Uramix CuraWay Biopsy Needle

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below the words "U.S. FOOD & DRUG". September 17, 2021 Uramix, Inc. % Michael Mooreville, MD Medical Director Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, Pennsylvania 19050 Re: K203141 Trade/Device Name: URAMIX CuraWay Automatic Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: July 21, 2021 Received: July 21, 2021 Dear Dr. Mooreville : 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 approv al 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 {1}------------------------------------------------ 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) 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, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K203141 #### Device Name Uramix Curaway Automatic Core Biopsy Instrument #### Indications for Use (Describe) The Uramix Curaway Automatic Core Biopsy Instrument is intended for use in obtaining biopsies from soft tissues such as liver, kidneys, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone, or breast. | 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}------------------------------------------------ #### SUBMITTER Uramix, Inc 272 N. Lansdowne Ave. Lansdowne, PA 19050 | Contact Person: | Michael Mooreville, MD | |-----------------|------------------------| | | Medical Director | | Telephone: | (610) 304-9070 | | Email: | uramix@comcast.net | ## DEVICE Name of the Device: URAMIX CuraWay Automatic Core Biopsy Instrument Regulation Number: 21 CFR 876.1075 Regulation Name: Instrument, Biopsy/Regulatory Class II Regulatory Specialty: Gastroenterology/Urology KNW Product code: Manufacturer: Zhejiang CuraWay Medical Technology Co., Ltd Company Address: Room 106, Building 1, No.600, 21st Street, Qiantang New Area, Hangzhou, Zhejiang, China ## PREDICATE DEVICE K133948, BARD® MAX-CORE® Disposable Core Biopsy Primary: ## DEVICE DESCRIPTION The URAMIX CuraWay Automatic Core Biopsy Instrument is a single use only core biopsy device and is individually packaged and sterilized. The packaging is compatible with the product's EO sterilization method. The sterilization validation confirms the packaging is qualified to maintain the sterilization condition of the device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color coded according to the various gauge sizes. The 18 gauge is the one used for current intended marketing, for prostate and kidney biopsies. {4}------------------------------------------------ ### K203141 ### 510(k) Summary | ABN 1208,<br>ABN 1208A | ABN 1408,<br>ABN 1408A | ABN 1608,<br>ABN 1608A | ABN 1808,<br>ABN 1808A | ABN 2008,<br>ABN 2008A | |------------------------|-------------------------|--------------------------|------------------------|--------------------------| | ABN 1210,<br>ABN 1210A | ABN 1410,<br>ABN 1410A | ABN 1610,<br>ABN 1610A | ABN 1810,<br>ABN 1810A | ABN 2010,<br>ABN 2010A | | ABN 1213,<br>ABN 1213A | ABN 1413,<br>ABN 1413A | ABN 1613,<br>ABN 1613A | ABN 1813,<br>ABN 1813A | ABN 2013,<br>ABN 2013A | | ABN 1216,<br>ABN 1216A | ABN 1416,<br>ABN 1416A | BN 1616,<br>ABN 1616A | ABN 1816,<br>ABN 1816A | ABN 2016,<br>ABN 2016A | | ABN 1220,<br>ABN 1220A | ABN 1420,<br>ABN 1420A | ABN 1620,<br>ABN 1620A | ABN 1820,<br>ABN 1820A | ABN 2020,<br>ABN 2020A | | ABN 1225,<br>ABN 1225A | ABN 1425,<br>ABN 1425A | ABN 1625,<br>ABN 1625A | ABN 1825,<br>ABN 1825A | ABN 2025,<br>ABN 2025A | | 12G<br>(2.7mm)<br>Blue | 14G<br>(2.1mm)<br>Green | 16G<br>(1.7mm)<br>Violet | 18G<br>(1.2mm)<br>Pink | 20G<br>(0.9mm)<br>Yellow | According to gauge and length, the following variants are available: The operating handle is color coded and the Type A is a variant in the position of the needle markings, which provide reference for depth of placement. ### INDUCATIONS FOR USE The URAMIX CuraWay Automatic Core Biopsy Instrument is intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone, or breast. {5}------------------------------------------------ ## COMPARISON TO PREDICATE | | Predicate Device | Subject Device | | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Item | BARD® MAX-CORE® Disposable<br>Core Biopsy Instrument, K133948 | URAMIX CuraWay Automatic Core<br>Biopsy Instrument, K203141 | Outcome | | Intended<br>Use | Obtaining biopsies from soft tissues<br>such as liver, kidney, thyroid,<br>prostate, spleen, lymph nodes and<br>various soft tissue tumors.