(29 days)
No
The summary describes a mechanical device (a balloon catheter with a scoring element) and its performance and biocompatibility testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as "intended for dilatation of lesions" and "assists with luminal expansion of stenotic arteries," which indicates it is used for treatment to restore normal function to a diseased or damaged body part.
No
The device description clearly states it is "intended for dilatation of lesions" and helps with "luminal expansion of stenotic arteries," 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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "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." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a catheter with a balloon and scoring element designed to be inserted into blood vessels to physically expand them. This is a medical device used for intervention within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, tissue, and urine, taken from the human body to provide information for diagnosis, monitoring, or screening purposes. This device does not perform any such examination of specimens outside the body.
The AngioSculpt PTA Scoring Balloon Catheter is a therapeutic medical device used for angioplasty procedures.
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
PNO, 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, 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
Mechanical testing: Conducted in accordance with AngioScore's Risk Analysis and applicable FDA guidance and standards. Test articles were finished sterilized catheters. Tests included: Catheter Diameter and Balloon Profile, Minimum Burst Strength (RBP), Balloon Compliance (Diameter vs. Pressure), Balloon Inflation and Deflation Time, Device Fatigue, Bond (Tensile) Strength, Tip Pull Strength, Catheter Body Integrity, 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.
Biocompatibility testing: Categorized as an "External communicating device in contact with circulating blood with limited exposure time". Assessed per ISO 10993-1:2009 and FDA Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices: PTCA Catheters, Atherectomy Catheters, Lasers and Intravascular Stents (2008). Tests included: Cytotoxicity (MEM Elution Test using L-929 Mouse Fibroblast cells), Sensitization (Guinea Pig Maximization Sensitization Test), Irritation (Intracutaneous Reactivity Test), Systemic Toxicity (Acute Systemic Injection Test), Hemocompatibility (Partial Thromboplastin Time (PTT), Thrombosis (in vivo), Hemolysis Direct Contact Method (NIH)). Results: non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and non-hemolytic. No thrombo-embolism observed in GLP animal study.
Animal testing: An acute GLP study. Objective: determine safety and deliverability. Results: successfully introduced using standard guidewires with 6F sheath or 7F guide catheter; expanded in targeted tissue with no evidence of dissection or embolization. Devices maintained integrity with no loss of components. Procedures performed with ease, no adverse events. Clinically acceptable in peripheral (femoral) arteries.
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).
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 caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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 Mr. Jonathan S. Kahan Hogan Lovells US, LLP 555 Thirteenth Street NW Washington, DC 20004
Re: K112182
Trade/Device Name: AngioSculpt® PTA Scoring Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 28, 2011 Received: July 28, 2011
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of August 26, 2011.
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 - Mr. Jonathan S. Kahan
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
Image /page/2/Picture/0 description: The image shows the logo for AngioScore. The logo consists of a triangular shape on the left, with the word "AngioScore" to the right of the shape. The triangular shape is made up of three curved shapes that are arranged in a circular pattern. There is a small circle above the end of the word "AngioScore".
INDICATIONS FOR USE STATEMENT
K112182 510(k) Number (if known): __
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 | Page 1 of 1 |
| Division of Cardiovascular | |
| 510(k) Number | K112182 |
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
3
AUG 26 2011
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 27, 2011
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 |
| (K100303/K110767) | |
| VascuTrak® PTA Dilatation Catheter | |
| (K103459) |
3. Intended Use / Indications
The AngioSculpt PTA Scoring Balloon Catheter is intended for the dilatation of lesions in the illiac, 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.
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.
4
5. Technological Characteristics .
There are no technological changes to the subject AngioSculpt catheters as compared to the 510(k) cleared AngioSculpt catheter family (K100303/K110767).
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.
- Catheter Diameter and Balloon Profile
- . Minimum Burst Strength (RBP)
- . Balloon Compliance (Diameter vs. Pressure)
- . Balloon Inflation and Deflation Time
- Device Fatigue, Bond (Tensile) Strength ●
- Tip Pull Strength
- Catheter Body Integrity
- . 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
7. 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 - Biological evoluation of medical devices, Part 1 -Evaluation and tests within a 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 Intravascular Stents(2008) – Biocompatibility testing for all interventional cardiology devices.
The blocompatibility 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 ●
5
- Systemic Toxicity Acute Systemic Injection Test (ISO) .
- Hemocompatibility Partial Thromboplastin Time (PTT) ●
- Hemocompatibility - Thrombosis (in vivo)
- Hemocompatibility Hemolysis Direct Contact Method (NIH) .
The blocompatibility 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 results demonstrated that the AngloSculpt catheter was successfully introduced using standard guidewires in combination with a 6F sheath or 7F guide catheter and expanded in the targeted tissue while demonstrating no evidence of dissection, 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 subject catheters share 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.
The subject catheters also have similar intended use and device operation, materials, design, dimensions/size configuration, guidewire platform and overall technical and functional capabilities as the BARD/YMed, Inc. VascuTraK® PTA Dilatation Catheters.
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 AngioSculpt PTA Scoring Balloon Catheters are therefore, substantially equivalent to the predicate catheters.