The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

Device Description

The D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter is an over-the-wire balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.035" guidewires. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter in a Y-connector manifold with luer lock fillings. There are radiopaque marker bands located under the balloon to aid in positioning the system during the procedure. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter will be available with balloon diameters 3.0 mm to 12.0 mm, balloon lengths 20 mm to 150 mm and with shaft lengths of 50 cm, 75 cm, and 130 cm.

AI/ML Overview

This is a medical device submission, specifically for a balloon dilatation catheter, not an AI/ML powered device. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance) are not applicable here.

The document describes the performance criteria for the physical medical device and the studies conducted to demonstrate that the device meets those criteria, ensuring its substantial equivalence to a legally marketed predicate device.

Here's the information extracted based on your request, adapted for a medical device:

1. A table of acceptance criteria and the reported device performance

The document lists various in-vitro performance tests that were conducted and states that "The test results met all acceptance criteria" and "ensure the design and construction are suitable for its intended use." Specific numerical acceptance criteria are not detailed in this summary, but the successful outcome is reported. Some of these performance characteristics are implied comparisons to the predicate device, where "SE" (Substantial Equivalence) indicates the performance is considered comparable.

Acceptance Criteria (Implied / Tested)	Reported Device Performance
In vitro performance tests:	All met acceptance criteria and ensure design suitability.
Visual inspection	Met
Dimensional verification	Met
Crossing profile	Met
Guidewire compatibility	Met
Simulated use	Met
Air/liquid leak	Met
Flexibility and kink	Met
Torque strength	Met
Particulate release	Met
Coating integrity	Met
Lubricity	Met
Balloon rated burst pressure	Met
Balloon fatigue	Met
Balloon compliance	Met
Balloon inflation and deflation time	Met
Catheter bond strength	Met
Tip pull strength	Met
Trackability	Met
Radiopacity	Met
Biocompatibility testing:	Met all acceptance criteria; Device is biocompatible.
Cytotoxicity	Met
Sensitization test	Met
Intracutaneous reactivity test	Met
Systemic Toxicity test (Acute)	Met
Material-mediated pyrogenicity	Met
Hemocompatibility (hemolysis, complement activation, PTT, in vivo thrombo resistance)	Met
Sterility:	Sterile with SAL of 10-6 via EO sterilization.
Packaging/Shelf Life:	Shelf life of 2 years.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses in-vitro testing for the device. It does not mention a "test set" in the context of clinical data for AI/ML. The performance data is derived from laboratory tests on the physical device prototypes. No mention of country of origin or retrospective/prospective nature is given for these laboratory tests.

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

This concept is not applicable to the evaluation of a physical medical device like a balloon catheter. "Ground truth" established by experts is relevant for diagnostic AI/ML models.

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

This concept is not applicable to the evaluation of a physical medical device.

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 such study was conducted or mentioned, as this is not an AI-assisted device.

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

This refers to AI/ML algorithm performance. The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is a physical medical device, not an algorithm.

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

For the physical performance tests, the "ground truth" would be established engineering specifications, industry standards (like ISO 10993-1), and FDA guidance for Class II Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submission. Device performance against these established criteria forms the basis of proving suitability.

8. The sample size for the training set

This is not applicable to a physical medical device.

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

This is not applicable to a physical medical device.

Summary

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April 5, 2023

DK Medical Technology Co., Ltd. % Yuling Chen Consultant Microkn Business Consulting (Shanghai) Co., Ltd Room 1219, Block A, No 3699, Gonghexin Road, Jingan District Shanghai. 200435 China

Re: K214009

Trade/Device Name: D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: February 26, 2023 Received: March 2, 2023

Dear Yuling Chen:

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,

Digitally signed by Gregory W. Gregory W. O'connell O'connell -S Date: 2023.04.05 12:23:00 -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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K214009

Device Name

D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter

Indications for Use (Describe)

The D Kaptain™ PTA High Pressure Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, tibial, peroneal, subclavian, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in the coronary vasculature.

