(63 days)
Not Found
No
The device description focuses on mechanical components (balloon, scoring element) and standard angioplasty principles, with no mention of AI/ML terms or functions.
Yes
The device is used for balloon dilatation of lesions in infrapopliteal arteries, which directly treats a medical condition.
No
The device description clearly states its purpose is for "balloon dilatation of lesions in infrapopliteal arteries" and "assists 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, 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Description: The AngioSculpt Scoring Balloon Catheter is a device used inside the body (in vivo) to physically dilate arteries. It's a mechanical device used for a therapeutic procedure, not for analyzing biological samples.
- Intended Use: The intended use is "balloon dilatation of lesions in infrapopliteal arteries," which is a direct intervention on the patient's anatomy.
Therefore, based on the provided information, the AngioSculpt Scoring Balloon Catheter is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neurovasculature.
Product codes
PNO
Device Description
The modified 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 diagneter 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
infrapopliteal arteries
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
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
Not Found
Predicate Device(s)
AngioSculpt® Scoring Balloon Catheter (K050629), Cordis Savvy® PTA Dilatation Catheter (K971010)
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 and Human Services. 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 symbol that resembles a human figure embracing a globe, representing the department's mission to protect the health of all Americans.
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. Melinda Swanson 5055 Brandlin Court Fremont, CA 94538
Re: K072225
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: September 11, 2007 Received: September 12, 2007
Dear Ms. Swanson:
This letter corrects our substantially equivalent letter of October 12, 2007.
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 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
1
Page 2 - Ms. Melinda Swanson
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 STATEMENT
510(k) Number (if known): K072225
Device Name: AngioSculpt® Scoring Balloon Catheter
Indications for Use:
The AngioSculpt Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neurovasculature.
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 CDRII, Office of Device Evaluation (ODE)
Blumensons
ardlovascular Devi 510(k) I
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UC7 1 2 2007
510(k) Summary for the Modified AngioSculpt Scoring Balloon Catheter
1. Submitter's Name / Contact Person
| Submitter: | AngioScore, Inc.
5055 Brandin Court
Fremont, CA 94538 |
|-----------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Melinda Swanson
Director, Clinical and Regulatory Affairs
Phone: 510-933-7910
Fax: 510-933-7994 |
September 11, 2007 Summary Preparation Date:
2. General Information
| Trade Name: | AngioSculpt® PTA Scoring Balloon Catheter |
|---|---|
| Common / Usual Name: | Angioplasty catheter |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal (DQY and LIT) |
| Predicate Devices: | AngioSculpt® Scoring Balloon Catheter (K050629) |
| Cordis Savvy® PTA Dilatation Catheter (K971010) |
3. Intended Use / Indications
The modified AngioSculpt PTA Scoring Balloon Catheter is intended for balloon dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.
4. Device Description
The modified 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 diagneter and length at a specific pressure.
5. Substantial Equivalence Comparison
There is no difference between the modified AngioSculpt catheter intended use and that of the predicate devices. The modified AngioSculpt catheter shares the same fundamental design, scientific technology (operating principle), functional performance, and similar materials as the original AngioSculpt catheter. The modified AngioSculpt catheter has similar dimensions and size configurations as the Savvy 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 modified AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate devices.