(24 days)
Not Found
No
The device description focuses on mechanical components and does not mention any software, algorithms, or data processing related to AI/ML.
Yes.
The device is used for percutaneous transluminal angioplasty of obstructive lesions in synthetic arteriovenous dialysis fistulae, which is a therapeutic intervention aimed at treating a medical condition.
No
The device description clearly states its purpose as "Percutaneous Transluminal Angioplasty of obstructive lesions," which is a treatment procedure, not a diagnostic one. It uses blades to cut and balloons to dilate, indicating an interventional rather than a diagnostic function.
No
The device description clearly details a physical catheter with a balloon, blades, lumens, and radiopaque markers, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Peripheral Cutting Balloon catheter is a device used inside the body (in vivo) to physically treat obstructive lesions in synthetic arteriovenous dialysis fistulae. It uses a balloon and blades to open up narrowed vessels.
- Intended Use: The intended use clearly states "Percutaneous Transluminal Angioplasty," which is a procedure performed directly on the patient's blood vessels.
The description and intended use of this device clearly indicate it is an interventional medical device used for treatment within the body, not for diagnostic testing of samples 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 arteriovenous dialysis fistulae.
Product codes
PNO, LIT
Device Description
The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
synthetic 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
Bench testing and biocompatibility testing were 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.
Key Metrics
Not Found
Predicate Device(s)
K040155, K960501, K030742, K022061
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
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 Principal Specialist, Regulatory Affairs 3574 Ruffin Road San Diego. CA 92123
Re: K041993
2 cm Peripheral Cutting Balloon™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 22, 2004 Received: July 23, 2004
Dear Ms. Krishnan:
This letter corrects our substantially equivalent letter of August 16, 2004.
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
K041993 510(k) Number (if known):
Device Name:
2 cm Peripheral Cutting Balloon™
Indications For Use:
The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic 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)
DANA R. Richards
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number K041993
Page 1 of 1
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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 Name | 2 cm Peripheral Cutting Balloon™ |
Predicate Devices
Boston Scientific 1 cm Peripheral Cutting Balloon 114, K040155 Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath ™ Peripheral Balloon Catheter system, K030742 CVSi Peripheral Balloon Catheter system, K022061
Device Description
The 2 cm Pcripheral Cutting Balloon (2 cm PCB) is a product line extension to the 1 cm Peripheral Cutting Balloon, and uses longer balloons to support 2 cm blades. It is available in nominal balloon diameters of 5.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The catheter body has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire. Radionaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. One end of the catheter is attached to a Y-connector, the other end is attached to the balloon. The Rated Burst Pressure (RBP) of the device is 10 atm. The device is compatible with 0.018" guide wire.
| Nom. Diameter (mm) | Catheter Length | ||
|---|---|---|---|
| 50 cms | 90 cms | 135 cms | |
| 5.0 | PCB502050 | PCB502090 | PCB5020135 |
| 6.0 | PCB602050 | PCB602090 | PCB6020135 |
| 7.0 | PCB702050 | PCB702090 | PCB7020135 |
| 8.0 | PCB802050 | PCB802090 | PCB8020135 |
Table 1. Model Numbers, 2 cm PCB
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Intended Use
The 2 cm Peripheral Cutting Balloon catheters are recommended for Percutaneous Transluminal Angioplasty of obstructive lesions in synthetic arteriovenous dialysis fistulae.
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 were 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.
Conclusion
The 2 cm Peripheral Cutting Balloon catheter has been shown to be Substantially Equivalent to the predicate devices.