(144 days)
P790017 S096, P810046 S216, P860019 S160, P860019 S208, P880003 S090
Not Found
No
The device description focuses on the physical components and mechanical properties of a balloon dilatation catheter. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for "Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis...for the purpose of improving myocardial perfusion" and "Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction," which are therapeutic actions.
No
The Artimes Balloon Dilatation Catheter is intended for therapeutic purposes (balloon dilatation of stenotic portions of coronary arteries or bypass grafts), not for diagnosing medical conditions.
No
The device description clearly details a physical medical device, a balloon dilatation catheter, made of materials like Pebax, PTFE, and stainless steel, with specific dimensions and features for insertion into the body. It does not describe software as the primary or sole component.
Based on the provided text, the Artimes Balloon Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening.
- Artimes Function: The Artimes Balloon Dilatation Catheter is a medical device used within the body (in vivo) to physically dilate stenotic or occluded coronary arteries or bypass grafts. It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's anatomy to improve blood flow, not the analysis of biological samples.
- Device Description: The description details the physical components of a catheter designed for insertion into blood vessels and inflation of a balloon, consistent with an in-vivo procedure.
Therefore, the Artimes Balloon Dilatation Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Artimes Balloon Dilatation Catheter is indicated for:
-
Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients coronary ischemia for the purpose of improving myocardial perfusion
-
Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
Product codes (comma separated list FDA assigned to the subject device)
LOX
Device Description
The Artimes1 (Rx type) device is a coronary dilatation catheter designed for easy guidewire exchange. The catheter working length is 140cm. Lubricious coatings are applied to the distal section. Balloon diameters range from Ø1.5mm to Ø4.0mm. The balloon material is made of a semi-compliant Pebax material for diameter 1.5mm to 4.0mm with a rated burst pressure of 14 atmospheres. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube with a wire. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of pebax/nylon and a tri-extrusion inner tube with a balloon laser welded to both tubes at the distal tip. Two radiopaque platinum/iridium marker bands are located within the balloon segment with the exception of balloon diameters less than 2.0mm which incorporate a centrally positioned single marker band. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of either a brachial or femoral guiding catheter. The design of this dilatation catheter does not incorporate a lumen for distal dye injections or distal pressure measurements.
Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x 5-30mm configurations which are NOT intend for sales in the United States (US) but rest of world (ROW) based upon availability of regulatory approvals. Separate Catalog numbers have been assigned to the Artimes US product (801-DDLLU, reference section 11.0) for the Ø1.5-4.0mm x 5-30mm configurations with its IFU and label, compared with Artimes ROW product (801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510k or relevant (e.g. IDE or PMA) submission will be executed if BrosMed Medical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) in the United States.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary artery, bypass graft
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, and particulate evaluation, 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 Artimes PTCA catheter. The test results met all acceptance criteria, were similar to predicate devices, and ensure that the Artimes PTCA catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P790017 S096, P810046 S216, P860019 S160, P860019 S208, P880003 S090
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.
(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 12, 2014
BrosMed Medical Co., Ltd % Stephen Lee Deputy General Manager 15th Building, SMEs Venture Park SongShan Lake Hi-Tech Industrial Development Zone Dongguan 523808 CHINA
Re: K141025
Trade/Device Name: Artimes Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1340 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: August 15, 2014 Received: August 18, 2014
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
M.A. Hillebrenner
for
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Artimes Balloon Dilatation Catheter
Indications for Use (Describe) The Artimes Balloon Dilatation Catheter is indicated for:
-
Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients coronary ischemia for the purpose of improving myocardial perfusion
-
Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
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:
Date Prepared
Trade Name: | Stephen Lee
April, 06th, 2014
Artimes Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR
870.5100(a), Product Code LOX) |
| Predicate Devices: | Sprinter Legend RX (P790017 S096; cleared October 31, 2008)
Voyager RX (P810046 S216; cleared June 18, 2004)
Maverick (P860019 S160; cleared September 27, 2000)
Apex (P860019 S208; cleared November 7, 2008)
Fire Star (P880003 S090; cleared August 31, 2007) |
| Device Description: | The Artimes1 (Rx type) device is a coronary dilatation catheter
designed for easy guidewire exchange. The catheter working length is
140cm. Lubricious coatings are applied to the distal section. Balloon
diameters range from Ø1.5mm to Ø4.0mm. The balloon material is
made of a semi-compliant Pebax material for diameter 1.5mm to
4.0mm with a rated burst pressure of 14 atmospheres. The proximal
shaft of the catheter is composed of a female luer connector bonded to
a PTFE coated stainless steel tube with a wire. The proximal shaft
joins with a smooth transition to a distal shaft composed of an outer
tube of pebax/nylon and a tri-extrusion inner tube with a balloon laser
welded to both tubes at the distal tip. Two radiopaque platinum/iridium
marker bands are located within the balloon segment with the
exception of balloon diameters less than 2.0mm which incorporate a
centrally positioned single marker band. The inner tube accepts a
standard 0.014 inch PTCA guidewire. The guide wire enters the
catheter's tip and advances coaxially out the distal Rx port, thereby
allowing both coaxial guidance and rapid exchange of catheter with a
single standard length guide wire. Two marked sections of 5mm length
each located on the proximal shaft indicate catheter position relative to
the tip of either a brachial or femoral guiding catheter. The design of
this dilatation catheter does not incorporate a lumen for distal dye
injections or distal pressure measurements.
Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x
5-30mm configurations which are NOT intend for sales in the United States
(US) but rest of world (ROW) based upon availability of regulatory approvals.
Separate Catalog numbers have been assigned to the Artimes US product
(801-DDLLU, reference section 11.0) for the Ø1.5-4.0mm x 5-30mm
configurations with its IFU and label, compared with Artimes ROW product
(801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510k
Artimes PTCA
Page 1 of 2 |
| | or relevant (e.g. IDE or PMA) submission will be executed if BrosMed
Medical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) in
the United States. |
| Intended Use: | The Artimes PTCA catheter is indicated for:
balloon dilatation of the stenotic portion of a coronary artery
or bypass graft stenosis in patients evidencing coronary
ischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for the
treatment of acute myocardial infarction |
| Technological Characteristics: | Comparisons of the new and predicate devices show that the
technological 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, and particulate
evaluation, 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 Artimes PTCA
catheter. The test results met all acceptance criteria, were similar to
predicate devices, and ensure that the Artimes PTCA catheter design
and construction are suitable for its intended use as recommended by
the Class II Special Controls Guidance Document for Certain
Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
(FDA; September 8, 2010). |
| Conclusion: | This information supports as determination of substantial equivalence
between the Artimes PTCA catheter and the predicate devices
described above. |
4
510(k) Notification (21CFR 807.90(e))