The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained and experienced in embolization techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters, and guide wires should be employed.

Device Description

The Medusa™ Vascular Plug is a coil-based occlusion device intended for embolization procedures in the peripheral vasculature. The Medusa™ Vascular Plug consists of an implant and a delivery system. The implant is constructed of multiple polymer coils that are pre-loaded on to the delivery system. The Medusa™ Vascular Plug coils are delivered concurrently for vascular occlusion in a single application. Like predicate embolic coils, vascular occlusion with the Medusa™ Vascular Plug is achieved by mechanical flow restriction resulting from coil pack delivery that leads to thrombus formation and rapid cessation of blood flow.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Medusa™ Vascular Plug, focusing on its substantial equivalence to predicate devices. The review is based on non-clinical and animal testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Medusa™ Vascular Plug)
Equivalent occlusion performance in a clinically relevant model	Exhibited performance equivalent to the predicate Cook stainless steel embolization coils through the 95-day time point.
Comparable stability of occlusion	Achieved comparable stability of occlusion to predicate coils.
Comparable occlusion times	Achieved comparable occlusion times to predicate coils.
Comparable or better durability of occlusion	Achieved comparable or better durability of occlusion compared to predicate coils.
No acute or chronic complications	Did not exhibit any acute or chronic complications.
No new issues of safety	Did not raise any new questions of safety.
Meets established specifications for consistent performance for intended use	Collective results of non-clinical testing demonstrate that the device meets established specifications necessary for consistent performance for its intended use.

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

The study was an in-vivo animal validation study conducted in an ovine (sheep) model. The sample size for this animal study is not explicitly stated in the provided text.

The data provenance is prospective animal study data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions "occlusion assessed by the physician" during the angiographic assessment. This implies clinical assessment was part of the ground truth determination. However, the number of physicians/experts and their specific qualifications are not explicitly stated.

4. Adjudication Method for the Test Set

The adjudication method for the angiographic assessment and subsequent histopathology is not explicitly detailed. It mentions "occlusion assessed by the physician," but whether this involved multiple physicians, consensus, or a specific rule (e.g., 2+1) is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This study focused on an animal model, not human readers assessing cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a vascular plug, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The performance evaluated here is the physical device's occlusive capabilities.

7. The Type of Ground Truth Used

The ground truth was established through a combination of:

Angiographic assessment (visual assessment of occlusion by a physician).
Gross necropsy (post-mortem examination of the animal).
Microscopic examination.
Histopathology (microscopic examination of tissues for disease or abnormalities).

This provides a multi-faceted biological and anatomical ground truth from the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device (vascular plug), not an AI algorithm that requires a training set. The "testing" in this context refers to performance validation of the physical device.

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

Not applicable, as there is no training set for a physical device like a vascular plug. The "ground truth" (or established performance criteria) for the device's function was derived from the performance of the predicate devices.

Summary

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4.0 510(K) SUMMARY

510(k) Notification K_123696

GENERAL INFORMATION

Applicant:

EndoShape, Inc.

Phone:

Contact Person:

Michael Parmenter Quality Manager EndoShape, Inc. Phone: 303-951-6898 x106 Fax: 303-416-8849

Date Prepared:

November 30, 2012

DEVICE INFORMATION

Trade Name:

Medusa™ Vascular Plug

Generic/Common Name:

Vascular Embolization Device

Classification: 21 CFR§870.3300, Class Il

Product Code:

KRD

PREDICATE DEVICE(S)

. Cook Embolization Coils (Pre-Amendment)
Amplatzer Vascular Plug (K031810) .

OCT 2 5 2013

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INDICATIONS FOR USE

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The Medusa™ Vascular Plug and the predicate devices, the Cook Coils and the Amplatzer, have the same intended use and use similar technological characteristics to achieve the same mechanism of action. Any technological characteristics that are unique to the Medusa™ Vascular Plug have been validated to raise no new issues of safety or effectiveness. Therefore, the Medusa™ Vascular Plug is substantially equivalent to the Cook Coils and the Amplatzer.

NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary performance testing was conducted on the Medusa™ Vascular Plug to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench and animal testing included:

Design verification and bench validation studies .
In-vivo animal validation studv ●
Biocompatibility .
Sterilization .
o Packaging and shelf-life

The collective results of the non-clinical testing demonstrate that the Medusa™ Vascular Plug meets the established specifications necessary for consistent performance for its intended use.

ANIMAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

In-vivo animal testing was conducted to demonstrate that the Medusa™ Vascular Plug exhibits substantially equivalent occlusion performance in a clinically relevant model. A direct comparison was conducted in accordance with Good Laboratory Practices (GLP) in an ovine model to provide a direct comparison of the Medusa™ Vascular Plug and the Cook

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Coils. Animals were sacrificed at 33 and 95 days post-implantation. At these time points, test subjects underwent angiographic assessment of stability and durability of occlusion (occlusion assessed by the physician), followed by euthanasia, gross necropsy, microscopic examination, and histopathology.

The Medusa™ Vascular Plug exhibited performance equivalent to the predicate Cook stainless steel embolization coils through the 95-day time point, resulting in comparable stability of occlusion, comparable occlusion times, and comparable or better durability of occlusion. At the same time, the Medusa™ Vascular Plug did not exhibit any acute or chronic complications, or raise any other questions of safety, demonstrating that it is as safe as the predicate coils. The Medusa™ Vascular Plug was shown to be substantially equivalent to the predicate coils in this chronic study and the results support a substantially equivalent determination.

CONCLUSION

The results of the nonclinical testing demonstrate that the new technological characteristics employed by the Medusa™ Vascular Plug do not raise any new issues of safety or effectiveness. Therefore, the Medusa™ Vascular Plug is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2013

Endoshape, Inc. c/o Mr. Michael Parmenter Quality Manager 2450 Central Avenue #I Boulder, CO 80301

Re: K123696

Trade/Device Name: Medusa™ Vascular Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 9, 2013 Received: October 10, 2013

Dear Mr. Parmenter:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Michael Parmenter

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Z.m.Z

Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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ENDOSHAPE, INC.

3.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ________

Device Name: Medusa™ Vascular Plug

Indications For Use:

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Lisa M. Lim -S 2013.10.24
Lisa M. Lim -S 15:55:44 -04'00'

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).