The Medusa™ Vascular Plug is intended for arterial and venous embolizations in the peripheral vasculature. The product is intended for use by physicians trained 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 is a 510(k) Pre-market Notification for the Medusa™ Vascular Plug, and it describes modifications made to an existing device (Delta model MVP-020) to create a new model (Epsilon models MVP-022, and MVP-025). The purpose is to demonstrate substantial equivalence to the predicate device.

Here's an analysis of the acceptance criteria and study data based on the provided text, recognizing that this is a medical device submission and not a typical AI/software study. Therefore, some categories may not be directly applicable or will have different interpretations.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: No new safety issues raised compared to the predicate device.	The Epsilon Medusa™ Vascular Plug did not exhibit any acute complications, or raise any other questions of safety. The nonclinical testing and animal study collective results indicate meeting established specifications necessary for consistent performance.
Effectiveness/Performance:
1. Stability: Comparable stability to the predicate device.	The Epsilon Medusa™ Vascular Plug exhibited comparable stability to the predicate Delta Medusa™ Vascular Plug in an ovine animal model.
2. Size of Coil Pack: Comparable coil pack lengths to the predicate device.	The Epsilon Medusa™ Vascular Plug exhibited comparable coil pack lengths to the predicate Delta Medusa™ Vascular Plug in an ovine animal model.
3. Occlusion Time: Comparable occlusion times to the predicate device.	The Epsilon Medusa™ Vascular Plug exhibited comparable occlusion times to the predicate Delta Medusa™ Vascular Plug in an ovine animal model.
4. Functionality: Meets established specifications for consistent performance for intended use.	The collective results of the non-clinical testing (design verification, in-vivo animal validation, sterilization, packaging, and shelf-life) demonstrate that the Medusa™ Vascular Plug meets the established specifications necessary for consistent performance for its intended use. The technological characteristics of the Epsilon model have been validated to raise no new issues of safety or effectiveness.
5. Substantial Equivalence: Demonstrated substantial equivalence to the predicate device.	Based on the nonclinical and animal testing results showing comparable safety and effectiveness parameters, the Medusa™ Vascular Plug is substantially equivalent to the predicate Delta Medusa™ Vascular Plug. The changes "do not raise any new issues of safety or effectiveness."

Study Details (Interpreted for a Medical Device)

Sample size used for the test set and the data provenance:
- Animal Study: An "ovine model" was used for the in-vivo animal testing. The specific number of animals (sample size) is not provided in this document.
- Bench Testing: Nonclinical, bench testing was conducted as part of the design verification. The sample size for these tests is not provided.
- Data Provenance: The animal study was conducted in-vivo (within living organisms). The document does not specify the country of origin, but generally, medical device testing for FDA submission is expected to adhere to international standards or US-based regulations. This is a prospective experimental study in an animal model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable in the typical sense of AI/software studies where human experts annotate data. For a medical device like this, "ground truth" and "expert assessment" would be based on established physiological measurements and observations during the animal study, likely conducted by qualified veterinary and medical researchers/staff. The document does not specify the number or qualifications of these individuals directly, but it's implied that the studies were performed by appropriately trained personnel.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not directly applicable to the device testing described. Adjudication typically refers to resolving disagreements among multiple human readers on diagnostic tasks. For device testing, measurements and observations (e.g., occlusion time, coil pack length, complications) are objectively recorded or assessed by trained individuals. Standard scientific protocols and statistical analyses would be used to interpret results, rather than an adjudication process between conflicting readings.
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 comparative effectiveness study was not done. This document pertains to a medical device (a vascular plug), not an AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not relevant here. The study compares the performance of the modified device to its predicate, not human performance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in concept. The "standalone" performance here refers to the device itself operating according to its design specifications. The nonclinical bench testing and the animal study evaluate the device's intrinsic performance (e.g., stability, occlusion ability, mechanical integrity) independent of human-in-the-loop diagnostic interpretations. The device's function is to occlude vasculature, and its performance is measured directly (e.g., as measured occlusion time, coil pack characteristics).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the animal study, the "ground truth" was established by direct physiological measurements and observations in the ovine model. This would include:
  - Direct observation: For stability, acute complications.
  - Measurement: For size of coil pack, occlusion time.
  - Pathology/Histology: Although not explicitly stated as "pathology," assessment of occlusion and any tissue reactions would inherently involve pathological evaluation.
- For bench testing, "ground truth" is defined by engineering specifications and established test methodologies to evaluate material properties, mechanical integrity, and functional performance.
The sample size for the training set:
- Not applicable. This submission is for a physical medical device, not an AI model requiring a training set. The device itself is "designed," "verified," and "validated," not "trained."
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model, there is no ground truth establishment for a training set in this context.

