PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION". August 3, 2021 QualiMed USA, LLC. % Marc Scheineson, Esq Alston & Bird LLP 950 F Street N.W. Washington, D.C., District of Columbia 20004 Re: K201246 Trade/Device Name: PTA Balloon Catheter (PVO), MIT PTA Balloon Catheter (PVO) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: June 22, 2021 Received: June 22, 2021 ## Dear Marc Scheineson: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201246 Device Name PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) Indications for Use (Describe) The PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including illac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 510(k) Summary - K201246 ### Submitted By: | Contact Person: | Guelcher Manfred<br>CRO | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | | QualiMed USA, LLC.<br>1800 Camden Rd,<br>Suite 107 (P.O Box 252),<br>Charlotte North Carolina 28203,<br>USA<br>Email: guelcher@qualimed.de | | Alternative Contact: | Marc J. Scheineson, Esq.<br>950 F. St. N.W.<br>Washington, D.C. 20004<br>Email: Marc.Scheineson@Alston.com | Date Prepared: August 3rd, 2021 - 1.1. Trade and or Proprietary Name are the same. | Trade and or Proprietary Name | Model | Note | |---------------------------------|--------------------------------------------------|-------------------------------| | PTA Balloon Catheter (PVQ): | PVQ 14, PVQ 18, PVQ 18DF,<br>PVQ 35 and PVQ 35HP | For the whole family | | MIT PTA Balloon Catheter (PVQ): | PVQ 14, PVQ 18 and PVQ 18DF | For these small sizes<br>only | Over the wire (OTW) Percutaneous Transluminal 1.2. Common/Usual Name: Angioplasty (PTA) Balloon Dilatation Catheter 1.3. Classification Name: Catheter, Angioplasty, Peripheral, Transluminal 1.4. Classification: Class II Division of Cardiovascular Devices (DCD) Panel: Peripheral Interventional Devices Branch (PIDB) Product Code: LIT Regulation: 21 CFR 870.1250 #### 1.5. Purpose of Submission: To introduce a line of OTW Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheters (PVQ) to the marketplace. {4}------------------------------------------------ #### 1.6. Device Description The PTA Balloon Catheters (PVQ) is a sterile, single use, non-pyrogenic balloon catheter for peripheral indication. The device features an ultra-low profile, semi-compliant balloon combined with a low-profile tip. The PTA Balloon Catheters (PVQ) has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of 0.014 in (0.36 mm), 0.018 in (0.46mm), guidewires to facilitate advancement of the catheter to and through the stenosis to be dilated. The PTA Balloon Catheters (PVQ) features a dual lumen shaft that provides rapid inflation/deflation times for the catheters compatible with 0.035 in (0.89mm) guidewires. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures. The catheter includes a tapered tip to facilitate advancement of the catheter. The working lengths of the balloon catheter range between 10 mm and 280 mm. and are selected based on patient requirements for PTA. The radiopaque marker(s) (see RMD in Figure 1) are placed beneath the "usable balloon length" of the balloon and are visible when used in conjunction with fluoroscopy and aid in the placement of the balloon. The effective length could increase by 1 cm in a fully hydrated state. Each balloon inflates to the stated diameter and length at a specific pressure. The maximum rated burst pressure is different for each size. It is important that the balloon not be inflated beyond the rated burst pressure. The proximal portion of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock port for the guidewire lumen. The devices can be supplied with and without hydrophilic coating. The hydrophilic coating when applied is applied proximally to the balloon for a length of 20 mm and 40 mm. Each PTA Balloon Catheters (PVQ) is packaged as follows: - . The balloon is protected within a protective tube with an inner lumen protective stainless-steel wire. - The entire catheter is provided in a Polyethylene or Poly propylene Protectivetubing ● spiral dispenser. - The protected catheter is placed in a Tyvec pouch, which is sealed to form the sterile ● barrier. - Then the pouch is placed into an outer box. . The PTA Balloon Catheters (PVQ) is used with commercially available sheath introducers, guide catheter and guidewires. These are not included with the PTA Balloon Catheter (PVQ). ### 1.7. Indication for Use: The PTA Balloon Catheter (PVQ) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infrapopliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. {5}------------------------------------------------ #### 1.8. Technological Characteristics: The technological characteristics of the PTA Balloon Catheters (PVQ) are the same as for the predicate and reference devices as they have no significant differences in the materials, sterilization, specifications, design, and intended uses). #### 1.9. Substantial Equivalence: The PTA Balloon Catheters (PVQ) are substantially equivalent