ALLIGATOR RETRIEVAL DEVICE (ARD)

K043580 · Chestnut Medical Technologies, Inc. · DQY · Mar 24, 2005 · Cardiovascular

Device Facts

• Record ID: K043580
• Device Name: ALLIGATOR RETRIEVAL DEVICE (ARD)
• Applicant: Chestnut Medical Technologies, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature.

Device Story

Alligator Retrieval Device (ARD) is a single-use endovascular snare consisting of grasping jaws attached to a flexible wire. Designed for use with standard 0.21 in. (0.51mm) ID microcatheters. Distal end and jaws are radio-opaque for fluoroscopic visualization. Operated by clinicians in peripheral and neuro-vascular procedures to retrieve foreign bodies. Device provides mechanical grasping capability; output is the physical removal of the foreign object. Benefits include minimally invasive retrieval of objects from vasculature.

Clinical Evidence

Bench testing only. Device meets ISO 10993 biocompatibility standards for short-term (less than 24-hour) implants and performance requirements for weld strength and force-to-open.

Technological Characteristics

Endovascular snare with grasping jaws on a flexible wire. Radio-opaque distal end/jaws for fluoroscopy. Compatible with 0.21 in. (0.51mm) ID microcatheters. Single-use. Sterile. Biocompatibility per ISO 10993.

Indications for Use

Indicated for the retrieval of foreign objects in the peripheral and neuro-vasculature for patients requiring such intervention.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Boston Scientific "In-Time" retriever
• Microvena microsnare

Submission Summary (Full Text)

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c)

Submitted by: Chestnut Medical Technologies, Inc. 173 Jefferson Drive Menlo Park, CA 94025 Tel [phone] Fax [phone]

MAR 2 4 2005

Contact Person: Anna Longwell Anna Longwell PC 3583 Ross Road Palo Alto, CA 94303 Tel [phone] Fax [phone] [e-mail]

Date summary prepared: 29 October 2004

Trade Name: Alligator™ Retrieval Device (ARD)

Common Name: Endovascular snare device

Classification Name: unknown

Device Description:

The Alligator Retrieval Device (ARD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD device are made of radio opaque material facilitating fluoroscope visualization. The ARD is for single use only.

Indications for Use: The device is intended for use in the peripheral and neuro-vasculature for foreign body removal.

Predicate Devices: Boston Scientific "In-Time" retriever Microvena microsnare

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Comparision to Predicate Devices to Support Substantial Equivalence Determination:

The ARD is made of similar materials and has similar construction to the predicate devices listed above. Also, the ARD has substantially the same intended use as the predicate devices. Although the differences in construction and materials are incidental, the ARD was tested for biocompatibility. The ARD meets ISO 10993 for short-term (less than 24-hours) implantables, meets performance requirements of weld strength and force-to-open, and is provided sterile.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 2005

Chestnut Medical Technologies, Inc. c/o Ms. Patricia L. Murphy KEMA Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K043580

K043380
Trade/Device Name: Alligator™ Retrieval Device (ARD) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: March 8, 2005 Received: March 9, 2005

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section >10(x) premainer nethstantially equivalent (for the indications referenced above and nave uctchined the acrescented cate devices marketed in interstate for use stated in the encrosule) to regary mances promotical Device Ameridatest Hood Drun commerce prior to May 28, 1970, the chance with the provisions of the Federal Food, Drug. devices that have been reciassified in accordance while as proval approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approvalize and Cosment Act (Act) that do not require apple var seneral controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provi You may, therefore, market the device, beefer courements for annual registration. Iisting of general controls provisions of the free mendate comments of the magainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it if your device is classifica (see above) the existing major regulations allecting your device can may be subject to such adultional controlls. Entrological on 898. In addition, FDA may be found in the Code of Pouchar Sneerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issuates or wordevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other require that FDA has made a delommance in administered by other Federal agencies. You must of any Federal statutes and regulations administered by comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act stequirements, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFRT art 807), government (20); and if applicable. the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 1950 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Patricia L. Murphy

This letter will allow you to begin marketing your device as described in your Section 5 (0(k) I his letter will anow you to begin manceing your intial equivalence of your device your device premarket nothcation. The PDA miding of backerial of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 ), please If you desire specific advice for your done of [phone]. Also, please note the regulation entitled, contact the Office of Complance at (210) = if & = = = = = 807.97). You may obtain "Misbranding by reference to premance notifications in the Act from the Division of Small other geleral information on your responser Assistance at its toll-free number [phone] or btw.) Manufacturers, International and Outsahher villeww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Elithm br

Miriam C. Provost, Ph Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | Pending |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Alligator™ Retrieval Device (ARD) |
| Indications For Use: | The Alligator Retrieval Device (ARD) is indicated for the use in retrieval of foreign objects in peripheral and neuro vasculature. |

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

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Signature

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