(202 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 is used for pre-dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion, which is a therapeutic intervention.
No
This device is a therapeutic device (micro-dilatation catheter) used for pre-dilatation of stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion, not for diagnosing conditions.
No
The device description clearly states it is a physical medical device consisting of a catheter shaft and a balloon, and the performance studies involve bench testing and biocompatibility testing of physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for mechanical procedures (pre-dilatation, guidewire support, contrast injection) within the coronary arteries. IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details a catheter with a balloon designed for insertion into the body. This is consistent with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Threader Micro-Dilatation Catheter is an invasive medical device used for therapeutic and procedural purposes within the cardiovascular system, not an IVD.
N/A
Intended Use / Indications for Use
The Threader™ Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader™ Micro-Dilatation Catheters are intended to provide support to facilitate the placement of guidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader™ Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile, single-use, intravascular medical device. The catheter consists of a shaft with a semi-compliant balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter (1.2 mm) and length (12 mm) at recommended pressures. The Threader™ Micro-Dilatation Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW) platforms. There is a single radiopaque marker band located in the center of the balloon body to aid in positioning the system during the procedure. Coatings are applied to the balloon and catheter to enhance insertion and withdrawal performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries or bypass grafts, coronary vasculature
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)
The Threader™ Micro-Dilatation Catheter was subjected to testing according to the requirements of Guidance for Industry and FDA Staff – Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010. 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 and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and chemical characterization tests were completed on the Threader™ Micro-Dilatation Catheter:
Cytotoxicity Hemolysis (Direct Contact & Extract)
Sensitization Complement Activation
Intracutaneous Reactivity Coagulation
Acute Systemic Toxicity In Vitro Hemocompatibility
Materials Mediated Pyrogenicity USP Physicochemical
The following in-vitro performance tests were completed on the Threader™ Micro-Dilatation Catheter:
Effective Length Catheter Bond Strength
Shaft Inner and Outer Diameter Tip Pull Test
Balloon Crossing Profile Flexibility and Kink
Balloon Preparation, Deployment, Torque Strength
and Retraction
Withdrawal into a Guide Catheter Radiopacity
Balloon Rated Burst Pressure Coating Integrity
Balloon Fatigue (Repeat Inflations) Particulate Evaluation
Balloon Compliance Catheter Body Burst Pressure
Balloon Inflation/Deflation Time Contrast Media Flow Rate
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.
K130391, K102725, K111295, K083127
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
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
510(k) Summary
per 21 CFR §807.92
X134031 JIII 2 1 2014
| Submitter's
Name and
Address | Boston Scientific Corporation
Cardiovascular Division
One Scimed Place
Maple Grove, MN 55311
Phone: 763-494-1700
Fax: 763-494-2222 | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------|
| Contact Name
and
Information | Vicky L. Hagens
Principal Regulatory Affairs Specialist
Phone: 763-494-1522
Fax: 763-494-2222
e-mail: vicky.hagens@bsci.com | | |
| Date Prepared | January 27, 2014 | | |
| Proprietary
Name(s) | Threader™ Monorail ™ Micro-Dilatation Catheter
Threader™ Over-The-Wire Micro-Dilatation Catheter | | |
| Common Name | Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation
Catheter | | |
| Product Code | LOX | | |
| Classification | Class II, 21 CFR Part 870.5100 | | |
| Predicate
Devices | Emerge™ PTCA Dilatation
Catheter (1.20 mm) | K130391 | July 10, 2013 |
| | CrossBoss™ Catheter | K102725 | May 10, 2011 |
| | Coyote™ PTA Balloon Dilatation
Catheter | K111295 | May 31, 2011 |
| | Asahi Corsair Microcatheter | K083127 | February 3, 2009 |
| Device
Description | The Boston Scientific Threader ™ Micro-Dilatation Catheter is a sterile,
single-use, intravascular medical device. The catheter consists of a shaft
with a semi-compliant balloon near the distal tip. The balloon is designed
to provide an inflatable segment of known diameter (1.2 mm) and length
(12 mm) at recommended pressures. The Threader™ Micro-Dilatation
Catheter is offered in both Monorail (MR) and Over-The-Wire (OTW)
platforms. There is a single radiopaque marker band located in the center
of the balloon body to aid in positioning the system during the procedure.
