RC-15 Model: The Recovery Cone Removal System is intended for use to percutaneously remove the Recovery Filter, Recovery G2 Filter and G2 X Filter from the vena cava.

FBRC Model: The Recovery Cone Removal System is intended for use to percutaneously remove the G2 X Filter, G2 Express Filter, G2 Filter and the Recovery Filter from the vena cava, or facilitate the retrieval of foreign objects from the peripheral vascular system.

Device Description

The Recovery Cone® Removal System is intended to percutaneously remove the G2® X Filter, G2® Express™ Filter, G2® Filter or Recovery® Filter from the vena cava or facilitate the retrieval of foreign objects from the peripheral vascular system. The device is provided sterile and is single use only. The Recovery Cone® Removal System consists of the Removal Cone and Introducer Catheter. The cone consists of a reinforced urethane cone. 15-mm in diameter. The cone is connected to a plastic (Pebax) shaft and handle. The shaft has a central lumen that accommodates a 0.035" guidewire. A Touhy-Borst Y-adapter is used to connect the cone to the Introducer Catheter and to a saline flush or drip. The Introducer Catheter consists of a 10 French I.D. introducer sheath and dilator. The introducer sheath has a radiopaque marker for enhanced fluoroscopic visualization.

AI/ML Overview

The provided document is a 510(k) summary for the Recovery Cone® Removal System, a medical device intended for percutaneous removal of vena cava filters or retrieval of foreign objects from the peripheral vascular system.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported device performance values for most tests. It primarily states that tests were performed and conclude the device is substantially equivalent to the predicate.

However, based on the testing categories, the general implied acceptance criteria would be successful completion of the test without failure, comparable performance to the predicate device where applicable, and demonstration of safety and efficacy for its intended use.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
In-Vitro Filter Performance	Successfully tested.
Filter Retrieval	Successfully demonstrated in-vitro, in-vivo, and through clinical references.
Foreign Body Retrieval	Successfully demonstrated in-vitro, in-vivo, and through clinical references.
Sheath and Dilator Integrity (Tensile, Torque, Leak)	Successfully met integrity requirements.
Catheter Simulated Use Test	Successfully passed simulated use.
Marker Band Integrity	Maintained integrity.
Filter Removal Force	Successfully demonstrated appropriate removal force.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility, Thromboresistance, Coagulation)	Successfully met ISO 10993 standards and demonstrated biocompatibility.
Substantial Equivalence Determination	Device is substantially equivalent to the predicate device based on all tests.

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

Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of devices, number of animals, number of clinical cases) for any of the in-vitro, in-vivo, or clinical reference testing.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: Not explicitly stated for either in-vivo animal testing or clinical references. The mention of "clinical references" suggests a review of existing data rather than a new prospective clinical trial for this submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

This information is not provided in the document. The document refers to "in-vivo animal testing and within clinical references" for evaluating filter capture and retrieval, but it does not detail how ground truth was established by experts for these.

4. Adjudication Method for the Test Set

This information is not provided in the document. There is no mention of expert adjudication for any test results.

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

No, an MRMC comparative effectiveness study is not mentioned in the document. This is a device for percutaneous retrieval, not an imaging or diagnostic device typically evaluated with such studies.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This question is not applicable as the Recovery Cone® Removal System is a physical medical device. It does not involve an algorithm or AI component in the way this question implies.

7. Type of Ground Truth Used

For the performance testing, the ground truth appears to be based on:
- Successful mechanical operation: Demonstrating that the device can successfully capture and retrieve filters/foreign objects.
- Compliance with engineering standards: Meeting specifications for tensile strength, torque, leak integrity, etc.
- Compliance with biocompatibility standards: Meeting ISO 10993 requirements.
- Successful clinical outcomes: Implied from "clinical references" demonstrating its ability to be used for its intended purpose.

8. Sample Size for the Training Set

This question is not applicable as the Recovery Cone® Removal System does not involve machine learning or AI that would require a "training set." Performance testing typically involves a "test set" to validate the device's design.

9. How Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary

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

February 18, 2016

Bard Peripheral Vascular, Inc. Ms. Joni Creal Regulatory Affairs Program Manager 1625 West 3rd Street Tempe, Arizona 85281

Re: K152136

Trade/Device Name: Recovery Cone® Removal System Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX Dated: December 29, 2015 Received: January 05, 2016

Dear Ms. Creal:

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 devicerelated 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.

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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/ResourcesforYou/Industry/default.htm. 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 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) K152136

Device Name Recovery Cone® Removal System

Indications for Use (Describe)

RC-15 Model: The Recovery Cone Removal System is intended for use to percutaneously remove the Recovery Filter, Recovery G2 Filter and G2 X Filter from the vena cava.

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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Recovery Cone® Removal System 510(k) Summary

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
Phone:	480-638-2906
Fax:	480-449-2546
Contact:	Joni Creal, Regulatory Affairs Program Manager
Date:	July 30, 2015

Subject Device Name:

Device Trade Name:	Recovery Cone® Removal System
Common or Usual Name:	Device, Percutaneous Retrieval
Classification:	Class II
Review Panel:	Cardiovascular Devices
Product Code:	MMX

Cook FourSnare Vascular Retrieval Snare (K112185) Predicate Devices:

Device Description:

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I.D. introducer sheath and dilator. The introducer sheath has a radiopaque marker for enhanced fluoroscopic visualization.

Indications for Use of Device:

RC-15 Model: The Recovery Cone Removal System is intended for use to percutaneously remove the Recovery Filter, Recovery G2 Filter and G2 X Filter from the vena cava.

Technological Comparison to Predicate Devices:

The technological characteristics of the subject device, Recovery Cone® Removal System, are substantially equivalent to the legally marketed predicate device, the Cook FourSnare Retrieval Snare, in terms of intended use, indications for use, operating principle and fundamental scientific technology. Both devices are catheter based systems that have collapsible wires for filter engagement and withdraw into an outer sheath. Both systems are designed to be used over a quidewire. Both devices contain marker bands for visibility. The predicate device contains four wire loops to engage the foreign objects while the Recovery Cone® utilized a urethane cone reinforced with wire claws. The predicate wire loop system is designed to advance through a 80cm, 10 French introducer catheter, and the subject device cone is designed to advance through a 75 cm, 10 French I.D. introducer catheter.

Performance Testing Summary:

To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated using in-vitro testing as outlined below. In addition, the ability to capture the filter and retrieve the filter was evaluated in in-vivo animal testing and within clinical references.

In-Vitro Filter .
- Tensile

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| Leak Test
Filter Retrieval ।
-Foreign Body Retrieval
Sheath and Dilator Tensile, Torque and Leak Integrity Test -
Catheter Simulated Use Test -
Marker Band Integrity —
-Filter Removal Force
Biocompatibility, per ISO 10993 ●
- Cytotoxicity (ISO 10993-5) -
- Sensitization (ISO 10993-10) |
- -Irritation - Intracutaneous Reactivity (ISO10993-10)
- Acute Systemic Toxicity (ISO10993-11) -
- -Pyrogenicity (ISO 10993-11)
- Hemocompatibility —
- Thromboresistance -
- Coagulation (ISO 10993-4) |

In conclusion, the results of these tests provide reasonable assurance that the device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).