(73 days)
Not Found
No
The document describes a physical medical device (balloon dilatation catheter) and its intended use and technical specifications. There is no mention of software, algorithms, or any components that would suggest the use of AI or ML.
Yes
The device is indicated for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic intervention aimed at improving patient health outcomes by dilating blood vessels or fistulae.
No
This device is a therapeutic device (balloon dilatation catheter) used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, rather than for diagnosing conditions.
No
The device description clearly details physical components like catheters, balloons, lumens, and guidewires, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The descriptions clearly state that these are balloon dilatation catheters used for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. This is a procedure performed within the body to open narrowed or blocked blood vessels.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens. The device is used directly on the patient's anatomy.
Therefore, these devices fall under the category of medical devices used for therapeutic procedures, not IVDs.
N/A
Intended Use / Indications for Use
The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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.
The Sterling SL Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Ultra-soft SV Balloon Dilatation Catheter is recommended for the 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 (comma separated list FDA assigned to the subject device)
LIT, DOY
Device Description
The Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheters (Coyote MR) are high performance balloon catheters for peripheral vascular indications. The devices feature an ultra low profile, semi-compliant balloon combined with a low profile tip. The catheter is compatible with 0.014 in (0.36 mm) guidewires.
The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling MR) 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 Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter (Sterling SL) is high performance balloon catheter for peripheral vascular indications featuring a low profile, semi-compliant balloon combined with a low profile tip. They are a line extension to the existing Sterling catheters and include smaller diameter and longer length balloons. The catheters have 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" (0.36 mm) or 0.018" (0.46 mm) to facilitate advancement of the catheter to and through the stenosis to be dilated.
The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018 is a sterile, single use, Monorail catheter with a semi-compliant balloon near the distal tip which inflates to a known diameter and length at a specific pressure. The catheter consists of a double lumen at the distal end and a single lumen catheter at the proximal end. The 0.018 in. guide wire compatible balloon catheter is available in diameters of 4.0 - 7.0 mm in 1.5 and 2.0 cm balloon lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coyote: peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries.
Sterling: peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries.
Sterling SL: peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries.
Ultra-Soft SV: iliac, femoral, ilio-femoral, popliteal, renal arteries.
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 and first article testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device with the modified corewire 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 device testing.
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.
K111295, K053118, K141150, K093720, K021735
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.
November 4. 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Boston Scientific Corporation Ka Xiong Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K162350
Trade/Device Name: Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter. Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter. Sterling SL Monorail Percutaneous Transluminal Angioplastv Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018" Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: October 6. 2016 Received: October 7, 2016
Dear Ka Xiong:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices 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 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 devices 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Mache Jackson
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K162350
Device Name
Coyote™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter
Indications for Use (Describe)
The Coyote MONORAIL PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
3
510(k) Number (if known) K162350
Device Name
Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
4
510(k) Number (if known)
Device Name
Sterling™ Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
5
510(k) Number (if known)
Device Name
Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter
Indications for Use (Describe)
The Sterling SL Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
