MMS PTA Balloon Catheter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," which are arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 25, 2016 Micro Medical Solutions, Inc. Mr. Gregory Mathison Vice President, Regulatory, Clinical & Quality 790 Willard Street #209 Ouincy, MA 02169 Re: K152934 Trade/Device Name: MMS PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: February 29, 2016 Received: March 17, 2016 Dear Mr. Mathison: 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 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. {1}------------------------------------------------ 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, Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K152934 Device Name MMS PTA Balloon Catheter Indications for Use (Describe) The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, posterior tibial, and pedal. Not for use in coronary arteries. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="padding-right:5px">☒</span>Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="padding-right:5px">☐</span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo is clean and modern, with a focus on the company's name and its connection to medical solutions. # 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## General Information | Applicant: | Micro Medical Solutions<br>240 Andover Street<br>Wilmington, MA 01887<br>Tel: 978.909.3045 | | |------------------------|--------------------------------------------------------------------------------------------|--| | Trade Name: | MMS PTA Balloon Catheter | | | Common Name: | Balloon Catheter | | | Classification Name: | Catheter, continuous flush | | | 21CFR Number: | 870.1250 | | | Device Classification: | Class II | | | Product Code: | LIT | | | Predicate Devices: | Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter<br>(K122940) | | | Contact | Greg Mathison<br>VP Regulatory, Clinical & Quality | | | Date: | March 1, 2016 | | ### Substantially Equivalent to: The MMS PTA Balloon Catheter is equivalent in intended use, principal of operation and technological characteristics to the Advance Micro 14 catheter (K122940). {4}------------------------------------------------ ### Description of the device subject to premarket notification The Micro Medical Solutions PTA Balloon Catheter is a single lumen catheter with a balloon located at the distal tip. As the MMS PTA Balloon Catheter is not an Over-The-Wire device. The catheter consists of a single lumen for balloon inflation and deflation.. Inscribed on the proximal strain relief of the catheter is the balloon diameter (mm) and balloon length (mm). Platinum/Iridium marker bands are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. ### Indications for Use The Micro Medical Solutions PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including anterior tibial, and pedal. Not for use in coronary arteries. ### Materials All materials used in the manufacture of the MMS PTA Balloon Catheter are suitable for this use and have been used in numerous previously cleared products. The MMS PTA Balloon Catheter materials were tested per ISO10993 and found to be biocompatible. Testing included the following: - Cytotoxicity ● - Sensitization ● - Acute Systemic Toxicity ● - Hemolysis Extract - Hemolysis Direct Contact ● - Pyrogen - Complement Activation ● - Canine Thrombogenicity ● ## Animal Testing Animal testing was conducted to assess the simulated clinical performance of the Guide Catheter. The product performed to specification. #### Cadaver Experience Cadaver testing was conducted using the vasculature below the knee to assess the simulated clinical use of the product. The product performed to specification. {5}------------------------------------------------ ## Non-Clinical Testing Product testing was completed and met all of the acceptance criteria. Testing was conducted on sterile final product. Testing was performed on baseline (non-aged) and aged products. Testing included: - Dimensional verification ● - Surface Review ● - Leak ● - Tracking ● - Flex/Kink ● - Torque ● - Tensile ● - Balloon fatigue ● - Balloon burst ● - Packaging ● - Aging ● ### Performance Data All necessary verification and validation testing has been performed for the MMS PTA Balloon Catheter to assure substantial equivalence to the predicate devices. ### Basis for Determination of Substantial Equivalence Upon reviewing the performance testing provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MMS PTA Balloon Catheter is determined to be substantially equivalent to existing legally marketed devices. #### Comparison of Product Features | Trade name | MMS PTA Balloon Catheter | Advance Micro 14 Ultra Low-Profile PTA Balloon | SE Discussion | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Product code | LIT | DQY | Equivalent | | 510(k) number | K152934 | K122940 | | | 21CFR | 870.1250 | 870.1250 | Same CFR number | | Device<br>Classification | II | II | Same - Class II | | Device<br>description | The Micro Medical Solutions<br>PTA Balloon Catheter is a<br>single lumen catheter with a<br>balloon located at the distal<br>tip. As the MMS PTA<br>Balloon Catheter is not an<br>Over-The-Wire device. The<br>catheter consists of a single<br>lumen for balloon inflation<br>and deflation.. Inscribed on<br>the proximal strain relief of | The Advance Micro 14 Ultra Lo The device description is the<br>Profile PTA Balloon Catheter is same.<br>over-the-wire catheter available<br>with an inflated balloon diameter<br>of 1.5 mm with balloon lengths<br>2 and 4 cm and balloon diameter<br>of 2, 2.5, and 3 mm with balloon<br>lengths of 2, 3, 4, 6,8, 10, and 12<br>cm. The catheter is 2.5 French in<br>outer diameter with a length of 5<br>90, or 150 cm. The catheter is | The device description is the<br>same. | | | the catheter is the balloon<br>diameter (mm) and balloon<br>length (mm).<br>Platinum/Iridium marker<br>bands are positioned on the<br>shaft within the balloon to<br>enable visualization of the<br>catheter/balloon under<br>fluoroscopy. | compatible with a 0.014 inch (0.<br>mm) diameter wire guide. It will<br>supplied sterile, intended for one<br>time use. | | | Intended Use | The Micro Medical Solutions<br>PTA Balloon Catheter is<br>intended for percutaneous<br>transluminal angioplasty<br>(PTA) of lesions in peripheral<br>arteries including anterior<br>tibial, posterior tibial, and<br>pedal. Not for use in coronary<br>arteries. | The Advance Micro 14 Ultra<br>Low-Profile PTA Balloon<br>Catheter is intended for<br>percutaneous<br>transluminal angioplasty<br>(PTA) of lesions in peripheral<br>arteries including internal<br>pudendal,<br>iliac, renal; popliteal, femoral,<br>iliofemoral, anterior tibia],<br>posterior tibial, peroneal,<br>pedal, radial, brachial, and<br>ulnar, as well as obstructive<br>lesions of native or synthetic<br>arteriovenous dialysis fistulae.<br>Not for use in the coronary<br>arteries. | Same Indications for Use | | Catheter Length | 65 cm working length | 50cm, 90cm, and 150cm | | | Catheter<br>Diameter | 3.2 Fr | 3.2 Fr maximum | Equivalent | | Balloon<br>Diameters | 2.0, 2.5, 4.0 F | 2, 2.5, and 3 mm | Equivalent | | Balloon length | 20, 40 and 80mm | 2, 3, 4, 6, 8, 10, and 12 cm | Equivalent | | Guidewire | Not over-the-wire<br>Removable stylet | .014 compatible | Equivalent | | Method of<br>visualization | Fluoro / Ultrasound | Fluoro | Equivalent | | Sterilization | Yes - ETO | Yes - ETO | Both devices are supplied<br>sterile. | | Single use | Yes | Yes | Same | | Shelf life | 12 months after production | Not indicated on submission | This will be on the product<br>label | {6}------------------------------------------------ {7}------------------------------------------------ | Packaging | Hoop sealed in a Tyvek / Poly<br>pouch | Hoop sealed in a Tyvek / Poly<br>pouch | Equivalent | |-----------|----------------------------------------|----------------------------------------|---------------| | Materials | Biocompatible | Biocompatible | Biocompatible | # Conclusion The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.