J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. June 12, 2019 Ranfac Corporation Eric Kreuz Director of Quality Assurance/Regulatory Affairs 30 Doherty Ave Avon, Massachusetts 02322 Re: K190177 Trade/Device Name: Ranfac Bone Marrow Biopsy Needles (J-Type Marrow Biopsy Needle, T-Type Marrow Biopsy Needle, and Tweezer Bone Marrow Biopsy Needle) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: May 9, 2019 Received: May 13, 2019 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). 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 {1}------------------------------------------------ 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) 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 medical devices and radiation-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. for Jennifer R. Stevenson Acting Division 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K190177 Device Name Ranfac Bone Marrow Biopsy Needle Indications for Use (Describe) The Ranfac Bone Marrow Biopsy Needles are indicated for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow. **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 ### I. SUBMITTER | Sponsor: | Ranfac Corp.<br>30 Doherty Ave.<br>Avon, MA | |--------------------------|----------------------------------------------------------------------------------| | Contact Person:<br>Date: | Eric Kreuz<br>May 9, 2017<br>Ph: 1-508-584-4400, Ext. 137<br>Fax: 1-508-584-8588 | #### II. DEVICE | Device Trade Name: | Ranfac Bone Marrow 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 - primary predicate), Ranfac Goldenberg Bone Marrow Biopsy Needle (K983187) and the CareFusion Jamshidi Bone Marrow Biopsy/Aspiration Needle (K171531). ### DEVICE DESCRIPTION IV. The Ranfac Bone Marrow Biopsy Needles subject of this premarket notification (RTN-114, RTN-116, RTN-84, RTN-86, RTN-114-T, RTN 116-T, RTN-84-T, RTN-86-T, RJN -114, RJN -116, RJN-84, RJN-86) are manual, sterile disposable needles intended for the purpose of harvesting bone marrow specimens. The device is comprised of an outer cannula with handle and an inner stylet. The cannula has graduated etched markings spaced in 1 cm intervals. The product is provided with a probe guide and marked probe to assist with the extraction of the bone marrow specimen from the needle. The probe guide facilitates the insertion of the marked probe through the distal end of the needle. The marked 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. Specific models of the Ranfac Bone Marrow Biopsy Needles are also provided with a stainless steel marrow extraction cannula (either Canoe or Tweezer design) which fit inside the needle to facilitate capture and retrieval of bone marrow samples. The specimen is contained within the extraction cannula during withdrawal from the needle. The Ranfac Bone Marrow Biopsy Needles are provided with a luer cap to prevent back flow of blood during needle insertion and product with the optional extraction cannula are provided with two needle vices to cap the needle and stylet tip prior to disposal. {4}------------------------------------------------ ### V. INDICATIONS FOR USE The Ranfac Bone Marrow Biopsy Needles are intended for use in aspirating bone marrow and for use in obtaining core biopsy samples of bone marrow. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The Ranfac Bone Marrow Biopsy Needles are similar to the predicate Ranfac Needles in intended use (i.e., acquisition of bone marrow), fundamental scientific technology, operating principles, fundamental mechanical design, performance characteristics, packaging, sterility, shelf-life and biocompatibility. The Ranfac Bone Marrow Biopsy Needles and predicate devices share a similar basic design (needle cannula and stylet) and are provided sterile for single use, have the same materials, and operation. A comparison of the Ranfac Bone Marrow Biopsy Needles with the predicate devices is provided in Table 5-1. This table details the closely shared indications for use, materials and design and principle of operation between