(179 days)
The balloon dilatation catheter is intended to dilate stenoses in the iliac, 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.
The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral balloon catheters designed for Percutaneous Transluminal Angioplasty (PTA). These three PTA balloon dilatation catheters have been bundled in one 510(k) submission due to the similar/equivalent construction and identical material of the products. As summarized by the comparison between the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters in Table 1, the devices only differ in guidewire compatibility, balloon diameter, and balloon length. The devices are offered with catheter working lengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" for the Polux device, 0.018" for the Minerva device and 0.035" for the Atropos device. The balloon diameters range from 1.5 mm to 10.0 mm, with balloon working lengths ranging from 5 mm to 200 mm. The balloon material is made of a semi-compliant Pebax material and offered in diameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. It is a coaxial double lumen catheter with a balloon located near the distal tip. 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 guide wire insertion. The balloon has radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The balloon is dilated using the side leg port, at which the balloon material expands to a known diameter depending on the pressure delivered. The working pressure range for the balloon is between the nominal size pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
This document describes the BrosMed Medical Co., Ltd. Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters and their substantial equivalence to predicate devices. It does not contain information about an AI/ML device. Therefore, I cannot provide a response based on the request's specific requirements concerning AI/ML performance.
However, I can extract the acceptance criteria and study information related to the device performance of these balloon catheters, as presented in the provided text.
Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)
The document primarily focuses on demonstrating the substantial equivalence of the Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters to existing predicate devices (NanoCross Elite, Sterling, Mustang Balloon Dilatation Catheters). The "Performance Data" section summarizes the testing conducted to ensure the device's suitability for its intended use.
Here's a table based on the provided text, outlining the types of performance tests conducted and the general outcome:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| In vitro Performance Tests | |
| Dimensional Verification | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Preparation, Deployment, Retraction | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Rated Burst Pressure | Test results met all acceptance criteria and were similar to predicate devices. (Rated Burst Pressure 14atm, as per Table 1). |
| Balloon Fatigue | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Compliance | Test results met all acceptance criteria and were similar to predicate devices. (Semi-compliant balloon characteristic, as per Table 1). |
| Balloon Inflation and Deflation Time | Test results met all acceptance criteria and were similar to predicate devices. |
| Catheter Bond Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Tip Pull Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Flexibility and Kinking | Test results met all acceptance criteria and were similar to predicate devices. |
| Torque Strength | Test results met all acceptance criteria and were similar to predicate devices. |
| Radiopacity | Test results met all acceptance criteria and were similar to predicate devices. (The balloon has radiopaque markers for positioning, as described in the device description). |
| Coating Integrity | Test results met all acceptance criteria and were similar to predicate devices. |
| Particulate Evaluation | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Burst (in stents) | Test results met all acceptance criteria and were similar to predicate devices. |
| Balloon Fatigue (in stent) | Test results met all acceptance criteria and were similar to predicate devices. |
| Biocompatibility Tests | |
| Cytotoxicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Sensitization | Test results met all acceptance criteria and were similar to predicate devices. |
| Hemocompatibility | Test results met all acceptance criteria and were similar to predicate devices. |
| Pyrogenicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Acute Systemic Toxicity | Test results met all acceptance criteria and were similar to predicate devices. |
| Intracutaneous Reactivity | Test results met all acceptance criteria and were similar to predicate devices. |
| Genotoxicity (Bacterial Mutagenicity) | Test results met all acceptance criteria and were similar to predicate devices. |
| Genotoxicity (In vitro Mouse Lymphoma) | Test results met all acceptance criteria and were similar to predicate devices. |
Missing Information (Relevant to AI/ML, but not present in the document):
- Sample size used for the test set and data provenance: Not applicable as this is not an AI/ML device or study. The document states "test results met all acceptance criteria" but does not detail sample sizes for the various performance and biocompatibility tests.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images) is not relevant here. The "ground truth" for these tests would be established by industry standards, engineering specifications, or biological assay controls.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: For this type of medical device, the "ground truth" for performance evaluations typically refers to established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards for medical devices, FDA guidance documents). For biocompatibility, it's based on established biological assays and toxicology principles.
