(94 days)
Not Found
No
The summary describes a mechanical device (a balloon catheter with a scoring element) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the dilatation and treatment of obstructive lesions in various arteries and arteriovenous dialysis fistulae, which indicates a therapeutic purpose.
No
The device is intended for the 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.
Based on the provided information, 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 of the body (in vitro).
- Device Description and Intended Use: The AngioSculpt PTA Scoring Balloon Catheter is a device used inside the body (in vivo) to physically dilate blood vessels and treat obstructive lesions. It is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the AngioSculpt PTA Scoring Balloon Catheter is a therapeutic medical device, not 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, illio-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
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 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, illio-femoral, popliteal, and infra popliteal 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
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)
K013581, K971010, K050629, K072225
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design. The eagle is facing to the right.
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. Karin J. Gastineau Vice President Medical, Regulatory and Quality 5055 Brandin Court Fremont, CA 94538
Re: K080151
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: March 31, 2008 Received: April 1, 2008
Dear Ms. Gastineau:
This letter corrects our substantially equivalent letter of April 25, 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
1
Page 2 - Ms. Karin J. Gastineau
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 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 vours.
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): ____________________________________________________________________________________________________________________________________________________
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, illio-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)
| -- | ---------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | Page 1 of 1 |
| 510(k) Number | K080151 |
|---|---|
| --------------- | --------- |
Page 4 of 18
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APR 2 5 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: | Karin J. Gastineau
Vice President, Medical, Regulatory, Quality
Phone: 510.933.7904
Fax: 510.933.7994 |
Summary Preparation Date: March 31, 2008
2. General Information
| Trade Name: | AngioSculpt® PTA Scoring Balloon Catheter |
|---|---|
| Common / Usual Name: | Angioplasty catheter |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Codes: | DQY and LIT |
| Predicate Devices: | Cordis Aviator® PTA Dilatation Catheter (K013581) |
| Cordis Savvy® PTA Dilatation Catheter (K971010) | |
| AngioSculpt® Scoring Balloon Catheter (K050629) | |
| AngioSculpt® Scoring Balloon Catheter (K072225) |
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.
4
5. Substantial Equivalence Comparison
The AngioSculpt catheter intended use and that of the predicate devices, the Cordis Aviator PTA Dilatation Catheter and the Cordis Savvy PTA Dilatation Catheter are substantially the same.
The indications for use of the subject device are an expanded list of indications for the 510(k) cleared AngioSculpt Scoring Balloon Catheter.
The AngioSculpt catheter shares the same fundamental design, scientific technology (operating principle), functional performance, and materials as the currently marketed AngioSculpt catheter. The subject device has similar design, operating principle, and functional performance as the Cordis Aviator and Savvy Dilitation Catheters.
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 AngioSculpt PTA Scoring Balloon Catheter is therefore, substantially equivalent to the predicate devices.
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