the devices, therefore establishing substantial equivalence of the devices subject of this current submission with the predicate products. | | Ranfac Bone<br>Marrow Biopsy<br>Needle<br>(This Submission) | Ranfac Bone<br>Marrow<br>Aspiration Needle<br>(K131157) | Goldenberg Bone<br>Marrow Biopsy<br>Needle (K983187) | Jamshidi<br>Bone Marrow<br>Biopsy/Aspiration<br>Needle<br>(K171531) | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Regulation<br>Number | 21 CFR §876.1075 | Same | Same | Same | | Intended Use | Intended for use in<br>aspirating bone<br>marrow and for use<br>in obtaining<br>cylindrical core<br>biopsy samples of<br>bone marrow | Intended for use in<br>aspirating bone<br>marrow | Intended for use in<br>obtaining<br>cylindrical core<br>biopsy samples of<br>bone marrow | Intended for use in<br>aspirating bone<br>marrow and for use<br>in obtaining<br>cylindrical core<br>biopsy samples of<br>bone marrow | | Indication for Use | The Ranfac Bone<br>Marrow Biopsy<br>Needles are<br>indicated for use in<br>aspirating bone<br>marrow and for use<br>in obtaining core<br>biopsy samples of<br>bone marrow. | The Ranfac Bone<br>Marrow Aspiration<br>Needle is intended<br>for use in<br>aspirating bone<br>marrow | For procuring bone<br>marrow core<br>biopsies from<br>patients with<br>hematologic<br>abnormalities. | Intended for the<br>posterior iliac crest<br>biopsy technique. | ### Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles {5}------------------------------------------------ | | Ranfac Bone<br>Marrow Biopsy<br>Needle<br>(This Submission) | Ranfac Bone<br>Marrow<br>Aspiration Needle<br>(K131157) | Goldenberg<br>Bone Marrow<br>Biopsy Needle<br>(K983187) | Jamshidi<br>Bone Marrow<br>Biopsy/Aspiration<br>Needle<br>(K171531) | |-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Overall Product<br>Design | Single-use, sterile<br>disposable needle to<br>acquire tissue<br>specimen. The<br>device is comprised<br>of an outer cannula<br>with handle and an<br>inner stylet. | Same | Same | Same | | Mechanics of<br>Operation | Manual instrument | Manual Instrument | Manual<br>Instrument | Manual Instrument | | Patient/Tissue<br>Contact Materials | Stainless steel and<br>plastic | Stainless steel and<br>plastic | Stainless steel and<br>plastic | Stainless steel and<br>plastic | | Gauge x Length | 8 and 11 Gauge in<br>lengths of 4 and 6<br>inches | 11 Gauge x 4<br>inches | 11 Gauge x 4<br>inches | 8 and 11 Gauge x 4<br>and 6 inches | | Cannula<br>Configuration | 304 stainless steel<br>hollow cannula with<br>no side ports | 304 stainless steel<br>hollow cannula<br>with side ports | 316L stainless<br>steel with internal<br>polyurethane<br>molded spiral<br>snare | Stainless steel hollow<br>cannula with multiple<br>cutting edges and no<br>side ports | | Stylet<br>Configuration | Solid stainless-steel<br>wire | Same | Same | Same | | Handle<br>Configuration | "T-Style" mating<br>plastic handle on<br>cannula and stylet | "T-Style" mating<br>plastic handle on<br>cannula and stylet | "T-Style" mating<br>aluminum handle<br>on cannula and<br>threaded retainer<br>knob on stylet | Mating plastic handle<br>on cannula | | Needle Cutting<br>Tip Configuration | Beveled Swaged<br>Needle Tip | 5-point Needle Tip | 5-point Needle<br>Tip | Beveled Swaged<br>Needle Tip | Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles {6}------------------------------------------------ | | Ranfac Bone<br>Marrow Biopsy<br>Needle<br>(This Submission) | Ranfac Bone<br>Marrow<br>Aspiration Needle<br>(K131157) | Goldenberg<br>Bone Marrow<br>Biopsy Needle<br>(K983187) | Jamshidi<br>Bone Marrow<br>Biopsy/Aspiration<br>Needle<br>(K171531) | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Bone Marrow<br>Extraction<br>Accessories | Probe guide and<br>probe provided to<br>expel tissue<br>specimen from<br>needle cannula –<br>Tweezer and Canoe<br>Extraction Cannula<br>optionally provided | None: tissue is<br>aspirated through<br>needle using<br>standard<br>hypodermic<br>syringe. | Spiral snare<br>internal to needle<br>is used to