<br>It is not intended for use in bone. | The URAMIX Curaway Automatic<br>Core Biopsy Instrument is<br>intended for use in obtaining<br>biopsies from soft tissues such<br>as liver, kidney, prostate, spleen,<br>lymph nodes and various soft<br>tissue tumors. It is not intended<br>for use in bone, or breast. | It was used for the same<br>clinical condition, and same<br>intended purpose, and at the<br>same site. | | Material | Stainless steel + ABS | The shaft of cutting cannula and inner<br>stylet is made of medical grade stainless<br>steel (SUS304/06Cr19Ni10). The operating<br>handle and actuator button are made of<br>acrylonitrile butadiene styrene (ABS). | Same material used | | Types/<br>Sizes | 14G, 16G, 18G, 20G | 12G, 14G, 16G, 18G, 20G | 12G is also available from<br>Zhejiang CuraWay, this has<br>no significant influence on<br>clinical use. | | Design<br>Attributes | Each needle has numerically ordered<br>centimeter markings on the outer<br>cannula to provide reference for depth<br>placement<br>Needles feature an adjustable needle<br>stop which allows the user to restrict<br>forward movement, localizing the<br>needle tip to the biopsy site<br>Color coded stylet hubs indicate<br>gauge size of needles available in a<br>variety of gauge sizes and centimeter<br>lengths<br>Available with an echogenic tip on the<br>outer cannula to promote accurate<br>placement under ultrasound guidance | Automatic Core Biopsy Instrument is a<br>puncture needle consisting of an inner<br>stylet and a cutting cannula with etched tip<br>(s. Figure 1). The cutting cannula has<br>numerically ordered centimeter markings<br>on it to provide reference for depth<br>placement. In the distal area of the cutting<br>cannula, an ultrasound enhancement is<br>available to promote accurate placement<br>under ultrasound or X-ray guidance. An<br>adjustable depth stopper allows the user to<br>restrict forward movement, localizing the<br>needle tip to the biopsy site. The Type A is<br>a variant in position of the depth stopper.<br>The operating handle is color-coded, which<br>indicates gauge size of the needle. The<br>needle is protected in a needle sheath.<br>Automatic Core Biopsy Instrument is<br>available in several needle gauge sizes<br>and lengths. | Very similar design | | Length<br>(mm) | 100mm, 160mm, 200mm, 250mm | 80mm, 100mm, 130mm, 1600mm, 200mm,<br>250mm | This has no significant<br>influence on clinical use. | | Slot size | 18mm | 18mm | Same | | Structure<br>a. Photo<br>(examples) | | | Very similar structure and<br>design concept | | Packaging | Tyvek 1073B + PE | Tyvek 1073B + PET/PE | Critical component Tyvek is<br>the same.<br>Both packaging systems are<br>common packaging. | | Biocompati<br>bility | ISO 10093-1, ISO 10993-5 and ISO<br>10993-10 | ISO 10093-1, ISO 10993-5 and ISO 10993-<br>10 | Same. | | Sterilizatio<br>n method | EO sterilization | EO sterilization | Same. | | Conclusion | After comparison of the device in question with the predicate device, K133948 regarding<br>clinical, technical and biological characteristics, it can be concluded that both devices have<br>similar design, perform the same function under the same clinical conditions. They use the<br>same materials and have the same durability. Tissue penetration and sample size are the same<br>and the device is in contact with the same human tissues and body fluids. They can be<br>considered as equivalent devices. | | | {6}------------------------------------------------ ## SUMMARY OF NON CLINICAL TESTING The following testing was conducted to demonstrate the safe and effective use of the URAMIX Curaway Automatic Core Biopsy Instrument: - Biocompatibility Testing per ISO 10993-5, including in vitro cytotoxicity ● - ISO 10993-10 tests for irritation and skin sensitization ● - ISO 10883-11 test for systemic toxicity ● - Sterilization Testing per ISO 11138-2, and ISO 11737-2 sterility test ● - Residuals per EN ISO 10993-7 EO residuals = 1.13 mg/device ● - Packaging and Shelf-life per ISTA2A and ASTM F1980-16 3-year shelf life ● {7}------------------------------------------------ - Puncture Force Value: Predicate 5.3N; Subject 2.7N ● - Resistance during operation: Predicate none; Subject none ● - Abnormal noise during operation: Predicate none: Subject none . - Connection firmness (needle tube + plastic parts): P 181 to 230N; S 190 to 212N ● - Samples of various tissues: similar length, weight between Predicate and Subject . - The ex-vivo tissue studies (porcine muscle, liver) demonstrate equivalent tissue . samples in terms of length and weight. ## CONCLUSION Based upon the performance data provided in this submission and comparing indicated use, design, materials, principle of operation and overall technological characterisitics, the URAMIX Curaway Automatic Core Biopsy Instrument has been determined to be substantially equivalent to the predicate device, BARD Max-Core, K133948