This catheter is not for use in the coronary 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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510K summary

According to the requirements Per 21 CFR §807.92, the following information is provided sufficient detail to understand the basis for a determination of substantial equivalence.

Company:	DK Medical Technology CO., Ltd.(DK)
Address:	301 unit, bioBAY B1, 218 Xinghu Str., Suzhou Industrial Park
Proprietary Name	PTA High Pressure Balloon Dilatation Catheter
Trade Name	D-KaptainTM PTA High Pressure Balloon Dilatation Catheter
Classification Name	Peripheral Transluminal Angioplasty Catheter
Regulation productcodes	LIT, DQY
Classification	Class 11, 21 CFR Part 870.1250
LegalManufacturer:	DK Medical Technology CO., Ltd.(DK)
Predicate Device	Mustang™ Balloon Dilatation Catheter
510(k) ofthepredicate device	K103751
Consultant
Company	Microkn Business Consulting (Shanghai) Co., Ltd.
Address	Room 1219, Block A, No 3699, Gonghexin Road, Jingan District,Shanghai, China
Contact Person	Yuling Chen
Telephone	+86 15021397762
Email	yuling.chen@microkn.com

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission

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1.Indications for use

This catheter is not for use in the coronary vasculature.

2. Description of the Device

3. Comparison to Predicate Device

To verify the Proposed device equivalent with the predicate device, the tab.1 listed the comparison results of clinical characteristics, technical characteristics, biological characteristics.

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Tab.1 Descriptive Comparison
SerialNumber	ITEMProduct Code510(k) number	Proposed deviceLIT, DQYK214009	Predicate deviceLIT, DQYK103751	Discussion
01	Intended use	The D·KaptainTM PTA High Pressure BalloonDilatation Catheter is a device that is introducedinto a vein or artery through the skin using adilator and a sheath (introducer) or guide wirefor Percutaneous Transluminal Angioplasty inthe peripheral vasculature and for the treatmentof obstructive lesions of native or syntheticarteriovenous dialysis fistulae.	The Mustang TM Balloon Dilatation Catheter isintended for dilatation of Device stenosis in theperipheral vascular, for the treatment ofobstructive lesions of native or syntheticarteriovenous dialysis fistulae andpost-deployed stent expansion of self-expandingand balloon expandable peripheral vascularstents.	SE
02	Indication for use	The D·KaptainTM PTA High Pressure BalloonDilatation Catheter is indicated for PercutaneousTransluminal Angioplasty (PTA) in theperipheral vasculature, including iliac, femoral,popliteal, tibial, peroneal, subclavian, and renalarteries and for the treatment of obstructivelesions of native or synthetic arteriovenousdialysis fistulae.This catheter is not for use in the coronary	The MustangTM Balloon Dilatation Catheter isindicated for percutaneous transluminalangioplasty (PTA) in the peripheral vasculatureincluding iliac, femoral, popliteal, tibial,peroneal, subclavian, and renal arteries, and forthe treatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae.The MustangTM Balloon Dilatation Catheter isalso indicated for post-dilatation of balloonexpandable and self-expanding stents in the	SE
	Tab.1 Descriptive Comparison
Serial	ITEM	Proposed device	Predicate device	Discussion
Number	Product Code	LIT, DQY	LIT, DQY
	510(k) number	K214009	K103751
		vasculature.	peripheral vasculature.
			This catheter is not for use in coronary arteries.
03	Location	Peripheral vasculature, including iliac, femoral,	Peripheral vasculature, including iliac, femoral,	SE
		popliteal, tibial, peroneal, subclavian, and renal	popliteal, infra-popliteal and renal arteries, and
		arteries and for the treatment of obstructive	for the treatment of obstructive lesions of native
		lesions of native or synthetic arteriovenous	or synthetic arteriovenous dialysis fistulae.
		dialysis fistulae.
04	Procedure	Percutaneous Transluminal Angioplasty (PTA)	Percutaneous Transluminal Angioplasty (PTA)	SE
05	Contraindications	This catheter is not for use in the coronary.vasculature.	This catheter is not for use in coronary arteries.	SE
06	Site of use	Hospitals and physician offices	Hospitals and physician offices	SE
Tab.1 Descriptive Comparison
Serial	ITEM	Proposed device	Predicate device	Discussion
Number	Product Code	LIT, DQY	LIT, DQY
	510(k) number	K214009	K103751
07	Intended user	Physicians with adequate training in performance of percutaneous transluminal angioplasty	Physicians with adequate training in performance of percutaneous transluminal angioplasty	SE
08	Components	Integral exchange balloon expandable catheters with components : tip, balloon, marker bands, inner lumen, strain relief, shaft tubing and hub.	Integral exchange balloon expandable catheters with components : tip, balloon, marker bands, inner lumen, strain relief, shaft tubing and hub.	SE
09	Catheter Type	OTW	OTW	SE
10	Materials	Nylon 12 , polyether block amide	Pebax7033, nylon 12	Difference 1
11	Device Coating(s)	No coating.	No coating.	SE
12	Models	189 models; balloon diameter: 3mm~~12mm; balloon length: 20mm~~150mm.	203 models; diameter: 3mm~12mm; balloon length: 20-200 mm.	Difference 2
13	Useable Catheter Length	75-130 cm	80-150 cm	SE
14	Guidewire Compatibility	0.035"	0.035"	SE
15	Nominal Pressure (atm)	8	8	SE
16	RBP (atm)	14-26	16-24	SE
17	Marker Bands	YES	YES	SE
Tab.1 Descriptive Comparison
SerialNumber	ITEM	Proposed device	Predicate device	Discussion
	Product Code	LIT, DQY	LIT, DQY
	510(k) number	K214009	K103751
18	Can Infuse Contrast	YES	YES	SE
19	Packaging	Pouch in Pressboard carton	Pouch in Pressboard carton	SE
20	Sterilization	EO, the SAL is 10-6	EO, the SAL is 10-6	SE

