(39 days)
Not Found
No
The description focuses on the physical components and function of a balloon catheter, with no mention of AI/ML or related concepts.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in the peripheral vasculature and arteriovenous dialysis fistulae, which are therapeutic procedures aimed at restoring blood flow.
No
This device is a therapeutic device (balloon dilatation catheter) used for angioplasty and post-dilatation of stents, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, and radiopaque markers, indicating it is a hardware 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 is for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature and for treating obstructive lesions in arteriovenous dialysis fistulae. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter designed to be inserted into blood vessels to dilate them. This is a medical device used for treatment, not for analyzing samples from the body.
- No mention of analyzing samples: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. There is no indication that this device performs any such analysis.
Therefore, the Sterling OTW PTA Balloon Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Sterling OTW PTA Balloon Dilatation Catheter is an Over-The-Wire catheter with a semi-compliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in/0.018 in (0.36 mm/0.46 mm) guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The working lengths of the balloon catheter are 40 cm, 80 cm and 135 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of 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)
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 (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
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311 |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Maureen Montbriand
Specialist, Regulatory Affairs
Phone: 763-494-2903
Fax: 763-494-2981
e-mail: montbrim@bsci.com |
| Date Prepared | November 4, 2005 |
| Proprietary
Name(s) | Sterling ™ OTW PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | DQY |
| Classification of
Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Ultra-soft™ SV
Balloon Dilatation
Catheter
K021735 August 8, 2002 |
| | Ultra-soft™ SV
Balloon Dilatation
Catheter
K050389 May 25, 2005 |
| Device
Description | The Sterling OTW PTA Balloon Dilatation Catheter is an
Over-The-Wire catheter with a semi-compliant balloon fixed
at the distal tip. The balloon catheter has a coaxial shaft
design. The outer lumen is used for inflation of the balloon,
and the wire lumen permits the use of 0.014 in/0.018 in
(0.36 mm/0.46 mm) guidewires to facilitate advancement of
the catheter to and through the stenosis to be dilated. The
balloon is designed to provide an inflatable segment of
known diameter and length at recommended pressures.
Two radiopaque marker bands (one proximal and one
distal), in conjunction with fluoroscopy, enable accurate
positioning of the balloon. The working lengths of the
balloon catheter are 40 cm, 80 cm and 135 cm. |
| Intended Use of
Device | The Sterling OTW PTA Balloon Dilatation Catheter is
indicated for Percutaneous Transluminal Angioplasty
(PTA) in the peripheral vasculature, including iliac, femoral,
ilio-femoral, popliteal and renal arteries, and for the
treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. This device is also
indicated for post-dilatation of balloon expandable and self-
expanding stents in the peripheral vasculature. |
| Comparison of
Technological
Characteristics | The Sterling OTW catheter will incorporate a substantially
equivalent design, packaging, fundamental technology,
manufacturing, sterilization and intended use as those
featured in the predicate BSC Ultra-soft SV Balloon
Dilatation Catheter. |
| Support of
Substantial
Equivalence | 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, safety and performance testing, the Sterling
OTW PTA Balloon Dilatation Catheter has been shown to
be appropriate for its intended use and is considered to be
substantially equivalent to the Ultra-soft SV Balloon
Dilatation Catheter (K050389; cleared May 25, 2005 and
K021735; cleared August, 8 2002). |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporattion c/o Ms. Maureen Montbriand Regulatory Affairs Specialist Two Scimed Place Maple Grove, MN 56311-1566
Re: K053116
Sterling™ OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: DQY Dated: November 4, 2005 Received: November 7, 2005
Dear Ms. Montibriand:
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.
3
Page 2 - Ms. Maureen Montibriand
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); 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), please contact the Office of Compliance 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 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/industry/support/index.html.
Sincerely yours,
Duna R. Vachner
A 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 Statement
| 510(k) Number (if known) | K053116 |
|---|---|
| Device Name | Sterling TM OTW PTA Balloon Dilatation Catheter |
| Indications For Use | The Sterling OTW PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. |
Prescription Use: ____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR §801 Subpart D) 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)
Dune R. Vachner
Division Sign-Off)
Division of Cardiovascular Devices
ok) Number_K05311 (