- Sample size for the training set: Not applicable as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study per the Document:
The document describes a 510(k) submission for PTA balloon dilatation catheters. The study conducted was a series of "in vitro performance tests" and "biocompatibility tests". These tests were designed to evaluate the physical characteristics, functional performance, and biological safety of the Polux, Minerva, and Atropos catheters. The overall conclusion is that the "test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use." The intent was to demonstrate substantial equivalence to legally marketed predicate devices, not to benchmark the performance of an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
BrosMed Medical Co., Ltd. Mr. Stephen Lee Deputy General Manager 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Development Zone Dongguan, 523808 China
Re: K160256
Trade/Device Name: Polux, Minerva, and Atropos PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 05, 2016 Received: July 08, 2016
Dear Mr. 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 (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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160256
Device Name
Polux PTA Balloon Dilatation Catheter Minerva PTA Balloon Dilatation Catheter Atropos PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The balloon dilatation catheter is intended to dilac, 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.
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
This 510(k) Summary is submitted in accordance with 21 CFR 807.92(c).
| Submitter: | BrosMed Medical Co., Ltd.15th Building, SMEs Venture ParkSongShan Lake Hi-Tech Industrial Development ZoneDongguan 523808, ChinaOffice: +86 (769) 2289 2018Fax: +86 (769) 2289 2016 |
|---|---|
| Contact Person: | Stephen Lee |
| Date Prepared | July 29, 2016 |
| Trade Name: | Polux PTA Balloon Dilatation CatheterMinerva PTA Balloon Dilatation CatheterAtropos PTA Balloon Dilatation Catheter |
| Common Name: | PTA Balloon Dilatation Catheter |
| Classification Name: | Percutaneous catheter (21 CFR 870.1250, Product Code LIT) |
| Predicate Devices: | NanoCross Elite 0.014" Over-The-Wire PTA Balloon Dilatation Catheter(K141118; cleared July 18, 2014)Sterling Over-The-Wire (OTW) PTA Balloon Dilatation Catheter(K132430; cleared October 17, 2013)Mustang Balloon Dilatation Catheters(K103751; cleared March 22, 2011) |
| Device Description: | The Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters are over-the-wire (OTW) peripheral balloon catheters designed for PercutaneousTransluminal Angioplasty (PTA). These three PTA balloon dilatation cathetershave been bundled in one 510(k) submission due to the similar/equivalentconstruction and identical material of the products. As summarized by thecomparison between the Polux, Minerva, and Atropos PTA Balloon DilatationCatheters in Table 1, the devices only differ in guidewire compatibility, balloondiameter, and balloon length. The devices are offered with catheter workinglengths of 70, 90 and 150 cm. The guidewire compatibility includes 0.014" forthe Polux device, 0.018" for the Minerva device and 0.035" for the Atroposdevice. The balloon diameters range from 1.5 mm to 10.0 mm, with balloonworking lengths ranging from 5 mm to 200 mm.The balloon material is made of a semi-compliant Pebax material and offered indiameters 1.5 mm to 10.0 mm with a rated burst pressure of 14 atmospheres. Itis a coaxial double lumen catheter with a balloon located near the distal tip. Onelumen is used for inflation of the balloon and accessed via the side leg port. Thesecond lumen, starting at the straight entry port, allows access to the distal tip ofthe catheter for guide wire insertion. The balloon has radiopaque markers forpositioning the balloon relative to the stenosis. The radiopaque marker bandsindicate the dilating section of the balloon and aid in balloon placement. Theballoon is dilated using the side leg port, at which the balloon material expandsto a known diameter depending on the pressure delivered. The working pressurerange for the balloon is between the nominal size pressure and the rated burstpressure. All balloons distend to sizes above the nominal size at pressuresgreater than the nominal pressure. The design of this dilatation catheter does notincorporate a lumen for distal dye injections or distal pressure measurements. |
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The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, Intended Use: 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 Technological Characteristics: Comparing the subject devices against their corresponding predicates reveal similarities in technological characteristics including: indications for use, operating principle. guidewire compatibility. catheter design. sheath compatibility, sterilization method, sterility assurance level, and similar ranges of balloon diameters, balloon effective lengths, and catheter working lengths. The major differences between the subject and predicate devices include materials, smaller balloon lengths, and different balloon configurations. Performance Data: Both in vitro performance tests, such as dimensional verification, balloon preparation, deployment, and retraction, 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 integrity, particulate evaluation, balloon burst (in stents, balloon fatigue (in stent) and also biocompatibility tests. such as cytotoxicity, sensitization. hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genotoxicity (bacterial mutagenicity and in vitro mouse lymphoma) were conducted on the PTA balloon catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the PTA balloon catheter design and construction are suitable for its intended use. Conclusion: This information supports the determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above.
