(28 days)
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its intended use and performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The "Intended Use / Indications for Use" section states it's for Percutaneous Transluminal Angioplasty (PTA) and for the treatment of obstructive lesions, which are therapeutic interventions. Additionally, it mentions the "infusion of diagnostic or therapeutic fluids."
No
The device is a therapeutic device used for Percutaneous Transluminal Angioplasty (PTA) that enables the infusion of diagnostic or therapeutic fluids. While it can infuse diagnostic fluids, its primary function is therapeutic (angioplasty), not diagnostic imaging or analysis.
No
The device description clearly describes a physical balloon catheter, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Chameleon PTA Balloon Catheter is a medical device used for a procedure performed inside the body (Percutaneous Transluminal Angioplasty). It is used to mechanically open narrowed arteries and fistulae and can also infuse fluids directly into the body.
- Lack of In Vitro Testing: The description focuses on the device's physical properties and performance during the angioplasty procedure. There is no mention of testing samples outside the body.
Therefore, the Chameleon PTA Balloon Catheter is a therapeutic and diagnostic (due to the infusion of diagnostic fluids) medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Chameleon PTA Balloon Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive regions of native or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
Product codes
LIT, KRA
Device Description
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids 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
femoral, iliac, and renal arteries; obstructive 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
The Chameleon PTA Balloon Catheter was evaluated using bench testing and simulated use test data to confirm the performance characteristics. Bench top tests performed with the 9.0X40mm & 10.0X40mm balloon sizes included dimensional inspection, balloon compliance, balloon burst, fatigue, and leakage. All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.
March 30, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AV Medical Technologies Ltd. % Ms. Eliza Malo Director, Regulatory Affairs Dohmen Life Sciences Services. LLC 11925 W I-70 Frontage Road North, Suite 900 Wheat Ridge, CO 80033
Re: K170635
Trade/Device Name: Chameleon PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, KRA Dated: March 2, 2017 Received: March 3, 2017
Dear Ms. Malo:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
Sincerelv.
Fernando Aguel
Fernando Aguel -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
510(k) Number (if known) K170635
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 femoral, iliac, and renal arteries and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510(k) Summary
510(k) Owner: 1.
AV Medical Technologies Ltd.
2. Address:
21 B Habarzel St. Tel Aviv, 6971029, ISRAEL
3. Contact Person:
Eliza Malo, M.S. RA; Director, Regulatory Affairs Email: eliza.malo@dlss.com Tel: 303 832 8200 Direct: 303 952 7267
Date 510(k) Summary Prepared: 4.
March 29, 2017
5. Trade Name:
Chameleon PTA Balloon Catheter
6. Common Name:
Angioplasty, Peripheral, Transluminal Catheter
7. Classification Name:
21 CFR 870.1250, Percutaneous Catheter (LIT) 21 CFR 870.1210, Continuous Flush Catheter (KRA)
Predicate Device(s): 8.
AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K163231
9. Purpose of Submission
This Special 510(k) premarket notification submission addresses a line extension to the Chameleon PTA Balloon Catheter. Specifically, the line extension is for the addition of two new balloon diameter sizes of 9.0mm and 10.0mm within the previously cleared range of available balloon diameter sizes.
10. Device Description:
The Chameleon Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is an over-the-wire, multi-lumen balloon catheter. The Chameleon enables the injection of diagnostic fluids, such as contrast medium or therapeutics fluids 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.
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11. Indications for Use:
The Chameleon PTA Balloon 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. The Chameleon enables the infusion of diagnostic or therapeutic fluids. This catheter is not for use in coronary arteries or cerebral vasculature.
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. ●
12. Technological Characteristics
The Chameleon PTA Balloon Catheter changes include the addition of the 9.0X40mm & 10.0X40mm balloon sizes. The Chameleon PTA Balloon Catheter has substantially equivalent indications for use, principle of operation, and technological characteristics as the AV Medical Technologies Ltd., Chameleon PTA Balloon Catheter, K163231.
13. Performance Data (Nonclinical)
The Chameleon PTA Balloon Catheter was evaluated using bench testing and simulated use test data to confirm the performance characteristics.
Bench top tests performed with the 9.0X40mm & 10.0X40mm balloon sizes included dimensional inspection, balloon compliance, balloon burst, fatigue, and leakage.
All test results demonstrate that the Chameleon PTA Balloon Catheter met the established specifications necessary for consistent performance during its intended use.
14. 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.