Ranfac Cartilage Biopsy Needle

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April 25, 2019 Ranfac Corporation Eric Kreuz Director of Quality Assurance/Regulatory Affairs 30 Doherty Ave Avon, Massachusetts 02322 Re: K183146 Trade/Device Name: Ranfac Cartilage Biopsy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: November 8, 2018 Received: November 13, 2018 Dear Eric Kreuz: 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). 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The signature is for an unspecified purpose. Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183146 Device Name Ranfac Cartilage Biopsy Needle Indications for Use (Describe) The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| > 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}------------------------------------------------ Page 1 of 4 # 510(k) Summary #### I. SUBMITTER | Sponsor: | Ranfac Corp.<br>30 Doherty Ave<br>Avon, MA | |-----------------|-----------------------------------------------------------------------| | Contact Person: | Eric Kreuz | | Date: | March 23, 2019<br>Ph: 1-508-588-4400, Ext. 137<br>Fax: 1-508-584-8588 | #### II. DEVICE | Device Trade Name: | Ranfac Cartilage Biopsy Needle | |--------------------------|--------------------------------| | Common or Usual Name: | Biopsy Needle | | Device Classification: | Class II | | Classification Name: | Instrument, Biopsy | | Regulation: | 876.1075 | | Device Regulation Panel: | Gastroenterology/Urology | | Device Product Code: | KNW & FCG | #### III. PREDICATE DEVICES Ranfac Bone Marrow Aspiration Needle (K131157). This device has not been subject to a design-related recall. A reference predicate for this device is the CareFusion Jamshidi-Type Bone Marrow Biopsy/Aspiration Needle (K171531). #### IV. DEVICE DESCRIPTION The Ranfac Cartilage Biopsy Needle is a manual, sterile disposable needle intended to obtain a sample of cartilage during arthroscopy. The device is comprised of an outer cannula with handle and an inner stylet. The product is provided with probe guide and probe to assist with the extraction of the cartilage from the needle. The probe guide facilitates the insertion of the probe through the distal end of the needle. The probe is introduced into the probe guide at the distal tip of the needle and advanced forward to move and expel the specimen out through the needle handle. This premarket notification is for both an 8-gauge and 11-gauge needle (product catalog numbers: CBN-84 and CBN-114, respectively). {4}------------------------------------------------ Page 2 of 4 #### INDICATIONS FOR USE V. The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy. The Indications for Use statement for the Cartilage Biopsy Needle is not identical to the predicate device which is used for obtaining a sample of bone marrow; however, the differences do not alter the high-level intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices are used to harvest a tissue specimen near bone. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE The Ranfac Cartilage Biopsy Needles ("CBN)" are similar to the predicate Ranfac Bone Marrow Aspiration Needle ("BMA Needle" - K131157) in intended use (i.e., acquisition of tissue), fundamental scientific technology, operating principles, fundamental mechanical design, performance characteristics, packaging, sterility, shelf-life and biocompatibility. The proposed and predicate devices share a similar design (needle cannula and stylet) and are provided sterile for single use, have the same materials, and operate in the Ranfac CBN with the primary predicate Ranfac BMA Needle is provided in Table 5-1. This table details the closely shared indications for use, materials and design and principle of operation therefore establishing substantial equivalence of the proposed device with the presently commercialized predicate product. | | Ranfac Cartilage Biopsy<br>Needle (This Submission) | Ranfac Bone Marrow Aspiration<br>Needle (K131157) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation<br>Number | 21 CFR §876.1075 | Same | | Intended Use<br>Indication for Use | For harvest of a tissue sample/tissue biopsy<br>The Ranfac Cartilage Biopsy Needle is<br>intended to obtain a sample of articular<br>cartilage tissue during arthroscopy. | Same<br>The Ranfac Bone Marrow Aspiration<br>Needle is intended for use in<br>aspirating bone marrow | | Overall Product<br>Design | Single-use, sterile disposable needle to<br>acquire tissue specimen. The device is<br>comprised of an outer cannula with handle<br>and an inner stylet. The device is provided<br>in two gauge sizes; i.e., 8 gauge (CBN-84)<br>and 11 gauge (CBN-114). | Single-use, sterile disposable needle to<br>acquire tissue specimen. The device