(23 days)
Not Found
No
The device description and performance studies focus on mechanical and biocompatibility properties, with no mention of AI or ML.
Yes
The device is intended for the dilatation of lesions in various arteries and for the treatment of obstructive lesions, which are therapeutic interventions.
No
The device description clearly states its purpose is for "dilatation of lesions" and "treatment of obstructive lesions", which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical catheter with a balloon and scoring element, indicating it is a hardware device, not software-only.
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).
- AngioSculpt Device Function: The AngioSculpt PTA Scoring Balloon Catheter is a device used inside the body (in vivo) to physically dilate blood vessels and treat lesions. It is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Testing: The description focuses on the mechanical function of the balloon and scoring element for physical intervention, not on analyzing biological samples for diagnostic purposes.
The information provided clearly describes a device used for a therapeutic procedure within the body, which is the opposite of an in vitro diagnostic.
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 nitinol 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 ald 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. Not for use in the coronary or neuro-vasculature.
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
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: Balloon Rated Burst Pressure, Balloon Inflation and Deflation, Balloon and Scoring Element Fatigue, Bond Strength, Crossing Profile, Trackability and Pushability, Over-the-Arch Torque Strength, Catheter Body Integrity, Balloon Compliance, Surface Appearance, Secure Edges, Freedom from Interference, Scoring Element Creates Focal Force.
An acute GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The study was conducted in the femoral peripheral arteries of one experimental animal. The catheter was evaluated on deliverability and trackability), passability, device inflation and deflation parameters, radiopacity, and device removal. The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guide wires in combination with a 5F sheath or 6F guide catheter and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, or embolization. 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
Not Found
Predicate Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers.
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 Ms. Kimberley Kline Regulatory Affairs Manager 5055 Brandin Court Fremont, CA 94538
Re: K101735
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: June 18, 2010 Received: June 21, 2010
Dear Ms. Kline:
This letter corrects our substantially equivalent letter of July 14, 2010.
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. 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/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
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Image /page/2/Picture/0 description: The image shows the logo for AngioScore. The logo consists of a square with the letter A inside, followed by the word "AngioScore" in a sans-serif font. The word "AngioScore" is written in black, and there is a trademark symbol after the word.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): __ K 10 1 7 3 5
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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K101735 |
| 5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7900 Fax: 1.510.933.7901 | |
| CONFIDENTIAL | Page 39 of 561 |
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Image /page/3/Picture/0 description: The image contains the logo for AngioScore. The logo consists of a stylized letter "A" inside a square on the left, followed by the word "AngioScore" in a sans-serif font. A small circle is present to the upper right of the word "AngioScore", likely indicating a registered trademark symbol.
K 101735
'JUL 1 4 2010
510(k) Summary for the AngioSculpt Scoring Balloon Catheter
1. Submitter's Name / Contact Person
Submitter:
AngioScore, Inc. 5055 Brandin Court Fremont, CA 94538
Contact Person:
Kimberley Kline Regulatory Affairs Manager Phone: 510-933-7989 Fax: 510-933-7994
Summary Preparation Date: July 13, 2010
-
- 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 |
| (K100303) |
3. Intended Use / Indications
The AngioSculpt PTA Scoring Balloon Catheter is intended for the dilatation of lesions in the iliac, femoral, illo-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.
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 nitinol 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 ald in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.877.264.4692 Phone: 1.510.933.7901
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5. Technological Characteristics
There are no technological changes to the subject AngioSculpt catheters as compared to the 510(k) cleared AngioSculpt catheter family (K100303).
6. 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.
- . Balloon Rated Burst Pressure
- . Balloon Inflation and Deflation
- Balloon and Scoring Element Fatigue
- Bond Strength
- Crossing Profile
- . Trackability and Pushability
- . Over-the-Arch Torque Strength
- . Catheter Body Integrity
- . Balloon Compliance
- Surface Appearance
- Secure Edges
- . Freedom from Interference
- Scoring Element Creates Focal Force
-
- Summary of Biocompatibility Testing
The AngioSculpt catheter is categorized as an "External communicating device in contact with circulating blood with limited exposure time". The biocompatibility of the device was assessed in accordance with ISO 10993-1:2009 - Blological evaluation of medical devices, Part 1 -Evaluation and tests within o risk management 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 Catheters, Lasers and Introvascular Stents(1995) – Blocompatibility testing for all interventional cardiology devices.
The biocompatibility tests listed below, except Thrombosis (in-vivo), were 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.
- . Cytotoxicity - MEM Elution Test using L-929 Mouse Fibroblast cells (ISO)
- Sensitization Guinea Pig Maximization Sensitization Test �
- Irritation Intracutaneous Reactivity (Irritation) Test ●
- . Systemic Toxicity - Acute Systemic Injection Test (ISO)
- Hemocompatibility Partial Thromboplastin Time (PTT) ●
- Hemocompatibility - Thrombosis (in vivo)
- . Hemocompatibility - Hemolysis Direct Contact Method (NIH)
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The biocompatibility test results confirmed that the AngioSculpt catheter is non-cytotoxic, nonsensitizing, non-irritating, not systemically toxic, and non-hemolytic when evaluated under the respective test conditions. As shown in the GLP animal study, no thrombo-embolism was observed when the AngioSculpt catheter was evaluated under simulated use conditions.
8. Summary of Animal Testing
An acute GLP study was conducted to determine the safety and deliverability of the AngioSculpt catheter. The study was conducted in the femoral peripheral arteries of one experimental animal. The catheter was evaluated on deliverability and trackability), passability, device inflation and deflation parameters, radiopacity, and device removal.
The study results demonstrated that the AngioSculpt catheter was successfully introduced using standard guide wires in combination with a 5F sheath or 6F guide catheter and expanded in the targeted tissue while demonstrating no evidence of dissection, perforation, or embolization. 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.
9. Substantial Equivalence Comparison
The AngloSculpt catheter shares the same indications for use, fundamental design, scientific technology (operating principle), functional performance, and materials as the currently marketed AngioSculpt catheter. 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 AngioSculpt PTA Scoring Balloon Catheter 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 AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate AngioSculpt catheters.