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Difference 1

The material is different. The biocompatibility testing and evaluation result of the subject device is biocompatible.

The difference does not raise new questions of safety or effectiveness.

Difference 2

The balloon length size of the subject device. The verification and validation testing of all sizes demonstrate the

difference does not raise new questions of safety or effectiveness.

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4. Performance data in support of the substantial equivalence

The following performance data were provided in support of the substantial equivalence.

4.1 Performance

In vitro performance tests, including visual inspection, dimensional verification, crossing profile, guidewire compatibility, simulated use, air/liquid leak, flexibility and kink, torque strength, particulate release, coating integrity, lubricity, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, trackability, and radiopacity were conducted. The test results met all acceptance criteria and ensure the design and construction are suitable for its intended use as recommended by the Class II Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submission (FDA; January 13, 2020).

4.2 Biocompatibility testing

Biocompatibility testing for the D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter was performed in accordance with the recommendations of ISO 10993-1, Biological Evaluation of Medical Device - Part 1: Evaluation and Testing. Tab.2 listing the testing results. The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible.

Tab.2 Biocompatibility testing
Cytotoxicity
Sensitization test
Intracutaneous reactivity test
Systemic Toxicity test (Acute)
Material-mediated pyrogenicity

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Tab.2 Biocompatibility testing

hemocompatibility (hemolysis, complement activation, PTT, and in vivo thrombo resistance)

4.3 STERILITY

The D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter is sterile. The method employed for the sterilization of the D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter is Ethylene oxide sterilization according to the EN ISO 11135:2014 sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

4.4 Clinical Evidence

N/A

4.5 Animal Study

4.6 PACKAGING/SHELF LIFE

Simulated shipping testing, accelerated aging testing, and sterility package validation were carried out to decide the shelf life of the D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter. Testing results demonstrated that the shelf life of the D.Kaptain™ PTA High Pressure Balloon Dilatation Catheter was 2 years.

5. Conclusion

Based on the verification and validation testing, the D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter does not raise new questions of safety and effectiveness compared to the

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predicate device.

DK Medical Technology CO., Ltd.(DK) believes that the information and data provided clearly describes the D·Kaptain™ PTA High Pressure Balloon Dilatation Catheter and demonstrates that the device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).