Möller Medical Biopsy Needles and Systems

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 19, 2017 Möller Medical GmbH Ms. Angela Kikowatz Regulatory Affairs Manager Wasserkuppenstrasse 29-31 Fulda, 36043 Germany Re: K162588 Trade/Device Name: Möller Medical Biopsv Needles and Systems Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: May 31, 2017 Received: June 5, 2017 Dear Ms. Kikowatz: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Jennifer R. Stevenson -S3 For 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) K162588 ## Device Name Möller Medical Biopsy Needles and Systems #### Indications for Use (Describe) The Möller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen. Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow. Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or lilac crest. Application areas of the products are bone respectively bone marrow. Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow. Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy guns. Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various soft tissue lesions , and should be used with the Möller Medical Blue (RBG-1000-10-1000) biopsy gun. Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidnev. Model COX is for safe needle guidance and for taking several biopsy specimens. for example from liver, kidney, breast. thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture. Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model Möller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of {3}------------------------------------------------ | | | using standard surgical procedures. | | |--|--|-------------------------------------|--| | | | | | 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. 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Submitter | | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Möller Medical GmbH<br>Wasserkuppenstrasse 29-31<br>36043 Fulda, Germany<br>Tel.: +49 (0) 661-94195-0<br>Fax: +49 (0) 661-94195-850 | | | Establishment Registration Number: 3006611221 | | Contact Person: | Grant Geckeler<br>Free lance consultant<br>1612 Jenks Drive<br>Corona, CA 92880<br>Phone: +1 858 603 1838<br>E-mail: grant.geckeler@gmail.com | | Date Prepared: | September 01, 2016 | | 2. Device | | | Trade name: | Möller Medical Biopsy Needles and Systems<br>Consists of: Bone and Bone Marrow Aspiration Needles, Fine<br>Needles, Disposable Needles for Biopsy Guns, Coaxial<br>Needles, Manual Cut Biopsy Needles, Semi-automatic and<br>automatic Biopsy Guns | | Common or Usual Name: | Biopsy Instruments | | Classification Name: | Instrument Biopsy (21 CFR 876.1075) | | Regulatory Class: | II | | Product Code: | KNW | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image features the logo for "MöllerMedical". To the left of the text is a graphic of four light blue circles clustered together. The text "MöllerMedical" is in a simple, sans-serif font and is black. Page: 2 (7) #### 3. Predicate Device The Möller Medical Biopsy Portfolio is coincident with other different biopsy products which are already FDA approved and distributed in the US market. Table 1 shows the identified appropriate predicate devices for the Möller Medical Biopsy Portfolio with the corresponding 510(k) number. The product codes and classes are also named. #### Table 1: Predicate devices | Möller Medical Product | Predicate Device with 510(k) No. | Code and<br>Class | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Möller Medical Blue Biopsy<br>Gun<br>(RBG-xxxx) | Pro-Mag Ultra 2.2 Automatic Biopsy<br>Instrument; Pro Mag Ultra Biopsy<br>Needles, Pro-Mag Ultra Automatic Biopsy<br>Instrument<br>510(k) No.: K980226 | KNW<br>Class II | | Bone Marrow Biopsy<br>System<br>(BOW-1060) | Bone Marrow Aspiration Needles; Bone<br>Marrow Biopsy Trays; Bone Marrow<br>Harvest Needles; Osty-Core Bone Biopsy<br>Needles; Pediatric Bone Marrow Access<br>Needles; T-Lok Bone Marrow | KNW<br>Class II | | Bone Marrow Aspiration<br>Biopsy<br>(BOW-1070) | Bone Marrow Aspiration Needles; Bone Marrow<br>Biopsy Trays; Bone Marrow Harvest<br>Needles; Osty-Core Bone Biopsy Needles<br>; Pediatric Bone Marrow Access Needles;<br>T-Lok Bone Marrow Needles | KNW<br>Class II | | Bone Biopsy Needles<br>(BOY-1080) | 510(k) No.: K980196 | | | Fine Needle Biopsy<br>(FNB-xxxx) | Fine Needle Aspiration (FNA) Biopsy<br>Needles Chiba; Franseen; Green;<br>MaxiCELL; Pro-Cut; Spinal; Trocar;<br>Turner; Westcott