ULTRA -THIN SDS BALLOON DILATATION CATHETER

K011889 · Boston Scientific Corp · DQY · Dec 21, 2001 · Cardiovascular

Device Facts

• Record ID: K011889
• Device Name: ULTRA -THIN SDS BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 21, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed Ultra-Thin SDS Balloon Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.

Device Story

Over-the-wire balloon dilatation catheter; used for percutaneous transluminal angioplasty (PTA) of peripheral arteries and dialysis fistulae. Device tracks over guidewires (≤ .035" diameter). Operated by physicians in clinical settings. Inflation of balloon dilates stenotic vessels/fistulae to improve blood flow. Mechanical operation; no electronic or software components.

Clinical Evidence

Bench testing and biocompatibility testing only. No clinical data provided.

Technological Characteristics

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤ .035". Mechanical device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for percutaneous transluminal angioplasty of iliac, femoral, ilio-femoral, popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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

• Marshal (submitted as Courier ST) Balloon Dilatation Catheter (K972744)

Submission Summary (Full Text)

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Ultra-Thin SDS Balloon Dilatation Catheter

## ATTACHMENT H

DEC 21 2001

## SUMMARY OF SAFETY AND EFFECTIVENESS

K011889

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate Summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and oorporation onooooo to Sabmit a US/13((1)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "

The summary regarding the adverse health effects of the proposed Ultra-Thin SDS Balloon Dilatation Catheter is as follows:

| Trade Name: | Ultra-Thin SDS Balloon Dilatation Catheter |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation<br>Ballybrit Business Park<br>Galway, Ireland |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and<br>Cosmetic Act, the device classification is Class II,<br>Performance Standards. |
| Predicate Devices: | The following device is referenced in this premarket<br>notification as the predicate device for the Ultra-Thin SDS<br>Balloon Dilatation Catheter:<br>Boston Scientific Corporation -- Marshal (submitted as<br>Courier ST) Balloon Dilatation Catheter (K972744)<br>The device mentioned above has been determined<br>substantially equivalent by FDA. |

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Ultra-Thiri SDS Balloon Dilatation Catheter

| Device Description: | The proposed Ultra-Thin SDS Balloon Dilatation Catheter is<br>an over-the-wire catheter indicated for percutaneous<br>transluminal angioplasty of the iliac, femoral, ilio-femoral,<br>popliteal, renal arteries and for the treatment of obstructive<br>lesions of native or synthetic arteriovenous dialysis fistulae.<br>The proposed device is designed to be placed over<br>guidewires which have outer diameters of .035" or smaller. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Ultra-Thin SDS Balloon Dilatation Catheters are Indications for Use: recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Safety and Performance: Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen.

Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the Ultra-Thin SDS Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2001

Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

Re: K011889

Trade Name: Ultra-Thin SDS Balloon Dilatation PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Balloon Dilatation Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 26, 2001 Received: September 28, 2001

Dear Ms. Bolton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the excreations of the enactment date of the Medical Device Amendments, or to conmise of the to 112) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , answer 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.

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Page 2 - Ms. Jennifer Bolton, RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issumes of a basements with other requirements of the Act that I DA has inado a determinations administered by other Federal agencies. You must of any I ecolar statutes and regulations and limited to: registration and listing (21 Comply with an the rice orequirements) and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (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) I his ictier will anow you to ough maing of substantial equivalence of your device to a legally premaince hotification. The Price is 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 If you desire speonne au roo for you in vitro diagnostic devices), please contact the Office of additionally 21 CLTC at 007.10 for in Trace visitions on the promotion and advertising of Compliance at [phone]. The Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation childed, "Nilocranians on your responsibilities under the Act may be obtained from the Other general information on your responsional 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,

Dale Tell

ram D. 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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New Application 510(k) Number (if known):

Ultra-Thin SDS Balloon Dilatation Catheter Device Name:

Indications for Use:

Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the illio-femoral, popliteal, renal arteries and for translaninal angloplace of the illus, it native or synthetic arteriovenous dialysis fistulae.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011889

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)