(143 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes.
The device's intended use is for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions and for post-dilatation of stents, aiming to restore blood flow, which constitutes a therapeutic intervention.
No
The device is a therapeutic device used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions by dilating arteries and fistulae. It is not used to diagnose conditions.
No
The device description clearly outlines a physical medical device (catheter, balloon, guidewires, etc.) and the performance studies focus on bench testing and biocompatibility of these physical components. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Sterling Monorail PTA Balloon Dilatation Catheter is a medical device used inside the body (in vivo) to physically dilate blood vessels and treat blockages. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's vasculature, not on a sample taken from the patient.
- Device Description: The description details the physical components and function of a catheter used for angioplasty, not for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and safety of the catheter itself (bond integrity, burst pressure, etc.), not on the accuracy of a diagnostic test.
Therefore, based on the provided information, the Sterling Monorail PTA Balloon Dilatation Catheter is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, renal, and carotid 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
LIT
Device Description
The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter is a high performance balloon catheter for peripheral indications. The device features an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires.
The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand rapid exchange 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 guidewires 0.014 in / 0.018 in (.36 mm / .46 mm) 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.
The catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. Markers on the 80 cm and 90 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective length catheters indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with a luer port is included for flushing the distal inner lumen prior to the insertion of appropriate guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid 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. The Sterling Monorail PTA Balloon Dilatation Catheter met all acceptance criteria for the bench and biocompatibility testing with results similar to the predicate. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and bench testing were completed on the Sterling Monorail PTA Balloon Dilatation Catheter:
Biocompatibility: The device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol resembling a stylized human figure, with three faces merging into one another. The symbol is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2014
Boston Scientific Corp. Ms. Diane Nelson Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311-1566
Re: K141150
Trade/Device Name: Sterling MR PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 21, 2014 Received: August 25, 2014
Dear Ms. Nelson.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K141150 510(k) Number (if known):
Device Name: Sterling™ Monorail™ Balloon Dilatation Catheter
Indications for Use:
Sterling™ Monorail™ Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, infrapopliteal, renal, and carotid 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 × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary
per 21 CFR §807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Diane Nelson
Regulatory Affairs Specialist
Phone: 763-255-0813
Fax: 763-494-2222
e-mail: diane.nelson@bsci.com |
| Date Prepared | 02 May 2014 |
| Proprietary
Name | Sterling™ Monorail™ PTA Balloon Dilatation Catheter |
| Common Name | PTA Balloon Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 - Percutaneous Catheter |
| Predicate
Device(s) | Sterling™ Monorail™ PTA Balloon Dilatation Catheter, K053118, cleared
16 December 2005 |
| | Sterling™ OTW PTA Balloon Dilatation Catheter, K132430, cleared 17
October 2013 |
| | Sterling™ SL Monorail™ and OTW PTA Balloon Dilatation Catheters,
K093720, cleared 23 December 2009 |
| Device
Description | The Sterling Monorail Percutaneous Transluminal Angioplasty (PTA)
Balloon Dilatation Catheter is a high performance balloon catheter for
peripheral indications. The device features an ultra low profile, semi-
compliant balloon combined with a low profile tip. The catheter is
compatible with either 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewires. |
| | The Sterling Monorail PTA Balloon Dilatation Catheter is a Monorail brand
rapid exchange 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 guidewires
0.014 in / 0.018 in (.36 mm / .46 mm) 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. |
| | The catheter includes a tapered tip to facilitate advancement of the catheter
to and through the stenosis. Two radiopaque marker bands (one proximal
and one distal), in conjunction with fluoroscopy, enable accurate positioning
of the balloon. Markers on the 80 cm and 90 cm effective length catheters
indicate the exit of the dilatation catheter tip out of the guiding catheter (one
at 50 cm and two at 60 cm). Markers on the 135 cm and 150 cm effective
length catheters indicate the exit of the dilatation catheter tip out of the
guiding catheter (one at 90 cm and two at 100 cm). The effective lengths of
the balloon catheter are 80 cm, 90 cm, 135 cm, and 150 cm. A needle with
a luer port is included for flushing the distal inner lumen prior to the |
| Intended Use/
Indications for
Use of Device | The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for
Percutaneous Transluminal Angioplasty in the peripheral vasculature,
including iliac, femoral, popliteal, infra-popliteal, renal, and carotid 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. |
4
insertion of appropriate guidewires.
5
Comparison of Technological Characteristics
The Sterling Monorail PTA Balloon Dilatation Catheter will incorporate a substantially equivalent design, packaging, fundamental technology, materials, manufacturing, sterilization and intended use as those featured in the predicate BSC Sterling Monorail and OTW Balloon Dilatation Catheters.
Comparison to Predicate Device in Materials and Manufacturing
| Characteristic | Comparison to Predicates |
|---|---|
| Manifold | Same material and design serving the same function. |
| Manifold Bond | |
| Adhesive | Same material and design serving the same function. |
| Corewire | Same material and design serving the same function. |
| Outer Shaft | Same material and design serving the same function. |
| Inner Shaft | Same material, colorant and design serving the same |
| function. | |
| Balloon | Same material and design serving the same function |
| and fundamental technology. | |
| Markerbands | Same component serving the same function. |
| Proximal Marks | Same material and design serving the same function. |
| Coating | Same coating serving the same function. |
| Bumper Tip | Same material, colorant and design serving the same |
| function. | |
| Sterilization | |
| Method | Same method. |
| SAL | Same level of assurance. |
| Balloon | |
| Diameters | Additional balloon diameters: 1.5, 2.0, and 2.5mm. |
| Balloon | |
| Lengths | Additional balloon lengths: 100, 150, 200, and |
| 220mm. | |
| Usable | |
| Catheter | |
| Lengths | Additional catheter lengths: 90 and 150cm. |
| Rated Burst | |
| Pressure | |
| (RBP) | Same Rated Burst Pressure. |
| Recommended | |
| Introducer | |
| Sheath | |
| Compatibility | Sheath compatibility within the predicate compatibility |
| range, same function. | |
| Recommended | |
| Guidewire | Same compatibility. |
| Packaging | Same function and design. |
6
| Performance
Data | 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. The
Sterling Monorail PTA Balloon Dilatation Catheter met all acceptance
criteria for the bench and biocompatibility testing with results similar to the
predicate. No new safety or performance issues were raised during the
testing and, therefore, these devices may be considered substantially
equivalent to the predicate devices. | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The following biocompatibility and bench testing were completed on the
Sterling Monorail PTA Balloon Dilatation Catheter: | | |
| | Biocompatibility
The device was tested for biocompatibility per ISO 10993-1 for short
duration contact with blood (