capture<br>and retain tissue | Probe guide and<br>probe provided to<br>expel tissue specimen<br>from needle cannula<br>– some versions of<br>the Jamshidi needle<br>are provided with a<br>specimen cradle<br>which is a component<br>similar to the<br>extraction cannulas<br>provided with the<br>Ranfac needle. | | Packaging | Tyvek/Mylar Pouch | Tyvek/Mylar<br>Pouch | Tyvek/Mylar<br>Pouch | Tyvek/Mylar Pouch | | Sterilization | Supplied sterile via<br>Ethylene Oxide<br>validated to 10-6<br>Sterility Assurance<br>Level | Same | Same | Supplied sterile via<br>Gamma irradiation | | Shelf-Life | 5 years | 5 years | Not stated in<br>K983187 | 5 years | Table 5-1. Comparison of the Ranfac Bone Marrow Biopsy Needle to the Primary and Secondary Predicate Bone Marrow Biopsy Needles The differences between the Ranfac Bone Marrow Biopsy Needles and predicate Ranfac Bone Marrow Aspiration Needle include the addition of the 8 gauge and 6 inch length needles, as well as the addition of the bone marrow extraction accessories; i.e., probe guide, marked probes and extraction cannula used to facilitate retrieval of a trephine biopsy. These changes have been incorporated to adapt for user preferences. Additionally, the Ranfac Bone Marrow Biopsy Needle has a swaged needle tip vs. a 5-point tip configuration to facilitate coring of bone. The predicate Jamshidi Bone Marrow Biopsy/Aspiration Needles (reference K171531) classified under 21 CFR §876.1075 (procode KNW) is provided in sizes of 8 and 11 gauge, lengths of 4 and 6 inch, with swaged needle tip and with an extraction cannula (referred to as a marrow acquisition or "specimen" cradle) and probe for retrieving and expelling the tissue sample. Similar to the Ranfac Goldenberg Bone Marrow Biopsy and Jamshidi Bone Marrow Biopsy/Aspiration Needles, the needles subject of this 510k are used to obtain a trephine biopsy (i.e., "core-type" biopsy"); whereas, the predicate Ranfac Bone Marrow Aspiration Needle has side holes on the needle cannula to allow for bone marrow acquisition via aspiration. Both types of tissue samples (trephine core biopsy and aspirate) are important to the diagnosis of hematological disorders. The general procedures and guidelines in the Ranfac Bone Marrow Biopsy Needle labeling provide instructions for biopsy sample collection. {7}------------------------------------------------ ## Page 5 of 5 In summary, the changes were appropriately assessed through risk analysis activities and do not raise any new or significant questions of safety or effectiveness. The Ranfac Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices presented. ### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility Testing: The Ranfac Bone Marrow Biopsy Needle has been demonstrated to be biocompatible with passing results for the following testing: - . Cytotoxicity - Sensitization - . Intracutaneous Reactivity - Acute Systemic toxicity - Material-Mediated Pyrogenicity The Ranfac Bone Marrow Biopsy Needles are considered tissue contacting for a duration of less than 24 hours. ## Bench Testing: Structural integrity testing (tensile/torque) was conducted on the Ranfac Bone Marrow Biopsv Needles demonstrating robustness and appropriateness of the design. All samples met or exceeded acceptance criteria. Testing was consistent with methods used for the predicate Ranfac Bone Marrow Aspiration Needle. Comparative performance testing using the Jamshidi Bone Marrow Biopsy/Aspiration Needle for reference demonstrates that the Ranfac Bone Marrow Biopsy Needle are suitably designed for bone marrow sampling. Additionally, simulated use testing was performed to validate that the design output of the Ranfac Bone Marrow Biopsy Needles met design input requirements. ## 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 Bone Marrow Biopsy Needles are substantially equivalent to the predicate devices with regard to intended use (harvest of a bone marrow specimen), operation, function, and technological characteristics, all devices being manually operated to obtain a bone marrow specimen.