(133 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter with a scoring element. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is specifically designed for the dilatation of lesions in various arteries and for treating obstructive lesions in dialysis fistulae, which are therapeutic interventions.
No
The device is a scoring balloon catheter intended for the dilatation and treatment of obstructive lesions, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details a physical catheter with a balloon and scoring element, indicating it is a hardware device. The performance studies also focus on mechanical and biocompatibility testing of a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body for the mechanical dilatation of blood vessels and fistulae. This is an in vivo procedure.
- Device Description: The description details a catheter with a balloon and scoring element designed to interact directly with tissue inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body for a therapeutic purpose (dilatation).
N/A
Intended Use / Indications for Use
The AngioSculpt® PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Product codes
DQY, LIT
Device Description
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or 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)
Summary of Bench Testing:
Mechanical testing of the AngioSculpt catheter was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.
The following bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters: Catheter Diameter and Balloon Profile, Device Burst Strength (RBP), Balloon Compliance (Diameter vs. Pressure), Balloon Inflation and Deflation Time, Device Fatigue, Bond (Tensile) Strength, Tip Pull Strength, Catheter Diameter and Balloon Profile (with Scoring Element), Flexibility and Kink, Torque Strength, Pushability, Trackability and Secure Edges, Balloon Preparation, Deployment and Retraction, Freedom from Stent Interference, Focal Force, Corrosion Resistance.
Summary of Biocompatibility Testing:
The AngioSculpt catheter is categorized as an "External communicating device in contact with circulating blood with Ilmited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 – Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk monagement process. Also complies with FDA Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Cotheters, Lasers and Introvascular Stents(2008) -Biocompatibility testing for all Interventional cardiology devices.
Biocompatibility tests were not conducted as part of this device modification. Materials were shown to be equivalent to currently marketed AngioScore products. Biocompatibility testing confirmed that the AngioSculpt catheter is non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and nonhemolytic when evaluated under the respective test conditions. Thrombosis (in-vivo), was conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study. No thrombo-embolism was observed.
Summary of Animal Testing:
An acute GLP and non GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The studies were conducted in the Ilio-femoral peripheral arteries of one experimental animal. The catheter was evaluated on deliverability and trackability), passability, device inflation and deflation parameters, overall radiopacity, and device removal.
The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guldewires in combination with a 5F sheath or 6F guide catheter and a 6F sheath or 0.079"/2.0 mm guide catherer and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, embolization, or thrombosis. All devices maintained integrity with no loss of components during the procedure. All treatment procedures were performed with ease and no adverse events occurred in any of the animals.
The objectives of the study were met. The catheters evaluated in the peripheral (femoral) arteries were found to be clinically acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AngioSculpt® Scoring Balloon Catheter (K101735/K112182)
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 stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
AngioScore, Inc. c/o Kimberley Kline Regulatory Affairs Manager 5055 Brandin Court Fremont, CA 94538
Re: K122685
Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PNO Dated: January 04, 2013 Received: January 07, 2013
Dear Ms. Kline:
This letter corrects our substantially equivalent letter of January 11, 2013.
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. Kimberley Kline
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
ioScore
INDICATIONS FOR USE STATEMENT
510{k} Number (if known):
122682
Device Name: AngioSculpt® PTA Scoring Balloon Catheter
.
Indications for Use:
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
RH, Office of Device Evaluation (ODE)
on of Cardiovascular Devices
Page 1 of 1
510(k) Number: K12268
CONFIDENT Court Fremont CA 94538. www.angioscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7900 Fax: 1.510.988.680 of 289
3
JAN 1 1 2013
510(k) Summary for the AngloSculpt Scoring Balloon Catheter
1. Submitter's Name / Contact Person
Submitter:
AngioScore, Inc. 5055 Brandin Court Fremont, CA 94538
Contact Person:
Alison Schlosser
Regulatory Affairs Specialist II Phone: 510-933-7936 Fax: 510-933-7994
Summary Preparation Date:
November 21, 2012
2. General Information
Trade Name: AngioSculpt® PTA Scoring Balloon Catheter Common / Usual Name: Angioplasty catheter Classification Name: Percutaneous catheter Product Codes: DQY and LIT Predicate Devices: AngioSculpt® Scoring Balloon Catheter (K101735/K112182)
3. Intended Use / Indications
The AngioSculpt PTA Scoring Balloon Catheter is intended for the dilatation of lesions in the illiac, femoral, illo-femoral, popliteal, infra popliteal, and renal arterles, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neurovasculature.
