(273 days)
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
This balloon dilatation catheter is not intended for the expansion or delivery of a stent.
Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The proximal shaft is a polymer coated stainless steel tube. The steel construction is designed to optimize proximal pushability with a smooth transition to a distal shaft specifically designed to be highly trackable. The semi-compliant balloon material allows dilatation with precise control of balloon diameter and length. Two radiopaque platinum marker bands are located within the balloon segment. The catheter is compatible with 5F or larger guiding catheters. The internal lumen of the catheter accepts a standard 0.014 inch PTCA guide wire. The proximal part of the guide wire enters the catheter's tip and advances coaxially out the catheter's proximal port, thereby allowing both coaxial guidance and rapid exchange of catheters with a single standard length guide wire.
Two marked sections are located on the hypo tube shaft to 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 product can be used to expand stenotic coronary vessel, and improve myocardial bleeding. This kind of balloon catheter possesses such merits as moderate compliance, high pressure resistance, minor diameter, etc.
The provided text describes a medical device, the Hoper™ PTCA Balloon Dilatation Catheter, and its 510(k) summary for FDA clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or a comparative effectiveness study with human readers.
The "Performance Testing" section lists various in vitro performance tests and biocompatibility tests. It states that "The test results met all acceptance criterions, were similar to predicate devices, and ensured that the Hoper™ PTCA Balloon Dilatation 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)."
This indicates that acceptance criteria were met for these technical and biological safety aspects, but the specific numerical acceptance criteria and detailed study results for each test are not provided in the summary.
Based on the provided text, I cannot answer the specific questions about clinical acceptance criteria and related studies, as the document focuses on regulatory clearance based on substantial equivalence to predicate devices through technical performance and biocompatibility testing, rather than a clinical trial or AI performance evaluation.
Therefore, for the requested information, the answer is:
-
A table of acceptance criteria and the reported device performance:
- The document states that "The test results met all acceptance criterions" for the listed in vitro performance tests and biocompatibility tests.
- However, specific numerical acceptance criteria or detailed quantitative performance data for each test (e.g., maximum allowable balloon inflation/deflation time, minimum bond strength, specific cytotoxicity results) are not provided in this summary. The summary only confirms compliance without detailing the criteria or results.
-
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided for the in vitro performance tests or biocompatibility tests. No clinical test set is described.
-
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):
- This is not applicable, as no clinical test set or ground truth established by experts is mentioned in the provided text.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable, as no clinical test set requiring adjudication is mentioned.
-
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:
- This is not applicable. The device is a PTCA Balloon Dilatation Catheter, not an AI imaging analysis tool, and no MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as the device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the in vitro tests, the "ground truth" would be the engineering specifications and recognized standards (e.g., ISO, ASTM, FDA guidance documents) against which the device performance was measured. For biocompatibility, it's about meeting established safety limits for chemical and biological interactions. No clinical ground truth (like pathology or outcomes data) is mentioned as being used for these tests.
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The sample size for the training set:
- This is not applicable, as the device is not an AI system that requires a training set.
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How the ground truth for the training set was established:
- This is not applicable, as the device is not an AI system.
