(139 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is a PTCA Balloon Dilatation Catheter, used for dilating stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion, which is a therapeutic intervention.
No.
The device is a treatment device (dilatation catheter) used for improving myocardial perfusion by dilating stenotic coronary arteries or bypass grafts, rather than for diagnosing a condition. Its primary function is therapeutic.
No
The device description clearly details a physical catheter with a balloon, lumens, hypotube, luer hub, and coatings, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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.
- Device Function: The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a device used inside the body during a medical procedure (angioplasty). It is used to physically dilate a narrowed blood vessel.
- Intended Use: The intended use clearly states it's for "balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion." This is a therapeutic intervention performed directly on the patient's anatomy.
The device is a therapeutic medical device, not a diagnostic one that analyzes samples.
N/A
Intended Use / Indications for Use
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Product codes
LOX
Device Description
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single luer hub for balloon inflation /deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip aids advancement to and through the stenosis. The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Coronary artery or bypass graft
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
Non-clinical laboratory testing was performed on the SC HONKYTONK™ PTCA Balloon Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed: Dimensional Verification, Simulated Use, Balloon Fatique, Inflation/Deflation Time, Flexibility/Kink, Radiopacity, Particulate, Component Dimensional Compatibility, Rated Burst Pressure, Compliance, Bond Strength (including Tip Pull), Torque, Coating Integrity. The in vitro bench tests demonstrated that the SC HONKYTONK™ PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and does not introduce new risks to safety or effectiveness when compared to the predicate device.
Biocompatibility testing was performed including: Cytotoxicity, Intracutaneous Reactivity, Complement Activation (SC5b-9), Material Mediated Pyrogenicity, Partial Thromboplastin Time, Sensitization, Hemolysis (Direct and Extract), Thrombogenicity, Acute Systemic Toxicity, Heparinized Blood Platelet and Leukocyte Count Assay. The results from the testing performed showed the SC HONKYTONK™ PTCA Balloon Dilatation Catheter to be biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 15, 2023
Sino Medical Sciences Technology Inc. c/o Semih Oktay President and CEO CardioMed Device Consultants, LLC 1783 Forest Drive, #254 Suite 254 Annapolis, Maryland 21401
Re: K223022
Trade/Device Name: SC HONKYTONK PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: January 12, 2023 Received: January 13, 2023
Dear Semih Oktay:
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.
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
1
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,
Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Date: 2023.02.15
05:00 nell -S 13:09:55 -05'00'
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) K223022
Device Name SC HONKYTONK PTCA Dilatation Catheter
Indications for Use (Describe)
The SC HONK YTONK PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
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
Image /page/3/Picture/1 description: The image shows the logo for Sinomed. The logo is blue and features the word "SINOMED" in a bold, sans-serif font. Below the word "SINOMED" is the tagline "Innovation for health" in a smaller, sans-serif font. The "O" in Sinomed is a lighter blue than the rest of the logo and has a small blue dot above it.
510(k) Summary
(as required by 21 CFR 807.92)
PTCA Dilatation Catheter
510(k) K223022
| Date Prepared: | September 28, 2022 |
|---|---|
| Applicant: | SINO Medical Sciences Technology Inc. |
| Contact Name: | H. Semih Oktay, PhD |
| Title: | President, CardioMed Device Consultants |
| Email: | soktay@cardiomedllc.com |
| Telephone: | (410) 271-2088 |
| Fax: | (410) 674-2133 |
| Trade Name: | SC HONKYTONK™ PTCA Dilatation Catheter |
| Device Classification: | Class II per 21 CFR §870.5100 |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, |
| Percutaneous | |
| Product Code: | LOX |
| Predicate Devices: | Emerge™ Monorail PTCA Dilatation Catheter,K163174 |
INTENDED USE/INDICATIONS FOR USE:
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
DEVICE DESCRIPTION:
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter is a rapid exchange catheter, including a semi-compliance balloon close to the distal tip. The catheter's distal portion is dual lumen and coaxial. The dual lumen includes an outer lumen for balloon inflation, and an inner lumen to allow a ≤0.014 in (0.36 mm) quidewire to facilitate catheter advancement to and through the stenosis that is to be dilated. The proximal portion of the catheter is a single-lumen, stainless steel hypotube that includes a single luer hub for balloon inflation /deflation. The balloon design provides for an inflatable segment of both known diameter and length at recommended pressures. A balloon protective sheath placed over the balloon maintains a low profile. A mandrel is positioned inside the inner lumen to protect catheter patency. The catheter's tapered tip aids advancement to and through the stenosis.
