(91 days)
Not Found
No
The 510(k) summary describes a mechanical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter used for treatment in various arteries and fistulae, which is a therapeutic intervention.
No
Explanation: The Chameleon PTA Balloon Catheter is described as a treatment device used for Percutaneous Transluminal Angioplasty (PTA) to dilate vessels. Its intended use is to treat existing conditions, not to diagnose them. While it can inject contrast media, which is often used in diagnostic imaging, the device's primary function as described is therapeutic (balloon dilation), not image acquisition or interpretation for diagnostic purposes.
No
The device description clearly describes a physical catheter with multiple lumens and a balloon, 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:
- Intended Use: The intended use clearly describes a procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat blockages in arteries and fistulae. This is an interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a catheter with lumens for inflation, guide wire, and fluid injection, all designed for use within the vascular system. This aligns with an interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the fenoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fenoral, iliac, and renal arteries, and 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)
The Chameleon PTA Balloon Catheter was evaluated using biocompatibility, bench testing, package and simulated use test data to confirm the performance characteristics.
Biocompatibility testing included: cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, pyrogen, hemolysis, C3a and SC5b-9 complement activation, and in-vivo thrombo-resistance.
Bench top tests included: visual inspection, dimensional inspection, air and liquid leakage, balloon compliance, balloon inflation time, tensile strength, tippull test, balloon rated burst pressure, balloon fatigue, catheter body burst strength, contrast media flow rate, torque strength, transportation testing, simulated use and kink resistance, packaging tests and visual inspections.
All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.
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.
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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2015
AV Medical Technologies Ltd. % Ian Marsden Assistant Director of Regulatory Affairs Dohmen Life Science Services. LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, Colorado 80033
Re: K151678
Trade/Device Name: Chameleon PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 27, 2015 Received: August 28, 2015
Dear Ian Marsden:
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 (for the indications for use stated in the enclosure) 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 device
1
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" (21 CFR 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,
Kenneth J. Cavanaugh -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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Chameleon PTA Balloon Catheter
Indications for Use (Describe)
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the fenoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information, Send comments regarding this burden estimate or any other aspect, of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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AV Medical Technologies Ltd. – Traditional 510(k) – Chameleon PTA Balloon Catheter Section 7: 510(k) Summary
510(k) Summary
510(k) Owner: 1.
AV Medical Technologies Ltd.
2. Address:
21 B Habarzel st Tel Aviv, 6971029, ISRAEL
3. Contact Person:
lan Marsden, Assistant Director Regulatory Affairs, MS, US (RAC) Email: ian.marsden@dlss.com Phone: 303 832 8200 Direct: 303 223 4331
Date 510(k) Summary Prepared: 4.
July 1, 2015
5. Trade Name:
Chameleon PTA Balloon Catheter
6. Common Name:
Angioplasty, Peripheral, Transluminal Catheter
7. Classification Name:
21 CFR 870.1250, Percutaneous Catheter
Predicate Device(s): 8.
Hotspur Technologies, Inc. Arrow GPSCath Balloon Dilation Catheter, K130397
Device Description: 9.
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The catheter enables the injection of fluids such as contrast media through a dedicated opening proximal to the balloon. The multi-lumen shaft incorporates a balloon inflation/deflation lumen and a Guide Wire (GW) lumen which also serves as the infusion lumen.
Indications for Use:
The Chameleon PTA Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
DO NOT use the Chameleon Device:
- · For coronary arteries nor for the delivery and/or expansion of stents.
- In patients who cannot tolerate anticoagulation therapy.
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AV Medical Technologies Ltd. – Traditional 510(k) – Chameleon PTA Balloon Catheter Section 7: 510(k) Summary
10. Technological Characteristics
The Chameleon PTA Balloon Catheter has identical indications for use, substantially equivalent principle of operation, and technological characteristics as the Hotspur Technologies, Inc. Arrow GPSCath Balloon Dilation Catheter, K130397.
11. Performance Data (Nonclinical)
The Chameleon PTA Balloon Catheter was evaluated using biocompatibility, bench testing, package and simulated use test data to confirm the performance characteristics.
Biocompatibility testing included: cytotoxicity, sensitization, intracutaneous irritation, systemic toxicity, pyrogen, hemolysis, C3a and SC5b-9 complement activation, and in-vivo thrombo-resistance.
Bench top tests included: visual inspection, dimensional inspection, air and liquid leakage, balloon compliance, balloon inflation time, tensile strength, tippull test, balloon rated burst pressure, balloon fatigue, catheter body burst strength, contrast media flow rate, torque strength, transportation testing, simulated use and kink resistance, packaging tests and visual inspections.
All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.
12. Conclusion
The Chameleon PTA Balloon Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, and test protocols.
The Chameleon PTA Balloon Catheter is substantially equivalent to the legally marketed predicate device.