to the primary predicate device (Cordis Savvy 18 - K971010), and the Bard Ultraverse PTA Catheters (K142261 - 0.035, K121856 - 0.018 and 0.014) as reference devices. The equivalence is supported by the attached documentation. ### 1.10. Comparison to Predicate Devices: | | PTA Balloon Catheter<br>(PVQ)<br>Q3 Medical Device<br>Limited<br>(Proposed Device) | Predicate Device -<br>Cordis Savvy 18<br>(K971010) | Reference Device -<br>Bard Ultraverse<br>0.014 & 0.018<br>(K121856) | Reference Device -<br>Bard Ultraverse<br>0.035 (K142261) | | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Characteristics | LIT | LIT | LIT | LIT | Comparison | | Product<br>FDA<br>Code | LIT | LIT | LIT | LIT | Same | | Indications<br>for<br>Use | The PTA Balloon<br>Catheters are indicated<br>for Percutaneous<br>Transluminal<br>Angioplasty (PTA) in<br>the peripheral<br>vasculature, including<br>iliac, femoral, ilio-<br>femoral, popliteal,<br>infrapopliteal, and renal<br>arteries, and for the<br>treatment of obstruction<br>lesions of native or<br>synthetic arteriovenous<br>dialysis fistulae. | The Cordis PTA<br>Catheters are<br>intended for balloon<br>dilatation of lesions<br>in peripheral<br>arteries (iliac, renal,<br>popliteal, infra<br>popliteal, femoral,<br>and ilio-femoral)<br>and are also<br>intended to treat<br>obstructive lesions<br>of native or<br>synthetic<br>arteriovenous<br>dialysis fistulae. | The Ultraverse®<br>014 & 018 PTA<br>Balloon Dilatation<br>Catheters, are<br>recommended for<br>use in Percutaneous<br>Transluminal<br>Angioplasty of the<br>renal, tibial,<br>popliteal, femoral<br>and peroneal<br>arteries. These<br>catheters are not for<br>use in coronary<br>arteries. | The Ultraverse®<br>035 PTA Dilatation<br>Catheter is intended<br>to dilate stenoses in<br>the peripheral<br>arteries, to treat<br>obstructive lesions<br>of native or<br>synthetic AV<br>fistulae and/or re-<br>expand<br>endoluminal stent<br>graft elements in<br>the iliac arteries.<br>This device is also<br>recommended for<br>post-dilatation of<br>balloon expandable<br>and self-expanding<br>stents in the<br>peripheral<br>vasculature. This<br>catheter is not for<br>use in coronary<br>arteries. | Similar | {6}------------------------------------------------ | Catheter Design | Over the Wire (OTW) | Over the Wire (OTW) | Over the Wire (OTW) | Over the Wire (OTW) | Same | |---------------------------|--------------------------------------------------------|---------------------------|--------------------------------------------------------------------|--------------------------|---------| | Ballon Materials | Nylon,<br>Pebax, hydrophilic coating | Nylon, Polyethylene, PTFE | Balloon and Lumen Material: N/A<br>Coating:<br>hydrophilic coating | N/A | Similar | | Sheath Size/Fit | 4 to 9 (F) | 4 to 5 (F) | 4 to 5 (F) | 5 to 6 (F) | Similar | | Compatible<br>Guidewires | 0.014, 0.018, 0.018<br>Dialysis Fistulae, and<br>0,035 | 0.018 | 0.014 & 0.018 | 0.035 | Same | | Balloon Diameter | 1.25 to 12.0 mm | 2 to 6 mm | 1.5 to 5 mm | 3-12 mm | Similar | | Balloon Length | 10 to 280 mm | 20 to 100 mm | 2 to 30 cm (20 mm<br>to 300 mm) | 20-300 mm | Similar | | Usable Catheter<br>Length | 45 to 160 cm | 80 to 150 cm | 75 to 150 cm | 75 to 130 cm | Similar | | Nominal<br>Pressure | 2.00 to 7.00, bar | 6 to 8 atm | N/A | N/A | | | Rated Burst<br>Pressure | 18 — 22 bar | 10 atm | N/A | 9 to 21 atm | Similar | | lMarker Bands | Dual Pt/Ir Markers | Two Radiopaque<br>Markers | Two Radiopaque<br>Markers | GeoAlign Marker<br>Bands | Same | | Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same | # 1.11. Performance Testing: The PTA Balloon Catheters (PVQ) were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre- defined acceptance criteria. To demonstrate substantial equivalence of PTA Balloon Catheters (PVQ) to the predicate devices, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" dated September 8, 2010. The following performance tests were completed: - Surface Visual Inspection ● - Dimension Verification and Photo Documentation of Catheter and Accessories ● - Component Dimension Compatibility ● - Trackability - Pushability ● - Simulated Use Test: ● - o Passage - o Flex/Kink - Torqueability O - 2 Point Bending - 3 Point Bending {7}------------------------------------------------ - Deflation Time and Rate ● - Nominal Pressure ● - . Rated Burst Pressure - Dynamic Friction - Friction of guidewire lumen ● - Kink Resistance - Conical Fitting Test/Luer Lock Stress Test - Bond Strength - X-Ray Visibility ● - . Biocompatibility - Bioburden ● - Endotoxine - Haemolysis ● The results of these tests demonstrate the technological characteristics and performance criteria of the PTA Balloon Catheters (PVQ) are adequate for its intended use, and is substantially equivalent to the predicate devices. # 1.12. Conclusion QualiMed USA has concluded that the information provided supports that the PTA Balloon Catheters (PVQ) are substantially equivalent to the predicate and reference devices.