Soft Tissue Biopsy<br>Needles<br>510(k) No.: K980122 | KNW<br>Class II | | Disposable Needles for<br>Biopsy Gun (DNG) | | | | DNG-1010 | ACN, SACN, Biopsy Needle;<br>510(k) No.: K974446 | KNW<br>Class II | | DNG-1020; DNG-1030 | Pro-Mag Ultra 2.2 Automatic Biopsy<br>Instrument; Pro-Mag Ultra Biopsy<br>Needles; Pro-Mag Ultra Automatic Biopsy<br>Instrument<br>510(k) No.: K980226 | KNW<br>Class II | | DNG-1040 | Magnum Core Tissue Biopsy Needle<br>Model MN1820, RP Cutting Needle Model<br>RP-1820, MCN Core Tissue Biopsy<br>Needle Model MCN<br>510(k) No.: K111529 | KNW<br>Class II | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for MöllerMedical. The logo consists of a cluster of light blue circles on the left side. To the right of the circles is the text "MöllerMedical" in a sans-serif font. K162588 Traditional 510(k) Submission 510(k) Summary Page: 3 (7) | Möller Medical Product | Predicate Device with 510(k) No. | Code and<br>Class | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------| | fullsCore® Biopsy Needle<br>(DNG-2020) | BioPince FullCore Biopsy Instrument<br>510(k) No.: K904987 | KNW<br>Class II | | Semi-automatic Biopsy<br>Gun<br>(SBG-xxxx) | Speedybell<br>510(k) No.: K010735 | KNW<br>Class II | | Automatic Biopsy Gun<br>(ABG-xxxx) | Manual-Bone-Marrow-Biopsy-Needles,<br>Semi-Automatic-Biopsy-Needles,<br>Automatic-Biopsy Needles<br>510(k) No.: K130616 | KNW<br>Class II | | Coaxial Needles<br>(COX-xxxx) | Co-Axial Introducer Needle<br>510(k) No.: K980004 | KNW<br>Class II | | Manual Cut Biopsy<br>(MBY-xxxx) | 18 Gauge Tru-Cut Biopsy Needle<br>510(k) No.: K960509 | KNW<br>Class II | The presented Möller Medical products have the same indication and the same technology as the selected predicate devices. #### 4. Device Description #### Möller Medical Blue RBG The Möller Medical Blue RBG is a re-usable biopsy gun to be used with corresponding needles to obtain core samples from soft tissue. It is a re-usable device, which has to be reprocessed. The biopsy needles used with this device are disposable products. The Möller Medical Blue RBG is intended to be used with the DNG-1020 and the DNG-2020 needles. The following steps are needed to prepare for the puncture. The first step is to open the cover of the Möller Medical Blue. Generally spoken the insertion of biopsy needles into the re-usable biopsy gun is dependent from the biopsy needle. It is important that the plastic hubs of the compatible needles are positioned carefully onto the locking pins. After needle insertion into the device the cover of the decocked re-usable biopsy gun shall be closed and the needle's protective sheath can be removed. By pulling the lever twice the device is ready for use and can be approached to the biopsy site - as a last step before triggering the safety lock has to switch from "locked" to "unlocked". Then introduce the needle under imaging control through the incision until the needle point is proximal to the area to be biopsied. When the position is confirmed the energized Möller Medical Blue RBG biopsy instrument hast to be triggered. Therefor the trigger button has to be depressed to cause both the stylet and cannula to automatically advance. Then the instrument has to be removed from the patient and the core tissue sample has to be exposed by pulling back the lever once from the side-notch. If additional biopsies are not being taken the used needle has {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for MöllerMedical. The logo consists of a cluster of light blue circles on the left side, resembling a stylized molecule or a group of cells. To the right of the circles, the text "MöllerMedical" is written in a simple, sans-serif font. The text is black and appears to be the company's name. Page: 4 (7) to be removed from the decocked biopsy qun and discarded. Bone Marrow Biopsy System (BOW-1060). Bone Marrow Aspiration Biopsy (BOW-1070) and Bone Biopsy Needles (BOY-1080): The purpose of the Bone Marrow Biopsy System, Bone Marrow Aspiration Biopsy and Bone Biopsy Needles is the harvesting of bone and bone marrow specimens. Access to the bone or bone marrow is achieved manually under the support of the devices cutting edge. Harvesting of bone or bone marrow specimens is accomplished manually and if required by aspirating which a syringe which is adapted to the Luer-Lock connector located at the handle of the cannula. Specimens are collected within