MULTI-SNARE SET

K011783 · Pfm Produkte Fur Die Medizin AG · DXE · Jan 24, 2002 · Cardiovascular

Device Facts

• Record ID: K011783
• Device Name: MULTI-SNARE SET
• Applicant: Pfm Produkte Fur Die Medizin AG
• Product Code: DXE · Cardiovascular
• Decision Date: Jan 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2

Intended Use

The Multi-Snare Set (and its components) is intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera . Assistance in creating loops where cross-over technique is applied . Repositioning of indwelling venous catheters . Assistance in performing venipuncture to obtain access to central vein .

Device Story

Multi-Snare Set is a mechanical retrieval device; consists of highly elastic Nitinol wire with pre-formed distal loop, coil, and shaft body (outside coil and core wire). Used in vascular system and hollow viscera; operated by clinicians. Device introduced via insertion sheath (polyethylene tubing with luer adapter and radiopaque marker). Snare diameter adjusted by sheath position; torquer provided for manipulation/torque-ability. Functions as a snare for foreign object retrieval, catheter repositioning, and venipuncture assistance. No electronic or software components.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Nitinol (loop), polyethylene (sheath). Design: Pre-formed loop, coil-mounted wire, shaft with core wire. Connectivity: None. Energy: None (mechanical). Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring retrieval/manipulation of foreign objects in the vascular system or hollow viscera, creation of loops for cross-over techniques, repositioning of indwelling venous catheters, or assistance in venipuncture for central vein access.

Regulatory Classification

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.

Predicate Devices

• Microsnare (K925439)
• Welter Snare Retriever (K920823)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | pfm Produkte f ür die Medizin AG |
|-----------------|-------------------------------------------|
| Address: | Wankelstr. 60<br>50996 Cologne<br>Germany |
| CONTACT PERSON: | Salvadore F. Palomares, RAC |

**JAN 24 2002**

## 510(k) Summary of Safety and Effectiveness

JTD(K) Summary of Salety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K011783 Multi-Snare Set Trade Name: Embolectomy Catheter Common Name: Classification Name: Same

#### Equivalent Devices:

| Manufacturer: | Microvena Corporation |
|---------------|------------------------|
| Name: | Microsnare |
| 510(k) #: | K925439 |
| Manufacturer: | Cook Inc. |
| Name: | Welter Snare Retriever |
| 510(k) #: | K920823 |

### Device Description:

The Multi-Snare Set is designed for the following indications:

- Retrieval and manipulation of foreign objects from the vascular system and hollow . viscera
- Assistance in creating loops where cross-over-technique is applied .
- Repositioning of indwelling venous catheters .

The pfm Multi-Snare Set is contains of the following parts:

- Inner wire which forms the loop; ●
- Coil mounted on the inner wire in the loop section; .
- Shaft body consisting of an outside coil and a core wire; and .
- Transition from loop wire to shaft body. ●

The Multi-Snare Set consists of a highly elastic Nitinol wire with a pre-formed loop on its distal end. The ware of the snare's highly elastic design, the snare can be introduced through an insertion sheath. The diameter of the snare can be adjusted depending on the position of the sheath. For better manipulation and torque-ability a torquer is provided.

The introducer sheath is designed for interventional insertion of instruments and systems into the vascular system.

The insertion sheath consists of polyethylene tubing, which is curved at its distal end and has a luer adapter at its proximal end. For better visualization the introducer sheath has an additional distal radiopaque marker.

#### Intended Use:

The Multi-Snare Set (and its components) is intended for:

- Retrieval and manipulation of foreign objects from the vascular system and hollow viscera .
- Assistance in creating loops where cross-over technique is applied .
- Repositioning of indwelling venous catheters .
- Assistance in performing venipuncture to obtain access to central vein .

#### Biocompatibility:

The materials used to manufacture the Multi-Snare Set comply with the requirements of ISO 1093-1.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 4 2002

Mr. Salvadore F. Palomares Regulatory Consultant for pfm PFM Produkte Fur Die Medizen AG C/O Salvadore F. Palomares, RAC 15 Cherokee Streeet Trabuco Canyon, CA 92679

Re: K011783

Trade Name: Multi-Snare Ser Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: II Product Code: 74 MMX Dated: January 17, 2002 Received: January 18, 2002

Dear Mr. Palomares:

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 for use surve in the encreations) it etgansy actment 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Salvadore F. Palomares

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bram Zuckerman, M.D.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### K011783 510(k):

Multi-Snare Set Device Name:

The Multi-Snare Set (and its components) is Indications for Use: intended for: Retrieval and manipulation of foreign objects from the vascular system and hollow viscera Assistance in creating loops where cross-over technique is applied Repositioning of indwelling venous catheters Assistance in performing venipuncture to obtain access to central vein

Concurrence of CDRH, Office of Device Evaluation (ODE)

> Prescription Use (Per 21 CFR 801.109)

Over the Counter Use

(Division Sign-On)
Division of Dental Infection Control, and
General Hospital Devices

Or

510(K) K011783 Number

Division of Cardiovascular & Respiratory Devices
510(k) Number K011783