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Section 5: 510k) Summary
| Applicant | Lepu Medical Technology (Beijing) Co., Ltd.No. 37 Chaoqian RoadChangping District, Beijing 102200P.R. China |
|---|---|
| Telephone | +86-10-80120641 |
| Contact: | Arthur Goddard216-233-5722asjgoddard@aol.com |
| Date | November 6, 2012 |
| Name | HoperTM PTCA Balloon Dilatation Catheter |
| Common Name: | PTCA Catheter |
| Classification Name: | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Classification | 21 CFR 870.5100 |
| Product Code: | LOX |
| Predicate: | EmpiraTM Rx PTCA Dilatation Catheter, Creganna Tactx Medical, Inc.(K110133), FireStar® PTCA Dilatation Catheter, Cordis - Johnson &Johnson, (P880003), and FX miniRAILTM RX PTCA Catheter(P020037). |
| Description: | Hoper Rapid Exchange (LPRX) Balloon Dilatation Catheter is aPercutaneous Transluminal Coronary Angioplasty (PTCA) RapidExchange System. The proximal shaft is a polymer coated stainlesssteel tube. The steel construction is designed to optimize proximalpushability with a smooth transition to a distal shaft specificallydesigned to be highly trackable. The semi-compliant balloon materialallows dilatation with precise control of balloon diameter and length.Two radiopaque platinum marker bands are located within the balloonsegment. The catheter is compatible with 5F or larger guiding catheters.The internal lumen of the catheter accepts a standard 0.014 inch PTCAguide wire. The proximal part of the guide wire enters the catheter's tipand advances coaxially out the catheter's proximal port, therebyallowing both coaxial guidance and rapid exchange of catheters with asingle standard length guide wire.Two marked sections are located on the hypo tube shaft to indicatecatheter position relative to the tip of either a brachial or femoralguiding catheter.The design of this dilatation catheter does not incorporate a lumen fordistal dye injections or distal pressure measurements.The product can be used to expand stenotic coronary vessel, andimprove myocardial bleeding. This kind of balloon catheter possessessuch merits as moderate compliance, high pressure resistance, minordiameter, etc. |
| Specification | |
| Balloon Diameter: | 1.5mm, 1.75mm, 2.0mm, 2.5mm, 2.75mm, 3.0mm, 3.5mm, and 4.0mm |
| Balloon Length: | 9mm, 12mm, 14mm, 16mm, 18mm, 20mm, 24mm, 26mm, and 30mm |
| Intended Use | The balloon dilatation catheter is indicated for balloon dilatation of thestenotic portion of a coronary artery or bypass graft stenosis for thepurpose of improving myocardial perfusion.This balloon dilatation catheter is not intended for the expansion ordelivery of a stent. |
| Contraindication: | • Unprotected left main coronary artery.• Coronary artery spasm in the absence of significant stenosis.• In patients who are unable to receive anticoagulation therapy. |
| Warning | • For single patient use only. Do not re-sterilize as this can potentiallyresult in compromised device performance, lead to device failure,increase risk of cross contamination, patient injury, illness and/ ordeath.• The product is sterile and non-pyrogenic. Do not use the catheter if itspackage has been opened or damaged.• To reduce the potential for vessel damage, the inflated diameter of theballoon should approximate the diameter of the vessel just proximaland distal to the stenosis.• Do not subject catheter to more than four (4) rotation turns as this canpotentially result in the catheter kinking and affect catheterperformance.• To prevent possible damage to the balloon, do not remove the balloonprotective jacket until ready to insert balloon catheter into the guidingcatheter.• Purge the air and liquid in the balloon before operation.• Use only the recommended balloon inflation medium. To prevent thepossibility of an air embolus, never use air or any gaseous medium toinflate the balloon.• PTCA in patients who are not acceptable candidates for coronary arterybypass graft surgery requires careful consideration, including possiblehemodynamic support during PTCA, as treatment of this patientpopulation carries special risk.• When the catheter is exposed to the vascular system, it should bemanipulated while under high-quality fluoroscopic observation.• Do not advance or retract the catheter unless the balloon is fullydeflated under vacuum as this can potentially result in damage to thevessel wall.• If resistance is met during manipulation, determine the cause of theresistance before proceeding.• Balloon pressure should not exceed the rated burst pressure indicatedon the package label for each balloon model. The rated burst pressureis based on the results of in vitro testing. Use of a manual pressuremonitoring device is recommended to prevent over pressurization.• After surgery, the balloon should be deflated before removing out from |
| Warning continued | • PTCA should only be performed at hospitals where emergencycoronary artery bypass graft surgery can be quickly performed in theevent of a potentially injurious or life-threatening complication.• The product should be used only by physicians who have taken thetraining of percutaneous transluminal coronary angioplasty. |
