MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System

Q: Who is the manufacturer of MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System?

Medax Srl Unipersonale filed the 510(k) submission for MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System (K192099).

Q: What is the FDA product code for MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System?

KNW. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System?

HANDLEX Bone marrow aspiration needle (K181803); PERFECTUS Bone marrow aspiration needle (K181803); MEDLOCK Bone marrow biopsy and aspiration system (K172344); MEDBONE Bone marrow biopsy system (K172344); Jamshidi Bone Marrow Biopsy/Aspiration Needle (K171531).

Q: Who can help prepare an FDA 510(k) submission like MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K192099 · Medax Srl Unipersonale · KNW · Apr 2, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K192099
Device Name	MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
Applicant	Medax Srl Unipersonale
Product Code	KNW · Gastroenterology, Urology
Decision Date	Apr 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum. MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest. MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure.

Device Story

Single-use manual bone marrow biopsy and aspiration needles; comprised of outer cannula with handle and inner stylet. Used by clinicians to retrieve bone marrow aspirate and core biopsy samples from iliac crest or sternum. Device provides physical access to bone marrow; specimen contained within cradle during withdrawal. Luer-lock connector allows for aspiration. Benefits include diagnostic sampling for blood cell abnormalities. No electronic or automated components.

Clinical Evidence

Bench testing only. Performance and functional tests per ISO 9626; biocompatibility per ISO 10993; bioburden, sterility, and packaging validation per ISO 11737, ISO 11607, and EN ISO 10993-7. Results demonstrate compliance with specifications and comparability to predicate devices.

Technological Characteristics

Manual biopsy/aspiration needles. Materials: AISI 304 stainless steel. Dimensions: 7G to 18G gauge; 20mm to 150mm length. Sterilization: Ethylene Oxide (EO) per ISO 11135-1. Standards: ISO 9626 (tubing), ASTM F899-12b (stainless steel), ISO 10993 (biocompatibility).

Indications for Use

Indicated for bone marrow aspiration and/or biopsy from the iliac crest or sternum in individuals requiring bone marrow sampling for blood cell abnormalities or disease diagnosis.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

HANDLEX Bone marrow aspiration needle (K181803)
PERFECTUS Bone marrow aspiration needle (K181803)
MEDLOCK Bone marrow biopsy and aspiration system (K172344)
MEDBONE Bone marrow biopsy system (K172344)
Jamshidi Bone Marrow Biopsy/Aspiration Needle (K171531)

