(136 days)
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter for angioplasty. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for "balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion" and "balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction", which are therapeutic actions.
No
Explanation: The device is a balloon catheter used for dilatation of coronary arteries, which is a therapeutic intervention, not a diagnostic one. Its purpose is to treat stenosis or occlusion, not to identify or characterize medical conditions.
No
The device description clearly details physical components like a balloon made of Nylon, a stainless steel tube, and radiopaque marker bands, indicating it is a physical medical device, not software-only.
Based on the provided text, 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.
- Device Description: The description clearly states that the Coronary Dilatation Balloon Catheter is a percutaneous transluminal coronary angioplasty (PTCA) device. This is an invasive medical device used to physically open narrowed or blocked coronary arteries.
- Intended Use: The intended use is to perform balloon dilatation within the coronary artery or bypass graft, which is a surgical procedure performed directly on the patient's body.
- Lack of Mention of Samples: There is no mention of the device being used to test samples taken from the body.
Therefore, the device described is a therapeutic medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
The VexPander® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary artery, bypass graft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 subject device, coronary dilatation balloon catheter (VesTraveler®, VexPander®), was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters and ensure that the design and construction are suitable or its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010):
The results of these tests provided reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new questions of safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate device.
Biocompatibility Testing:
Per ISO 10993-1:2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subjective device.
- In vitro cytotoxicity, per ISO 10993-5:2009
- Intracutaneous reactivity, per ISO 10993-10: 2010
- . Skin sensitization, per ISO 10993-10: 2021
- . Acute systemic toxicity, per ISO 10993-11: 2017
- . Hemocompatibility (hemolysis, complement activation (SC5b-9, C3a), coagulation (partial thromboplastin time, prothrombin time), in vivo thromboresistance), per ISO 10993-4:2017
- . Material mediated pyrogenicity, per USP General Chapter
Non-clinical Testing/Performance Data:
The following tests were completed and support the coronary dilatation balloon catheter (VesPenetrator®, VesTraveler®, VexPander®)
- . Catheter visual inspection
- Catheter dimensional inspection
- Guide wire compatibility test
- Guiding catheter compatibility test
- . Haemostasis valve compatibility
- . Balloon preparation, deployment and retraction
- Balloon fatigue test
- Balloon rated burst pressure (RBP)
- Balloon compliance
- . Balloon inflation and deflation time
- Catheter bond strength
- Tip pull test
- Flexibility and kink test
- Torque strength test
- . X-Ray detectability
- Particle contamination test
- . Balloon rated burst pressure (RBP; in stent)
- Balloon fatigue (repeat balloon inflations; in stent)
- . Bacterial endotoxin testing
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.
Sapphire® NC Coronary Dilatation Catheter (K103808, cleared August 9, 2011)
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.
Mozec ™ NC-Rx PTCA Balloon Dilatation Cather (K160961, cleared July 20, 2016), Tamarin Blue® PTCA RX Dilatation Cather (K112735, cleared November 2, 2012), Sapphire® Coronary Dilatation Catheter (K103657, cleared August 9, 2011)
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
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2023
Dongguan TT Medical, Inc Yuying Bi R&D Director Bld #1, Rm 501, 502,1 Taoyuan Rd Songshan Lake,Guangdong Dongguan, GD 523808 China
Re: K230374
Trade/Device Name: Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: February 13, 2023 Received: February 13, 2023
Dear Yuying Bi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the name "Gregory W. O'connell - S" in black text. The text is arranged in two lines, with "Gregory W." on the first line and "O'connell - S" on the second line. The font appears to be a simple, sans-serif typeface.
Digitally signed by Gregory W. O'connell -S Date: 2023.06.29 20:19:00 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230374
Device Name
Coronary Dilatation Balloon Catheter (VesPenetrator®); Coronary Dilatation Balloon Catheter (VesTraveler®); Coronary Dilatation Balloon Catheter (VexPander®)
Indications for Use (Describe)
The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
The VexPander® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) Summary
510(k) number: K230374
This 510(k) summary is submitted in according with 21 CFR 807.92.
