The Parafleet SC 014 / Parafleet SC 035 is intended to dilate stenoses in the iliac. femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

Device Description

The Parafleet balloon dilatation catheter family consists of Parafleet SC 014, Parafleet SC 018 and Parafleet SC 035 PTA balloon catheter. The PTA (OTW type) device is an over the wire (OTW) peripheral balloon catheter, specially designed for Percutaneous Transluminal Angioplasty (PTA). The Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

AI/ML Overview

The BrosMed Medical Co., Ltd.'s Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 PTA Balloon Dilatation Catheters underwent various performance tests to ensure substantial equivalence to predicate devices and suitability for their intended use.

1. Acceptance Criteria and Reported Device Performance:

The document lists several performance tests conducted, implying that the acceptance criteria for these tests were met to demonstrate substantial equivalence. The reported device performance is that "The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use."

While specific numerical acceptance criteria and precise performance values are not provided in the summary, the general categories of tests and their "met" status serve as the reported performance against inferred acceptance criteria derived from FDA guidance and predicate device characteristics.

Here’s a table summarizing the types of tests (representing categories of acceptance criteria) and the reported performance:

Category of Acceptance Criteria (Test)	Reported Device Performance
Bench Testing
Dimensional Verification	Met acceptance criteria
Simulated Use	Met acceptance criteria
Balloon Rated Burst Pressure	Met acceptance criteria
Balloon Fatigue	Met acceptance criteria
Balloon Compliance	Met acceptance criteria
Balloon Inflation and Deflation Time	Met acceptance criteria
Catheter Bond Strength	Met acceptance criteria
Tip Pull Strength	Met acceptance criteria
Flexibility and Kinking	Met acceptance criteria
Torque Strength	Met acceptance criteria
Radiopacity	Met acceptance criteria
Coating Friction	Met acceptance criteria
Coating Integrity	Met acceptance criteria
Particulate Evaluation	Met acceptance criteria
Catheter Body Burst Pressure	Met acceptance criteria
Balloon Rated Burst Pressure (in stent)	Met acceptance criteria
Balloon Fatigue (in stent)	Met acceptance criteria
Biocompatibility Testing
Cytotoxicity	Met acceptance criteria
Sensitization	Met acceptance criteria
Intracutaneous Reactivity	Met acceptance criteria
Systemic Toxicity	Met acceptance criteria
Hemolysis	Met acceptance criteria
Thrombosis	Met acceptance criteria
Complement Activation	Met acceptance criteria
Pyrogenicity	Met acceptance criteria
Sterilization Packaging and Shelf Life	Met acceptance criteria

2. Sample Size for the Test Set and Data Provenance:

The document does not specify the exact sample sizes used for each of the performance tests. The data provenance (e.g., country of origin, retrospective/prospective) for these tests is also not explicitly stated in the provided text. However, it's typical for such bench and biocompatibility tests to be conducted in a laboratory setting by the manufacturer (BrosMed Medical Co., Ltd. in China) or a contract research organization.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable to the provided document. The submission pertains to a medical device's performance characteristics (e.g., mechanical, material, biocompatibility) rather than an AI/ML-driven diagnostic or prognostic device that would require expert-established ground truth for interpretation of images or patient data. The tests performed are objective, physical, and chemical evaluations.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. No subjective interpretation requiring adjudication is mentioned for the performance testing of these physical medical devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable as the device is a PTA Balloon Dilatation Catheter, not an AI-assisted diagnostic tool. Therefore, there is no human-in-the-loop performance or comparison with AI assistance.

6. Standalone Performance (Algorithm Only):

This section is not applicable as the device is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests in this context is established by objective engineering specifications, material standards, and regulatory guidance documents (e.g., FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff' and ISO 10993-1 for biocompatibility).

For example:

Dimensional verification checks against the device's design specifications.
Balloon Rated Burst Pressure tests against the manufacturer's specified burst pressure and regulatory safety limits.
Biocompatibility testing assesses against established biological safety endpoints defined by ISO standards.

8. Sample Size for the Training Set:

This section is not applicable as the device is a physical medical device and does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reasons as point 8.

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.

February 27, 2025

BrosMed Medical Co., Ltd. Crystal Lee Registration and Clinical Medicine Department Manager 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan, Guangdong 523808 China

Re: K243704

Trade/Device Name: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 28, 2024 Received: November 29, 2024

Dear Crystal Lee:

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.

