(160 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of the balloon catheter and its clinical outcomes compared to conventional angioplasty, with no mention of AI or ML.
Yes
The device is indicated for Percutaneous Transluminal Angioplasty of obstructive lesions, which is a therapeutic procedure designed to treat a medical condition.
No
Explanation: The device, a Peripheral Cutting Balloon, is indicated for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to treat obstructive lesions. It features microsurgical blades to modify the lesion. It does not perform any diagnostic function such as detecting, monitoring, or identifying the disease.
No
The device description clearly details a physical catheter with a balloon, atherotomes (blades), a stainless folding spring, and lumens, indicating it is a hardware device.
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 arteriovenous dialysis fistulae." This describes a surgical procedure performed directly on a patient's body to treat a physical obstruction.
- Device Description: The description details a physical catheter with a balloon and blades designed for mechanical intervention within a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic procedure.
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 (comma separated list FDA assigned to the subject device)
PNO, LIT
Device Description
The Peripheral Cutting Balloon (PCB) is available in nominal balloon diameters of 5.0 mm to 8.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The proximal end of the balloon is equipped with a stainless folding spring to enhance balloon refold. The spring consists of a collar, proximal to the balloon cone; and four fingers that extend across the balloon cone and terminate before the pads that hold the atherolomes to the surface of the balloon. 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. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The 1 cm Peripheral Cutting Balloon™ was studied in a prospectively randomized clinical trial, Cutting EDGE (CUTTING Balloon HEmoDialysis Access ManaGEment Trial) that compared the Peripheral Cutting Balloon to conventional angioplasty (PTA) in the treatment of stenosed or thrombosed synthetic hemodialysis grafts. The study enrolled 340 patients, 173 in the Peripheral Cutting Balloon arm and 167 in the PTA arm at 27 centers in the US. The primary endpoint was primary patency through 6 months post-procedure. Secondary efficacy endpoints included: access circuit primary patency; procedural success; and the number of target lesion reinterventions through 6 months. Secondary endpoints also included safety: occurrence of adverse events. Adverse events were adjudicated by a CEC; a DSMB reviewed safety information throughout the enrollment portion of the study.
The Peripheral Cutting Balloon is not signficantly different from PTA with respect to the rate of target lesion primary patency through 6 months post-proccdure: 47.9% pcs vs. 40.5% PTA.D=0.37.
The target lesion primary patency rates for subjects with stenosed grafts were not significantly different: 51.3% Kir vs. 46.9% PTA . p = 0.84.
The PCB target lesion primary patency for thrombosed grafts was greater but not significant: 43.1% PCB vs. 32.0% PTA, p = 0.15.
Sccondary efficacy endpoints did not differ significantly between treatments: procedural success, p = 0.24; hemodialysis access circuit patency at 6-months, p = 0.45; mean number of target lesion reinterventions through 6 months, n = 0.22. Subjects with thrombosed grafts had fewer target lesion interventions after treatment with the Peripheral Cutting Balloon; the difference between means is marginally significant: 0.7 pcu vs. 1.0 pra, p = 0.06.
Device-related events, limited to dissections and perforations, were significantly more frequent in the Peripheral Cutting Balloon arm: 1.7% (3/173) dissections and 2.9% (5/173) perforations after use of the Peripheral Cutting Balloon vs. no events in the PTA arm (p = 0.007). When the dissection and perforation rates are considered independently, rather than pooled, the rates are not significantly different. Two of the cases (one perforation and one dissection) are protocol deviations because the Peripheral Cutting Balloon was oversized beyond the limits specified in the Directions for Use. The Peripheral Cutting Balloon perforation rate of 2.9% falls within this expected range.
Only PTA balloons were used for reinterventions; 213 reinterventions were recorded during the trial. Among these reintervention procedures, there were two procedurerelated vessel ruptures and two device-related perforations.
In summary, the Peripheral Cutting Balloon™ is not significantly different from conventional angioplasty in overall safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Primary Patency:
- Target lesion primary patency at 6 months, PCB vs. PTA: 47.9% vs. 40.5%, p=0.37
- Target lesion primary patency for stenosed grafts, PCB vs. PTA: 51.3% vs. 46.9%, p=0.84
- Target lesion primary patency for thrombosed grafts, PCB vs. PTA: 43.1% vs. 32.0%, p=0.15
Secondary Efficacy Endpoints:
- Procedural success: p=0.24
- Hemodialysis access circuit patency at 6-months: p=0.45
- Mean number of target lesion reinterventions through 6 months: n=0.22
- For thrombosed grafts, mean number of target lesion interventions, PCB vs. PTA: 0.7 vs. 1.0, p=0.06
Safety:
- Device-related dissections: 1.7% (3/173) in PCB arm vs. 0% in PTA arm
- Device-related perforations: 2.9% (5/173) in PCB arm vs. 0% in PTA arm
- Combined dissection and perforation rate: p=0.007
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 features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
Boston Scientific Corporation Ms. Renuka S. Krishnan Principal Specialist, Regulatory Affairs 3574 Ruffin Road San Diego, CA 92123
Re: K040155
Peripheral Cutting Balloon Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: April 28, 2004 Received: April 29, 2004
Dear Ms. Krishnan:
This letter corrects our substantially equivalent letter of July 1, 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/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): K040155
Device Name:
Peripheral Cutting Balloon"M
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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K040/55/5/
Page I of ____________________________________________________________________________________________________________________________________________________________________
3
K04-01-5
'JUL - 1 2004
510(k) SUMMARY
| Submitter's Name and Address | Boston Scientific Corporation
3574 Ruffin Road
San Diego, CA 92123 |
|------------------------------|--------------------------------------------------------------------------|
| Contact Person | Paul Mason, Ph.D
Director, Regulatory Affairs
(858)268-4488 x 2869 |
| Common or Usual Name | PTA catheter |
| Product Code | LIT |
| Classification | Class II |
| Proprietary Name | Peripheral Cutting Balloon™ |
Predicate Devices
Boston Scientific Ultra-Thin Diamond Balloon Dilatation Catheter, K960501 Polarcath™ Peripheral Balloon Catheter system, K022061 CVSi Peripheral Balloon Catheter system, K030742
Device Description
The Peripheral Cutting Balloon (PCB) is available in nominal balloon diameters of 5.0 mm to 8.0 mm (Table 1). The device features a non-compliant balloon with four Atherotomes (microsurgical blades) mounted longitudinally on its outer surface. The proximal end of the balloon is equipped with a stainless folding spring to enhance balloon refold. The spring consists of a collar, proximal to the balloon cone; and four fingers that extend across the balloon cone and terminate before the pads that hold the atherolomes to the surface of the balloon. 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. 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.