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Table 1: Comparison of Technical Characteristics between the Subject Devices (BrosMed Polux, Minerva, and Atropos PTA Balloon Dilatation Catheters)
| Polux 0.014" | Minerva 0.018" | Atropos 0.035" | Difference | ControlMethod | |
|---|---|---|---|---|---|
| Device | catheter, angioplasty,peripheral, transluminal | catheter, angioplasty,peripheral, transluminal | catheter, angioplasty,peripheral, transluminal | Identical | n/a |
| RegulationDescription | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | |
| RegulationMedical Specialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Product Code | LIT | LIT | LIT | Identical | |
| Premarket Review | Office of Device Evaluation6(ODE)Division of CardiovascularDevices (DCD) | Office of Device Evaluation6(ODE)Division of CardiovascularDevices (DCD) | Office of Device Evaluation6(ODE)Division of CardiovascularDevices (DCD) | Identical | |
| Peripheral InterventionalDevices Branch (PIDB) | Peripheral InterventionalDevices Branch (PIDB) | Peripheral InterventionalDevices Branch (PIDB) | Identical | ||
| Submission Type | 510(k) | 510(k) | 510(k) | Identical | |
| RegulationNumber | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | |
| Device Class | 2 | 2 | 2 | Identical | |
| Intended Use | Theballoondilatationcatheter is intended to dilatestenoses in the iliac, femoral,iliofemoral,popliteal,infrapopliteal,andrenalarteries, and for the treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.This device is also indicatedfor stent post-dilatation in theperipheral vasculature | Theballoondilatationcatheter is intended to dilatestenoses in the iliac, femoral,iliofemoral,popliteal,infrapopliteal,andrenalarteries, and for the treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.This device is also indicatedfor stent post-dilatation in theperipheral vasculature | Theballoondilatationcatheter is intended to dilatestenoses in the iliac, femoral,iliofemoral,popliteal,infrapopliteal,andrenalarteries, and for the treatmentof obstructive lesions of nativeor synthetic arteriovenousdialysis fistulae.This device is also indicatedfor stent post-dilatation in theperipheral vasculature | Identical | IFU |
| BalloonCharacteristic | semi-compliant | semi-compliant | semi-compliant | Identical | DesignVerification;labeling |
| NominalPressure (Nom) | 6atm | 6atm | 6atm | Identical | DesignVerification;labeling |
| Rated BurstPressure (RBP) | 14atm | 14atm | 14atm | Identical | DesignVerification;labeling |
| Guide wireCompatibility | Max. 0.014"(0.36mm) | Max. 0.018" (0.46mm) | Max. 0.035"(0.89mm) | Different | DesignVerification;labeling |
| BalloonDiameter | 1.5-6.0mm | 1.5-10.0mm | 3.0-10.0mm | Different | DesignVerification;labeling |
| Balloon Length | 5-200mm | 5-200mm | 20-200mm | Different | DesignVerification;labeling |
| Shaft Length | 70,90,150 | 70,90,150 | 70,90,150 | Identical | DesignVerification;labeling |
§ 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).