6
510(k) Number (if known) K162350
Device Name Ultra-Soft SVTM Monorail™ Balloon Dilatation Catheter 0.018"
Indications for Use (Describe)
The Ultra-soft SV Balloon Dilatation Catheter is recommended for the 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
7
510(k) Summary Per 21 CFR §807.92
| Common or
| Usual Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
|---|---|
| Trade Name(s) | Coyote™ Monorail™ Percutaneous Transluminal Angioplasty |
| Balloon Dilatation Catheter - formally known as .014 | |
| Monorail PTA Dilatation Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification of | |
| Device | Class II - 21 CFR 870.1250 |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name | |
| and Information | Ka Zoua Xiong |
| Regulatory Affairs Specialist | |
| Phone: 763-494-2970 | |
| Fax: 763-494-2222 | |
| Email: Kazoua.Xiong@bsci.com | |
| Date Prepared | 06 October 2016 |
| Section 514 of the | |
| Act Performance | |
| Standards | Currently no FDA mandated or voluntary performance |
| standards exist for this device. | |
| Establishment | |
| Registration | |
| Numbers | Owner /Operator: |
| Boston Scientific | |
| Corporation | |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 |
Manufacturing Facility:
Boston Scientific
Corporation
Two Scimed Place
Maple Grove, MN 55311
ERN: 2134265
Sterilization Facilities:
BSC Coventry
8 Industrial Drive
Coventry, RI 02816
USA |
| Predicate Devices | K111295 - Coyote™ Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter, cleared 31 May
2011 |
8
| Device
Description | The Coyote™ Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheters (Coyote MR) are
high performance balloon catheters for peripheral vascular
indications. The devices feature an ultra low profile, semi-
compliant balloon combined with a low profile tip. The
catheter is compatible with 0.014 in (0.36 mm) guidewires. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The Coyote MONORAIL PTA Balloon Dilatation Catheter is
indicated for Percutaneous Transluminal Angioplasty (PTA)
in the peripheral vasculature, including iliac, femoral,
popliteal, infra-popliteal and renal arteries, and for the
treatment of obstructive lesions of native or synthetic
arteriovenous dialysis fistulae. |
| Comparison of
Required
Technological
Characteristics | The proposed Coyote MR is substantially equivalent to the
existing Coyote MR cleared by FDA under premarket
notification K111295 (31May2011). Coyote MR has the same
intended use, scientific technology, design (with the
exception of the corewire design), materials, sterilization
method, and packaging materials as the applicable predicate
device. |
| Summary of Non-
Clinical Test
Summary | Bench and first article testing were performed to support a
determination of substantial equivalence. The results of these
tests provide reasonable assurance that the proposed device
with the modified corewire 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
device testing. |
| Conclusion | Based on the indications for use, technological
characteristics, and safety and performance testing, the
proposed Coyote MR with the modified corewire has been
shown to be appropriate for its intended use and is
considered to be substantially equivalent to its predicate
(K111295). |
9
| Common or Usual
| Name | PTA Balloon Dilatation Catheter | |
|---|---|---|
| Trade Name(s) | Sterling™ Monorail™ Percutaneous Transluminal Angioplasty | |
| Balloon Dilatation Catheter | ||
| Product Code | DQY - Catheter, Percutaneous | |
| Classification of | ||
| Device | Class II - 21 CFR 870.1250 | |
| Submitter's Name | ||
| and Address | Boston Scientific Corporation | |
| One Scimed Place | ||
| Maple Grove, MN 55311-1566 | ||
| Contact Name and | ||
| Information | Ka Zoua Xiong | |
| Regulatory Affairs Specialist | ||
| Phone: 763-494-2970 | ||
| Fax: 763-494-2222 | ||
| Email: Kazoua.Xiong@bsci.com | ||
| Date Prepared | 06 October 2016 | |
| Section 514 of the | ||
| Act Performance | ||
| Standards | Currently no FDA mandated or voluntary performance standards | |
| exist for this device. | ||
| Establishment | ||
| Registration | ||
| Numbers | Owner /Operator: | Boston Scientific Corporation |
| 300 Boston Scientific Way | ||
| Marlborough, MA 01752 | ||
| ERN: 9912058 | ||
| Manufacturing | ||
| Facility: | Boston Scientific Corporation | |
| Two Scimed Place | ||
| Maple Grove, MN 55311 | ||
| ERN: 2134265 | ||
| Sterilization | ||
| Facilities: | BSC Coventry | |
| 8 Industrial Drive | ||
| Coventry, RI 02816 | ||
| USA | ||
| Synergy Health (Tullamore) | ||
| IDA Business & Technology Park | ||
| Tullamore | ||
| County Offaly | ||
| Ireland |
10
| Predicate Devices | K053118 - Sterling™ Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter, cleared 16 December 2005
K141150 - Sterling™ Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter, cleared 25 September
2014 |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description | The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty
Balloon Dilatation Catheter (Sterling MR) 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 |
| Intended Use/