Summary

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

December 2, 2014

Endoshape, Inc. Michael Parmenter Director, Regulatory Affairs and Quality Assurance 2450 Central Ave, Suite I Boulder, Colorado 80301

Re: K140796

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 16, 2014 Received: October 17, 2014

Dear Michael 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -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) K140796

Device Name Medusa™ Vascular Plug

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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APPENDIX A

510(K) SUMMARY

510(k) Notification K________________________

GENERAL INFORMATION

Applicant:

EndoShape, Inc.

Phone: 303-951-6898

Contact Person:

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

Date Prepared:

March 31, 2014

DEVICE INFORMATION

Trade Name:

Medusa™ Vascular Plug

Generic/Common Name:

Vascular Embolization Device

Classification:

21 CFR§870.3300, Class II

Product Code:

KRD

PREDICATE DEVICE

Medusa™ Vascular Plug (K123696)

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INDICATIONS FOR USE

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

SUBSTANTIAL EQUIVALENCE

The Medusa™ Vascular Plug (Epsilon models MVP-022, and MVP-022, and MVP-025) and the predicate device, the Medusa™ Vascular Plug (Delta model MVP-020), have the same intended use and use similar technological characteristics to achieve the same mechanism of action. The minor changes implemented to create the Epsilon MVP-020 include:

. Revised control handle design to improve ergonomics, simplify detachment process, and incorporate graphical instructions
Shortened implant by 2.5% to accommodate new control handle design .
. Removed positioning marker bands from coils – initial positioning is now controlled bv revised control handle
Updated IFU to reflect modified handle design and delivery instructions
Modified subassemblies to improve manufacturability, including: ●
- o Distal and proximal PEEK end pieces modified from a two-piece assembly to a single part to eliminate an adhesive joint
- Proximal wire modified from ball wire to loop wire to replace an interference о fit and single adhesive joint with two redundant adhesive joints
- Reshaped proximal PEEK end piece to accommodate wire loop interlock о design
. Modified positioning of thrombogenic fibers from placement on 5 of 7 coils to placement on all 7 coils while maintaining the same number and amount of thrombogenic fibers.

All technological characteristics that are unique to the Epsilon Medusa™ Vascular Plug have been validated to raise no new issues of safety or effectiveness. Therefore, the Epsilon Medusa™ Vascular Plug is substantially equivalent to the Delta Medusa™ Vascular Plug.

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NONCLINICAL TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

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

Design verification studies ●
In-vivo animal validation study
Sterilization .
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 Epsilon Medusa™ Vascular Plug models exhibit substantially equivalent performance to the Delta Medusa™ Vascular Plug model MVP-020 with regard to parameters that cannot be confirmed in bench testing. Stability, size of coil pack, and occlusion time for the Epsilon Medusa™ Vascular Plug were measured in an ovine model to provide a direct comparison to performance of the Delta Medusa™ Vascular Plug.

The Epsilon Medusa™ Vascular Plug exhibited performance equivalent to the predicate Delta Medusa™ Vascular Plug, resulting in comparable stability, comparable coil pack lengths, and comparable occlusion times. At the same time, the Epsilon Medusa™ Vascular Plug did not exhibit any acute complications, or raise any other questions of safety, demonstrating that it is as safe as the predicate Delta Medusa™ Vascular Plug. The Epsilon Medusa™ Vascular Plug was shown to be substantially equivalent to the predicate Delta Medusa™ Vascular Plug in this acute 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.

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).