Biowy PlCC Catheter

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 21, 2018 Biowy Corporation Andre Muller Regulatory Affairs and Quality Assurance Manager 27031/27002 Vista Terrace Lake Forest, California 92630 Re: K173956 Trade/Device Name: Biowy PlCC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: April 16, 2018 Received: April 17, 2018 Dear Andre Muller: 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Tina Kiang S Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173956 Device Name Biowy PICC Catheter Indications for Use (Describe) The Biowy PICC catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:20px">☐</span> 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}------------------------------------------------ # K173956 510(k) Summary #### 1. Submitter Information | | Submitter Name:<br>Address: | Biowy Corporation<br>27031/27002 Vista Terrace<br>Lake Forest, CA 92630<br>Telephone No. 1-(949) 305-8211<br>Fax Number: 1-(866) 506-5094 | |--|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Primary Contact: | Andre von Muller<br>RA/QA Manager<br>Email: Avonmuller@biowy.com | | | Date of Preparation: | December 20, 2017 | | | 2. Device Information | | | | Device Name<br>Trade Name: | Biowy PICC Catheter<br>Biowy PICC Catheter | | | Common/Usual Name:<br>Regulation Number<br>Regulation Name:<br>Regulatory Class:<br>Product Code:<br>Classification Panel: | Peripherally Inserted Central Catheter (PICC)<br>21 CFR 880.5970<br>Percutaneous, implanted, long-term intravascular catheter<br>II<br>LJS<br>General Hospital | #### 3. Predicate Device: | Device Name: | 5Fr DL PowerPICC® Catheter | |-------------------------|-----------------------------------------------------------| | Trade Name: | 5Fr DL PowerPICC® Catheter | | Premarket Notification: | K051672 | | Common/Usual Name | Peripherally Inserted Central Catheter (PICC) | | Regulation Number | 21 CFR 880.5970 | | Regulation Name: | Percutaneous, implanted, long-term intravascular catheter | | Regulatory Class: | II | | Product Code: | LJS | | Classification Panel: | General Hospital | ## 4. Device Description: The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. ## 5. Indications for Use {4}------------------------------------------------ | SUBJECT (K173956) | PREDICATE (K051672) | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Indications for Use | Indications for Use | | The Biowy PICC catheter is indicated for short or long term<br>peripheral access to the central venous system for intravenous<br>therapy and power injection of contrast media. For blood<br>sampling, infusion or therapy, use 4 French or larger catheter.<br>The maximum recommended infusion rate is 5ml/sec for power<br>injection of contrast media. The maximum pressure of power<br>injectors used with the Biowy catheter may not exceed 300psi. | Identical to the FDA cleared<br>510(k) Indications for Use | # 6. Technological Comparison to Predicate | Element Comparison | Subject Device<br>K173956 | Predicate<br>K051672 | |------------------------------------------|----------------------------------------------------------|-----------------------------------| | Mode of operation | Power Injection | Same | | Size | 5F and 4F | 5F | | Priming volume | 4F (0.6ml), 5F (purple lumen 0.6ml, red<br>lumen 0.6 ml) | 0.57 ml | | Length | 60cm (5F), 55cm (4F) | 55cm | | Lumens | Dual (5F), Single (4F) | Dual | | Distal end configuration | Oval (5F), Round (4F) | Oval | | Intended anatomic location of distal end | lower 1/3 of Superior Vena Cava | Same | | Proximal end configuration | Oval (5F), Round (4F) Reverse taper<br>design | Oval (5F) Reverse taper<br>design | | Gravity water flow rate (ml/h) | 695ml/h (5F) 434ml/h(4F) | 578 ml/h | | Power Injection 10x | Meet design requirement | N/A* | | Burst pressure | 267psi (5F), 278psi (4F) | 223 psi | | Biocompatibility (See list below) | Biocompatible | Same | | Primary Device Materials | Polyurethane and barium sulfate | Same | | Radiopacity | Detectable | Same | *Power Injection 10x: The subject device is additionally evaluated for worst-case scenario of 10x power injection. This difference of the power injection, flow rate and the burst pressure do not raise issues of safety and efficacy because the subject device is examined using the same ISO 1055-1 standard testing requirement as the predicate. The results fall within the limits allowed in the standard (ISO 10555-1). The subject device (single lumen 4F and dual lumen 5F) are examined using the same testing requirements as the predicate. Therefore, the configuration difference does not raise issues of safety and efficacy. The comparison above shows substantial equivalence of the subject device