The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress release tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to difference dimension by inflating different pressure. The soft tip at the end of the balloon is to make the balloon catheter more easily to push to the stenosis position. The inner tubing which connects to the tip tubing is for guide wire passage and the pushing road. The two marker bands which wrapping on the inner tubing are for positioning the balloon location by cooperating in vitro monitoring equipment. The distal of the outer tube is connected with the balloon by a variable-diameter stretching structure, which can make the balloon get smaller winding diameter. The proximal of the outer tube is connected with the hub as the inflation passage and the pushing shaft. The hub is for connecting the outer pressure filling equipment. The stress release tubing is for protecting the outer tube from bending. The outer surface of the catheter is coated with a hydrophilic coating that ranges 400mm in length from the tip tube to the proximal end of the balloon, including part of the outer tube.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a PTA Balloon Dilatation Catheter. It outlines the device's characteristics, its comparison to a predicate device, and the performance data used to demonstrate substantial equivalence. However, it does not involve an AI/ML powered device, therefore no information about AI/ML specific aspects likes performance data, sample sizes for training/testing, ground truth establishment, or expert involvement for ground truth creation.

Here's the information based on the provided text, with "N/A" for criteria not applicable to this type of device submission:

Acceptance Criteria and Device Performance Study

The submission demonstrates substantial equivalence for the PTA Balloon Dilatation Catheter to a legally marketed predicate device (SABER .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, K133843). The acceptance criteria are based on meeting performance standards primarily through bench testing and biocompatibility assessments, ensuring the device is suitable for its intended use and does not raise new questions of safety or effectiveness compared to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The general acceptance criteria are that the device's design and construction are suitable for its intended use, and its performance is equivalent to the predicate device, as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020). Specific acceptance criteria were applied to each bench test listed below.

Acceptance Criterion (General)	Reported Device Performance
Device design and construction suitable for intended use, meeting relevant recommendations.	"The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use..."
Biocompatibility of body-contacting materials in accordance with ISO 10993-1 and FDA draft guidance.	"The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible."
Performance characteristics (e.g., burst pressure, flexibility, coating integrity) equivalent to or better than predicate, and safe for use.	See specific bench tests below. "The results met all acceptance criteria..."

Specific Bench Tests Conducted:

Visual inspection
Dimensional verification
Hydration test
Leakage test
Balloon inflation and deflation time
Balloon fatigue
Radiopacity
Simulated use test/guidewire and introducer sheath compatibility test
Tip pull strength
Catheter bond strength
Torque strength
Balloon rated burst pressure
Balloon compliance
Catheter body burst pressure
Flexibility and kinking
Coating integrity
Particulate evaluation
Infusion flow rate
Corrosion resistance test
Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility)
Shelf life testing

Specific Biocompatibility Tests Conducted:

Cytotoxicity
Sensitization
Intracutaneous reactivity
Acute systemic toxicity
Hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance)
Material-mediated pyrogenicity

All these tests "met all acceptance criteria."

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

The document indicates that bench testing and biocompatibility testing were performed. However, it does not specify the exact sample sizes used for each of these tests.

Data Provenance: Not explicitly stated, but typically, these tests are conducted under controlled laboratory conditions by the manufacturer or a contracted testing facility.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Ground truth is established through physical and chemical testing against engineering specifications and industry standards, not expert annotation of data.

4. Adjudication method for the test set

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. The "acceptance criteria" are based on quantitative measurements from bench and biocompatibility tests.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.

7. The type of ground truth used

The "ground truth" for this device is based on established engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and performance benchmarks derived from the predicate device and relevant FDA guidance documents. This is determined through physical measurements, chemical analyses, and simulated use tests.

8. The sample size for the training set

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device. There is no concept of a "training set" in this context.

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

N/A. This is a medical device (PTA Balloon Dilatation Catheter) submission, not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2022

Kossel Medtech (Suzhou) Co., Ltd. Ron Lv Regulatory Affair Engineer BLDG 6, No. 8, Jinfeng Road Suzhou, Jiangsu Province 215163 China

Re: K221245

Trade/Device Name: PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 1, 2022 Received: November 7, 2022

Dear Ron Lv:

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 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

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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 -
S
O'connell -S Date: 2022.12.14
13:02:23 -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) K221245

Device Name PTA Balloon Dilatation Catheter

Indications for Use (Describe)