| Caution: | • Federal (USA) law restricts this device to sale by or on the order of aphysician.• Read the Instructions for Use to understand the using method andperformance of the product detailed before use, and ensure theeffectiveness and safety.• Use the catheter prior to the “Use By” date (Expiration Date) specifiedon the package.• Prior to angioplasty, the catheter should be examined to verifyfunctionality and ensure that its size and shape are suitable for theprocedure for which it is to be used.• The hydrophilic coating needs to be pre-wet to “activate” the coatingfor enhanced lubricity prior to use.• During the procedure, appropriate anticoagulant and coronaryvasodilator therapy must be provided to the patient as needed. Afterthe procedure, anticoagulant therapy should be continued for a periodof time as determined by the physician.• When using two guide wires, care should be taken when introducing,torqueing and removing one or both guide wires to avoid entanglement.It is recommended that one guide wire be completely withdrawn fromthe patient before removing any additional equipment.• Treat all disposable devices according to the local requirements formedical device waste disposal. |
| Adverse Effects: | Potential complications and adverse effects due to the use of this productinclude, but are not limited to, the following:• Death• Acute myocardial infraction• Total occlusion of the coronary artery or bypass graft coronaryvessel dissection, perforation, rupture or injury• Restenosis of the dilated vessel• Hemorrhage or hematoma• Unstable angina• Arrhythmias, including ventricular fibrillation• Drug reactions, allergic reaction to contrast medium• Hypo/hypertension• Infection• Coronary artery spasm• Arteriovenous fistula• Embolism• Stroke• Cardiovascular accident• Transient ischemic attack• Myocardial ischemia• Pseudo aneurysm (at site of catheter insertion) |
| Adverse Effects continue: | • Cardiac tamponade / pericardial effusion Renal failure• Coronary aneurysm• Vessel trauma requiring surgical repair or intervention• Cardiogenic shock• Coronary artery bypass graft surgery |
| SubstantialEquivalencyInformation | Comparisons of the Hoper Balloon Dilatation Catheter and predicatedevices demonstrated that the technological characteristics such asproduct performance, design, and intended use are substantiallyequivalent to the currently marketed predicate devices. |
| PerformanceTesting | The following in vitro performance tests were performed:• Dimensional verification• Balloon preparation, deployment,and retraction• Balloon rated burst pressure• Balloon fatigue• Balloon compliance (diameter vs. pressure)• Balloon inflation and deflationtime• Catheter bond strength• Tip pull strength• Flexibility and kink• Torque strength• Radiopacity• Coating integrity• Particulate evaluation |
| The following Biocompatibility tests were performed:• Cytotoxicity Study - ISO Elution Method• ISO Guinea Pig MaximumSensitization Test• ISO Intracutaneous Study• ISO Systemic Toxicity Study• ASTM Hemolysis Study• In vivo Thromboresistance Studyin the Dog, Jugular Vein• ASTM Partial Thromboplastin Time• USP Pyrogen Study - MaterialMediated• C3a Complement Activation Assay• SC5b-9 Complement ActivationAssay• Radiopacity• Coating integrity• Particulate evaluationThe test results met all acceptance criterions, were similar to predicatedevices, and ensured that the HoperTM PTCA Balloon Dilatation Catheterdesign and construction are suitable for its intended use as recommended | |
| by the Class II Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA) Catheters(FDA, September 8, 2010). | |
| Conclusion | The information supports a determination of substantial equivalencebetween the HoperTM PTCA Balloon Dilatation Catheter and thepredicate devices described above |
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Section 5: 510k) Summary, continue
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Section 5: 510k) Summary, continue
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Section 5: 510k) Summary, continue
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13. 2013
Lepu Medical Technology (Beijing) Co., Ltd % Arthur Goddard FDA Regulatory and Quality Systems Consultant 1531 Felton Road South Euclid, OH 44121-2722
Re: K123473
Trade/Device Name: Hoper™ PTCA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty Catheter Regulatory Class: Class II Product Code: LOX Dated: June 17, 2013 Received: June 20, 2013
Dear Mr. Goddard:
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Sincerely yours,
MDA
M L Hilleman
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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| Section 4: Indication for Use Summary | |
|---|---|
| 510(k) Number (if known): | K123473 |
| Device Name: | Hoper TM PTCA Balloon Dilatation Catheter |
| Indications For Use: |
The balloon dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
This balloon dilatation catheter is not intended for the expansion or delivery of a stent.
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Lillehemann
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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.