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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification for the SC HONKYTONK™ PTCA Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, the Emerge™ Monorail PTCA Dilatation Catheter (K163174), through non-clinical testing. This type of submission generally relies on bench testing and does not typically involve clinical studies with human participants or AI performance evaluations as described in your prompt.

Therefore, many of the requested categories are not applicable to this type of regulatory submission and the provided document.

Here's an breakdown based on the information provided and standard 510(k) practices for this type of device:

Acceptance Criteria and Device Performance for SC HONKYTONK™ PTCA Dilatation Catheter

This submission relies on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. The "acceptance criteria" are implied by the successful completion and meeting of specifications for each test. The "reported device performance" refers to the outcomes of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Device meets specified engineering and functional requirements.	"Met all acceptance criteria and performed similarly to the predicate device."
Dimensional Verification	Within specified tolerances.	Successful
Simulated Use	Functions correctly under simulated clinical conditions.	Successful
Balloon Fatigue	Maintains integrity after multiple inflation/deflation cycles.	Successful
Inflation/Deflation Time	Within specified time limits.	Successful
Flexibility/Kink	Maintains patency and structural integrity during manipulation.	Successful
Radiopacity	Clearly visible under fluoroscopy.	Successful
Particulate	Meets limits for particulate matter release.	Successful
Component Dimensional Compatibility	Components fit and function together as designed.	Successful
Rated Burst Pressure	Withstands specified pressure without bursting prematurely.	Successful (Specific pressures listed in Table 5-1 match expectations)
Compliance	Balloon expands to expected diameter at rated pressure.	Successful
Bond Strength (including Tip Pull)	Connections remain secure under stress.	Successful
Torque	Transmits rotational force effectively.	Successful
Coating Integrity	Coatings remain intact and functional.	Successful
Biocompatibility	Materials are biocompatible and do not elicit adverse biological responses.	"SC HONKYTONK™ PTCA Balloon Dilatation Catheter to be biocompatible."
Cytotoxicity	Non-toxic to cells.	Successful
Intracutaneous Reactivity	No significant irritation.	Successful
Complement Activation (SC5b-9)	Low or acceptable level of complement activation.	Successful
Material Mediated Pyrogenicity	No pyrogenic response.	Successful
Partial Thromboplastin Time	No or acceptable impact on blood clotting time.	Successful
Sensitization	No allergic/sensitization response.	Successful
Hemolysis (Direct and Extract)	Acceptable level of red blood cell lysis.	Successful
Thrombogenicity	Low thrombogenic potential.	Successful
Acute Systemic Toxicity	No short-term systemic toxic effects.	Successful
Heparinized Blood Platelet and Leukocyte Count Assay	Acceptable impact on blood cell counts.	Successful

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a number of "patients" or "images" since this is a non-clinical bench study. The "sample size" refers to the number of devices or components tested for each specific bench test (e.g., a certain number of balloons for burst pressure, a certain number of catheters for simulated use). These numbers are not detailed in the summary document but would be part of the full testing report submitted to the FDA.
Data Provenance: Non-clinical (bench) laboratory testing performed by the manufacturer, Sino Medical Sciences Technology Inc. The data is generated in a controlled laboratory environment, not from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). This is a non-clinical bench study for a PTCA catheter. "Ground truth" in the clinical sense (e.g., expert diagnosis of an image) is not established. The "truth" is based on engineering specifications and validated test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple readers (typically human experts reviewing images/data). This submission is based on automated or semi-automated bench test results against predefined criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a non-clinical 510(k) submission for a medical device (catheter), not an AI/CADe/CADx device that would involve human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a non-clinical 510(k) submission for a medical device (catheter) with no AI component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications and Industry Standards: The "ground truth" for non-clinical testing is based on the device's design specifications, relevant ISO/ASTM standards (e.g., for material properties, biocompatibility), and comparison to the predicate device's established performance parameters. For example, a balloon's rated burst pressure is a design specification, and the test verifies it meets that "ground truth."

8. The sample size for the training set

Not Applicable (N/A). There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, and specific units are selected for verification and validation (V&V) testing.

9. How the ground truth for the training set was established

Not Applicable (N/A). As there is no training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K223022

Device Name SC HONKYTONK PTCA Dilatation Catheter

Indications for Use (Describe)

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)

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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:

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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.

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Table 5-1: Comparison of SC HONKYTONK™ PTCA Balloon Dilatation Catheter and Predicate Device

		Subject	Predicate
Name of Device		SC HONKYTONK™ PTCABalloon Dilatation Catheter	Emerge ™ Monorail PTCA DilatationCatheter
Manufacturer		SINO Medical SciencesTechnology Inc.	Boston Scientific Corporation
510(k)		TBD	K163174
Indications for Use		The SC HONKYTONK™ PTCABalloon Dilatation Catheter isindicated for the balloon catheterdilatation of the stenotic portion ofa coronary artery or bypass graftstenosis for the purpose ofimproving myocardial perfusion.	The Emerge Over-The-Wire andEmerge Monorail PTCA DilatationCatheters (1.20 mm balloon models)are indicated as pre-dilatationcatheters in the stenotic portion of acoronary artery or bypass graftstenosis (≥70% stenosis).The Emerge Over-The-Wire andEmerge Monorail PTCA DilatationCatheters (balloon models 1.50-4.00mm) are indicated for the ballooncatheter dilatation of the stenoticportion of a coronary artery or bypassgraft stenosis for thepurpose of improving myocardialperfusion.The Emerge Over-The-Wire andEmerge Monorail PTCA DilatationCatheters (balloon models 2.00-4.00mm) are also indicated for the post-delivery expansion of balloonexpandable stents (bare metal anddrug-eluting).
CatheterShaftCharacteristic	Device Design	Rapid Exchange PTCA Catheter	Rapid Exchange PTCA Catheter
	RadiopaqueMarker(s)	2 Platinum iridium (For Ø 2.00-4.00mm)/1 Platinum iridium(For Ø1.50mm)	2 Platinum iridium (For Ø 2.00-4.00mm)/1 Platinum iridium(For Ø 1.20and 1.50mm)
	UseableLength	145cm	144cm
BalloonCharacteristics	BalloonDiameters	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
	BalloonLengths	9, 12, 15, 20, 25, 30 and 35mm	8, 12, 15, 20 and 30mm
	Rated BurstPressure	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 cathetercompatibility		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

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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

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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.

Regulation Number and Section

§ 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.