4
4. Device Description
The AngioSculpt catheter is a standard two-lumen catheter with a scoring balloon near the distal tip. The distal end of the catheter has a conventional nylon-blend balloon with a scoring element that wraps around the balloon. The scoring element creates focal concentrations of dilating force which minimizes balloon slippage and assists with luminal expansion of stenotic arteries. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
Technological Characteristics s.
The AngioSculpt catheters as compared to the 510(k) cleared AngloSculpt catheter family (K101735/K112182) incorporate substantially equivalent design, dimensional, and performance specification as the predicate catheters with the following changes:
- t the smallest diameter AngioSculpt balloon sizes (2.0-3.5mm) are now available in the longest AngioSculpt balloon length (100mm),
- . the distal tip of the subject catheter was modified to a tapered profile and the nominal length extended. The distal extrusion and soft tip used to form the distal bond and distal tip are replaced with a molded tip comprised of already approved AngioSculpt materials,
- a different material blend was used for the Intermediate Extrusion (a component of the . Intermediate Bond); a slightly more elastic polymer was used for ease of manufacturability. The polymer is currently used in the strain relief of the device (a component of the proximal end).
Summary of Bench Testing ર.
Mechanical testing of the AngioSculpt catheter was conducted in accordance with AngioScore's Risk Analysis and all applicable FDA guidance documents and relevant standards.
The following bench tests were conducted to verify that design outputs met design requirements and to confirm proper function and durability. Test articles consisted of finished sterilized catheters.
- . Catheter Diameter and Balloon Profile
- Device Burst Strength(RBP) ●
- Balloon Compliance (Diameter vs. Pressure) ●
- Balloon Inflation and Deflation Time ●
- Device Fatigue �
- Bond (Tensile) Strength �
- Tip Pull Strength
- Catheter Diameter and Balloon Profile (with Scoring Element)
- Flexibility and Kink
- Torque Strength
- Pushability, Trackability and Secure Edges
- Balloon Preparation, Deployment and Retraction
5
- Freedom from Stent Interference
- Focal Force
- Corrosion Resistance
7. Summary of Blocompatibility Testing
The AngioSculpt catheter is categorized as an "External communicating device in contact with circulating blood with Ilmited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 – Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk monagement process. In addition, the product complies with the requirements identified in FDA Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Cotheters, Lasers and Introvascular Stents(2008) -Biocompatibility testing for all Interventional cardiology devices.
Biocompatibility tests were not conducted as part of this device modification. Materials were shown to be equivalent to currently marketed AngioScore products. Biocompatibility testing confirmed that the AngioSculpt catheter is non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and nonhemolytic when evaluated under the respective test conditions. As a conservative measure Thrombosis (in-vivo), was conducted in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58. Thrombogenicity was evaluated as part of a GLP animal study. No thrombo-embolism was observed.
8. Summary of Animal Testing
An acute GLP and non GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The studies were conducted in the llio-femoral peripheral arteries of one experimental animal. The catheter was evaluated on deliverability and trackability), passability, device inflation and deflation parameters, overall radiopacity, and device removal.
The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guldewires in combination with a 5F sheath or 6F guide catheter and a 6F sheath or 0.079"/2.0 mm guide catherer and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, embolization, or thrombosis. All devices maintained integrity with no loss of components during the procedure. All treatment procedures were performed with ease and no adverse events occurred in any of the animals.
The objectives of the study were met. The catheters evaluated in the peripheral (femoral) arteries were found to be clinically acceptable.
g. Substantial Equivalence Comparison
The subject catheters share the same intended use, principles of operation, overall technical and functional capabilities, packaging and sterilization process, and similar design and materials as the predicate AngioSculpt catheters and are therefore substantially equivalent.
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Although there are minor differences between the subject catheters and its predicate devices those differences do not raise new questions of safety or efficacy. Design verification and validation testing demonstrated adequate device performance and confirmed that no new questions of safety or effectiveness for peripheral balloon angioplasty devices were raised. The changes to the subject catheters do not affect the intended use of the device, alter the fundamental scientific technology of the device, or raise new Issues of safety and effectiveness. The subject AngloSculpt PTA Scoring Baller o Catheters are therefore, substantially equivalent to the predicate catheters.
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