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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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

ARIEL G. ASH- Digitally signed by ARIEL
SHAKOOR -S G. ASH-SHAKOOR -S
Date: 2025.02.27 10:00:55
-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

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Indications for Use

510(k) Number (if known) K243704

Device Name Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter

Indications for Use (Describe)

This device is also indicated for stent dilatation post-deployment in the peripheral 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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510(k) SUMMARY

1. GENERAL INFORMATION

1.1 Submitter

BrosMed Medical Co., Ltd. 15th Buildings, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China Office: +86 (769) 2289 2018 Fax: +86 (769) 2289 2016

1.2 Contract person

Crystal Lee, Email: crystallee@brosmed.com Office: +86 (769) 2289 2018

1.3 Date of Preparation January 24, 2025

2. NAME OF THE DEVICE

2.1.1 Trade/Proprietary Name Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter;

2.1.2 Common/Usual Name Percutaneous Transluminal Angioplasty (PTA) Catheter

2.1.3 Classification Information

Classification Name:	Percutaneous Catheter
Classification Regulation:	21 CFR 870.1250
Device Class:	Class II
Product Code:	LIT
Review Panel:	Cardiovascular

3. PREDICATE DEVICE AND REFERENCE DEVICES

. Primary Predicate Device: Polux, Minerva, Atropos PTA Balloon Catheter (K160256, cleared on July 29, 2016)
Reference Devices: . Ultraverse 014 and 018 PTA Balloon Dilatation Catheters (K192318, cleared on October 3, 2019) Ultraverse 035 PTA Balloon Dilatation Catheter (K142261, cleared on September 24, 2014) Sleek OTW PTA Catheter (K102035, cleared on December 1, 2010)

DESCRIPTION OF THE DEVICE 4.

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Parafleet SC catheter is available in working lengths of 40cm, 90cm, 120cm, 150cm and 200cm, with balloon diameters ranging from 1.25mm to 12.0mm. The Parafleet features an outer tube and inner tube lumen shaft ending in a Y-hub manifold with luer lock fittings. One lumen is used for inflation of the balloon and accessed via the side leg port. The second lumen, starting at the straight entry port, allows access to the distal tip of the catheter for a standard 0.014 inch / 0.018 inch / 0.035 inch guide wire insertion. The catheter is sterilized with EO and for single use only. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.

న. INDICATION FOR USE

The Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 is intended to dilate stenoses in the illiac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

COMPARISION SUMMARY WITH PREDICATE DEVICES 6.

The information of subject devices and predicate devices summarized as below Table 1.

Table 1 Subject Device & Predicate Devices

Trade Name	Parafleet SC014, ParafleetSC 018,Parafleet SC035 PTABalloonDilatationCatheter- Proposeddevice	Polux, Minerva,Atropos PTABalloonDilatationCatheter- Predicatedevice	Ultraverse 014and 018 PTABalloonDilatationCatheters- Referencedevice	Ultraverse 035PTA BalloonDilatationCatheter- Referencedevice	Sleek OTWPTA Catheter-Referencedevice
510(K) Number	K243704	K160256	K192318,K121856,K093965	K142261	K102035
Owner/Operator	BrosMedMedical Co.,Ltd	BrosMedMedical Co.,Ltd	Bard PeripheralVascular, Inc	Bard PeripheralVascular, Inc	Clear StreamTechnologies,Ltd

The subject devices have the following similarities to the predicate devices:

Same principle of operation
Same mechanism of action ●
Same indication for use
Same sterilization method
Same balloon size
Similar materials
. Similar device components

Please see below Table 2 and Table 3 for the comparison between Subject devices and Predicate devices.

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Element of	Proposed	Predicate	Reference	Reference	Reference	Judgement
Comparison	device	device	device	device	device
ProductName	Parafleet SC014, ParafleetSC 018,Parafleet SC035	Polux,Minerva,Atropos	Ultraverse014 and 018	Ultraverse035	Sleek	/
ProductCode	LIT	LIT	LIT	LIT	LIT	Same
RegulationNumber	870.1250	870.1250	870.1250	870.1250	870.1250	Same
DeviceName	Catheter,Angioplasty,Peripheral,Transluminal	Catheter,Angioplasty,Peripheral,Translumina	Catheter,Angioplasty,Peripheral,Transluminal	Catheter,Angioplasty,Peripheral,Transluminal	Catheter,Angioplasty,Peripheral,Transluminal	Same
Target Area	Peripheralarteries andarteriovenousdialysisfistulae	Peripheralarteries andarteriovenousdialysisfistulae	Peripheralarteries andarteriovenousdialysisfistulae	Peripheralarteries andarteriovenousdialysisfistulae	Peripheralarteries andarteriovenousdialysisfistulae	Same
Intendeduse	The ParafleetSC 014/Parafleet SC018/ ParafleetSC 035 isintended todilatestenoses inthe iliac,femoral,iliofemoral,popliteal,infrapopliteal, and renalarteries, andfor thetreatment ofobstructivelesions ofnative orsyntheticarteriovenousdialysisfistulae. Thisdevice is alsoindicated forstentdilatation	Polux,Minerva,Atropos areindicated todilatestenoses inthe iliac,femoral,iliofemoral,popliteal,infrapopliteal,and renalarteries, andfor thetreatment ofobstructivelesions ofnative orsyntheticarteriovenousdialysisfistulae. Thisdevice is alsoindicated fordilatation ofpost-deployedstent in the	Ultraverse014 andUltraverse018 PTABalloonDilatationCatheters arerecommendedfor use inpercutaneoustrasluminalangioplasty(PTA) of therenal,popliteal,tibial,femoral, andperonealarteries.Thesecatheters arenot for use incoronaryarteries.	TheUltraverse035 PTADilatationCatheter isintended todilatestenoses inthe peripheralarteries, totreatobstructivelesions ofnative orsynthetic AVfistulaeand/or re-expandendoluminalstent graftelements inthe iliacarteries. Thisdevice is alsorecommendedfor post-dilatation ofballoonexpandable	Balloondilatation ofthe femoral,popliteal, andinfra-poplitealarteries.Thesecatheters arenot designedto be used inthe coronaryarteries.	Same withPolux,Minerva,Atropos
post-deploymentin theperipheralvasculature.	peripheralvasculature.	and self-expandingstents in theperipheralvasculature.This catheteris not for usein coronaryarteries.

