NUMED PTS X SIZING BALLOON CATHETER

K041306 · NuMED, Inc. · MJN · Jun 10, 2004 · Cardiovascular

Device Facts

• Record ID: K041306
• Device Name: NUMED PTS X SIZING BALLOON CATHETER
• Applicant: NuMED, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jun 10, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended Use

For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

Device Story

Coaxial sizing balloon catheter; used to measure cardiovascular defects for occluder device selection. Input: guidewire passage through central lumen; fluoroscopic visualization via radiopaque platinum marker bands. Operation: inflation of non-compliant balloon via inflation lumen; balloon shoulders feature marker bands for defect sizing; two additional bands spaced 10mm apart provide distance reference. Used in clinical settings by physicians. Output: physical balloon expansion for measurement. Benefit: enables accurate sizing of occluder devices for cardiovascular defects.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in compliance with Tripartite Biocompatibility Guidance for Medical Devices. No clinical data presented.

Technological Characteristics

Coaxial catheter; outer body polymeric tubing; inner tubing multi-layer polyamide (Vestamid PA12) with 304 LV Stainless Steel braid. Non-compliant balloon; single wall thickness 0.0004". Radiopaque platinum marker bands for fluoroscopic placement and distance reference. Sterilized; non-electronic/mechanical device.

Indications for Use

Indicated for patients with cardiovascular defects requiring accurate measurement of the defect to select an appropriately sized occluder device.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• NuMED PTS Catheter

Reference Devices

• PTA Catheters (K931009)
• PTV Catheters (K991977)
• PTS Catheter (K003320)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

May 14, 2004

Submitted By: NuMED, Inc., 2880 Main St., Hopkinton, NY 12965 (Ph) 315-328-4491

Contact Person: Nichelle LaFlesh

Device Name: NuMED PTS X Catheter

Predicate Devices: NuMED PTS Catheter

Device Description: The NuMED, Inc. PTS X™ Sizing Balloon catheter is a coaxial catheter for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. Additionally, there are two radiopaque platinum marker bands spaced at 10mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used as a distance reference. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.

Biocompatibility Testing: The materials used in the NuMED PTS X Catheter are the same as those used in our other PTA Catheters (510(k) #K931009) and PTV Catheters (510(k) #K991977) which were tested for biocompatibility in compliance with the Tripartite Biocompatibility Guidance for Medical Devices. There have been no changes in material from the original PTS approval (K003320) except for the change to the inner tubing. The inner tubing has already been use in our other catheters and has been approved through 510(k) #022722. Test results indicate that all materials demonstrate the biocompatibility of the NuMED catheter and are on file at NuMED, Inc.

Laboratory (Bench) Testing: All bench testing was performed in accordance with GMP's and the results are kept on file at NuMED, Inc.

Intended Use: For use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.

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Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wing segments.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2004

NuMED Inc. c/o Ms. Nichelle LaFlesh Regulatory Affairs Manager 2880 Main Street Hopkinton, NY 12965

Re: K041306

NuMED PTS X Sizing Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (two) Product Code: MJN Dated: May 14, 2004 Received: May 17, 2004

Dear Ms. LaFlesh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endrobars) is regions and ment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have been rechasined in quire approval of a premarket approval application (PMA). alla Costience Act (710) that do november to the general controls provisions of the Act. The I ou may, dicrerere, maines of the Act include requirements for annual registration, listing of general controls provisions of uactice, 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 If your device is classified (600 a00 10) the existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Ms. Nichelle LaFlesh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I DTT 3 155 and 10 vice complies with other requirements of the Act that I DA has made a downlations administered by other Federal agencies. You must of any I edical statutes and regulations and limited to: registration and listing (21 Comply with an the Fee 310 cart 801); good manufacturing practice requirements as set CFK Fat 607), laboring (21 OF RT Rat 807), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (weeting your device as described in your Section 510(k) This leter will unow you to organization of substantial equivalence of your device to a legally premaired predicated on: "The 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), please If you desire specific at [phone]. Also, please note the regulation entitled, Connation of Comptains and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small outer general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(501) + / / www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dung R. Lochner

(JA 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): K041306

Device Name: PTS X Catheter

Indications For Use:

- For use in those patients with cardiovascular defects wherein accurate measurement . I of the defect is important to select the appropriately sized occluder device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

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)

Duane P. Schunel

Cantiovascula: Devices

306 ---------510(k) Numbe

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