Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard balloon dilatation catheter and does not mention any AI/ML components or capabilities.

Therapeutic

Yes
The device is used for "percutaneous transluminal angioplasty" to treat "obstructive lesions", which is a therapeutic intervention.

Diagnostic

No
The device is a balloon dilatation catheter used for therapeutic purposes (angioplasty and treatment of obstructive lesions), not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical catheter with a balloon, lumens, and the ability to use guidewires, indicating it is a hardware medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Description and Intended Use: The description and intended use clearly state that this device is a balloon catheter used for percutaneous transluminal angioplasty. This is a procedure performed inside the body to widen narrowed blood vessels. It does not involve testing samples taken from the body.

The device is an interventional medical device used for a therapeutic procedure, not a diagnostic test performed on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Ultra-soft SV Balloon Dilatation Catheters are 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.

Product codes

DQY, LIT

Device Description

The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The Ultra-soft SV will be available in the following sizes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

iliac, femoral, ilio-femoral, popliteal, renal arteries and arteriovenous dialysis fistulae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K001134

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Summary of Safety and Effectiveness Section 4

(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)

General Provisions

| Submitter's Name
and Address | Boston Scientific, Scimed, Inc.
One Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person | Candice Burns
(763) 494-2845 |
| Classification Name | Percutaneous Transluminal Angioplasty
Balloon Dilatation Catheter
(21CFR Part 870.1250) |
| Common or Usual Name | Balloon Dilatation Catheter |
| Proprietary Name | Boston Scientific Ultra-soft™ SV Balloon
Dilatation Catheter |

Classification

According to Section 13 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards

Predicate Devices

Boston Scientific Gazelle™ Balloon Dilatation Catheter (K001134; cleared April 7, 2000)

Device Description

The Ultra-soft SV Percutaneous Transluminal Angioplasty (PTA) catheter is a Monorail™ catheter with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The distal segment of the balloon catheter is dual lumen and coaxial. The outer lumen is used for inflation of the balloon. The wire lumen permits the use of guidewires (≤0.018 in / 0,46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated. The Ultra-soft SV will be available in the following sizes.

1

Section 4

Summary of Safety and Effectiveness

| Length

Balloon/Catheter	Balloon Diameter
	4.0mm	4.5mm	5.0mm	5.5mm	6.0mm	6.5mm	7.0mm
15 mm/90 cm	×	×	×	×	×	×	×
15 mm/150 cm	×	×	×	×	×	×	×
20 mm/90 cm	×	×	×	×	×	×	×
20 mm/ 150 cm	×	×	×	×	×	×	×

Device Description (continued)

Intended Use

The proposed Ultra-soft SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the iliac, femoral, iliofemoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Technological Characteristics

The Ultra-soft SV catheter will incorporate a substantially equivalent design, packaging, fundamental technology, manufacturing, sterilization and intended use as those featured in predicate Boston Scientific legally marketed balloon catheters.

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 Indications for Use, technological characteristics, and safety and performance testing, the Ultra-soft SV Balloon Dilatation Catheter has been shown to be adequate for its intended use and is considered to be substantially equivalent to the Gazelle PTA Catheter (K001134; cleared April 7, 2000).

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus-like symbol consists of three parallel lines that curve and undulate, suggesting movement and dynamism.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 8 2002

Ms. Candice Burns Boston Scientific Scimed, Inc. One Scimed Place Maple Grove, MN 55311-1566

K021735 Re:

Ultra-soft™ SV Balloon Dilatation Catheter Regulation Number: CFR: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, LIT Dated: May 24, 2002 Received: May 28, 2002

Dear Ms. Burns:

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.

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);

3

Page 2 - Ms. Candice Burns

labeling (21 CFR Part 801); 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.

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 (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Robert R. Tiller, Ph.D.

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) Notification 510(K) Notification
Boston Scientific Ultra-soft™ SV Balloon Dilatation PTA Catheter

Section 2

Indications for Use

510(k) Number (if known) _K021733 ك

Device Name: Ultra-soft™ SV Balloon Dilatation Catheter

Indications for Use:

The Ultra-soft SV Balloon Dilatation Catheters are 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number	K021735

| Prescription Use

(Per 21 CFR 801.109)
------------------------------------------	--

OR

Over The Counter Use
----------------------	--

(Optional Format 1-2-96)