(29 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions, which is a medical procedure intended to treat a health condition.
No
Explanation: The device is a cutting balloon catheter used for angioplasty, which is a therapeutic procedure to treat obstructive lesions. Its purpose is to open blocked vessels, not to diagnose conditions.
No
The device description clearly details a physical catheter with a balloon, lumens, and coatings, indicating it is a hardware medical device, not software-only.
No, 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. This testing is performed outside of the body (in vitro).
- Device Function: The Peripheral Cutting Balloon catheter is a medical device used inside the body (in vivo) during a procedure (Percutaneous Transluminal Angioplasty). It physically interacts with the patient's anatomy to treat a condition.
- Intended Use: The intended use clearly states it's for "Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions." This is a therapeutic procedure, not a diagnostic test performed on a specimen.
- Device Description: The description details a catheter with a balloon and guidewire, designed for insertion into blood vessels. This is consistent with an interventional device, not an IVD.
The device is a therapeutic medical device used for angioplasty, not a diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Peripheral Cutting Balloon catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lessions of synthetic or native arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
PNO, LIT
Device Description
The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and intended for single use in a radiology suite/catheterization laboratory/operating room in conjunction with radiologic equipment for fluoroscopic imaging. The device consists of a double-lumen catheter with a non-compliant balloon attached at the distal tip. One of the lumens connects the Y-Adaptor to the proximal end of the outer shaft and the other connects the Y-Adaptor wire port extending from the wire lumen to the distal end of the balloon. The outer lumen is the balloon inflation lumen and is used to inflate and deflate the balloon during the procedure. The inner lumen is used to pass the catheter over a guidewire. The product is intended to pass a 0.018" (0.46 mm) guidewire. The catheter useable length (effective length) is measured from the distal end of the strain relief to the tip and is available in three sizes - 50 cm, 90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The device is coated with MDX 4-4159 silicone coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
synthetic or native arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiology suite/catheterization laboratory/operating room
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 was 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 in-vitro performance tests were completed: Balloon Compliance, Freedom from Leakage, Balloon Rated Burst Pressure, Blade Attach, Balloon Multiple Inflation, Guide Catheter Compatibility, Balloon Deflation Time, Particulate Release, Introducer Sheath Compatibility, Bond Strength, Crossing Profile. The following biocompatibility tests were completed: In Vitro Cytotoxicity, Direct Contact Hemolysis, Guinea Pig Maximization Sensitization, Complement Activation C3a and SC5b-9 Assay, Intracutaneous Reactivity, Indirect Extract Hemolysis, Acute Systemic Injection, Partial Thromboplastin Time, Materials Mediated Rabbit Pyrogen, In Vitro Hemocompatibility, Ames Mutagenicity, USP Physicochemical, Mouse Lymphoma Assay, Natural Rubber Latex.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Boston Scientific Limited Ms. Lisa Mee Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K151253
Trade/Device Name: 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: May 8, 2015 Received: May 12, 2015
Dear Ms. Mee,
This letter corrects our substantially equivalent letter of June 10, 2015.
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 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
1
Page 2 - Ms. Lisa Mee
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 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/ResourcesforYou/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,
Misti L. Malone -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151253
Device Name
2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter
Indications for Use (Describe)
The Peripheral Cutting Balloon catheters are indicated for Perculaneous Transluminal Angioplasty (PTA) of obstructive lessions of synthetic or native 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510k 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 | Lisa Mee
Senior Specialist, Regulatory Affairs
Phone: +353 91 406184
Fax: 763-494-2222
e-mail: Meel@bsci.com
Or
Melissa Sommerfeld
Principal Specialist, Regulatory Affairs
Phone : 763-494-1219
Fax: 763-494-2222
e-mail: Melissa.Sommerfeld@bsci.com |
| Date Prepared | 8 May 2015 |
| Proprietary
Name | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter |
| Common Name | Percutaneous Transluminal Angioplasty Dilatation Catheter |
| Product Code | LIT - Catheter, Angioplasty, Peripheral, Transluminal |
| Classification | Class II, 21 CFR Part 870.1250 |
| Predicate
Device(s) | 2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K041993 Aug 16, 2004
2cm Peripheral Cutting Balloon® Microsurgical Dilatation Catheter K070951 June 04, 2007 |
| Device
Description | The 2cm PCB is an Over-The-Wire (OTW) catheter packaged as sterile and
intended for single use in a radiology suite/catheterization laboratory/operating
room in conjunction with radiologic equipment for fluoroscopic imaging.
The device consists of a double-lumen catheter with a non-compliant balloon
attached at the distal tip. One of the lumens connects the Y-Adaptor to the
proximal end of the outer shaft and the other connects the Y-Adaptor wire port
extending from the wire lumen to the distal end of the balloon. The outer
lumen is the balloon inflation lumen and is used to inflate and deflate the
balloon during the procedure. The inner lumen is used to pass the catheter
over a guidewire. The product is intended to pass a 0.018" (0.46 mm)
guidewire. The catheter useable length (effective length) is measured from the
distal end of the strain relief to the tip and is available in three sizes - 50 cm,
90 cm and 135 cm. Radiopaque markers are placed on the guidewire tubing
at the ends of the atherotomes to provide visual reference points for balloon
positioning within the vessel. The device is coated with MDX 4-4159 silicone
coating. |
| Intended Use of
Device | The Peripheral Cutting Balloon catheters are indicated for Percutaneous
Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native
arteriovenous dialysis fistulae. |
4
| Indications for Use | The Peripheral Cutting Balloon catheters are indicated for Percutaneous
Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native
arteriovenous dialysis fistulae | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--|
| Comparison of
Technological
Characteristics | The 2cm PCB incorporates substantially equivalent device materials, design,
packaging, catheter configuration, fundamental technology, manufacturing
processes, sterilization process, and intended use/indication for use as those
in the Boston Scientific predicate devices, K041993 and K070951. | | |
| Performance
Data | Bench testing was 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 in-vitro
performance tests were completed: | | |
| | Balloon Compliance | Freedom from Leakage | |
| | Balloon Rated Burst Pressure | Blade Attach | |
| | Balloon Multiple Inflation | Guide Catheter Compatibility | |
| | Balloon Deflation Time | Particulate Release | |
| | Introducer Sheath Compatibility | | |
| | Bond Strength | | |
| | Crossing Profile | | |
| | The following biocompatibility tests were completed: | | |
| | In Vitro Cytotoxicity | Direct Contact Hemolysis | |
| | Guinea Pig Maximization
Sensitization | Complement Activation C3a and
SC5b-9 Assay | |
| | Intracutaneous Reactivity | Indirect Extract Hemolysis | |
| | Acute Systemic Injection | Partial Thromboplastin Time | |
| | Materials Mediated Rabbit Pyrogen | In Vitro Hemocompatibility | |
| | Ames Mutagenicity | USP Physicochemical | |
| | Mouse Lymphoma Assay | Natural Rubber Latex | |
| Conclusion | Based on the indications for use, technological characteristics, and safety and
performance testing, the proposed 2cm PCB Dilatation Catheter has been
shown to be appropriate for its intended use and is considered to be
substantially equivalent to the Boston Scientific predicate 2cm PCB Dilatation
Catheter. | | |