IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm

K181051 · Shape Memory Medical · KRD · Jun 22, 2018 · Cardiovascular

Device Facts

• Record ID: K181051
• Device Name: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
• Applicant: Shape Memory Medical
• Product Code: KRD · Cardiovascular
• Decision Date: Jun 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Device Story

The IMPEDE Embolization Plug is a permanent, blood-contacting implant designed to obstruct or reduce blood flow in the peripheral vasculature. It consists of a self-expanding, degradable polyurethane-based foam plug, a distal helical platinum-iridium anchor coil, a superelastic nitinol core wire, and a proximal platinum-iridium marker band. The device is pre-loaded in a PEEK/polycarbonate introducer sheath. A physician delivers the device through a standard angiographic catheter using a guidewire. Upon deployment, the plug self-expands in the aqueous, body-temperature environment of the vessel. The anchor coil provides stability to prevent migration while the foam expands to conform to the vessel lumen. The polyurethane foam undergoes slow degradation over time. The device is intended for use in clinical settings by physicians to treat peripheral vascular conditions, providing a mechanical means to achieve embolization.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal studies. Bench testing included simulated use, delivery performance, radial force, radiopacity, and degradation analysis. Animal studies included a 30-90 day porcine intravascular study, 90-180 day subcutaneous rat studies, and 4-26 week intramuscular rabbit studies to evaluate foam degradation and biocompatibility. All testing demonstrated the device performs as intended.

Technological Characteristics

Materials: Polyurethane-based foam, nitinol core wire, platinum-iridium alloy anchor coil and marker band, PEEK/polycarbonate introducer. Principle: Self-expanding, pushable embolization plug. Dimensions: Various models (e.g., 6x10mm, 8x10mm, 12x15mm). Connectivity: None (standalone). Sterilization: E-beam. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for obstruction or reduction of 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

• 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)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

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 ([e-mail]) or phone [phone] 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: [phone] x 711 Fax: [phone]

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 (<24hour) circulating blood contacting device. 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.

### INDICATIONS FOR USE

The IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

#### COMPARSON OF TECHNOLOGICAL CHARACTERSTICS WITH THE PREDICATE DEVICES

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 blood flow to the vasculature. The following table shows the technological similarities and differences between the subject and predicate devices:

