K Number

Device Name

D·Kutting PTA Scoring Balloon Dilatation Catheter

Manufacturer

DK Medical Technology Co., Ltd.

Date Cleared

2024-03-07

(225 days)

Product Code

PNO

Regulation Number

870.1250

Intended Use

The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Device Description

The D·Kutting™ PTA Scoring Balloon Dilatation Catheter is an Over-The-Wire (OTW) balloon catheter with a dual lumen shaft design. One lumen is used to pass the catheter over 0.018" or 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. 3 scoring wires between the two marker bands are radially distributed every 120° and mounted on the surface of the balloon. A PVP coating is applied to the tip to enhance insertion and withdrawal performance. The D. Kutting™ PTA Scoring Balloon Dilatation Catheter will be available with balloon diameters 4.0 mm to 8.0 mm, balloon lengths 20 mm to 80 mm and with catheter lengths of 50 cm, 90 cm, and 130 cm. The diameter and length of the balloon and the diameter of the compatible guide wire are printed on the hub.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K151253

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML.

Therapeutic

Yes
The device is a therapeutic device because its intended use is for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which involves a direct medical intervention to restore normal function.

Diagnostic

No.
The device is a balloon dilatation catheter used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic intervention, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical balloon catheter with various hardware components (shaft, lumens, balloon, scoring wires, manifold, Luer lock fittings, coating). Performance studies also focus on physical characteristics and in vivo testing, not software validation.

IVD (In Vitro Diagnostic)

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 the body (in vitro).
Device Function: The D Kutting™ PTA Scoring Balloon Dilatation catheter is a device used inside the body (in vivo) to physically treat obstructive lesions in blood vessels. It's a therapeutic device, not a diagnostic one.
Intended Use: The intended use clearly states "Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions," which is a medical procedure performed on the patient's body.
Device Description: The description details a catheter with a balloon and scoring wires designed for mechanical dilation within a blood vessel.
Performance Studies: The performance studies focus on the physical properties, biocompatibility, and in vivo performance of the device, not on the analysis of biological specimens.

Therefore, based on the provided information, the D Kutting™ PTA Scoring Balloon Dilatation catheter is a therapeutic medical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Product codes (comma separated list FDA assigned to the subject device)

PNO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians with adequate training in performance of percutaneous transluminal angioplasty / Hospitals and physician offices

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)

Performance data provided in support of substantial equivalence included:

In vitro performance tests: visual inspection, dimensional verification, crossing profile, hydration, simulated use, guidewire compatibility, sheath compatibility, air/liquid leak, Luer lock. flexibility and kink test, torque strength, particulate release, coating integrity, lubricity, balloon inflation time, balloon deflation time, RBP and compliance, balloon fatigue and free from leakage, catheter bond strength, tip pull test and radiopacity. The test results met all acceptance criteria.
Biocompatibility testing: Performed in accordance with ISO 10993-1:2018. Tests included Cytotoxicity, Irritation test, Sensitization test, Intracutaneous reactivity test, Systemic Toxicity test (Acute), Pyrogen test, and Hemocompatibility (Hemolysis, Complement activation, in vivo thrombo resistance, Platelet Leukocyte Testing and Partial Thromboplastin Time). The results met all acceptance criteria and demonstrated biocompatibility.
Sterility: Ethylene oxide sterilization according to EN ISO 11135:2014.
Clinical Evidence: N/A
Animal Study: In vivo safety and performance of the subject device were studied in an animal model. Both the subject device and the predicate device were successfully deployed, demonstrating that the in vivo safety and operability of the subject device is not inferior to that of the predicate device.
Packaging/Shelf Life: Simulated shipping testing, accelerated aging testing, and sterility package validation were carried out. Testing results demonstrated a shelf life of 36 months.

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.

K151253

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.

Not Found

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

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).

Summary

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.

March 7, 2024

DK Medical Technology Co., Ltd. % Heather Wang Consultant Microkn Medical Technology Service (Shanghai) Co., Ltd. Room 901, No. 889, Pinglu Road, Jing'an District Shanghai. 200435 China

Re: K232207

Trade/Device Name: D.Kutting™ PTA Scoring Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: PNO Dated: January 30, 2024 Received: January 30, 2024

Dear Heather Wang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 Ariel Ariel G. Ash-G. Ash-shakoor -S Date: 2024.03.07 shakoor -S 08:22:54 -05'00'

For

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

Indications for Use

510(k) Number (if known) K232207

Device Name

D KuttingTM PTA Scoring Balloon Dilatation Catheter

Indications for Use (Describe)

The D Kutting™ PTA Scoring Balloon Dilatation catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

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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510(k) 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.

