(99 days)
Not Found
No
The document describes a mechanical balloon catheter and does not mention any AI/ML components or related performance metrics.
Yes
The device is indicated for percutaneous transluminal angioplasty (PTA) to treat obstructive lesions in various arteries and dialysis fistulae, which is a therapeutic intervention.
No
The device is a balloon dilatation catheter used for therapeutic angioplasty, not for diagnosing conditions.
No
The device description clearly describes a physical catheter with a balloon, lumens, and a guidewire lumen, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "percutaneous transluminal angioplasty (PTA)" and "treatment of obstructive lesions." These are procedures performed within the body to treat a condition, not tests performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a catheter with a balloon for inflation, designed to be inserted into blood vessels. This is consistent with an interventional device used for treatment, not a diagnostic device used for testing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Ultra-soft™ SV Balloon Dilatation Catheter is an interventional medical device used for therapeutic purposes within the body, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The proposed Ultra-soft™ SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Ultra-soft™ SV Balloon Dilatation Catheters are indicated for percutaneous transfulnimal angloplatiy (r 1) treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Ultra-soft™ SV Balloon Dilatation 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 Balloon Dilatation Catheter will be available in the sizes summarized in Table 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid, iliac, femoral, ilio-femoral, popliteal and renal arteries; native or synthetic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
K050389 Lof2
510(k) Summary
(as required per 21 CFR 807.92)
General Provisions
| Submitter's Name
and Address | Boston Scientific Corporation
Two Scimed Place
Maple Grove, Minnesota 55311 |
|---------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person | Angela Byland
Manager, Regulatory Affairs
(763) 494-2887 |
| Classification Name | Percutaneous Transluminal Angioplasty
Balloon Dilatation Catheter
(21CFR Part 870.1250) |
| Classification | Class II |
| Common or Usual Name | Balloon Dilatation Catheter |
| Proprietary Name | Boston Scientific Ultra-soft™ SV Balloon
Dilatation Catheter |
Predicate Device
Boston Scientific Corporation Ultra-soft™ SV Balloon Dilatation Catheter (K021735; cleared August 8, 2002)
Device Description
The Ultra-soft™ SV Balloon Dilatation 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 Balloon Dilatation Catheter will be available in the sizes summarized in Table 1.
Ultra-soft SV™ Balloon Dilatation Catheter Traditional 510(k) Premarket Notification
1
Section 4
Summary of Safety and Effectiveness
Device Description (continued)
| Length
| Balloon/Catheter | 4.0mm | 4.5mm | 5.0mm | 5.5mm | 6.0mm | 6.5mm | 7.0mm |
|---|---|---|---|---|---|---|---|
| 15 mm/90 cm | X | X | X | X | X | X | X |
| 15 mm/150 cm | X | X | X | X | X | X | X |
| 20 mm/90 cm | X | X | X | X | X | X | X |
| 20 mm/ 150 cm | X | X | X | X | X | X | X |
Table 1: Ultra-soft™ SV Size Matrix
Intended Use
The proposed Ultra-soft™ SV Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of the carotid, iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Technological Characteristics
The Ultra-soft™ SV Balloon Dilatation Catheter is substantially equivalent in design, packaging, fundamental technology, manufacturing, sterilization and intended use as compared to the predicate Boston Scientific Ultra-soft™ SV Balloon Dilatation Catheter.
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 acceptable for its intended use and is considered to be substantially equivalent to the Ultra-soft™ Balloon Dilatation Catheter (K021735; cleared August 8, 2002)
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three stylized wings or feathers.
MAY 2 5 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566
Re: K050389
Ultra-Soft SV Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: May 11, 2005 Received: May 12, 2005
Dear Ms. Byland:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Clerosule) to regarly mannent date of the Medical Device American Case of Drug commerce proof to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug. devices that have been recuire approval of a premarket approval application (PMA). allu Cosmetic Act (71ct) market the device, subject to the general controls provisions of the Act. The You may, therefore, market the devices, books of the virements for annual registration. Iisting of general controls provisions of the fret merade comments of and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (IPMA). it If your device is classified (500 above) the existing major regulations afficcting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obacements concerning your device in the Federal Register.
3
Page 2 - Ms. Angela Byland
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of advisou that I Draination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I catal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I all 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quarty bybeline (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) I mis lotter with and not your finding of substantial equivalence of your device to a legally prematice notification: "The President 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 rr you desire specific at no 10-12-1 at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely vours,
e Mdl.
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO 50389
Ultra-soft™ SV Balloon Dilatation Catheter Device Name:
Indications For Use:
The Ultra-soft™ SV Balloon Dilatation Catheters are indicated for percutaneous The Oltra-Solt - OV Balloon Bilatthe carotid, iliac, femoral, illio-femoral, popliteal, transfulnimal angloplatiy (r 1) treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
el.m.a
rdisvascular Devices K050389 510fk1 Number