TRANSLUMINAL BALLOON DILATATION CATHETER

K993305 · Boston Scientific Corp · LIT · Apr 10, 2000 · Cardiovascular

Device Facts

• Record ID: K993305
• Device Name: TRANSLUMINAL BALLOON DILATATION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SC 35 Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Over-the-wire balloon dilatation catheter; designed for percutaneous transluminal angioplasty (PTA) and treatment of arteriovenous dialysis fistulae lesions. Device tracks over guidewires (≤ .035" diameter). Used by physicians in clinical settings to dilate stenotic vessels/fistulae. Mechanical operation: catheter inserted into vasculature; balloon inflated to dilate obstructive lesions; deflated for removal. Benefits include restoration of blood flow in peripheral arteries and dialysis access sites.

Clinical Evidence

Bench testing only. In vitro functional testing included balloon burst, multiple inflation, inflation/deflation time, compliance, proximal bond, sheath withdrawal, wingfolded profile, coating coefficient of friction, particulate analysis, and solvent residual testing. Biocompatibility testing included cytotoxicity, hemolysis, acute intracutaneous reactivity, acute systemic toxicity, sensitization, and pyrogenicity.

Technological Characteristics

Over-the-wire balloon dilatation catheter; compatible with guidewires ≤ .035". Mechanical dilatation principle. Biocompatible materials verified via ISO/FDA standards. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) 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

• Ultra-thin Diamond Balloon Dilatation Catheter
• Courier ST Balloon Dilatation Catheter

Submission Summary (Full Text)

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SC 35 Balloon Dilatation Catheter

K993305

September 23, 1999

# ATTACHMENT H

# SUMMARY OF SAFETY AND EFFECTIVENESS

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 effectiveness. According to §513(i)(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 SC 35 Balloon Dilatation Catheter is as follows: र्

| Trade Name: | SC 35 Balloon Dilatation Catheter |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the<br>device classification is Class II, Performance Standards. |
| Predicate Devices: | The following devices are referenced in this premarket notification as<br>predicate devices for the SC 35 Balloon Dilatation Catheter:<br><br>Boston Scientific Corporation - Ultra-thin DiamondTM Balloon Dilatation<br>Catheter<br>Boston Scientific Corporation - Courier STTM Balloon Dilatation Catheter<br><br>All of the devices mentioned above have been determined substantially<br>equivalent by FDA. |
| Device Description: | The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter<br>indicated for percutaneous transluminal angioplasty of the iliac, femoral,<br>ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment of<br>obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The<br>proposed device is designed to be placed over guidewires which have<br>outer diameters of .035" or smaller. |

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SC 35 Balloon Dilatation Catheter

September 23, 1999

Indications for Use:

The SC 35 Balloon Dilatation Catheter is indicated for PTA 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:

The following in vitro functional tests were performed on the SC 35 Balloon Dilatation Catheter:

- Balloon Burst Testing
- . Multiple Inflation Testing
- . Inflation/Deflation Time Testing
- Balloon Compliance Testing .
- . Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing
- Wingfolded Balloon Profile Testing .
- Coating Coefficient of Friction Testing ●
- . Particulate Analysis Testing
- . Solvent Residual Testing

The following biocompatibility tests were performed:

- Cytotoxicity .
- . Hemolysis
- . Acute Intracutaneous Reactivity
- . Acute Systemic Toxicity
- . Sensitization
- . Pyrogenicity

#### Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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Public Health Service

APR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry A. McGovern Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

K993305 Re: Semi Compliant (SC) 35 Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 12, 2000 Received: January 18, 2000

Dear Ms. McGovern:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls The general controls provisions of the Act provisions of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Terry A. McGovern

This letter will allow you to begin marketing your device as described in your 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 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Chitophem. Ahtor

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

New Application

Device Name:

Semi-Compliant 35 Balloon Dilatation Catheter

The Semi-Compliant 35 Balloon Dilitation Indications for Use: Catheter is indicated for percutaneous transluminal angioplasty of the iliac, femoral, illio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chitophth for Dillard

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K993305

OR

Prescription Use / Use (Per 21 CRF 801.109)

Over-The-Counter

(Optional Format 1-2-96)