(179 days)
Not Found
No
The device description and performance studies focus solely on the physical characteristics and mechanical performance of a balloon dilatation catheter. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, which is typically used in medical procedures to dilate or open narrowed blood vessels (stenoses) with the intent of restoring proper blood flow and improving patient health. This fits the definition of a therapeutic device designed for the treatment of a medical condition.
No
The device description clearly states its purpose is for "Percutaneous Transluminal Angioplasty (PTA)" to dilate stenoses and treat obstructive lesions, indicating a therapeutic rather than diagnostic function. It is used to fix an existing condition, not identify one.
No
The device description clearly details a physical balloon dilatation catheter with various hardware components (catheter, balloon, lumens, radiopaque markers). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a balloon dilatation catheter used for Percutaneous Transluminal Angioplasty (PTA). This is a procedure performed inside the body to widen narrowed blood vessels.
- Intended Use: The intended use is to dilate stenoses in arteries and treat obstructive lesions in fistulae, and for stent dilatation. These are all therapeutic procedures performed directly on the patient's anatomy.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens.
Therefore, this device is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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 Park
SongShan Lake Hi-Tech Industrial Development Zone
Dongguan 523808, China
Office: +86 (769) 2289 2018
Fax: +86 (769) 2289 2016 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen Lee |
| Date Prepared | July 29, 2016 |
| Trade Name: | Polux PTA Balloon Dilatation Catheter
Minerva PTA Balloon Dilatation Catheter
Atropos 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 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. |
4
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.
5
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 | Control
Method |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| Device | catheter, angioplasty,
peripheral, transluminal | catheter, angioplasty,
peripheral, transluminal | catheter, angioplasty,
peripheral, transluminal | Identical | n/a |
| Regulation
Description | Percutaneous catheter. | Percutaneous catheter. | Percutaneous catheter. | Identical | |
| Regulation
Medical Specialty | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Review Panel | Cardiovascular | Cardiovascular | Cardiovascular | Identical | |
| Product Code | LIT | LIT | LIT | Identical | |
| Premarket Review | Office of Device Evaluation
6(ODE)
Division of Cardiovascular
Devices (DCD) | Office of Device Evaluation
6(ODE)
Division of Cardiovascular
Devices (DCD) | Office of Device Evaluation
6(ODE)
Division of Cardiovascular
Devices (DCD) | Identical | |
| | Peripheral Interventional
Devices Branch (PIDB) | Peripheral Interventional
Devices Branch (PIDB) | Peripheral Interventional
Devices Branch (PIDB) | Identical | |
| Submission Type | 510(k) | 510(k) | 510(k) | Identical | |
| Regulation
Number | 21 CFR 870.1250 | 21 CFR 870.1250 | 21 CFR 870.1250 | Identical | |
| Device Class | 2 | 2 | 2 | Identical | |
| Intended Use | 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 post-dilatation in the
peripheral vasculature | 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 post-dilatation in the
peripheral vasculature | 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 post-dilatation in the
peripheral vasculature | Identical | IFU |
| Balloon
Characteristic | semi-compliant | semi-compliant | semi-compliant | Identical | Design
Verification;
labeling |
| Nominal
Pressure (Nom) | 6atm | 6atm | 6atm | Identical | Design
Verification;
labeling |
| Rated Burst
Pressure (RBP) | 14atm | 14atm | 14atm | Identical | Design
Verification;
labeling |
| Guide wire
Compatibility | Max. 0.014"(0.36mm) | Max. 0.018" (0.46mm) | Max. 0.035"(0.89mm) | Different | Design
Verification;
labeling |
| Balloon
Diameter | 1.5-6.0mm | 1.5-10.0mm | 3.0-10.0mm | Different | Design
Verification;
labeling |
| Balloon Length | 5-200mm | 5-200mm | 20-200mm | Different | Design
Verification;
labeling |
| Shaft Length | 70,90,150 | 70,90,150 | 70,90,150 | Identical | Design
Verification;
labeling |