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.

AI/ML Overview

The provided text is a 510(k) summary for the IMPEDE Embolization Plug. It describes the device, its intended use, and comparison to predicate devices, along with performance data submitted to the FDA. However, it does not contain specific acceptance criteria with numerical thresholds or detailed results from a study proving these criteria were met. Instead, it lists the types of performance data that were provided in support of substantial equivalence.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.

Here's the information that can be extracted or deduced from the provided text, along with notations for information that is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993-1. (Specific criteria and quantitative results not detailed in the provided text, but testing for Cytotoxicity, Sensitization, Irritation, Genotoxicity, Hemocompatibility, Intramuscular Implantation, Materials Mediated Pyrogenicity, Systemic Toxicity, Subchronic Toxicity, and Chronic Toxicity was conducted for the implant. Introduction Sheath testing included Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Materials Mediated Pyrogenicity, and Systemic Toxicity.)
Mechanical, Visual, and Material Characterization	Bench testing conducted included: Simulated use testing (Accessory Compatibility, Delivery Performance (Working Time, Deliverability, Migration), Implantation Performance (Plug Expansion, Migration, Bond Integrity)), 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. (Specific criteria and quantitative results not detailed in the provided text).
In-Vivo Performance	Evaluated in animal studies. (Specific criteria and quantitative results not detailed in the provided text).
Degradation Rate (Foam)	Slow degradation with >90% remaining at 30 days in swine. Near complete degradation at majority of implant sites by 180 days (rat) and 26 weeks (rabbit). (Specific acceptance thresholds for degradation are not provided.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for each test beyond the number of animals in some studies.
Data Provenance:
- Animal 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
- Bench Testing & Biocompatibility: Performed according to ISO 10993-1. No specific country of origin or whether data was retrospective/prospective is mentioned, but typically these tests are prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable for a device of this type. The studies described are primarily non-clinical (bench and animal studies) and do not involve human diagnostic interpretation where expert ground truth would be established in this manner.

4. Adjudication Method (for the test set)

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. This type of study is more common for diagnostic devices where human reader performance is being evaluated with and without AI assistance. This document describes a vascular embolization device, not typically a diagnostic AI.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant, not a software algorithm or AI.

7. Type of Ground Truth Used

Non-clinical endpoints: The studies appear to use direct measurements and observations from bench tests and animal models as their "ground truth" or primary endpoints.
- For biocompatibility: Histology, toxicology analyses, serology, etc.
- For mechanical testing: Physical property measurements, visual inspection, simulated use outcomes (e.g., successful deployment, migration, expansion).
- For degradation: Histology and remaining foam analysis.

8. Sample Size for the Training Set

Not applicable. This document describes the testing of a physical medical device. It does not refer to an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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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 (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 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:

	IMPEDEEmbolizationPlug	ReverseMedical MicroVascular PlugSystem	BiomerixVascularOcclusionDevice andLoader	AmplatzerVascular Plug4	Vascular SolutionsGel-BlockEmbolizationPledgets
510(k) Number	K181051	K150108	K043371	K113658	K113266
Intended Use	The IMPEDE®EmbolizationPlug isindicated toobstruct orreduce the rateof blood flowin theperipheralvasculature	The ReverseMedicalCorporationMVP MicroVascular PlugSystem isindicated toobstruct orreduce the rateof blood flowin theperipheralvasculature	The BiomerixVascularOcclusionDevice isintended forarterial andvenousembolization inthe peripheralvasculature	TheAMPLATZERTM VascularPlug 4 isindicated forarterial andvenousembolizations inthe peripheralvasculature	Gel-Blockembolization pledgetsare intended foruse in embolization ofhypervascular tumorsandarteriovenousmalformations(AVMs).
	IMPEDEEmbolizationPlug	ReverseMedical MicroVascular PlugSystem	BiomerixVascularOcclusionDevice andLoader	AmplatzerVascular Plug4	Vascular SolutionsGel-BlockEmbolizationPledgets
Implant Dimensions	OD(mm) xL(mm)IMP-05: 6 x 10IMP-07: 8 x 10IMP-12: 12 x15	OD(mm) xL(mm)MVP-3: 5.3 x12MVP-5: 6.5 x12MVP-7: 9.2 x16MVP-9: 13 x18	OD(mm) xL(mm)4 x 156 x 158 x 15	OD(mm) xL(mm)4 x 76 x 78 x 710 x 712 x 814 x 816 x 8	OD(mm) x L(cm)5 x 0.53 x 0.53 x 0.25
Vessel Indication	2-10mm (3models)	1.5 - 9mm (4models)	4-16mm	2-20mm(Variousmodels)	Not stated in the IFU
Application / ProductCode	21 CFR870.330 (KRD)	21 CFR870.330 (KRD)	21 CFR 870.330(KRD)	21 CFR 870.330(KRD)	21 CFR 870.330(KRD)
Classification	Class II	Class II	Class II	Class II	Class II
Delivery/DeploymentMethod	Pushable via4F-6F catheterthroughintroducer totarget vessel byguidewire	Delivery wirethrough a .021"- .043" IDmicrocatheter	Commercial 5F-7F Catheters,advanced viaobturator	Via 4F-7Fcatheter throughthe Loader totarget vessel byDelivery Wire	Via .021" - .038" IDcatheter
How transferred tocatheter	Pre-loaded inPeek IntroducerSheath withpolycarbonateluer hub;transferred tocatheter byadvancingguidewire	Through anaccess sheath	Compressedinto Loader andtransferred toCatheter bypushing withguidewire.	Pre-loaded inLoader	Stored individually ina transparent deliverytube with a luer lockon the flushing endand a vented cap onthe delivery end. Onesyringe is included fordelivery of thepledgets.
Detachment	No	Yes	No	Yes	No
Implant Materials	PushablePolyurethane(polymerfoam), NitinolCore Wire,Pt/Ir Coil, Pt/Irmarkerband,Adhesive	MechanicalNitinol,platinum,ePTFE	PushablePolyurethane(polymer foam)	MechanicalNitinol,platinum,stainless steel	InjectablePorcine Gelatin
Anchoring Mechanism	Pt/Ir andNitinol AnchorCoil	Nitinol Basket	Polymer Foam	Nitinol Basket	N/A
Biocompatibility	Meetsrequirements ofISO 10993-1	Meetsrequirements ofISO 10993-1	Meetsrequirements ofISO 10993-1	Meetsrequirements ofISO 10993-1	Meets requirements ofISO 10993-1
How Provided	Sterile, singleuse, pre-loadedin introducer	Sterile, singleuse	Sterile, singleuse	Sterile, singleuse	Sterile, single-use, preloaded 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 ●
1. 1. 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.

Regulation Number and Section

§ 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).