the outer cannula which finally will be withdrawn from the patient. The needle has to be inserted by a qualified physician under imaging guidance such as CT. #### Fine Needle Biopsy (FNB-xxxx): The Fine Needle Biopsy is used for the percutaneous withdrawal of mainly cytological evidence of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs. For aspiration a Luer-Lock adapter is attached on the top of the Needle to connect a syringe. The needle has to be inserted by a qualified physician under imaging guidance such as Ultrasound. #### Disposable Needles for Biopsy Gun (DNG-1010, -1020, -1030, -1040): The Disposable Needles for Biopsy Gun are used for obtaining core biopsies of various tissues like lung, kidney, liver, prostate, abdominal soft tissue masses and breast. The needles are used in combination with different automatic biopsy guns and can be used with a corresponding coaxial needle for multiple sampling.The needle has to be inserted by a qualified physician under imaging guidance such as Ultrasound or CT. #### Full-sCore® Biopsy Needle (DNG-2020): The full-sCore® Biopsy Needle is used for biopsies of soft tissue in combination with the Möller Medical Blue. These biopsy needles are composed of a double-lumen cannula tube with bevelled edge tip cut; a trokar stylet is located inside the larger lumen. The stylet also has a polished tip. The smaller lumen contains a lengthwise spade, which works as a cutting mechanisms for the tissue collected inside the needle. Full-sCore® can be used with a corresponding coaxial needle for multiple sampling. The needle has to be inserted by a qualified physician under imaging guidance such as Ultrasound or CT. #### Semi-automatic Biopsy Gun (SBG-xxx): The intended purpose of the disposable Semi-automatic Biopsy Gun is to obtain histological core samples from soft tissue such as liver, kidney, prostate, breast, lung and various soft tissue lesions. SBG-2010 is composed of an spring loaded biopsy needle fitted into a plastic handle permitting single handed specimen collection. The placement of the needle may be visualized by imaging quidance. SGB can be used with a corresponding coaxial needle for multiple sampling.The needle has to be inserted by a qualified physician under imaging quidance such as Ultrasound or CT. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for MöllerMedical. The logo consists of a light blue graphic to the left of the company name. The graphic is made up of four circles of varying sizes, arranged in a cluster. The company name, "MöllerMedical", is written in black, sans-serif font. K162588 Traditional 510(k) Submission 510(k) Summary Page: 5 (7) #### Automatic Biopsy Gun (ABG-xxxx): The intended purpose of the disposable Automatic Biopsy Gun of Möller Medical is to obtain core samples for valuable histological evidence from soft tissue such as liver, kidney. prostate, breast, lung and various soft tissue lesions. ABG can be used with a corresponding coaxial needle for multiple sampling. The needle has to be inserted by a qualified physician under imaging guidance such as Ultrasound or CT. #### Coaxial Needles (COX-xxx): If several biopsy specimens have to be taken from the same target area, the biopsies can be performed by means of several direct punctures or by using the coaxial technique. When performing direct punctures each and every time the biopsy needle or system has to be interseted into the patient. If a quiding needle is used together with the biopsy needle or system, this is known as coaxial approach. With this technique, only a single puncture is necessary. The quiding needle, the Coaxial Needle, is placed towards the suspicious area. Once the the coaxial needle is in place several biopsies can be performed by the biopsy needle or systems using the COX-xxxx as a guiding needle resp. as an introducer needle. It should be noted, that the guiding needle (COX) has to have a larger total diameter than the corresbonding biopsy needle or system and has to be shorter in length. The needle has to be inserted by a qualified physician under imaging guidance such as Ultrasound or CT. #### Manual Cut Biopsy (MBY-xxxx): The Manual Cut Biopsy needle is a manual biopsy needle for the evidence of histological tissue specimen. As with ABG, SBG and DNG the tru-cut technique is used in MBY. The needle has to be inserted by a qualified physician under imaging quidance such as Ultrasound or CT. #### 5. Indications for Use The Möller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen. Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow. Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or iliac crest. Application areas of the products are bone respectively bone marrow. Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow. Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy quns. Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various {9}------------------------------------------------ Image /page/9/Picture/1 description: The image contains the logo for MöllerMedical. The logo consists of a light blue abstract shape resembling a cluster of cells or molecules on the left. To the right of the shape is the text "MöllerMedical" in a simple, sans-serif font. soft tissue lesions , and should be used with the Möller Medical Blue (RBG-1000-10-1000) biopsy gun. Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidney, Model COX is for safe needle guidance and for taking several biopsy specimens, for example from liver, kidney, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture. Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. Model Möller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needles for core needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions. When used for breast biopsy, the product is for diagnosis only. The extent of histological abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality; e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal of using standard surgical procedures. #### 6. Comparison of Technological Characteristics with the Predicate Devices The BiopC Portfolio is working equivalently to the predicate devices. The principles of biopsy are exactly the same. With exception of the Möller Medical Blue RBG Biopsy gun the products are for single-use like the appropriate predicate devices. The BiopC Portfolio and its predicate devices are sold sterile with exception of the Möller Medical Blue RBG which is suitable for reprocessing like the appropriate predicate device. The indication for use of the BiopC Portfolio is comparable with the indication for use of the predicate devices. #### 7. Performance Data The BiopC Portfolio has the same indication for use and performance as the predicate devices. In addition, the BiopC Portfolio is made from the same materials with patient contact as the predicate devices. Because of this, no new safety or effectiveness are introduces over the predicate devices. Please refer to Table 2 for the list of bench tests - there you find a list of all bench tests that have been performed. Other products of the BiopC Portfolio can be subordinated to the bench tests of the single products. The test series exhibits a very wide range of performance tests and all necessary and required tests for the BiopC Portfolio were appropriate performed and all tests passed according to the predetermined pass/fail criteria. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for MöllerMedical. The logo consists of a light blue abstract shape resembling a cluster of cells or a stylized flower. To the right of the abstract shape is the text "MöllerMedical" in a simple, sans-serif font. The text is black and appears to be the company's name. Page: 7 (7) #### Table 2: List of bench test | Test | Tested<br>Products | Test method summary | | |-------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---| | Intensity Test | RBG | Test for preclearance of the Biopsy Gun | ✓ | | Shelf Life | DNG | Test of tensile strength, impact strength and<br>functionality after 5 years | ✓ | | Artificial Ageing | DNG | Comparison new- 2 years - 5 years | ✓ | | Firing Test | DNG | Firing test with Biopsy Gun | ✓ | | Validation/Verification | DNG | Firing test with smallest widening tolerance | ✓ | | Firing test | DNG | Test of minimum pull-out force | ✓ | | Functionality test | DNG-2020 | Function after 50 insertions per needle | ✓ | | Performance test | All needles | Comparison of the general function, penetration<br>characteristics, tissue sample size and mechanical<br>durability of the different needles with the predicate<br>devices | ✓ | #### 8. Conclusion The BiopC Portfolio is equivalent to the predicate devices in that: - The devices have the same intended use and indication for use. - The devices have equivalent design, function and areas of application - The devices demonstrate equivalent performance.