and the predicate. ## 7. Summary of Performance Tests - . FDA Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters 1995 - 10555-1 Second Edition 2013-06-15 Intravascular Catheters -- Sterile and Single-Use ● Intravascular Catheters -- Part 1: General Requirements - FDA Guidance for Industry 2016: Use of International Standard ISO 10993-1, "Biological . evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Performance data gathered in design verification testing demonstrated that Biowy PICC catheter is substantially equivalent to the predicate 5 Fr DL PowerPICC catheter and the risk associated with use of the new device have been adequately mitigated. {5}------------------------------------------------ The performance tests are listed below to demonstrate substantial equivalence of the subject device K173956 (4F SL and 5F DL), and applicable standards. | Test | Standards | Results | |--------------------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------| | Critical Dimensions | ISO 9626:2015 | Passed and met requirement | | Priming Volume | Internal | Passed and met requirement | | Tensile Force | ISO 10555-1:2014 | Passed and met requirement | | Elongation and Stiffness | Internal | Passed and met requirement | | Flexural Fatigue | Internal | Passed and met requirement | | Aspiration Flow/ Catheter collapse | Internal | Passed and met requirement | | Air Leakage during Aspiration | ISO 10555-1:2014 | Passed and met requirement | | Gravity Flow | ISO 10555-1:2014 | Passed and met requirement | | Pump Flow | ISO 10555-1:2014 | Passed and met requirement | | Power Injection and Leak Testing | ISO 10555-1:2014 | Passed and met requirement | | Burst Pressure | ISO 10555-1:2014 | Passed and met requirement | | Power Injection/Burst Pressure | ISO 10555-1:2014 | Passed and met requirement | | Power Injection (10x)/ Burst Pressure | ISO 10555-1:2014 | Passed and met requirement | | Printing Marking | ISO 10555-3:2013 | Passed and met requirement | | 6% Luer Taper | ISO 594-1:1986 | Passed and met requirement | | Luer | ISO 594-1:1986<br>ISO 594-2:1998 | Passed and met requirement | | Luer Color Orientation | Internal | Passed and met requirement | | Radiopacity | ASTM F640-12 | Passed and met requirement | | List of Biocompatibility Tests: | | | | • Cytotoxicity | ISO 10993-5 | Non-cytotoxic | | • Sensitization | ISO 10993-10 | Non-sensitizer | | • Irritation | ISO 10993-10 | Non-irritant | | • Acute Systemic Injection | ISO 10993-11 | Non-toxic | | • Material Mediated Pyrogen | USP<151> | Non-pyrogenic | | • LAL (Bacterial Endotoxins) | USP <85>, <161> | Passed and met requirements | | • Hemolysis (extract) | ISO 10993-4 | Non-hemolytic | | • Hemolysis (direct) | ISO 10993-4 | Non-hemolytic | | • Complement Activation<br>Predicate: PowerPICC®<br>Catheter | ISO 10993-4 | Similar when compared to predicate | | • Partial Thromboplastin Time<br>(PTT) Predicate: PowerPICC®<br>Catheter | ISO 10993-4 | Minimal activator (same as predicate) | | • Dog Thrombogenicity | ISO 10993-4 | Similar to control | | • Implantation | ISO 10993-6 | Non-irritant | | • Subacute/sub Chronic Toxicity,<br>Genotoxicity, Chronic Toxicity,<br>and Carcinogenicity | ISO 10993-17<br>ISO 10993-18 | Passed and met requirement | | EtO sterilization | ISO 11135: 2014 | Met 10-6 SAL requirement | | Clinical Evaluation | Internal | Passed | | Accelerated Aging<br>1.5 year (4F SL, 5F DL)<br>3.0 year (4F SL, 5F DL) | ISO 11607-1:2006<br>ASTM F88/F88M-15<br>ISO 10555-1:2014 | Passed and met requirement | ## Brief discussion of the non-clinical tests submitted for a determination of substantial equivalence: Biowy has provided Performance Testing. The Biowy PICC Catheters are designed, and made of the same polymer materials, use similar technological manufacturing methods, and have the same intended use as the predicate devices (PowerPICC Catheters). Differences in technological characteristics (including flow rate, burst pressure, lumens, and the distal end configurations) of the device compared to the predicate do not raise different questions of safety and effectiveness. Biowy has evaluated the differences using the same test requirements as the predicate device. The subject devices are substantially equivalent to the predicate device in specifications comparison. {6}------------------------------------------------ # 8. Conclusion The Biowy PICC catheters (Model number PICC4SK and PICC5DK) has similar indications or use, technological characteristics and they meet all the predetermined performance acceptance criteria of the testing performed. Therefore, the devices are substantially equivalent to the predicate device the C.R. Bard 5 Fr DL PowerPICC® catheter, K051672.