(29 days)
No
The device description and performance studies focus on the mechanical properties and function of a standard balloon catheter, with no mention of AI/ML capabilities or data processing.
Yes
The device is used for "balloon dilatation of lesions," which is a therapeutic intervention aimed at treating medical conditions in the peripheral vasculature.
No
Explanation: The device is a Medical Device used to treat lesions in the peripheral vasculature. It is not used for diagnostic purposes.
No
The device description clearly details a physical balloon catheter with a braided shaft, tip, balloon, radiopaque markers, and a hub for inflation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "balloon dilatation of lesions in the peripheral vasculature". This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilatation within blood vessels. This is a medical device used for intervention, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct treatment within the body.
N/A
Intended Use / Indications for Use
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
Product codes
DQY, LIT
Device Description
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.
All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.
The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. The following in vitro tests were performed:
- Balloon Rated Burst Pressure .
- Balloon Inflation and Deflation .
- Balloon Fatigue /CS Fatigue ●
- Catheter Diameter, Balloon Profile and Tip Configuration .
- Balloon Compliance .
- . Trackability, Pushability
- Kink Resistance .
- Device Interface Compatibility .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090849, K082343, K094019, K101062, K103534, K112281, K111738, K120677
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
JUN - 8 2012
510(k) Summary [As required by 21 CFR 807.92(c)]
-
- Submitter's Name / Contact Person
Submitter:
- Submitter's Name / Contact Person
TriReme Medical, Inc. 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566
Contact Person:
Shiva Ardakani VP of RA/QA/CA Phone: 925-931-1300 Ext 209 Fax: 925-931-1361
Date Prepared: May 9, 2012
-
- General Information
| Trade Name: | Chocolate PTA Balloon Catheter |
|---|---|
| Common/Usual Name: | Angioplasty Catheter |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Product Code: | DQY / LIT |
| 510(k) number: | |
| Predicate Devices: | NanoCross PTA Dilatation Catheter (K090849) |
| VascuTrak PTA Dilatation Catheter (K082343) | |
| PTA Balloon Catheter Family (K094019, K101062, K103534, K112281, K111738, and K120677) |
3. Intended Use
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
-
- Device Description
The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm.
- Device Description
All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic
1
coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices.
The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
-
- Performance Data
Bench testing was performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. The following in vitro tests were performed:
- Performance Data
-
Balloon Rated Burst Pressure .
-
Balloon Inflation and Deflation .
-
Balloon Fatigue /CS Fatigue ●
-
Catheter Diameter, Balloon Profile and Tip Configuration .
-
Balloon Compliance .
-
. Trackability, Pushability
-
Kink Resistance .
-
Device Interface Compatibility .
-
- Substantial Equivalence Comparison and Conclusion
The additional balloon sizes of the Chocolate PTA Balloon Catheter are substantially equivalent to the predicate devices in design, materials, packaging, fundamental scientific. technology, manufacturing, sterilization and intended use. Performance testing demonstrated that the devices reliably achieved the desired effect and are safe for the intended use. No new questions of safety or effectiveness were identified during device testing. Therefore, additional sizes of the Chocolate PTA Balloon Catheters are considered substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TriReme Medical, Inc. c/o Shiva Ardakani 7060 Koll Center Parkway, Suite 300 Pleasanton, CA 94566
Re: K121402
Trade/Device Name: Chocolate PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: May 09, 2012 Received: May 10, 2012
Dear Ms. Ardakani:
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
JUN - 8 2012
3
Page 2 – Ms. Shiva Ardakani
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
M.A. Hillman
Cy Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (XXXXX): | 121402
· Device Name: Chocolate PTA Balloon Catheter
Indications for Use:
The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.S. Hillman
(Division Sign-Off) Division of Cardiovascular Devices
K121402 510(k) Number
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