4
Image /page/4/Picture/1 description: The image shows the Sinomed logo. The logo is blue and features the word "SINOMED" in a bold, sans-serif font. The "O" in "SINOMED" is a circle with a smaller circle above it. Below the logo is the tagline "Innovation for health" in a smaller, sans-serif font.
The effective length of the catheter is 145 cm. Radiopaque marker bands, in conjunction with fluoroscopy, are aid for the placement of the catheter's balloon. The 1.50 mm device size has one radiopaque marker band, while all other sizes have two radiopaque marker bands. The entire balloon has a hydrophobic coating. The shaft has a hydrophilic coating from the guidewire port to just distal of the balloon.
COMPARISON WITH PREDICATE DEVICES:
Comparison of the SC HONKYTONK™ PTCA Balloon Dilatation Catheter and predicate device shows that the technological characteristics of the subject device such as the components, design, materials, sterilization method, shelf life and operating principle are similar to the currently marketed predicate. The intended use of the subject device and the predicate are the same.
5
Image /page/5/Picture/1 description: The image shows the logo for Sinomed. The logo is blue and features the word "SINOMED" in large, bold letters. Below the word is the tagline "Innovation for health" in smaller letters. The logo is simple and modern, and the blue color gives it a sense of trustworthiness and reliability.
Table 5-1: Comparison of SC HONKYTONK™ PTCA Balloon Dilatation Catheter and Predicate Device
| Subject | Predicate | ||
|---|---|---|---|
| Name of Device | SC HONKYTONK™ PTCA | ||
| Balloon Dilatation Catheter | Emerge ™ Monorail PTCA Dilatation | ||
| Catheter | |||
| Manufacturer | SINO Medical Sciences | ||
| Technology Inc. | Boston Scientific Corporation | ||
| 510(k) | TBD | K163174 | |
| Indications for Use | The SC HONKYTONK™ PTCA | ||
| Balloon Dilatation Catheter is | |||
| indicated for the balloon catheter | |||
| dilatation of the stenotic portion of | |||
| a coronary artery or bypass graft | |||
| stenosis for the purpose of | |||
| improving myocardial perfusion. | The Emerge Over-The-Wire and | ||
| Emerge Monorail PTCA Dilatation | |||
| Catheters (1.20 mm balloon models) | |||
| are indicated as pre-dilatation | |||
| catheters in the stenotic portion of a | |||
| coronary artery or bypass graft | |||
| stenosis (≥70% stenosis). | |||
| The Emerge Over-The-Wire and | |||
| Emerge Monorail PTCA Dilatation | |||
| Catheters (balloon models 1.50-4.00 | |||
| mm) are indicated for the balloon | |||
| catheter dilatation of the stenotic | |||
| portion of a coronary artery or bypass | |||
| graft stenosis for the | |||
| purpose of improving myocardial | |||
| perfusion. | |||
| The Emerge Over-The-Wire and | |||
| Emerge Monorail PTCA Dilatation | |||
| Catheters (balloon models 2.00-4.00 | |||
| mm) are also indicated for the post- | |||
| delivery expansion of balloon | |||
| expandable stents (bare metal and | |||
| drug-eluting). | |||
| Catheter | |||
| Shaft | |||
| Characteristic | Device Design | Rapid Exchange PTCA Catheter | Rapid Exchange PTCA Catheter |
| Radiopaque | |||
| Marker(s) | 2 Platinum iridium (For Ø 2.00- | ||
| 4.00mm)/1 Platinum iridium(For Ø | |||
| 1.50mm) | 2 Platinum iridium (For Ø 2.00- | ||
| 4.00mm)/1 Platinum iridium(For Ø 1.20 | |||
| and 1.50mm) | |||
| Useable | |||
| Length | 145cm | 144cm | |
| Balloon | |||
| Characteristics | Balloon | ||