Submitter:
Name	DK Medical Technology Co., Ltd.
Address	301 unit, bioBAY B1, 218 Xinghu Str., Suzhou Industrial Park,
Jiangsu, China, 215123
Telephone	+86 512 69880808
Contact person	Shi Quan
Date of summary prepared	2024-02-27
Subject Device:
Name	PTA Scoring Balloon Dilatation Catheter
Trade name	D·Kutting™ PTA Scoring Balloon Dilatation Catheter
Device classification name	Percutaneous Cutting/Scoring Catheter
510(k) number	K232207
Regulation number	21 CFR Part 870.1250
Product code	PNO
Classification	Class II
Predicate Device:
Name	2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
Device classification name	Percutaneous Cutting/Scoring Catheter
510(k) number	K151253
Regulation number	21 CFR Part 870.1250
Product code	PNO
Classification	Class II

Image /page/5/Picture/0 description: The image contains the logo for DK Medtech. The logo consists of an orange circle with a white abstract design inside, followed by the text "DK MEDTECH" in orange. Above the text are three Chinese characters in black.

1. Indications for use

The D.Kutting™ PTA Scoring Balloon Dilatation Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

2. Description of the Device

3. Comparison to Predicate Device

To verify the subject device equivalent with the predicate device, the Table 1 lists the comparison results of clinical characteristics, technical characteristics, biological characteristics.

	Characteristics	Subject Device	Predicate Device
#	Product Code	PNO	PNO	Discussion
	510(k) Number	K232207	K151253
01	Intended use	The D-Kutting™ PTA Scoring
Balloon Dilatation Catheters are
indicated for Percutaneous
Transluminal Angioplasty (PTA)
of obstructive lesions of synthetic
or native arteriovenous dialysis
fistulae.	The Peripheral Cutting Balloon
catheters are indicated for
Percutaneous Transluminal
Angioplasty (PTA) of
obstructive lesions of synthetic
or native arteriovenous dialysis
fistulae.	SE
02	Indication for use	The D-Kutting™ PTA Scoring
Balloon Dilatation Catheters are
indicated for Percutaneous
Transluminal Angioplasty (PTA)
of obstructive lesions of synthetic
or native arteriovenous dialysis
fistulae.	The Peripheral Cutting Balloon
catheters are indicated for
Percutaneous Transluminal
Angioplasty (PTA) of
obstructive lesions of synthetic
or native arteriovenous dialysis
fistulae.	SE
03	Procedure	Percutaneous Transluminal
Angioplasty (PTA)	Percutaneous Transluminal
Angioplasty (PTA)	SE
04	Contraindications	Use of the D-Kutting™ PTA
Scoring Balloon Dilatation
Catheter is contraindicated in
situations where the product
would be passed through the
struts of a previously placed stent	Use of the Cutting Balloon
Device is contraindicated in
situations where the Cutting
Balloon Device would be
passed through the struts of a
previously placed stent as the	SE
	Characteristics	Subject Device	Predicate Device
#	Product Code	PNO	PNO	Discussion
	510(k) Number	K232207	K151253
		as the deflated product could
become entangled in the stent.
The product is not for use in the
coronary arteries and carotid
arteries.
The product is not intended for
the expansion or delivery of
stents.	deflated Cutting Balloon Device
could become entangled in the
stent.
The Peripheral Cutting Balloon
Device is not for use in the
coronary arteries and carotid
arteries.
The Peripheral Cutting Balloon
Device is not intended for the
expansion or delivery of stents.
05	Site of use	Hospitals and physician offices	Hospitals and physician offices	SE
06	Intended user	Physicians with adequate training
in performance of percutaneous
transluminal angioplasty	Physicians with adequate
training in performance of
percutaneous transluminal
angioplasty	SE
07	Components	Integral exchange balloon
dilatation catheters with
components: tip, balloon, scoring
wire, marker bands, inner lumen,
strain relief, shaft tubing and hub.	Integral exchange balloon
dilatation catheters with
components: tip, balloon, blade,
marker bands, inner lumen,
strain relief, shaft tubing and
hub.	SE
08	Catheter Type	OTW	OTW	SE
09	Materials	Proprietary Material Information	Proprietary Material
Information	Difference 1
10	Guidewire
Compatibility	0.018 inch/0.035 inch	0.018 inch	Difference 2
11	Sheath
Compatibility	7F	7F	SE
12	Models	120models;
Balloon diameter:4-8mm
Balloon length:20-80mm
Catheter Length:50-130cm	12models;
Balloon diameter:5-8mm
Balloon length:20mm
Catheter Length:50-135cm	Difference 3
13	Nominal
Pressure (atm)	8	6	Difference 4
14	RBP (atm)	20	10	Difference 4
15	Marker Bands
Present	YES	YES	SE
16	Can Infuse Contrast	YES	YES	SE
17	Packaging
Configuration	Pouch in Pressboard carton	Pouch in Pressboard carton	SE
18	Sterilization	EO sterilization, the SAL is 10-6	Irradiation sterilization	Difference 5

Table 1 Descriptive Comparison

Image /page/6/Picture/0 description: The image contains a logo for DK Medtech. The logo consists of an orange circle with a white abstract design inside. To the right of the circle are the Chinese characters for "DK Medtech" above the English letters "DK MEDTECH".

