12 x 15 | IMP-05: 6 x 10<br>IMP-07: 8 x 10<br>IMP-12: 12 x 15 |
| Vessel Indication | Not stated in the IFU | 2-10mm (3 models) |
| Product Code | 21 CFR 870.330 (KRD) | 21 CFR 870.330 (KRD) |
| Classification | Class II | Class II |
| Delivery/Deployment<br>Method | Pushable by guidewire through an 0.038"<br>(IMP-FX-06), 0.055' (IMP-FX-08) or<br>0.070" (IMP-FX-12) Min Catheter ID | Pushable by guidewire through an 0.038"<br>(IMP-05), 0.055' (IMP-07) or 0.070"<br>(IMP-10) Min Catheter ID |
| How transferred to<br>catheter | The plug implant is pre-loaded in PEEK<br>Introducer Sheath with polycarbonate luer<br>hub; transferred to the catheter by<br>advancing an off the shelf guidewire | The plug implant is pre-loaded in PEEK<br>Introducer Sheath with polycarbonate luer<br>hub; transferred to the catheter by<br>advancing an off the shelf guidewire |
| Detachment | No - Pushable | No - Pushable |
| Implant Materials | Polyurethane (polymer foam), Pt/Ir<br>markerband, Adhesive | Polyurethane (polymer foam), Nitinol<br>Core Wire, Pt/Ir Coil, Pt/Ir markerband,<br>Adhesive |
| Anchoring Mechanism | N/A | Pt/Ir and Nitinol Anchor Coil |
| How Provided | Sterile, single-use, pre-loaded in<br>introducer | Sterile, single-use, pre-loaded in introducer |
| Sterilization Method | E-Beam | E-Beam |
| Biodegradable | Yes - slow degradation with the majority<br>(>90%) of the foam remaining after 30<br>days in a swine intravascular occlusion<br>animal model. Near complete degradation<br>in 180-day rat subcutaneous implants and<br>26-week rabbit intramuscular implants | Yes - slow degradation with the majority<br>(>90%) of the foam remaining after 30<br>days in a swine intravascular occlusion<br>animal model. Near complete degradation<br>in 180-day rat subcutaneous implants and<br>26-week rabbit intramuscular implants |
| Radiopacity | Proximal Pt/Ir Marker Band | Proximal Pt/Ir Marker Band and distal<br>Pt/Ir and Nitinol Anchor Coil |

#### TABLE 1: PREDICATE DEVICE COMPARISON CHART

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### PERFORMANCE DATA - NEW

The following performance data were provided in support of the substantial equivalence determination.

### Mechanical, Visual and Characterization testing

- Simulated use testing ●
- o Accessory Compatibility (Guidewire, Catheter and Introducer)
- Delivery Performance (Deliverability, Migration) O
- Implantation Performance (Plug Expansion, Migration, Bond Integrity) о
- Radial Force ●
- Dimensional Inspection ●
- Visual Inspection

### Animal Study

The IMPEDE-FX Embolization Plug was evaluated acutely (i.e. 4 hour sacrifice) in a porcine large animal study to evaluate usability, performance, and vessel response.

# PERFORMANCE DATA - LEVERAGED

The following performance data was leveraged from the predicate IMPEDE device, due to similarities between the devices.

### 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 (<24hour) circulating blood contacting device.

The battery of testing for the implant portion of the device included the following tests:

- Cytotoxicity ●
- Sensitization
- Irritation ●
- Genotoxicity
- . Hemocompatibility
- . Intramuscular Implantation
- Materials Mediated Pyrogenicity
- Systemic toxicity
- Subchronic toxicity
- Chronic toxicity ●

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The battery of testing for the Introducer Sheath included the following tests:

- Cytotoxicity
- Sensitization
- . Irritation
- Hemocompatibility
- Materials Mediated Pyrogenicity
- Systemic toxicity ●

# Mechanical, Visual and Characterization testing

- Radiopacity
- Particulate Testing
- MRI Compatibility ●
- Packaging/Sterilization
- Material Characterization ●

# Animal Study

The IMPEDE Embolization Plug was evaluated in a number of animal studies including multiple animal species and implantation sites. This analysis included the following studies:

- 30, 60, and 90-day porcine large animal study
- 90 day standard subcutaneous rat study
- 90 and 180-day custom (foam only) subcutaneous rat study ●
- 4. 13. and 26-week intramuscular implant rabbit study

# BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The IMPEDE-FX Embolization Plug shares technology and functionality with the predicate IMPEDE Embolization Plug (K181051) and reference Gel-Block Embolization Pledgets (K113266) as all are embolic devices that are intended to obstruct blood flow in the vasculature. The subject, predicate, and reference devices are delivered in a compressed shape to allow delivery through a catheter and each expands in a similar fashion once deployed to facilitate occlusion. Each are similar in geometry and consist of degradable materials of construction. While the specific device materials for the subject and Gel-Block predicate devices are not identical, the subject and IMPEDE Embolization Plug predicate devices share many of the same materials. The primary difference between the subject IMPEDE-FX and predicate IMPEDE devices is the lack of the anchor coil in the subject device design. The reference Gel Block Embolization Pledgets (K113266) device, similar to the subject device, lacks a separate anchoring mechanism. Since the migration resistance of the subject device without the anchor coil may be different as compared to the predicate IMPEDE device, it has been indicated for use as an accessory or adjunct to the IMPEDE device.

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the IMPEDE-FX Embolization Plug is substantially equivalent to the predicate device.