is<br>comprised of an outer cannula with<br>handle and an inner stylet. The device is<br>an 11-gauge needle. | | Mechanics of<br>Operation | Manual instrument | Manual instrument | | Patient/Tissue<br>Contact Materials | Stainless steel and plastic | Stainless steel and plastic | | Gauge x Length | 8 and 11-Gauge x 4 inches | 11 Gauge x 4 inches | Table 5-1. Comparison of the Proposed Ranfac Cartilage Biopsy Needle to the Primary Predicate Ranfac Bone Marrow Aspiration Needle {5}------------------------------------------------ Page 3 of 4 | | Ranfac Cartilage Biopsy Needle<br>(This Submission) | Ranfac Bone Marrow Aspiration<br>Needle (K131157) | |----------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | Cannula<br>Configuration | 304 stainless steel hollow cannula with no side<br>ports | 304 stainless steel hollow cannula<br>with side ports | | Stylet<br>Configuration | Solid stainless-steel wire | Same | | Handle<br>Configuration | Mating plastic handle on cannula and stylet | Same | | Sample Extraction<br>Accessories | Probe guide and probe provided to expel tissue<br>specimen from needle cannula | None: tissue is aspirated through<br>needle using standard hypodermic<br>syringe. | | Packaging | Tyvek/Mylar Pouch | Same | | Sterilization | Supplied Sterile via Ethylene Oxide validated to<br>10-6 Sterility Assurance Level | Same | | Shelf-Life | 5 years | 5 years | | | Table 5-1. Comparison of the Proposed Ranfac Cartilage Biopsy Needle to the Primary | | |------------------------------------------------|-------------------------------------------------------------------------------------|--| | Predicate Ranfac Bone Marrow Aspiration Needle | | | The differences between the proposed and predicate devices is that the Ranfac CBN is intended for acquisition of cartilage; whereas, the Ranfac BMA needle is used to acquire bone marrow, both bone marrow aspirate and cartilage can be characterized as soft tissues and in both cases the needles must penetrate bone for purposes of acquiring the target tissue. The Ranfac BMA Needle is an 11-gauge needle and includes side-holes for aspiration of the bone marrow; whereas, the Ranfac CBN is provided in an 8 and 11-gauge configuration and without side holes. The Ranfac CBN is provided with a probe to facilitate tissue acquisition. These differences are not unique to the Ranfac CBN. The Jamshidi-type Bone Marrow Biopsy/Aspiration Needles (reference K171531) classified under 21 CFR §876.1075 (procode KNW) is provided in both an 8 gauge and 11-gauge configuration (no side ports on needle cannula), and provided with a probe for expelling the tissue sample. Both the Ranfac CBN and the reference Jamshidi-type needle acquire a solid core of tissue (trephine biopsy) using similar methods. The general procedures and guidelines in the proposed Ranfac CBN device's labeling provide instructions for cartilage biopsy sample collection. In summary, the proposed changes were appropriately assessed and do not raise any new or significant questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate devices presented. #### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. {6}------------------------------------------------ ### Page 4 of 4 ## Biocompatibility Testing: The biocompatibility evaluation for the Ranfac CBN was conducted in accordance with FDA's Guidance "Use of International Standard ISO-10993-1, "Biological evaluation of medical devices Part 1: Evaluation and Testing Within a Risk Management Process," as published by FDA on June 16, 2016. The battery of testing included the following tests with passing results for all: - Cytotoxicity - Sensitization - Intracutaneous Reactivity ● - Acute Systemic toxicity - Material-Mediated Pyrogenicity ● The Ranfac CBN is considered tissue contacting for a duration of less than 24 hours. ### Bench Testing: Structural integrity testing (tensile/torque) was conducted on the Ranfac CBN demonstrating robustness of the design. All samples met or exceeded acceptance criteria. Additionally, testing was performed to demonstrate that the Ranfac CBN was suitably designed for its intended purpose; i.e., acquisition of a cartilage biopsy, while maintaining the integrity of the sample as evaluated via histological analysis in a model in which articular cartilage was harvested from ex vivo bovine knees. ### Clinical Studies: No clinical studies were conducted for this submission. ## VIII. CONCLUSION Performance testing and comparison of characteristics between the subject and predicate devices have demonstrated that the Ranfac CBN is substantially equivalent to the primary and reference predicate devices with regard to intended use (biopsy for harvest of a tissue specimen), operation, function, and technological characteristics.