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

Submitter:	Kossel Medtech (Suzhou) Co., Ltd.BLDG 6, No. 8 Jinfeng RoadSuzhou New District, Jiangsu Province, China
Contact Person:	Ron LvF3, BLDG 6, No. 8 Jinfeng RoadSuzhou New District,Jiangsu Province, ChinaPhone: +86 150 5142 9102Mail:lvxin@kosselmed.com
Date Prepared:	November 22, 2022
Trade Name:	PTA Balloon Dilatation Catheter
Common Name:	Percutaneous Transluminal Angioplasty (PTA) Catheter
	Classification Name: Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250), Class II(special controls)
Product Code:	LIT
Predicate Device:	Predicate Device:SABER .018 Percutaneous Transluminal Angioplasty (PTA) DilatationCatheter (K133843, cleared May 19, 2014)
Device Description:	The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube,inner tube, balloon, marker bands, outer tube, stress release tube and hub.Among them the balloon is the most important part of the catheter. In order todilate different stenosis, the balloon should be dilated to difference dimensionby inflating different pressure. The soft tip at the end of the balloon is to makethe balloon catheter more easily to push to the stenosis position. The innertubing which connects to the tip tubing is for guide wire passage and thepushing road. The two marker bands which wrapping on the inner tubing arefor positioning the balloon location by cooperating in vitro monitoringequipment. The distal of the outer tube is connected with the balloon by avariable-diameter stretching structure, which can make the balloon get smallerwinding diameter. The proximal of the outer tube is connected with the hub asthe inflation passage and the pushing shaft. The hub is for connecting the outerpressure filling equipment. The stress release tubing is for protecting the outertube from bending.The outer surface of the catheter is coated with a hydrophilic coating that ranges400mm in length from the tip tube to the proximal end of the balloon, includingpart of the outer tube.

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Image /page/4/Figure/1 description: The image shows a diagram of a medical device, specifically a balloon catheter. The different parts of the catheter are labeled, including the tip tube, balloon tube, outer tube, hub, stylet, marker band, stress release, and inner tube. The catheter has a long, thin shape with a balloon at the end, and the hub is located at the opposite end.

Intended Use/ The PTA balloon dilatation catheter is indicated for the percutaneous Indications transluminal angioplasty (PTA) of the peripheral vascular system, including the for Use: iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Comparisons of the new and predicate devices show that the technological Technological Characteristics: characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
The following table lists the material and size comparisons between the subject device and the predicate device.

TechnologicalCharacteristics	PTA Balloon Dilatation Catheter	Predicate DeviceSABER® PTA Dilatation CatheterK133843	Comparison
Balloon material	Nylon12	Nylon12	Identical
Coating	Hydrophilic	Hydrophilic	Identical
Balloon Diameters(mm)	2.0~7.0	2.0~10.0	Equivalent
Balloon lengths(mm)	20~300	20~300	Identical
Balloon compliance	Semi-Compliant	Semi-Compliant	Identical
Catheter Type	OTW	OTW	Identical
Guide wire size (inch)	0.018"	0.018"	Identical
Sheath Compatibility	6F	6F	Identical
Proximal shaft diameter	4.0F(1.32mm)/4.7F(1.55mm)	3.9F/4.7F	Equivalent
Distal shaft diameter	4.0F(1.32mm)/4.7F(1.55mm)	3.9F/4.7F	Equivalent
Catheter length(cm)	90/150	90/150	Identical
Rated burst Pressure(atm)	16atm (ø2.0-2.5×20-120mm);14atm (ø2.0-2.5×150-300mm,ø5.0-6.0×20-120mm);12atm (ø5.0-6.0×150-300mm, ø7.0×20-120mm);10atm (ø7.0×150-300mm)	18atm (ø2.0-2.5mm, ø3.0-4.0×20-100mm);16atm(ø5.0-6.0×20-100mm);14atm (ø7.0mm, ø3.0-6.0×150-300mm);12atm (ø8.0mm);10atm (ø9.0-10.0mm)	Equivalent

The following table lists the material and device and the predicate device.

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TechnologicalCharacteristics	PTA Balloon Dilatation Catheter	Predicate Device	Comparison
		SABER® PTA Dilatation CatheterK133843
Nominal pressure(atm)	6	6/8	Equivalent
Sterilization Method	EO	EO	Identical

The PTA Balloon Dilatation Catheter and predicate device have following same technological elements:

Operating principle balloon dilatation of stenotic portion by pressurization of inflation ● medium
Fundamental catheter design balloon, shaft, radiopaque marker, hub, coating
Balloon Length
Balloon compliance - Semi-Compliant
Catheter type - OTW
Guide wire size
Sheath Compatibility
Catheter effective length
Sterilization Ethylene oxide

There are following minor technological differences between PTA Balloon Dilatation Catheter and predicate device:

Combination of balloon diameter
Proximal/Distal shaft diameters
Pressure - Nominal Pressure and Rated Burst Pressure

Any differences that exist between the PTA Balloon Dilatation Catheter and the predicate device did not raise any new questions of safety or effectiveness.

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Performance Data: Bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:

Visual inspection
Dimensional verification
Hydration test
Leakage test
Balloon inflation and deflation time
. Balloon fatigue
Radiopacity
Simulated use test/guidewire and introducer sheath compatibility test
. . . . . Tip pull strength
Catheter bond strength
Torque strength
Balloon rated burst pressure
Balloon compliance
Catheter body burst pressure
. . . . Flexibility and kinking
Coating integrity
Particulate evaluation
Infusion flow rate
Corrosion resistance test
Packaging performance Test (Visual inspection, Sealing strength,
Sealing integrity, Sterility)
Shelf life testing ●

The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020).

Biocompatibility To demonstrate the biological safety of the body-contacting materials, the following biocompatibility testing, which was performed in accordance with 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk mangement process'; draft 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions' were followed. Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance), materialmediated pyrogenicity were conducted. The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible.
Conclusion: This information supports a determination of substantial equivalence between the PTA Balloon Dilatation Catheter and the predicate device described above.

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).