(51 days)
Not Found
No
The device description focuses on mechanical features (balloon, atherotomes) and a physical mechanism of action (scoring plaque). There is no mention of software, algorithms, data processing, or terms related to AI/ML.
Yes
The device is indicated for percutaneous transluminal angioplasty, which is a therapeutic procedure to treat obstructive lesions.
No
The device is described as a treatment device (percutaneous transluminal angioplasty, dilatation of lesions). It does not gather information about the patient's health or disease state.
No
The device description clearly describes a physical catheter with a balloon and microsurgical blades, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a catheter used for percutaneous transluminal angioplasty. This is a procedure performed within the body to open narrowed blood vessels. It is a therapeutic device, not a diagnostic test performed on a sample outside the body.
The device's function is to physically modify a lesion within a blood vessel, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Product codes
PNO, LIT
Device Description
The small Peripheral Cutting Balloon Catheter (PCB) with Monorail (MR) delivery system has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The sPCB features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
My 31, 2016
Boston Scientific Corporation c/o Mr. Joseph Ostendorf Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K062387
Small Peripheral Cutting Balloon Monorail Delivery System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: PNO Dated: September 25, 2006 Received: September 26, 2006
Dear Mr. Ostendorf:
This letter corrects our substantially equivalent letter of October 5, 2006.
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
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Page 2 - Mr. Joseph Ostendorf
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
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Boston Scientific Corporation
100 - 100 - 11 - 12 - 12 - 12 - 12 -
- Indications for Use Statement
510(k) Number:
Device Name: System
small Peripheral Cutting Balloon with Monorail Delivery
Indications for Use:
The Small Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Prescription Use × (part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Jachus
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ko 6238 7
Page 1 of _l
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Boston Scientific Corporation
5. 510(k) Summary
| Submitter's Name
and Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Angie Byland
Regulatory Affairs Manager
Phone: (763) 494-2887
Fax: (763) 494-2981 |
| Date Prepared | August 14, 2006 |
| Proprietary
Name(s) | Small Peripheral Cutting Balloon™ |
| Common Name | PTA Catheter |
| Product Code | LIT |
| Classification of
Device | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Small Peripheral Cutting Balloon™
with Monorail
Delivery System
K052038 August 16, 2005 |
| Device
Description | The small Peripheral Cutting Balloon Catheter (PCB) with
Monorail (MR) delivery system has features of a
conventional angioplasty catheter with advanced
microsurgical capabilities. The sPCB features a balloon
with 3 or 4 atherotomes (microsurgical blades) mounted
longitudinally on its outer surface. The device is inserted
over a guidewire and delivered to the target lesion. When
the PCB device is inflated, the atherotomes score the
plaque, creating initiation sites for crack propagation.
Percutaneous Angioplasty (PTA) with the PCB device
allows dilatation of the target lesion with less pressure,
minimizing barotrauma. |
| Intended Use of
Device | The small Peripheral Cutting Balloon catheters are indicated
for percutaneous transluminal angioplasty of obstructive
lesions of synthetic or native arteriovenous dialysis fistulae. |
| Support of
Substantial
Equivalence | The small Peripheral Cutting Balloon Catheter with Monorail
delivery system with the modified port weld is the same
indication, design, composition, and function as the
Peripheral Cutting Balloon Catheter, small Monorail
(K052038), cleared August 16, 2005. |
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Boston Scientific Corporation
| Conclusion | Based on the indications for use and the technological
characteristics, the small Peripheral Cutting Balloon with
Monorail delivery system has been shown to be equivalent
in intended use and is considered to be substantially
equivalent to the Small Peripheral Cutting BalloonTM with
Monorail delivery system (K052038, cleared June 22,
2005). |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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