(28 days)
Not Found
No
The device description and intended use focus on the mechanical function of a scoring balloon catheter and do not mention any AI or ML components or capabilities.
Yes
The device is intended for the "dilatation of lesions" and "treatment of obstructive lesions," which are therapeutic actions aimed at addressing a medical condition.
No
The device description and intended use clearly state that it is for "dilatation of lesions" and "treatment of obstructive lesions," indicating 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, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The AngioSculpt PTA Scoring Balloon Catheter is a medical device used within the body for a therapeutic procedure (dilating arteries and treating lesions). It is a physical tool used to directly interact with anatomical structures.
The description clearly indicates its use in angioplasty procedures within blood vessels, which is an in vivo (within the living body) application, not an in vitro (in glass/outside the body) diagnostic test.
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, and infra popliteal 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 (comma separated list FDA assigned to the subject device)
DQY and 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 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, and infra popliteal 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
AngioSculpt® Scoring Balloon Catheter (K072225 and K080151)
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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is 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 Ms. Kimberley Kline Senior Regulatory Specialist 5055 Brandin Court Fremont, CA 94538
Re: K081220
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: April 28, 2008 Received: April 30, 2008
Dear Ms. Kline:
This letter corrects our substantially equivalent letter of May 28, 2008.
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
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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 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
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Image /page/2/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 distinct font. There is a small circle with a line through it, which is a registered trademark symbol, to the upper right of the word 'AngioScore'.
INDICATIONS FOR USE STATEMENT
K 081220
510(k) Number (if known):
Device Name: AngioSculpt® 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, and infra popliteal 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 X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mama R. Vclunes
(Division Sign-Off)
Division of Cardiovascular Devices
Page 1 of 1
510(k) Number_K68 | 220
5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.510.93.7900 [9]6]619.9339993
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K081220 page 1082.
Image /page/3/Picture/1 description: The image shows the word "AngioScore" with a registered trademark symbol. The word "AngioScore" is written in a bold, sans-serif font. To the left of the word is a logo that appears to be the letter "A" inside of a square. The logo and the word are both in black.
MAY 2 8 2008
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 Senior Regulatory Specialist Phone: 510-933-7989 Fax: 510-933-7994
Summary Preparation Date: May 27, 2008
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 |
| (K072225 and K080151) |
3. Intended Use / Indications
The AngioSculpt PTA Scoring Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra popliteal 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 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.
:
5055 Brandin Court Fremont CA 94538 www.angioscore.com Toll Free: 1.510.933.7900 Fax: 1.510.933.7901
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5. Substantial Equivalence Comparison
The AngioSculpt 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 raisc new issues of safety and effectiveness. The AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate AngioSculpt catheters.