(274 days)
The Apollo Balloon Dilatation Catheter is indicated for:
1.The balloon dilatation catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
2.Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
3.Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
The Apollo Balloon Dilatation Catheter is designed to allow easy exchange of the catheter using a standard length guidewire. Balloon diameters range from 2.0mm to 5.0mm. The balloon material is made of a minimally compliant material with a rated burst pressure of 22 atmospheres for Ø2.0-4.0mm and 20 atmospheres for Ø4.5-5.0mm balloon respectively. The minimally compliant balloon material will allow high pressure dilatation while maintaining precise control of the balloon diameter and length. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft allows superior proximal pushability with a smooth transition to a distal shaft composed of an outer tube of 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 positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch PTCA guidewire. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guidewire. Two marked sections, 5mm in length 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.
The BrosMed Medical Co., Ltd.'s Apollo Balloon Dilatation Catheter (K133852) underwent extensive testing to demonstrate its substantial equivalence to predicate devices. The study performed primarily focused on in vitro performance and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| In vitro Performance | Dimensional Verification | Met specifications (not detailed) | Met all acceptance criteria |
| Balloon Preparation, Deployment, and Retraction | Consistent and reliable operation (not detailed) | Met all acceptance criteria | |
| Balloon Rated Burst Pressure | 22 atmospheres (2.0-4.0mm balloons), 20 atmospheres (4.5-5.0mm balloons) | Met all acceptance criteria | |
| Balloon Fatigue | Withstood specified cycles/conditions (not detailed) | Met all acceptance criteria | |
| Balloon Compliance | Minimized compliance (not detailed) | Met all acceptance criteria | |
| Balloon Inflation and Deflation Time | Within acceptable limits (not detailed) | Met all acceptance criteria | |
| Catheter Bond Strength | Met specified strength requirements (not detailed) | Met all acceptance criteria | |
| Tip Pull Strength | Met specified strength requirements (not detailed) | Met all acceptance criteria | |
| Flexibility and Kinking | Maintained integrity and functionality (not detailed) | Met all acceptance criteria | |
| Torque Strength | Met specified strength requirements (not detailed) | Met all acceptance criteria | |
| Radiopacity | Sufficient for visualization (not detailed) | Met all acceptance criteria | |
| Coating Integrity | Maintained integrity (not detailed) | Met all acceptance criteria | |
| Particulate Evaluation | Within acceptable limits for human use (not detailed) | Met all acceptance criteria | |
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Met all acceptance criteria |
| Sensitization | Non-sensitizing | Met all acceptance criteria | |
| Hemocompatibility | Hemocompatible | Met all acceptance criteria | |
| Pyrogenicity | Non-pyrogenic | Met all acceptance criteria | |
| Acute Systemic Toxicity | Non-toxic acutely | Met all acceptance criteria | |
| Intracutaneous Reactivity | Non-reactive intracutaneously | Met all acceptance criteria | |
| Genotoxicity (Bacterial Mutagenicity and In vitro Mouse Lymphoma) | Non-genotoxic | Met all acceptance criteria |
Note: The document states that the test results "met all acceptance criteria" and "were similar to predicate devices," but specific quantitative acceptance criteria or detailed performance data for each test are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents." However, it does not specify the sample size for the test set used for the in vitro performance tests or the biocompatibility tests.
The data provenance is not explicitly stated beyond being "Bench testing." It is implied to be laboratory-based (in vitro) and is not described as retrospective or prospective clinical data. The manufacturer is BrosMed Medical Co., Ltd. from Dongguan, Guangdong, China.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as the summary describes in vitro and biocompatibility testing, not studies involving human interpretation or clinical ground truth assessments by experts.
4. Adjudication Method for the Test Set:
This information is not applicable as the summary describes in vitro and biocompatibility testing, not studies involving human interpretation where adjudication would be required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed, or at least not described in this 510(k) summary. The study focuses on demonstrating substantial equivalence through in vitro performance and biocompatibility, not on a direct comparison of human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable as the device is a physical medical device (balloon dilatation catheter), not an AI algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's evaluation was based on engineering specifications, material science standards, and established biocompatibility testing protocols and limits. For example, the rated burst pressure of the balloon is a direct engineering specification. Biocompatibility tests rely on recognized standards for assessing material safety.
8. Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical medical device and does not involve a "training set" or a ground truth established for such a set.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
BrosMed Medical Co., Ltd. Stephen Lee Deputy General Manager 15th building, SMEs Venture Park, SongShan Lake Hi-Tech Industrial Development Zone Dongguan, Guangdong 523808 China
Re: K133852
Trade/Device Name: Apollo Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100(a) Regulation Name: Catheters, transluminal coronary angioplasty, percutaneous Regulatory Class: Class II Product Code: LOX Dated: August 19, 2014 Received: August 21, 2014
Dear Mr. Stephen 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (21CFR 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
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) K133852
Device Name Apollo Balloon Dilatation Catheter
Indications for Use (Describe) The Apollo Balloon Dilatation Catheter is indicated for:
1.The balloon dilatation catheted for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
2.Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
3.Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)
Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design.
Type of Use (Select one or both, as applicable)
|× 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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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 Prepared | Stephen LeeDec. 05th. 2013 |
| Trade Name: | Apollo 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: | NC Sprinter RX (P790017S095; cleared October 10, 2008)Voyager NC (P810046S226; cleared August 21, 2008)Quantum Maverick (P860019S182; cleared October 1, 2002)NC Quantum (P860019S241; cleared April 16, 2010)Dura Star (P880003S089; cleared August 29, 2007) |
| Device Description: | The Apollo Balloon Dilatation Catheter is designed to allow easyexchange of the catheter using a standard length guidewire. Balloondiameters range from 2.0mm to 5.0mm. The balloon material is madeof a minimally compliant material with a rated burst pressure of 22atmospheres for Ø2.0-4.0mm and 20 atmospheres for Ø4.5-5.0mmballoon respectively. The minimally compliant balloon material willallow high pressure dilatation while maintaining precise control of theballoon diameter and length. The proximal shaft of the catheter iscomposed of a female luer connector bonded to a PTFE coatedstainless steel tube. The proximal shaft allows superior proximalpushability with a smooth transition to a distal shaft composed of anouter tube of nylon and a tri-extrusion inner tube with a balloon laserwelded to both tubes at the distal tip.Two radiopaqueplatinum/iridium marker bands are positioned within the balloonshoulders. The inner tube accepts a standard 0.014 inch PTCAguidewire. The guidewire enters the catheter tip and advancescoaxially out the distal Rx port, thereby allowing both coaxialguidance and rapid exchange of catheter with a single standard lengthTwo marked sections, 5mm in length located on theguidewire.proximal shaft, indicate catheter position relative to the tip of either abrachial or femoral guiding catheter. The design of this dilatationcatheter does not incorporate a lumen for distal dye injections or distalpressure measurements. |
| Intended Use: | The Apollo PTCA catheter is indicated for:The balloon dilatation catheter is indicated for balloon dilatationO |
of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion
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- balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction 0 Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only) Note: Bench testing was conducted with the Apollo Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to difference in stent design. Comparisons of the new and predicate devices show that the Technological Characteristics: 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 Apollo PTCA The test results met all acceptance criteria, were similar to catheter. predicate devices, and ensure that the Apollo 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 Apollo PTCA catheter and the predicate devices described
above.
§ 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.