(253 days)
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a balloon dilatation catheter intended to dilate stenoses in various arteries and treat obstructive lesions, which are actions aimed at restoring health or alleviating disease.
No
This device is a therapeutic device designed for dilating arteries and treating obstructive lesions, not for diagnosing medical conditions.
No
The device description clearly details a physical balloon dilatation catheter with lumens, a balloon, radiopaque markers, and material specifications. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for a therapeutic procedure (dilating arteries and fistulae). IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into blood vessels and inflated. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, this device is a therapeutic medical device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The balloon dilatation catheter is intended to dilate stenoral, 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 non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC (0.035") 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 catheter working length is 70, 90 and 150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work length range from 10mm to 150mm. The three PTA balloon dilatation catheters are filed in one 510(k) submission due to the similar/equivalent construction and identical material of the products. The comparison of them was summarized in Table 1. The differences only exist in the guide wire compatibility and the balloon configuration which have been controlled by the Design Verification. The balloon material is made of a non-compliant Nylon material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22 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 three products of the non-compliant PTA (OTW type) balloon catheter family have different diameter of the guide wire port from max.0.014" to 0.035". The guide wire compatibility was shown in table 1. 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 at specific pressure. 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; arteriovenous dialysis fistulae; 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 stents) and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genototocity (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 United States Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2016
BrosMed Medical Co., Ltd. Ms. Tina Yin Regulatory Affairs Manager 15th Bldg., SMEs Venture Park Songshan Lake Hi-Tech Industrial Development Zone Dongguan 523808, China
Re: K160941
Trade/Device Name: Castor, Achilles, and Hermes NC PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 31, 2016 Received: November 3, 2016
Dear Ms. Yin:
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
Indications for Use
510(k) Number (if known) K160941
Device Name Castor NC PTA Balloon Dilatation Catheter Achilles NC PTA Balloon Dilatation Catheter Hermes NC PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The balloon dilatation catheter is intended to dilate stenoral, 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: | Tina Yin |
| Date Prepared | December 2, 2016 |
| Trade Name: | Castor NC PTA Balloon Dilatation Catheter
Achilles NC PTA Balloon Dilatation Catheter
Hermes NC 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 TM Balloon Dilatation Catheter (K103751; cleared March 22, 2011) |
| Device Description: | The non-compliant PTA (Over-the-Wire, OTW) balloon dilatation catheter
family consists of Castor NC (0.014"), Achilles NC (0.018") and Hermes NC
(0.035") 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 catheter working length is 70, 90 and
150cm. Balloon diameters range from Ø2.0mm to Ø10.0mm, balloon work
length range from 10mm to 150mm. The three PTA balloon dilatation
catheters are filed in one 510(k) submission due to the similar/equivalent
construction and identical material of the products. The comparison of them
was summarized in Table 1. The differences only exist in the guide wire
compatibility and the balloon configuration which have been controlled by the
Design Verification. The balloon material is made of a non-compliant Nylon
material for diameter 2.0mm to 10.0mm with a rated burst pressure of 18-22
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 three
products of the non-compliant PTA (OTW type) balloon catheter family have
different diameter of the guide wire port from max.0.014" to 0.035". The
guide wire compatibility was shown in table 1. 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 at specific pressure. 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 |
4
| catheter does not incorporate a lumen for distal dye injections or distal | ||||||
|---|---|---|---|---|---|---|
| pressure measurements. |
- 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 dilatation post-deployment in the peripheral vasculature.
- 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.
- 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 stents) and also biocompatibility tests, such as cytotoxicity, sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity, intracutaneous reactivity and genototocity (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 a determination of substantial equivalence between the PTA balloon dilatation catheter and the predicate devices described above.
5
| | Castor NC 0.014 | Achilles NC 0.018 | Hermes NC 0.035 | Difference | Control
Method |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------|
| Device | catheter, angioplasty,
peripheral, transluminal | catheter, angioplasty,
peripheral, transluminal | catheter, angioplasty,
peripheral, transluminal | Identical | |
| 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 | |
| | Office of Device Evaluation
6(ODE) | Office of Device Evaluation
6(ODE) | Office of Device Evaluation
6(ODE) | Identical | n/a |
| Premarket Review | Division of Cardiovascular
Devices (DCD) | Division of Cardiovascular
Devices (DCD) | 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 | |
| Indications for Use | The PTA balloon dilatation
catheter is indicated for:
• dilating 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.
• stent dilatation
post-deployment in the
peripheral vasculature. | The PTA balloon dilatation
catheter is indicated for:
• dilating 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.
• stent dilatation
post-deployment in the
peripheral vasculature. | The PTA balloon dilatation
catheter is indicated for:
• dilating 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.
• stent dilatation
post-deployment in the
peripheral vasculature. | Identical | IFU |
| Balloon
Characteristic | non-compliant | non-compliant | non-compliant | Identical | Design
Verification;
labeling |
| Nominal
Pressure (Nom) | 12atm | 12atm | 12atm | Identical | Design
Verification;
labeling |
| Rated Burst
Pressure (RBP) | 18, 20, 22atm | 18, 20, 22atm | 18, 20, 22atm | 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 | 2.0-8.0mm | 2.0-8.0mm | 3.0-10.0mm | Different | Design
Verification:
labeling |
| Balloon Length | 10-150mm | 10-150mm | 20-150mm | Different | Design
Verification:
labeling |
| Shaft Length | 70, 90, 150 | 70, 90, 150 | 70, 90, 150 | Identical | Design
Verification:
labeling |
Table 1, BrosMed PTA Balloon Dilatation Catheter Comparison Table