Table 2 General and Intended Use Comparison

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TechnologicalCharacteristic	Proposed DeviceParafleet SC 014, ParafleetSC 018, Parafleet SC 035	Predicate/ Reference DevicesPolux, Minerva, Atropos(K160256), Ultraverse 014 and018 (K192318, K121856,K093965), Ultraverse 035(K142261), and Sleek (K102035)	Judgement
Design and Performance Specification
General Catheter Design	Consists of tip, markerbands, balloon, cathetershaft, strain relief, hub.Over-the-Wire (OTW)design	Consists of tip, marker bands,balloon, catheter shaft, strainrelief, hub.Over-the-Wire (OTW) design	Same
Compatible Guidewire(in)	0.014, 0.018, 0.035	0.014, 0.018, 0.035 (Polux,Minerva, Atropos);0.014, 0.018 (Ultraverse 014and 018)0.035 (Ultraverse 035)	Same
Compatible Sheath (F)	4, 5, 6, 7	4, 5, 6, 7 (Polux, Minerva,Atropos);4, 5, 6 (Ultraverse 014 and 018)5, 6, 7 (Ultraverse 035)	Same
Balloon ComplianceType	Semi-Compliant	Semi-Compliant	Same
Balloon Diameter Range(mm)	1.25-12.0	1.5-10.0 (Polux, Minerva,Atropos);1.5-9.0 (Ultraverse 014 and 018)3.0-12.0 (Ultraverse 035)1.25-5.0 (Sleek)	Same
Balloon Length Range(mm)	10-300	5-200 (Polux, Minerva,Atropos);20-300 (Ultraverse 014 and 018)20-300 (Ultraverse 035)	Similar
Catheter WorkingLength (cm)	40-200	40-150 (Polux, Minerva,Atropos);75-200 (Ultraverse 014 and 018)75-130 (Ultraverse 035)	Similar
Nominal Pressure (atm)	6	6	Same
Rated Burst Pressure(atm)	12-16	14 (Polux, Minerva, Atropos);11-16 (Ultraverse 014 and 018)10-14 (Ultraverse 035)	Similar
Radio-detectability	Yes	Yes	Same
Biological Characteristics
Tip	Parafleet SC 014 and Parafleet SC 018: Same as predicatedeviceParafleet SC 035: Similar to predicate device		SubstantiallyEquivalent
Balloon Tubing	Same as predicate device		Same
Catheter Shaft	Similar to predicate device		SubstantiallyEquivalent
Coating	Same as predicate device		Same
Sterilization Method	Ethylene Oxide (EtO)		Same

Table 3 Technological Comparison of Subject Device and Predicate Devices

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7. PERFORMANCE TESTING SUMMARY

Standard bench performance tests were conducted to confirm substantial equivalence between the Subject Device and the Predicate Devices.

> Bench Testing

The in vitro performance tests were conducted on subject device in accordance with FDA guidance 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions, Guidance for Industry and FDA Staff', including:

Dimensional verification
Simulated Use ●
Balloon Rated Burst Pressure ●
Balloon Fatigue
Balloon Compliance
Balloon Inflation and Deflation Time ●
Catheter Bond Strength
Tip Pull Strength
Flexibility and Kinking
Torque Strength
. Radiopacity
Coating Friction ●
Coating Integrity
Particulate Evaluation ●
Catheter Body Bust Pressure
Balloon Rated Burst Pressure (in stent)
. Balloon Fatigue (in stent)
A Biocompatibility Testing

The biocompatibility testing, conducted in accordance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and International Standard "ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA, included:

. Cytotoxicity
Sensitization ●
Intracutaneous Reactivity ●
Systemic Toxicity
Hemocompatibility ●
- Hemolysis
- Thrombosis ●
- . Complement Activation
Pyrogenicity ●

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> Sterilization Packaging and Shelf Life

The test results met all acceptance criteria, were same or similar to the predicate devices, and ensure that the Parafleet SC 014 / Parafleet SC 018 / Parafleet SC 035 PTA Balloon Dilatation Catheter design and construction are suitable for its intended use.

CONCLUSION 8.

The information presented in this 510(k) submission demonstrates that the Parafleet SC 014, Parafleet SC 018, and Parafleet SC 035 are Substantially Equivalent (SE) to the marketed predicate devices 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).