| Nom. Diameter | Catheter Length | ||
|---|---|---|---|
| 50 cm | 90 cm | 135 cm | |
| 5.0 mm | BP505010 | BP905010 | BP1355010 |
| 5.5mm | BP505510 | BP905510 | BP1355510 |
| 6.0mm | BP506010 | BP906010 | BP1356010 |
| 7.0mm | BP505010 | BP907010 | BP1357010 |
| 8.0 mm | BP508010 | BP908010 | BP1358010 |
Table 1. Model Numbers, 1 cm PCB
4
Intended Use
The Peripheral Cutting Balloon catheters are recommended for Percutancous 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 cquivalence. 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.
Clinical Experience
The 1 cm Peripheral Cutting Balloon™ was studied in a prospectively randomized clinical trial, Cutting EDGE (CUTTING Balloon HEmoDialysis Access ManaGEment Trial) that compared the Peripheral Cutting Balloon to conventional angioplasty (PTA) in the treatment of stenosed or thrombosed synthetic hemodialysis grafts. The study enrolled 340 patients, 173 in the Peripheral Cutting Balloon arm and 167 in the PTA arm at 27 centers in the US. The primary endpoint was primary patency through 6 months post-procedure. Secondary efficacy endpoints included: access circuit primary patency; procedural success; and the number of target lesion reinterventions through 6 months. Secondary endpoints also included safety: occurrence of adverse events. Adverse events were adjudicated by a CEC; a DSMB reviewed safety information throughout the enrollment portion of the study.
The Peripheral Cutting Balloon is not signficantly different from PTA with respect to the rate of target lesion primary patency through 6 months post-proccdure: 47.9% pcs vs. 40.5% PTA.D=0.37.
The target lesion primary patency rates for subjects with stenosed grafts were not significantly different: 51.3% Kir vs. 46.9% PTA . p = 0.84. The national Kidney Foundation; Kidney Disease Outcome Quality Initiative for Vascular Access (KDOQI) suggests achievable primary patency rates in this group of patients to be about 50% at 6 months.
The PCB target lesion primary patency for thrombosed grafts was greater but not significant: 43.1% PCB vs. 32.0% PTA, p = 0.15. KDOQI guidelines suggest that 40% patency is typical at 3 months; the Quality Improvement Guidelines for Percutancous Management of the Thrombosed or Dysfunctional Dialysis Access suggest that 20% patency is typical at 6 months. The target lesion primary patency rate for subjects
5
treated with the Peripheral Cutting Balloon was more than double the expected rate, suggesting a clinical benefit.
Sccondary efficacy endpoints did not differ significantly between treatments: procedural success, p = 0.24; hemodialysis access circuit patency at 6-months, p = 0.45; mean number of target lesion reinterventions through 6 months, n = 0.22. Subjects with thrombosed grafts had fewer target lesion interventions after treatment with the Peripheral Cutting Balloon; the difference between means is marginally significant: 0.7 pcu vs. 1.0 pra, p = 0.06.
Device-related events, limited to dissections and perforations, were significantly more frequent in the Peripheral Cutting Balloon arm: 1.7% (3/173) dissections and 2.9% (5/173) perforations after use of the Peripheral Cutting Balloon vs. no events in the PTA arm (p = 0.007). When the dissection and perforation rates are considered independently, rather than pooled, the rates are not significantly different. Two of the cases (one perforation and one dissection) are protocol deviations because the Peripheral Cutting Balloon was oversized beyond the limits specified in the Directions for Use. The Quality Improvement Guidelines for Percutaneous Management of the Thrombosed or Dysfunctional Dialysis Access, updated in 2003, summarizes published complication rates. Based on the literature, the expected rate of vascular perforations or ruptures from the perculaneous management of hemodialysis is 2% to 4%. The Peripheral Cutting Balloon perforation rate of 2.9% falls within this expected range.
Only PTA balloons were used for reinterventions; 213 reinterventions were recorded during the trial. Among these reintervention procedures, there were two procedurerelated vessel ruptures and two device-related perforations. Although no vessel perforations or ruptures occurred with PTA at the index procedure, these expected events did occur during reinterventions.
In summary, the Peripheral Cutting Balloon™ is not significantly different from conventional angioplasty in overall safety and effectiveness.
Conclusion
The Peripheral Cutting Balloon catheter has been shown to be Substantially Equivalent to the predicate devices.