1. Submitter Information
| Submitter's Name: | Dongguan TT Medical, Inc |
|---|---|
| Submitter's Address: | Bld #1, Rm 501, 502, Taoyuan Rd Songshan Lake, Guangdong |
| Dongguan GD 523808 China | |
| Contact Person: | Yuying Bi |
| Telephone: | +86-1555334190 |
| Email: | ybi@ttmedicalinc.com |
| Submission date: | October 10, 2022 |
2. Subject Device Information
| Device Trade Name: | Coronary Dilatation Balloon Catheter (VesPenetrator®);
Coronary Dilatation Balloon Catheter (VesTraveler®);
Coronary Dilatation Balloon Catheter (VexPander®) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Regulation Number: | 21 CFR 870.5100 |
| Product Code: | LOX |
| Device Class: | Class II |
| Classification Panel: | Cardiovascular |
| 510(k) Number: | K220279 |
3. Predicate Device Information
| Predicate Device: | Sapphire® NC Coronary Dilatation Catheter
(K103808, cleared August 9, 2011) |
|---------------------|----------------------------------------------------------------------------------|
| Reference Device 1: | Mozec ™ NC-Rx PTCA Balloon Dilatation Cather
(K160961, cleared July 20, 2016) |
| Reference Device 2: | Tamarin Blue® PTCA RX Dilatation Cather
(K112735, cleared November 2, 2012) |
| Reference Device 3: | Sapphire® Coronary Dilatation Catheter
(K103657, cleared August 9, 2011) |
4. Device Description Summary
The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female
4
luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.
5. Intended Use/ Indications for Use
The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
• balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
The VexPander® Coronary Dilatation Balloon Catheters are indicated for:
- · balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
- balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
- in-stent restenosis
- · post-delivery expansion of balloon expandable coronary stents
6. Comparisons with Predicate Device
Comparisons of the subject devices, coronary dilatation balloon catheter (VesPenetrator®, VesTraveler®, VexPander®), and the predicate device, Sapphire® NC plus coronary dilatation catheter shows that the subject device such as indication for use, prescription use and design (such as effective length, guide wire size, proximal shaft diameter, distal shaft diameter, monorail catheter, markers bands, sterilization method) are identical. In the terms of balloon diameter and balloon compliance, VesPenetrator® & VesTraveler® are identical to Sapphire® coronary dilatation catheter, and VexPander® is identical to Sapphire® NC plus coronary dilatation catheter, details are provided in Table 1.
Comparisons of the subject devices to the reference device show that the balloon length of subject device covered by reference device Mozec™ NC-Rx PTCA balloon dilatation catheter, the coating of subject device is identical to reference device Tamarin Blue® PTCA RX dilatation catheter, therefore the balloon length and coating do not raise any new questions of safety or effectiveness. Similar nominal pressure and rated bust pressure will be satisfied with technical requirement in compliance and do not raise any new questions of safety or effectiveness. The biocompatibility of subject device conforms to FDA guidance of biological evaluation of medical devices and do not raise any new questions of safety effectiveness.
5
7. Performance Data
The subject device, coronary dilatation balloon catheter (VesTraveler®, VexPander®), was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters and ensure that the design and construction are suitable or its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010):
The results of these tests provided reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new questions of safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate device.
Biocompatibility Testing:
Per ISO 10993-1:2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subjective device.
- In vitro cytotoxicity, per ISO 10993-5:2009
- Intracutaneous reactivity, per ISO 10993-10: 2010
- . Skin sensitization, per ISO 10993-10: 2021
- . Acute systemic toxicity, per ISO 10993-11: 2017
- . Hemocompatibility (hemolysis, complement activation (SC5b-9, C3a), coagulation (partial thromboplastin time, prothrombin time), in vivo thromboresistance), per ISO 10993-4:2017
- . Material mediated pyrogenicity, per USP General Chapter
Non-clinical Testing/Performance Data:
The following tests were completed and support the coronary dilatation balloon catheter (VesPenetrator®, VesTraveler®, VexPander®)
- . Catheter visual inspection
- Catheter dimensional inspection
- Guide wire compatibility test
- Guiding catheter compatibility test
- . Haemostasis valve compatibility
- . Balloon preparation, deployment and retraction
- Balloon fatigue test
- Balloon rated burst pressure (RBP)
- Balloon compliance
- . Balloon inflation and deflation time
- Catheter bond strength
- Tip pull test
- Flexibility and kink test
- Torque strength test
- . X-Ray detectability
- Particle contamination test
- . Balloon rated burst pressure (RBP; in stent)
6
- Balloon fatigue (repeat balloon inflations; in stent)
- . Bacterial endotoxin testing
8. Conclusion
Based on the indications for use, technological characteristics, and performance testing, the coronary dilatation balloon catheter (VesPenetrator®, VesTraveler®, VexPander®) has been shown to shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate device.