(37 days)
Not Found
No
The device description focuses on mechanical features (balloon, atherotomes, lumens, coatings) and performance is evaluated through bench and biocompatibility testing, with no mention of AI/ML algorithms or data processing.
Yes
The device is used for percutaneous transluminal angioplasty of obstructive lesions in arteriovenous dialysis fistulae, which is a therapeutic intervention.
No
This device is a therapeutic device designed for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, not to diagnose them. It actively modifies the lesion using microsurgical blades and balloon expansion.
No
The device description clearly details a physical catheter with a balloon, atherotomes (blades), lumens, and radiopaque markers. It is a hardware device used for angioplasty.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae." This describes a surgical procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The device is a catheter with a balloon and blades designed to be inserted into a blood vessel and physically modify the lesion. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVD devices are used to perform tests on samples taken from the body.
Therefore, the Peripheral Cutting Balloon™ catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous The I cripicial Culting Danoon - Sective lesions of synthetic or native arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
PNO, LIT
Device Description
The Peripheral Cutting Balloon™ (PCB) has the features of a conventional angioplasty catheter, with advanced microsurgical capabilities. The PCB features a non-compliant balloon with three or four atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. Upon inflation, the atherotomes score the plaque as the balloon expands and pushes the plaque radially. The scores serve as notches for stress concentration and allow dilatation at lower pressures, minimizing barotrauma.
Three of the PCB devices (1 cm, 2 cm and sPCB OTW) are offerred in Over-the-Wire delivery configuration, the sPCB is also available in Monorail configuration. The OTW devices are attached to a Y-connector at one end, the sPCB MR is attached to a female luer. The OTW catheters feature a co-axial shaft consisting of an inflation lumen and a guidewire lumen; the sPCB MR features a proximal shaft using a single lumen hypotube, which is attached to a coaxial distal section consisting of an inflation and guidewire lumen. The guidewire exit port for the sPCB MR is 24 cm from the catheter tip.
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 sPCB devices are coated with Bioslide at the distal section, the 1 cm and 2 cm PCB are coated with MDX 4-4159.
The Rated Burst Pressure (RBP) for all devices is 10 atm. The devices are available in nominal balloon diameters from 2.0 mm to 8.0 mm and blade lengths of 1 cm to 2 cm (Tables 1-2).
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)
Bench testing and biocompatibility testing 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.
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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with its wings spread, rendered in thick, black lines. The bird is positioned within a circular border. Encircling the bird and within the border are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Boston Scientific IVT c/o Ms. Renuka S. Krishnan Principal Specialist, Regulatory Affairs 3574 Ruffin Road San Diego, CA 92123
Re: K051254
Peripheral Cutting Balloon™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: May 13, 2005 Received: May 16, 2005
Dear Ms. Krishnan:
This letter corrects our substantially equivalent letter of June 22, 2005.
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. Renuka S. Krishnan
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/Resourcesfor You/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
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Peripheral Cutting Balloon™
Indications For Use:
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous The I cripicial Culting Danoon - Sective lesions of synthetic or native arteriovenous dialysis fistulae.
Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: No (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)
Donna R. Vaclunes
(Division Sign-Off) (Division Sign-On)
Division oi Cardiovascular Devices
510(k) Number Kestis 20
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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K051254
0. 1 of 3
JUN 2 2 2005
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510(k) SUMMARY
| Submitter's Name and Address | Boston Scientific Corporation
3574 Ruffin Road
San Diego, CA 92123 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Renuka Krishnan
Principal Specialist, Regulatory Affairs
(858)503-1815 |
| Common or Usual Name | PTA catheter |
| Product Code | LIT |
| Classification | Class II |
| Proprietary Names | 1 cm Peripheral Cutting Balloon™ 2 cm Peripheral Cutting Balloon™ small Peripheral Cutting Balloon™
Over-the -wire delivery system small Peripheral Cutting Balloon™
Monorail delivery system |
Predicate Devices
Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath™ Peripheral Balloon Catheter system, K030742 CVSi Peripheral Balloon Catheter system, K022061
Device Description
The Peripheral Cutting Balloon™ (PCB) has the features of a conventional angioplasty catheter, with advanced microsurgical capabilities. The PCB features a non-compliant balloon with three or four atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The device is inserted over a guidewire and delivered to the target lesion. Upon inflation, the atherotomes score the plaque as the balloon expands and pushes the plaque radially. The scores serve as notches for stress concentration and allow dilatation at lower pressures, minimizing barotrauma.
Three of the PCB devices (1 cm, 2 cm and sPCB OTW) are offerred in Over-the-Wire delivery configuration, the sPCB is also available in Monorail configuration. The OTW devices are attached to a Y-connector at one end, the sPCB MR is attached to a female luer. The OTW catheters feature a co-axial shaft consisting of an inflation lumen and a guidewire lumen; the sPCB MR features a proximal shaft using a single lumen hypotube, which is attached to a coaxial distal section consisting of an inflation and guidewire lumen. The guidewire exit port for the sPCB MR is 24 cm from the catheter tip.
4
| Device | Nom. Diameter | Catheter Length | ||
|---|---|---|---|---|
| 50 cms | 90 cms | 135 cms | ||
| 1 cm PCB | 5.0 mm | BP505010 | BP905010 | BP1355010 |
| 5.5 mm | BP505510 | BP905510 | BP1355510 | |
| 6.0 mm | BP506010 | BP906010 | BP1356010 | |
| 7.0 mm | BP507010 | BP907010 | BP1357010 | |
| 8.0 mm | BP508010 | BP908010 | BP1358010 | |
| 2 cm PCB | 5.0 mm | PCB502050 | PCB502090 | PCB5020135 |
| 6.0 mm | PCB602050 | PCB602090 | PCB6020135 | |
| 7.0 mm | PCB702050 | PCB702090 | PCB7020135 | |
| 8.0 mm | PCB802050 | PCB802090 | PCB8020135 |
Table 1. Model Numbers, 1 cm and 2 cm PCB
Table 2. Model Numbers, sPCB*
| Nom. Diameter (mm) | Over-the-Wire | Monorail |
|---|---|---|
| 2.00 | PCBO2015140 | PCBM2015140 |
| 2.50 | PCBO2515140 | PCBM2515140 |
| 3.00 | PCBO3015140 | PCBM3015140 |
| 3.50 | PCBO3515140 | PCBM3515140 |
| 4.00 | PCBO4015140 | PCBM4015140 |
- Catheter length: 140 cm; blade length: 1.5 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 sPCB devices are coated with Bioslide at the distal section, the 1 cm and 2 cm PCB are coated with MDX 4-4159.
The Rated Burst Pressure (RBP) for all devices is 10 atm. The devices are available in nominal balloon diameters from 2.0 mm to 8.0 mm and blade lengths of 1 cm to 2 cm (Tables 1-2).
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5
Intended Use
The Peripheral Cutting Balloon catheters are recommended for Percutaneous Transluminal Angioplasty of obstructive lesions in synthetic or native arteriovenous dialysis fistulac.
Substantial Equivalence
The Peripheral Cutting Balloon catheters will incorporate a substantially equivalent design, fundamental technology and intended use as those featured in predicate devices.
Performance Testing
Bench testing and biocompatibility testing 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.
Conclusion
The Peripheral Cutting Balloon catheters have been shown to be Substantially Equivalent to the predicate devices.
200