| Diameters | 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, | ||
| 3.50 and 4.00mm | 1.20, 1.50, 2.00, 2.25, 2.50, 2.75, 3.00, | ||
| 3.25, 3.50, 3.75 and 4.00mm | |||
| Balloon | |||
| Lengths | 9, 12, 15, 20, 25, 30 and 35mm | 8, 12, 15, 20 and 30mm | |
| Rated Burst | |||
| Pressure | Diameter 1.50 - 3.50 mm, | ||
| RBP is 14 atm; | |||
| Diameter 4.00 mm, | |||
| RBP is 12 atm. | Diameter 1.20 mm, | ||
| RBP is 18 atm; | |||
| Diameter 1.50 - 3.25 mm, | |||
| RBP is 14 atm; | |||
| Diameter 3.50 - 4.00 mm, | |||
| RBP is 12 atm. | |||
| Hydrophilic coating | Yes | Yes | |
| Hydrophobic coating | Yes | Yes | |
| Guide catheter | |||
| compatibility | Minimum I.D.=0.056in (1.42mm) | Minimum I.D.=0.056in (1.42mm) | |
| Guidewire compatibility | ≤0.014in (0.36 mm) | ≤0.014in (0.36 mm) | |
| Sterilization Method | EO Sterilization | EO Sterilization |
6
Image /page/6/Picture/1 description: The image shows the logo for Sinomed. The logo is blue and features the word "SINOMED" in a sans-serif font. Below the word "SINOMED" is the phrase "Innovation for health" in a smaller font. The dot on the "i" in "SINOMED" is a lighter blue than the rest of the logo.
NON-CLINICAL TESTING/PERFORMANCE DATA:
Non-clinical laboratory testing was performed on the SC HONKYTONK™ PTCA Balloon Dilatation Catheter to determine substantial equivalence. The following testing/assessments were performed:
- Dimensional Verification ●
- Simulated Use ●
- Balloon Fatique ●
- Inflation/Deflation Time ●
- Flexibility/Kink
- . Radiopacity
●
- Particulate
- Component Dimensional Compatibility
- Rated Burst Pressure ●
- Compliance ●
- Bond Strength (including Tip Pull) ●
- Torque ●
- Coating Integrity .
The in vitro bench tests demonstrated that the SC HONKYTONK™ PTCA Balloon Dilatation Catheter met all acceptance criteria and performed similarly to the predicate device. Performance data demonstrate that the device functions as intended and does not introduce new risks to safety or effectiveness when compared to the predicate device.
BIOCOMPATIBILITY:
Testing was performed to assess biocompatibility of the SC HONKYTONK™ PTCA Balloon Dilatation Catheter. The following tests were performed:
- Cytotoxicity
- Intracutaneous Reactivity 0
- Complement Activation (SC5b-9) ●
- Material Mediated Pyrogenicity ●
- Partial Thromboplastin Time 0
- Sensitization
- Hemolysis (Direct and Extract) ●
- Thrombogenicity ●
- Acute Systemic Toxicity ●
- Heparinized Blood Platelet and ● Leukocyte Count Assay
The results from the testing performed showed the SC HONKYTONK™ PTCA Balloon Dilatation Catheter to be biocompatible.
CONCLUSION:
The SC HONKYTONK™ PTCA Balloon Dilatation Catheter has the same intended use and the same or similar technological characteristics such as components, design, materials, and operating principles as the predicate
7
Image /page/7/Picture/1 description: The image shows the logo for Sinomed. The logo is blue and features the word "SINOMED" in a bold, sans-serif font. Below the wordmark is the tagline "Innovation for health" in a smaller, lighter font. The "O" in Sinomed is a lighter blue than the rest of the wordmark.
device. Performance data demonstrates that the device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the SC HONKYTONK™ PTCA Balloon Dilatation Catheter does not introduce new risks to safety or effectiveness when compared to the predicate device.
Therefore, the SC HONKYTONK™ PTCA Balloon Dilatation Catheter is substantially equivalent to the predicate device.