(61 days)
Not Found
No
The device description focuses on mechanical features (balloon, atherotomes) and the mechanism of action (scoring plaque). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used for "percutaneous transluminal angioplasty of obstructive lesions," which is a therapeutic intervention designed to treat a medical condition (obstructive lesions).
No
The device is described as an angioplasty catheter used for treating obstructive lesions by scoring and dilating plaque, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter with a balloon and microsurgical blades, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices 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 done outside of the body (in vitro).
- Device Description: The Peripheral Cutting Balloon catheter is a physical device inserted into the body (in vivo) to perform a therapeutic procedure (angioplasty) on blood vessels. It directly interacts with the anatomical site.
- Intended Use: The intended use is for percutaneous transluminal angioplasty, which is a medical procedure performed on a patient, not a laboratory test on a specimen.
The information provided clearly describes a medical device used for a therapeutic intervention within the body, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Peripheral Cutting Balloon catheters are indicated for percutaneous transluminal angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
PNO, LIT
Device Description
The family of Peripheral Cutting Balloon (PCB) Catheters has features of a conventional angioplasty catheter with advanced microsurgical capabilities. The PCB family 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K041993, K051254, K052038, K062387
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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Boston Scientific Corporation c/o Mr. Brian Park Principal Regulatory Affairs Specialist 3574 Ruffin Road San Diego, CA 92123
Re: K070951
Trade/Device Name: Peripheral Cutting Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: April 3, 2007 Received: April 4, 2007
Dear Mr. Park:
This letter corrects our substantially equivalent letter of June 4, 2007.
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
Page 2 - Mr. Brian Park
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
ll. INDICATIONS FOR USE STATEMENT
Kozo95) 510(k) Number:
Device Names: 2cm Peripheral Cutting Balloon® small Peripheral Cutting Balloon® with Monorail Delivery System small Peripheral Cutting Balloon® with Over-the-Wire Delivery System
Indications for Use:
The 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)
L
(Division of Cardio)
Division of Cardiovasc
510(k) Number K070695
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
3
510(k) SUMMARY lll.
JUN -- 4 2007
| Submitter's Name
and Address | Boston Scientific Corporation
3574 Ruffin Road
San Diego, CA 92123 | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------------|-----------------|
| Contact Name and
Information | Brian Park
Principal Regulatory Affairs Specialist
Phone: (858) 503-1822
Fax: (858) 292-8381 | | | |
| Date Prepared | April 3, 2007 | | | |
| Proprietary
Names | 2cm Peripheral Cutting Balloon®
small Peripheral Cutting Balloon® with Monorail Delivery System
small Peripheral Cutting Balloon® with Over-the-Wire Delivery System | | | |
| Common Name | PTA Catheter | | | |
| Product Code | LIT | | | |
| Classification of
Device | Class II, 21 CFR Part 870.1250 | | | |
| Predicate Device | 2cm Peripheral Cutting
Balloon® | K041993
K051254 | August 16, 2004
June 22, 2005 | |
| | Small Peripheral Cutting
Balloon® with Monorail Delivery
System | K052038
K062387 | August 16, 2005
October 5, 2006 | |
| | Small Peripheral Cutting
Balloon® with Over-the-Wire
Delivery System | K052038 | August 16, 2005 | |
| Device
Description | The family of Peripheral Cutting Balloon (PCB) Catheters has
features of a conventional angioplasty catheter with advanced
microsurgical capabilities. The PCB family 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 | PCB catheters are indicated for percutaneous transluminal
angioplasty of obstructive lesions of synthetic or native
arteriovenous dialysis fistulae. | | | |
| Support of
Substantial
Equivalence | There are no changes in design, composition, function or indication
of any of the proposed PCB devices compared to their respective
predicates: | | | |
| | Proposed Device | Predicate Device | 510(k) | Clearance Date |
| | 2cm PCB | 2cm PCB | K041993 | August 16, 2004 |
| | | | K051254 | June 22, 2005 |
| | small PCB with
Monorail Delivery
System | small PCB with
Monorail Delivery
System | K052038 | August 16, 2005 |
| | | | K062387 | October 5, 2006 |
| | small PCB with
OTW Delivery
System | small PCB with
OTW Delivery
System | K052038 | August 16, 2005 |
| | The only change being proposed is adding a new contraindication
and a new warning in the DFU. | | | |
| Conclusion | Based on the indications for use and the technological
characteristics, the PCB has been shown to be equivalent in
intended use and is considered to be substantially equivalent to
their respective predicate PCBs (K041993, cleared August 16,
2004; K051254, cleared June 22, 2005; K052038, cleared August
16, 2005; and K062387, cleared October 5, 2006.) | | | |
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