(19 days)
Not Found
No
The device description focuses on mechanical components (balloon, atherotomes, lumens) and physical properties (pressure, size, materials). There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae, which is a therapeutic procedure to treat a medical condition.
No
The device is indicated for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to treat obstructive lesions, not to diagnose them.
No
The device description clearly details a physical catheter with a balloon, atherotomes (microsurgical blades), radiopaque markers, lumens, and a hypotube. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae." This is a therapeutic procedure performed directly on the patient's body to treat a physical condition.
- Device Description: The device is a balloon catheter with blades designed to physically interact with and modify tissue within a blood vessel. This is a surgical/interventional device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
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 Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
PNO
Device Description
The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. 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.
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 Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length (Table 1, p. 2).
The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.
The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
obstructive lesions of 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
Bench testing and biocompatibility testing support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use.
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 devices have 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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 Ms. Renuka S. Krishnan 3574 Ruffin Road San Diego, CA 92123
Re: K052038
Trade/Device Name: Peripheral Cutting Balloon Small Monorail Over-The-Wire Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 27, 2005 Received: July 28, 2005
Dear Ms. Krishnan:
This letter corrects our substantially equivalent letter of August 16, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
Page 2 - Ms. Renuka S. Krishnan
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
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Peripheral Cutting Balloon™: small Monorail and Over-the-Wire Delivery systems
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: 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)
Blumermon
Myles Sign Off
(Division Sign-Off) Division of Cardiovascular Deviges 510(k) Number KO5dD
Page 1 of 1
3
AUG i 6 2005
53
510(k) SUMMARY
Boston Scientific Corporation Submitter's Name and Address 3574 Ruffin Road San Diego, CA 92123 Renuka Krishnan Contact Person Principal Specialist, Regulatory Affairs (858)203-1812 PTA catheter Common or Usual Name LIT Product Code Classification Class II Peripheral Cutting Balloon: small Monorail Proprietary Names and Over-the-Wire Delivery Systems (PCB: small MR and OTW).
Predicate Devices
Boston Scientific small Peripheral Cutting Balloon; K051254 Boston Scientific 1 cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K051254 and K041993
Device Description
The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. 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.
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 Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length (Table 1, p. 2).
page 1 of 2
4
| Nom. Diameter (mm) | Over-the-Wire | Monorail |
|---|---|---|
| 2.00 | PCBO2015140F | PCBM2015140F |
| 2.50 | PCBO2515140F | PCBM2515140F |
| 3.00 | PCBO3015140F | PCBM3015140F |
| 3.50 | PCBO3515140F | PCBM3515140F |
| 4.00 | PCBO4015140F | PCBM4015140F |
Table 1. Model Numbers, PCB:small MR and OTW
- Catheter length: 140 cm.
The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.
The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.
Intended Use
The Peripheral Cutting Balloons are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.
Substantial Equivalence
The PCB: small MR and OTW 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 devices have been designed and tested to assure conformance to the requirements for its intended use.
Conclusion
The PCB: small MR and OTW have been shown to be Substantially Equivalent to the predicate devices.
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