Indications for Use | 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. |
| Comparison of
Required
Technological
Characteristics | The proposed Sterling MR is substantially equivalent to the existing
Sterling MR devices cleared by FDA under premarket notifications
K053118 (16Dec2005) and K141150 (25Sep2014). Sterling MR has
the same intended use, scientific technology, design (with the
exception of the corewire design), materials, sterilization method,
and packaging materials as the applicable predicate device. |
| Summary of Non-
Clinical Test
Summary | Bench testing and first article testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device with the
modified corewire 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 device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Sterling MR with the
modified corewire has been shown to be appropriate for its
intended use and is considered to be substantially equivalent to its
predicate (K053118). |
11
| Common or Usual Name | PTA Balloon Dilatation Catheter |
|---|---|
| Trade Name(s) | Sterling™ Monorail™ Percutaneous Transluminal Angioplasty |
| Balloon Dilatation Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification of Device | Class II - 21 CFR 870.1250 |
| Submitter's Name and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and Information | Ka Zoua Xiong |
| Regulatory Affairs Specialist | |
| Phone: 763-494-2970 | |
| Fax: 763-494-2222 | |
| Email: Kazoua.Xiong@bsci.com | |
| Date Prepared | 06 October 2016 |
| Section 514 of the Act Performance Standards | Currently no FDA mandated or voluntary performance standards |
| exist for this device. | |
| Establishment Registration Numbers | Owner/Operator: Boston Scientific Corporation |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 |
Manufacturing Facility: Boston Scientific Corporation
Two Scimed Place
Maple Grove, MN 55311
ERN: 2134265
Sterilization Facilities: BSC Coventry
8 Industrial Drive
Coventry, RI 02816
USA
Synergy Health (Tullamore)
IDA Business & Technology Park
Tullamore
County Offaly
Ireland |
| Predicate Devices | K141150 - Sterling™ Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter, cleared 25 September
2014 |
| Device Description | The Sterling™ Monorail™ Percutaneous Transluminal Angioplasty
Balloon Dilatation Catheter (Sterling MR) 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. |
| Intended Use/
Indications for Use | 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. |
| Comparison of
Required
Technological
Characteristics | The proposed Sterling ME is substantially equivalent to the existing
Sterling ME cleared by FDA under premarket notification K141150
(25Sep2014). Sterling ME has the same intended use, scientific
technology, design (with the exception of the corewire design),
materials, sterilization method, and packaging materials as the
applicable predicate device. |
| Summary of Non-
Clinical Test
Summary | Bench testing and first article testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device with the
modified corewire 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 device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Sterling ME with the
modified corewire has been shown to be appropriate for its
intended use and is considered to be substantially equivalent to its
predicate (K141150). |
12
13
| Common or Usual
| Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
|---|---|
| Trade Name(s) | Sterling™ SL Monorail™ Percutaneous Transluminal Angioplasty |
| Balloon Dilatation Catheter | |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification of | |
| Device | Class II - 21 CFR 870.1250 |
| Submitter's Name | |
| and Address | Boston Scientific Corporation |
| One Scimed Place | |
| Maple Grove, MN 55311-1566 | |
| Contact Name and | |
| Information | Ka Zoua Xiong |
| Regulatory Affairs Specialist | |
| Phone: 763-494-2970 | |
| Fax: 763-494-2222 | |
| Email: Kazoua.Xiong@bsci.com | |
| Date Prepared | 06 October 2016 |
| Section 514 of the | |
| Act Performance | |
| Standards | Currently no FDA mandated or voluntary performance standards |
| exist for this device. | |
| Establishment | |
| Registration | |
| Numbers | Owner /Operator: Boston Scientific Corporation |
| 300 Boston Scientific Way | |
| Marlborough, MA 01752 | |
| ERN: 9912058 | |
| Manufacturing | |
| Facility: Boston Scientific Corporation | |
| Two Scimed Place | |
| Maple Grove, MN 55311 | |
| ERN: 2134265 | |
| Sterilization | |
| Facilities: BSC Coventry | |
| 8 Industrial Drive | |
| Coventry, RI 02816 | |
| USA |
Synergy Health (Tullamore)
IDA Business & Technology Park
Tullamore
County Offaly
Ireland |
| Predicate Devices | K093720- Sterling™ SL Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter, cleared 23 December 2009 |
14
| Device Description | The Sterling™ SL Monorail™ Percutaneous Transluminal
Angioplasty Balloon Dilatation Catheter (Sterling SL) is high
performance balloon catheter for peripheral vascular indications
featuring a low profile, semi-compliant balloon combined with a low
profile tip. They are a line extension to the existing Sterling
catheters and include smaller diameter and longer length balloons.