Coatings are applied to the balloon and catheter to enhance insertion and
withdrawal performance. | | |
| Intended Use
of Device | The Threader™ Micro-Dilatation Catheter is intended for dilatation of
stenosis in coronary arteries or bypass grafts. | | |
510(k) Summary . Threader™ Micro-Dilatation Catheter
.
:
1
| Indications for Use | The Threader™ Micro-Dilatation Catheters are indicated for pre-dilatation
of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70%
stenosis) for the purpose of improving myocardial perfusion.
The Threader™ Micro-Dilatation Catheters are intended to provide
support to facilitate the placement of guidewires in the coronary
vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can
also be used to exchange one guidewire for another.
The Threader™ Over-The-Wire Micro-Dilatation Catheter is also intended
to allow hand-injection of contrast media into the coronary vasculature. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
Characteristics | The Threader™ Micro-Dilatation Catheter incorporates substantially
equivalent device materials and design, packaging materials and design,
fundamental technology, manufacturing processes, sterilization process
and intended use as those featured in the predicate devices: Emerge™
PTCA Dilatation Catheter (1.20 mm), K130391 (cleared July 10, 2013);
CrossBoss™ Catheter, K102725 (cleared May 10, 2011); Coyote™ PTA
Dilatation Catheter, K111295 (cleared May 31, 2011); and Asahi Corsair
Microcatheter, K083127 (cleared February 3, 2009). |
| Performance
Data | The Threader™ Micro-Dilatation Catheter was subjected to testing
according to the requirements of Guidance for Industry and FDA Staff –
Class II Special Controls for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters, September 8, 2010. 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 and,
therefore, these devices may be considered substantially equivalent to the
predicate devices.
The following biocompatibility and chemical characterization tests were
completed on the Threader™ Micro-Dilatation Catheter:
|
| | Cytotoxicity Hemolysis (Direct Contact & Extract)
Sensitization Complement Activation
Intracutaneous Reactivity Coagulation
Acute Systemic Toxicity In Vitro Hemocompatibility
Materials Mediated Pyrogenicity USP Physicochemical |
| | The following in-vitro performance tests were completed on the
Threader™ Micro-Dilatation Catheter:
|
| | Effective Length Catheter Bond Strength
Shaft Inner and Outer Diameter Tip Pull Test
Balloon Crossing Profile Flexibility and Kink
Balloon Preparation, Deployment, Torque Strength
and Retraction
Withdrawal into a Guide Catheter Radiopacity
Balloon Rated Burst Pressure Coating Integrity
Balloon Fatigue (Repeat Inflations) Particulate Evaluation
Balloon Compliance Catheter Body Burst Pressure
Balloon Inflation/Deflation Time Contrast Media Flow Rate |
2
Conclusion
1
:
. .
Based on the indications for use, technological characteristics, and safety and performance testing, the Threader™ Micro-Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.
510(k) Summary Threader™ Micro-Dilatation Catheter
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MI) 20993-0002
July 21, 2014
Boston Scientific Corporation Ms. Vicky Hagens Principal Regulatory Affairs Specialist One Scimed Place Maple Grove. Minnesota 55311
Re: K 134031
Trade/Device Name: Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: June 16, 2014 Received: June 17, 2014
Dear Ms. Hagens.
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. Ilisting 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
4
Page 2 - Ms. Vicky Hagens
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 device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
M.A. Hillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K134031
Device Name: Threader™ Monorail™ Micro-Dilatation Catheter Threader™ Over-The-Wire Micro-Dilatation Catheter
Indications for Use:
The Threader Micro-Dilatation Catheters are indicated for pre-dilatation of the stenotic portion of a coronary artery or bypass graft stenosis (≥ 70% stenosis) for the purpose of improving myocardial perfusion.
The Threader Micro-Dilatation Catheters are intended to provide support to facilitate the placement of quidewires in the coronary vasculature. The Threader Over-The-Wire Micro-Dilatation Catheter can also be used to exchange one guidewire for another.
The Threader Over-The-Wire Micro-Dilatation Catheter is also intended to allow hand-injection of contrast media into the coronary 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. G. Hillemann