| | IMPEDE<br>Embolization<br>Plug | Reverse<br>Medical Micro<br>Vascular Plug<br>System | Biomerix<br>Vascular<br>Occlusion<br>Device and<br>Loader | Amplatzer<br>Vascular Plug<br>4 | Vascular Solutions<br>Gel-Block<br>Embolization<br>Pledgets |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181051 | K150108 | K043371 | K113658 | K113266 |
| Intended Use | The IMPEDE®<br>Embolization<br>Plug is<br>indicated to<br>obstruct or<br>reduce the rate<br>of blood flow<br>in the<br>peripheral<br>vasculature | The Reverse<br>Medical<br>Corporation<br>MVP Micro<br>Vascular Plug<br>System is<br>indicated to<br>obstruct or<br>reduce the rate<br>of blood flow<br>in the<br>peripheral<br>vasculature | The Biomerix<br>Vascular<br>Occlusion<br>Device is<br>intended for<br>arterial and<br>venous<br>embolization in<br>the peripheral<br>vasculature | The<br>AMPLATZER<br>TM Vascular<br>Plug 4 is<br>indicated for<br>arterial and<br>venous<br>embolizations in<br>the peripheral<br>vasculature | Gel-Block<br>embolization pledgets<br>are intended for<br>use in embolization of<br>hypervascular tumors<br>and<br>arteriovenous<br>malformations<br>(AVMs). |
| | IMPEDE<br>Embolization<br>Plug | Reverse<br>Medical Micro<br>Vascular Plug<br>System | Biomerix<br>Vascular<br>Occlusion<br>Device and<br>Loader | Amplatzer<br>Vascular Plug<br>4 | Vascular Solutions<br>Gel-Block<br>Embolization<br>Pledgets |
| Implant Dimensions | OD(mm) x<br>L(mm)<br>IMP-05: 6 x 10<br>IMP-07: 8 x 10<br>IMP-12: 12 x<br>15 | OD(mm) x<br>L(mm)<br>MVP-3: 5.3 x<br>12<br>MVP-5: 6.5 x<br>12<br>MVP-7: 9.2 x<br>16<br>MVP-9: 13 x<br>18 | OD(mm) x<br>L(mm)<br>4 x 15<br>6 x 15<br>8 x 15 | OD(mm) x<br>L(mm)<br>4 x 7<br>6 x 7<br>8 x 7<br>10 x 7<br>12 x 8<br>14 x 8<br>16 x 8 | OD(mm) x L(cm)<br>5 x 0.5<br>3 x 0.5<br>3 x 0.25 |
| Vessel Indication | 2-10mm (3<br>models) | 1.5 - 9mm (4<br>models) | 4-16mm | 2-20mm<br>(Various<br>models) | Not stated in the IFU |
| Application / Product<br>Code | 21 CFR<br>870.330 (KRD) | 21 CFR<br>870.330 (KRD) | 21 CFR 870.330<br>(KRD) | 21 CFR 870.330<br>(KRD) | 21 CFR 870.330<br>(KRD) |
| Classification | Class II | Class II | Class II | Class II | Class II |
| Delivery/Deployment<br>Method | Pushable via<br>4F-6F catheter<br>through<br>introducer to<br>target vessel by<br>guidewire | Delivery wire<br>through a .021"<br>- .043" ID<br>microcatheter | Commercial 5F-<br>7F Catheters,<br>advanced via<br>obturator | Via 4F-7F<br>catheter through<br>the Loader to<br>target vessel by<br>Delivery Wire | Via .021" - .038" ID<br>catheter |
| How transferred to<br>catheter | Pre-loaded in<br>Peek Introducer<br>Sheath with<br>polycarbonate<br>luer hub;<br>transferred to<br>catheter by<br>advancing<br>guidewire | Through an<br>access sheath | Compressed<br>into Loader and<br>transferred to<br>Catheter by<br>pushing with<br>guidewire. | Pre-loaded in<br>Loader | Stored individually in<br>a transparent delivery<br>tube with a luer lock<br>on the flushing end<br>and a vented cap on<br>the delivery end. One<br>syringe is included for<br>delivery of the<br>pledgets. |
| Detachment | No | Yes | No | Yes | No |
| Implant Materials | Pushable<br>Polyurethane<br>(polymer<br>foam), Nitinol<br>Core Wire,<br>Pt/Ir Coil, Pt/Ir<br>markerband,<br>Adhesive | Mechanical<br>Nitinol,<br>platinum,<br>ePTFE | Pushable<br>Polyurethane<br>(polymer foam) | Mechanical<br>Nitinol,<br>platinum,<br>stainless steel | Injectable<br>Porcine Gelatin |
| Anchoring Mechanism | Pt/Ir and<br>Nitinol Anchor<br>Coil | Nitinol Basket | Polymer Foam | Nitinol Basket | N/A |
| Biocompatibility | Meets<br>requirements of<br>ISO 10993-1 | Meets<br>requirements of<br>ISO 10993-1 | Meets<br>requirements of<br>ISO 10993-1 | Meets<br>requirements of<br>ISO 10993-1 | Meets requirements of<br>ISO 10993-1 |
| How Provided | Sterile, single<br>use, pre-loaded<br>in introducer | Sterile, single<br>use | Sterile, single<br>use | Sterile, single<br>use | Sterile, single-use, pre<br>loaded in delivery tube |

TABLE 1: PREDICATE DEVICE COMPARISON CHART

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# ങ്ങിSHAPE MEMORY MEDICAL

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# ങ്ങിSHAPE MEMORY MEDICAL

## PERFORMANCE DATA

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

#### 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

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## & SHAPE MEMORY MEDICAL

- Subchronic toxicity
- Chronic toxicity

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

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

### Mechanical, Visual, and Material Characterization testing

Bench testing conducted for the IMPEDE device included the following:

- Simulated use testing ●
- Accessory Compatibility (Guidewire, Catheter and Introducer) о
- Delivery Performance (Working Time, Deliverability, Migration) o
- Implantation Performance (Plug Expansion, Migration, Bond Integrity) O
- Extractables and Leachables Toxicological Analysis ●
- Degradation Products Toxicological Analysis
- In-Vitro Degradation Rate Analysis ●
- Radiopacity
- Radial Force
- Particulate Testing
- . . . . . MRI Compatibility
- . Packaging/Sterilization
- Material Characterization
- Corrosion Testing
- Dimensional Inspection
- Visual Inspection

### 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

### CONCLUSION

The IMPEDE Embolization Plug is substantially equivalent to the identified predicates in regards to performance, intended use, design, materials, principle of operation and overall technological characteristics. The nonclinical data support the substantial equivalence of the subject device and the verification and validation testing demonstrate that the subject device should perform as intended when used as instructed in the instructions for use.