The catheters have 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" (0.36 mm) or 0.018" (0.46 mm) to facilitate
advancement of the catheter to and through the stenosis to be
dilated. |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The Sterling SL Monorail PTA Balloon Dilatation Catheter is
indicated for Percutaneous Transluminal Angioplasty (PTA) in the
peripheral vasculature, including iliac, femoral, ilio-femoral,
popliteal, infra-popliteal and renal arteries, and for the treatment of
obstructive lesions of native or synthetic arteriovenous dialysis
fistulae. |
| Comparison of
Required
Technological
Characteristics | The proposed Sterling SL is substantially equivalent to the existing
Sterling SL cleared by FDA under premarket notification K093720
(23Dec2009). Sterling SL has the same intended use, scientific
technology, design (with the exception of the corewire design),
materials, sterilization method, and packaging materials as the
applicable predicate device. |
| Summary of Non-
Clinical Test
Summary | Bench testing and first article testing were performed to support a
determination of substantial equivalence. The results of these tests
provide reasonable assurance that the proposed device with the
modified corewire 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 device testing. |
| Conclusion | Based on the indications for use, technological characteristics, and
safety and performance testing, the proposed Sterling SL with the
modified corewire has been shown to be appropriate for its
intended use and is considered to be substantially equivalent to its
predicate (K093720). |
15
| Common or Usual Name | Balloon Dilation Catheter | ||||||
|---|---|---|---|---|---|---|---|
| Trade Name(s) | Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter 0.018" | ||||||
| Product Code | DQY - Catheter, Percutaneous | ||||||
| Classification of Device | Class II - 21 CFR 870.1250 | ||||||
| Submitter's Name and Address | Boston Scientific Corporation | ||||||
| One Scimed Place | |||||||
| Maple Grove, MN 55311-1566 | |||||||
| Contact Name and Information | Ka Zoua Xiong | ||||||
| Regulatory Affairs Specialist | |||||||
| Phone: 763-494-2970 | |||||||
| Fax: 763-494-2222 | |||||||
| Email: Kazoua.Xiong@bsci.com | |||||||
| Date Prepared | 06 October 2016 | ||||||
| Section 514 of the Act Performance Standards | Currently no FDA mandated or voluntary performance | ||||||
| standards exist for this device. | |||||||
| Establishment Registration Numbers | Owner /Operator:Boston Scientific Corporation | ||||||
| 300 Boston Scientific Way | |||||||
| Marlborough, MA 01752 | |||||||
| ERN: 9912058Manufacturing Facility:Boston Scientific Corporation | |||||||
| Two Scimed Place | |||||||
| Maple Grove, MN 55311 | |||||||
| ERN: 2134265Sterilization Facilities:BSC Coventry | |||||||
| 8 Industrial Drive | |||||||
| Coventry, RI 02816 | |||||||
| USA | Owner /Operator: | Boston Scientific Corporation | |||||
| 300 Boston Scientific Way | |||||||
| Marlborough, MA 01752 | |||||||
| ERN: 9912058 | Manufacturing Facility: | Boston Scientific Corporation | |||||
| Two Scimed Place | |||||||
| Maple Grove, MN 55311 | |||||||
| ERN: 2134265 | Sterilization Facilities: | BSC Coventry | |||||
| 8 Industrial Drive | |||||||
| Coventry, RI 02816 | |||||||
| USA | |||||||
| Owner /Operator: | Boston Scientific Corporation | ||||||
| 300 Boston Scientific Way | |||||||
| Marlborough, MA 01752 | |||||||
| ERN: 9912058 | |||||||
| Manufacturing Facility: | Boston Scientific Corporation | ||||||
| Two Scimed Place | |||||||
| Maple Grove, MN 55311 | |||||||
| ERN: 2134265 | |||||||
| Sterilization Facilities: | BSC Coventry | ||||||
| 8 Industrial Drive | |||||||
| Coventry, RI 02816 | |||||||
| USA | |||||||
| Predicate Devices | K021735- Ultra-Soft SV™ Monorail™ Balloon Dilatation | ||||||
| Catheter 0.018", cleared 08 August 2002 |
16
| Device
Description | The Ultra-Soft SV™ Monorail™ Balloon Dilatation Catheter
0.018 is a sterile, single use, Monorail catheter with a semi-
compliant balloon near the distal tip which inflates to a known
diameter and length at a specific pressure. The catheter
consists of a double lumen at the distal end and a single
lumen catheter at the proximal end. The 0.018 in. guide wire
compatible balloon catheter is available in diameters of 4.0 -
7.0 mm in 1.5 and 2.0 cm balloon lengths. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The Ultra-soft SV Balloon Dilatation Catheter is recommended
for the 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. |
| Comparison of
Required
Technological
Characteristics | The proposed USSV MR is substantially equivalent to the
existing USSV MR cleared by FDA under premarket
notification K021735 (08Aug2002). USSV MR has the same
intended use, scientific technology, design (with the exception
of the corewire design), materials, sterilization method, and
packaging materials as the applicable predicate device. |
| Summary of
Non-Clinical Test
Summary | Bench testing and first article testing were performed to
support a determination of substantial equivalence. The
results of these tests provide reasonable assurance that the
proposed device with the modified corewire 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 device testing. |
| Conclusion | Based on the indications for use, technological characteristics,
and safety and performance testing, the proposed USSV MR
with the modified corewire has been shown to be appropriate
for its intended use and is considered to be substantially
equivalent to its predicate (K021735). |