PTS-X SIZING BALLOON CATHETER

K110903 · NuMED, Inc. · MJN · Apr 29, 2011 · Cardiovascular

Device Facts

• Record ID: K110903
• Device Name: PTS-X SIZING BALLOON CATHETER
• Applicant: NuMED, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Apr 29, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4450
• Device Class: Class 2

Intended Use

Recommended 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

PTS-X Sizing Balloon Catheter; used by physicians in clinical settings to measure cardiovascular defects. Device functions as sizing tool to assist in selection of appropriate occluder device. Operates as mechanical catheter system; no electronic or software components. Provides physical measurement of defect size to guide clinical decision-making for subsequent interventional procedures. Benefits patient by ensuring accurate sizing of occluder devices, potentially improving procedural outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical sizing balloon catheter. Class II device (21 CFR 870.4450). No electronic components, software, or energy sources. Materials and sterilization methods consistent with standard cardiovascular catheter manufacturing.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

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

199 2 9 2011

Re: K110903

Trade/Device Name: PTS-X Sizing Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Temporary Intravascular Occluding Catheter Regulatory Class: Class II Product Code: MJN Dated: March 30, 2011 Received: March 31, 2011

Dear Ms. LaFlesh:

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Fili Cynd

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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Special 510(k)

## Indications for Use

510(k) Number (if known): K110903

## Device Name: PTS-X Sizing Balloon Catheter

Indications For Use:

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

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

F. G. for BDZ

iovascular Devices

510(k) Number K110903

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