(144 days)
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
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.
The provided document is a 510(k) summary for the Artimes Balloon Dilatation Catheter. It describes the device, its intended use, and claims substantial equivalence to predicate devices, supported by performance testing. However, it does not contain the level of detail requested for a typical AI/software device study, particularly regarding acceptance criteria, sample sizes, and ground truth for a clinical study. The device is a physical medical device (catheter), not primarily an AI or software device.
Therefore, many of the requested fields cannot be filled. I will provide what information is available and indicate when information is "Not Applicable" or "Not Provided" given the nature of the document.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Physical/Mechanical Tests | The document states: "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... 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)." |
| Biocompatibility Tests | The document states: "...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)." |
Specific numerical acceptance criteria for each test (e.g., specific burst pressure values, fatigue cycles) are not provided in this summary document. It only states that the tests were performed and "met all acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided (for clinical studies). The performance tests mentioned are in vitro and biocompatibility tests. The sample sizes for these engineering and lab tests are not specified.
- Data Provenance: Not Applicable/Not Provided (for a clinical study). The data described are from in vitro and biocompatibility testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not Applicable. This device is a physical medical device, not an AI/Software device requiring expert interpretation for ground truth.
- Qualifications of Experts: Not Applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not Applicable. This is not a study requiring expert adjudication of results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not done. This is a physical medical device, not an AI/Software device.
- Effect Size: Not Applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the performance tests, the "ground truth" would be established by validated engineering specifications and international standards for medical device testing, as referenced by the "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)." This typically involves objective measurements against predefined thresholds, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
- Sample Size for Training Set: Not Applicable. This is a physical medical device, not an AI/Software device that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not Applicable.
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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
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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
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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)
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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:
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FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
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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., Ltd15th building, SMEs Venture ParkSongShan Lake Hi-Tech Industrial Development ZoneDongguan 523808, ChinaOffice: +86 (769) 2289 2018Fax: +86 (769) 2289 2016 |
|---|---|
| Contact Person:Date PreparedTrade Name: | Stephen LeeApril, 06th, 2014Artimes Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
| Classification Name: | Catheters, transluminal coronary angioplasty, percutaneous (21 CFR870.5100(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 catheterdesigned for easy guidewire exchange. The catheter working length is140cm. Lubricious coatings are applied to the distal section. Balloondiameters range from Ø1.5mm to Ø4.0mm. The balloon material ismade of a semi-compliant Pebax material for diameter 1.5mm to4.0mm with a rated burst pressure of 14 atmospheres. The proximalshaft of the catheter is composed of a female luer connector bonded toa PTFE coated stainless steel tube with a wire. The proximal shaftjoins with a smooth transition to a distal shaft composed of an outertube of pebax/nylon and a tri-extrusion inner tube with a balloon laserwelded to both tubes at the distal tip. Two radiopaque platinum/iridiummarker bands are located within the balloon segment with theexception of balloon diameters less than 2.0mm which incorporate acentrally positioned single marker band. The inner tube accepts astandard 0.014 inch PTCA guidewire. The guide wire enters thecatheter's tip and advances coaxially out the distal Rx port, therebyallowing both coaxial guidance and rapid exchange of catheter with asingle standard length guide wire. Two marked sections of 5mm lengtheach located on the proximal shaft indicate catheter position relative tothe tip of either a brachial or femoral guiding catheter. The design ofthis dilatation catheter does not incorporate a lumen for distal dyeinjections or distal pressure measurements.Note 1: the Artimes balloon dilatation catheter family contains Ø1.0-1.25mm x5-30mm 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 5-30mmconfigurations with its IFU and label, compared with Artimes ROW product(801-DDLL) for the Ø1.0-4.0mm x 5-30mm configurations. Additional 510kArtimes PTCAPage 1 of 2 |
| or relevant (e.g. IDE or PMA) submission will be executed if BrosMedMedical is going to registry those configurations (Ø1.0-4.0mm x 5-30mm) inthe United States. | |
| Intended Use: | The Artimes PTCA catheter is indicated for:balloon dilatation of the stenotic portion of a coronary arteryor bypass graft stenosis in patients evidencing coronaryischemia for the purpose of improving myocardial perfusionballoon dilatation of a coronary artery occlusion for thetreatment of acute myocardial infarction |
| Technological Characteristics: | Comparisons of the new and predicate devices show that thetechnological characteristics such as product performance, design, andintended use are substantially equivalent to the currently marketedpredicate devices. |
| Performance Data: | Both in vitro performance tests, such as dimensional verification,balloon preparation, deployment, and retraction, balloon rated burstpressure, balloon fatigue, balloon compliance, balloon inflation anddeflation time, catheter bond strength, tip pull strength, flexibility andkinking, torque strength, radiopacity, coating integrity, and particulateevaluation, and also biocompatibility tests, such as cytotoxicity,sensitization, hemocompatibility, pyrogenicity, acute systemic toxicity,intracutaneous reactivity and genototocity (bacterial mutagenicity andin vitro mouse lymphoma) were conducted on the Artimes PTCAcatheter. The test results met all acceptance criteria, were similar topredicate devices, and ensure that the Artimes PTCA catheter designand construction are suitable for its intended use as recommended bythe Class II Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters(FDA; September 8, 2010). |
| Conclusion: | This information supports as determination of substantial equivalencebetween the Artimes PTCA catheter and the predicate devicesdescribed above. |
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510(k) Notification (21CFR 807.90(e))
§ 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.