Image /page/7/Picture/0 description: The image contains a logo for DK Medtech. The logo consists of an orange circular icon on the left, followed by the company name in both Chinese characters and English. The English name, "DK MEDTECH," is written in orange and is located directly below the Chinese characters.

Difference 1:

The materials used are different. The biocompatibility testing and evaluation result of the subject device demonstrated that the subject device is biocompatible. The difference does not raise new questions of safety or effectiveness.

Difference 2:

The guidewire compatibility of the subject device consists of 0.018 inch and 0.035 inch models, while the guidewire compatibility of the predicate device consists of only 0.018 inch models. The subject device underwent performance testing for both guidewire sizes and demonstrated that the guidewire sizes were compatible with their labeled respective models. The difference does not raise new questions of safety or effectiveness.

Difference 3:

The minimum diameter of the subject device's balloon is 4 mm, and the maximum diameter is 8 mm. It is divided into 1 mm steps (4 mm, 5 mm, 7 mm, 8 mm). The minimum length of the subject device's balloon is 20 mm, and the maximum length is 80 mm. It is divided into 20 mm steps (20 mm, 40 mm, 60 mm, 80 mm). The minimum effective catheter length is 50 cm and the maximum is 130 cm. It consists of 50 cm, 90 cm, 130 cm.

The minimum diameter of the predicate device's balloon is 5 mm, and the maximum diameter is 8 mm. It is divided into 1 mm steps (5 mm, 6 mm, 7 mm, 8 mm). The length of the predicate device's balloon is only 20 mm. The minimum effective catheter length is 50 cm and the maximum is 135 cm. It consists of 50 cm, 90 cm and 135 cm.

The subject device underwent performance testing representative of the product size matrix and demonstrated acceptable performance. The difference does not raise new questions of safety or effectiveness.

Difference 4:

The Nominal Pressure and RBP of subject device is 8atm and 20atm respectively, and predicate device's is 6atm and 10atm respectively. The subject device underwent performance testing with regards to balloon performance, including Balloon diameter to inflation pressure, Balloon inflation time, Balloon deflation time and Balloon rated burst pressure and demonstrated acceptable performance. The difference does not raise new questions of safety or effectiveness.

Difference 5:

The subject device uses EO Sterilization, while the predicate device uses Irradiation sterilization. Both are established sterilization methods that target SAL 106. The subject device underwent sterilization validation and sterility verification as part of shelf life testing, and demonstrated acceptable performance. The difference does not raise new questions of safety and effectiveness.

Image /page/8/Picture/0 description: The image is a logo for DK Medtech. The logo consists of an orange circular icon on the left, followed by the company name in both Chinese and English. The English name, "DK MEDTECH," is written in a sans-serif font and is placed below the Chinese characters.

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 are included: visual inspection, dimensional verification, crossing profile, hydration, simulated use, guidewire compatibility, sheath compatibility, air/liquid leak, Luer lock. flexibility and kink test, torque strength, particulate release, coating integrity, lubricity, balloon inflation time, balloon deflation time, RBP and compliance, balloon fatigue and free from leakage, catheter bond strength, tip pull test and radiopacity.

The test results met all acceptance criteria and verified that 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; April 14, 2023).

4.2 Biocompatibility testing

Biocompatibility testing for the D Kutting™ PTA Scoring Balloon Dilatation Catheter was performed in accordance with the recommendations of ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. Table 2 lists the testing. The results of the testing show that the subject device met all acceptance criteria and the subject device is biocompatible.

Biocompatibility testing
Cytotoxicity
Irritation test
Sensitization test
Intracutaneous reactivity test
Systemic Toxicity test (Acute)
Pyrogen test
Hemocompatibility
(Hemolysis, Complement activation, in vivo thrombo resistance, Platelet Leukocyte Testing and
Partial Thromboplastin Time)

Table 2 Biocompatibility testing

4.3 Sterility

The D.Kutting™ PTA Scoring Balloon Dilatation Catheter is sterile. The method employed for the sterilization of the D.Kutting™ PTA Scoring 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

Image /page/9/Picture/0 description: The image contains the logo for DK Medtech. The logo consists of an orange circle with a white abstract design inside. To the right of the logo are the Chinese characters for the company name, with the English name "DK MEDTECH" written in orange below the Chinese characters.

4.5 Animal Study

In vivo safety and performance of the subject device were studied in the animal model. Both the subject device and the predicate device were successfully deployed and it is demonstrated that the in vivo safety and operability of the subject device is not inferior to that of the predicate device.

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 subject device. Testing results demonstrated that the shelf life of the D·Kutting™ PTA Scoring Balloon Dilatation Catheter is 36 months.

5. Conclusion

Based on the verification and validation testing, the D.Kutting™ PTA Scoring Balloon Dilatation Catheter does not raise new questions of safety and effectiveness compared to the predicate device.

DK Medical Technology Co., Ltd.(DK) believes that the information and data provided clearly describes the D Kutting™ PTA Scoring Balloon Dilatation Catheter and demonstrates that the device is substantially equivalent to the predicate device.