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

AI/ML Overview

The provided document is a 510(k) summary for the IMPEDE-FX Embolization Plug. It describes the device, its indications for use, comparison with predicate devices, and performance data used to establish substantial equivalence.

Here's an analysis to answer your questions based on the provided text:

Acceptance Criteria and Device Performance Study

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly provided in a table format within this document.

The performance data section lists the types of tests conducted:

New Performance Data for IMPEDE-FX:
- Mechanical, Visual, and Characterization testing (Simulated use testing for Accessory Compatibility, Delivery Performance, Implantation Performance; Radial Force; Dimensional Inspection; Visual Inspection).
- Animal Study (acute porcine large animal study for usability, performance, and vessel response).
Leveraged Performance Data from Predicate IMPEDE device:
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Hemocompatibility, Intramuscular Implantation, Materials Mediated Pyrogenicity, Systemic toxicity, Subchronic toxicity, Chronic toxicity).
- Mechanical, Visual, and Characterization testing (Radiopacity, Particulate Testing, MRI Compatibility, Packaging/Sterilization, Material Characterization).
- 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).

Since the document does not provide a table of acceptance criteria with quantitative values and corresponding device performance, I cannot create one. It simply states that "all acceptance criteria were met."

Here's a breakdown of the other requested information based on the provided text:

A table of acceptance criteria and the reported device performance
- Not explicitly provided. The document states that "all acceptance criteria were met," but does not list the specific criteria or the quantitative results.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
  - IMPEDE-FX (new data):
    - Animal study: "an acutely (i.e. 4 hour sacrifice) in a porcine large animal study." The exact number of animals is not specified.
  - IMPEDE (leveraged data):
    - Animal studies: "a number of animal studies including multiple animal species and implantation sites," specifically:
      - "30, 60, and 90-day porcine large animal study" (number of animals not specified).
      - "90 day standard subcutaneous rat study" (number of animals not specified).
      - "90 and 180-day custom (foam only) subcutaneous rat study" (number of animals not specified).
      - "4, 13, and 26-week intramuscular implant rabbit study" (number of animals not specified).
    - In vivo degradation: "in vivo in 180-day rat subcutaneous implants and 26-week rabbit intramuscular implants." The number of animals for these specific degradation assessments is not detailed.
- Data Provenance: The studies are animal studies (porcine, rat, rabbit). The country of origin is not specified, but typically such studies supporting FDA submissions are conducted under GxP (e.g., GLP) guidelines, often in the US or accredited facilities internationally. The studies were prospective as they involved controlled animal experiments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. The studies described are primarily non-clinical performance evaluations involving mechanical testing and animal models, not human clinical trials requiring expert-established ground truth for diagnostic accuracy. The animal studies evaluate "usability, performance, and vessel response," likely assessed by veterinary pathologists and study investigators, but no specific number or qualifications of "experts" for establishing ground truth in a diagnostic sense are mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / None specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially for endpoints or image interpretation where human readers' opinions need to be reconciled. Since this document focuses on non-clinical performance and animal studies, such a method would not be relevant.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is not mentioned. The device is a physical embolization plug, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the animal studies, the "ground truth" would be established through pathology (histology slides) for degradation assessment, and direct observation/measurements of "usability, performance, and vessel response" in the animal models, along with other objective measurements from the mechanical and characterization tests.
The sample size for the training set
- Not applicable. This device is a physical embolization plug, not an AI/machine learning model that requires a training set.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 408-649-5175 x 711 Fax: 669-230-5932 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

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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 isindicated for use with the IMPEDEEmbolization Plug to obstruct or reducethe rate of blood flow in the peripheralvasculature	The IMPEDE Embolization Plug isindicated to obstruct or reduce the rate ofblood flow in the peripheral vasculature
Implant DimensionsOD (mm) x L (mm)	IMP-FX-06: 6 x 10IMP-FX-08: 8 x 10IMP-FX-12: 12 x 15	IMP-05: 6 x 10IMP-07: 8 x 10IMP-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/DeploymentMethod	Pushable by guidewire through an 0.038"(IMP-FX-06), 0.055' (IMP-FX-08) or0.070" (IMP-FX-12) Min Catheter ID	Pushable by guidewire through an 0.038"(IMP-05), 0.055' (IMP-07) or 0.070"(IMP-10) Min Catheter ID
How transferred tocatheter	The plug implant is pre-loaded in PEEKIntroducer Sheath with polycarbonate luerhub; transferred to the catheter byadvancing an off the shelf guidewire	The plug implant is pre-loaded in PEEKIntroducer Sheath with polycarbonate luerhub; transferred to the catheter byadvancing an off the shelf guidewire
Detachment	No - Pushable	No - Pushable
Implant Materials	Polyurethane (polymer foam), Pt/Irmarkerband, Adhesive	Polyurethane (polymer foam), NitinolCore Wire, Pt/Ir Coil, Pt/Ir markerband,Adhesive
Anchoring Mechanism	N/A	Pt/Ir and Nitinol Anchor Coil
How Provided	Sterile, single-use, pre-loaded inintroducer	Sterile, single-use, pre-loaded in introducer
Sterilization Method	E-Beam	E-Beam
Biodegradable	Yes - slow degradation with the majority(>90%) of the foam remaining after 30days in a swine intravascular occlusionanimal model. Near complete degradationin 180-day rat subcutaneous implants and26-week rabbit intramuscular implants	Yes - slow degradation with the majority(>90%) of the foam remaining after 30days in a swine intravascular occlusionanimal model. Near complete degradationin 180-day rat subcutaneous implants and26-week rabbit intramuscular implants
Radiopacity	Proximal Pt/Ir Marker Band	Proximal Pt/Ir Marker Band and distalPt/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 ●
1. 1. 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.

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).