Related Devices

K190177 — J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, · Ranfac Corporation · Jun 12, 2019
K242322 — Bone Marrow Biopsy Needle · Zhejiang Curaway Medical Technology Co., Ltd. · Jan 24, 2025
K962570 — ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE · Gallini Intl., Inc. · Nov 27, 1996
K180807 — Celling Aspiration Needle · Spine Smith Holdings, LLC · May 24, 2018
K131157 — RANFAC BONE MARROW ASPIRATION NEEDLE · Ranfac, Corp. · Oct 22, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a symbol. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. April 2, 2020 MEDAX S.R.L. UNIPERSONALE Stefano Cavalieri Quality Assurance Manager Via R. Piva 1/A Poggio Rusco Mantova, Italy 46025 Re: K192099 Trade/Device Name: Medax Bone Marrow Biopsy and Aspiration System: MED-B, MED-J, MED-L. and MED-S Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 21, 2020 Received: February 25, 2020 Dear Stefano Cavalieri: 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. {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) 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) K192099 Device Name Medax Bone Marrow Biopsy and Aspiration System #### Indications for Use (Describe) MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum. MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest. MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-B Bone Marrow Biopsy System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Medax Medical Devices. The logo is white text on a red background. The word "medax" is in large, bold letters, and the words "medical devices" are in smaller letters below it. There is a white line separating the two lines of text. Summary - Traditional 510(k) Medax Bone Marrow Biopsy and Aspiration System Rev.05 – March 30th 2020 # 510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92 | Submitter's Name | MEDAX S.R.L. UNIPERSONALE | |--------------------------------------|------------------------------------------------------| | Address | Via R. Piva 1/A Poggio Rusco Mantova, ITALY 46025 | | Establishment Registration Number | 3007648417 | | Summary Preparation Date | March 30th 2020 | | Contact Person | Stefano Cavalieri Quality Assurance Manager | | Telephone Number | +39.0535.1813915 | | Fax Number | +39.0535.1812744 | # Medax Bone Marrow Biopsy and Aspiration System | Name of the Device | Medax Bone Marrow Biopsy and Aspiration System | |---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common name of the device | Medax Bone Marrow Biopsy and Aspiration System (MED-B, MED-I, MED-J, MED-L, MED-S). | | Classification Name and class | Instrument, Biopsy Device Class: II Product Code: KNW Regulation Number 21 CFR 876.1075 | | Performance Standard | ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments ISO 10993:2009 series and FDA Guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ", Date:06/16/16 ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | | DESCRIPTION of the device: | Medax Bone Marrow Biopsy and Aspiration System portfolio is composed by single use devices intended to obtain biopsy samples from bone for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length. | | Indications for Use | MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has been designed to be used in bone marrow aspiration procedures from iliac crest or sternum. MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has been designed to be used in bone marrow aspiration procedures from sternum or iliac crest. | | | MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-B Bone Marrow Biopsy and aspiration System: MED-B biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. Note: Do not use in sternal procedure. | | Comparison of Technological Characteristics | Documental comparisons were performed to support a determination of substantial equivalence (refer to performance testing below) between Medax Bone Marrow Biopsy and Aspiration System portfolio and predicate devices. The results of these evaluation provide reasonable assurance that proposed devices have been designed and tested to assure conformance to the requirements for its intended use and perform comparably to the existing predicate devices. | | Performance Testing (non-clinical) | In vitro bench tests were carried out, according to the requirements of FDAs document Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s and applicable standards. The following areas have been tested and/or evaluated: - Performance and functional tests according to ISO 9626; - Biocompatibility tests according to ISO 10993 series and FDA Guidance on Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process " - Bioburden and Sterility tests; - Validation of the EtO Sterilization process, - Packaging validation, - Labelling evaluation, - EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7. Results from these performances evaluation demonstrated that the Medax Bone Marrow Biopsy and Aspiration System devices met the acceptance criteria defined in the product specification and performed comparably to the predicate device. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for MEDAX medical devices. The logo is in a red rectangle with rounded corners. The word "MEDAX" is in large, white, sans-serif letters. Below the word "MEDAX" is the phrase "medical devices" in smaller, white, sans-serif letters. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for MEDAX medical devices. The logo is red with white text. The word "MEDAX" is in large, bold letters, and the words "medical devices" are in smaller letters below it. There is a white line separating the two lines of text. ### SUBSTANTIAL EQUIVALENCE: Medax Bone Marrow Biopsy and Aspiration System devices are identical to the predicate device in terms of intended use, indications for use and medical technique. | Medax Bone Marrow Biopsy and Aspiration Systems Device | Name | Predicate Device Manufacturer | 510(k) ID | |-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------| | MED-I Bone marrow aspiration needle | HANDLEX Bone marrow aspiration needle | MEDAX S.R.L. UNIPERSONALE | K181803 - Medax Biopsy System III, cleared by FDA on 10/18/2018 | | MED-S Bone marrow aspiration needle | PERFECTUS Bone marrow aspiration needle | MEDAX S.R.L. UNIPERSONALE | K181803 - Medax Biopsy System III, cleared by FDA on 10/18/2018 | | MED-L Bone marrow biopsy and aspiration system | MEDLOCK Bone marrow biopsy and aspiration system | MEDAX S.R.L. UNIPERSONALE | K172344 - Medax Biopsy System II, cleared by FDA on 11/13/2017 | | MED-B Bone marrow biopsy and aspiration system | MEDBONE Bone marrow biopsy system | MEDAX S.R.L. UNIPERSONALE | K172344 - Medax Biopsy System II, cleared by FDA on 11/13/2017 | | MED-J Bone Marrow Biopsy and Aspiration System | BD/Carefusion, Original Jamshidi™ bone marrow biopsy aspiration needle | Carefusion | K171531 - Jamshidi Bone Marrow Biopsy/Aspiration Needle, cleared by FDA on 9/11/2017 | ### Equivalence has been identified as follows: A comparison of the Medax Bone Marrow Biopsy and Aspiration System with the predicate devices is provided in Table 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 subjected of this current submission with the predicate devices. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for MEDAX medical devices. The logo is red and white. The word "MEDAX" is in large, white, sans-serif letters on the top line. Below that, the words "medical devices" are in smaller, white, sans-serif letters. # Table 1 - Comparison of the Medax Bone Marrow Biopsy and Aspiration System to the predicate Bone Marrow Biopsy and Aspiration devices. | | Subject Device: | | Predicate Device: | | |-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Medax MED-I Bone Marrow Aspiration Needle | | HANDLEX Bone Marrow Aspiration Needle (K181803) | | | Regulation Number | 21 CFR §876.1075 | | Same | | | Device Description | Disposable bone marrow aspiration needle, used to aspirate bone marrow from sternum or iliac crest. The device is comprised of an outer cannula with handle and inner stylet. | | Disposable bone marrow aspiration needle, used to aspirate bone marrow from sternum or iliac crest. The device is comprised of an outer cannula with handle and inner stylet. | | | Indication for Use | The device is intended for aspiration of bone marrow from sternum or iliac crest. | | The device is intended for aspiration of bone marrow from sternum or iliac crest. | | | Target Population | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | | Mechanics of Operation | Manual instrument | | Manual instrument | | | Model Available (Needle, cannula(S), And Stylet Size: Diameter, Gauge And Length) | Needle cannula from 14G to 18G Available with aspiration tip and explant/transplant tip - Length from 30 mm to 110 mm | | Needle cannula from 14G to 18G Available with aspiration tip and explant/transplant tip - Length from 30 mm to 110 mm | | | Patient/Tissue Contact Materials | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | | Biocompatibility Requirements | Biocompatible according to ISO 10993 applicable parts | | Biocompatible according to ISO 10993 applicable parts | | | Sterilization | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | | | Subject Device | | Predicate Device | | | | Medax MED-S Bone Marrow Aspiration Needle | | PERFECTUS Bone Marrow Aspiration Needle (K181803) | | | Regulation Number | 21 CFR §876.1075 | | Same | | | Device Description | Disposable bone marrow aspiration needle with adjustable depth setter, used to aspirate bone marrow from sternum or iliac crest. | | Disposable bone marrow aspiration needle with adjustable depth setter, used to aspirate bone marrow from sternum or iliac crest. | | | Indication for Use | The device is intended for aspiration of bone marrow from sternum or iliac crest. | | The device is intended for aspiration of bone marrow from sternum or iliac crest. | | | Target Population | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | | Mechanics of Operation | Manual instrument | | Manual instrument | | | Model Available (Needle, cannula(S), And Stylet Size: Diameter, Gauge And Length) | Needle cannula from 14G to 18G Available with aspiration tip and explant/transplant tip - Length from 20 mm to 150 mm | | Needle cannula from 14G to 18G Available with aspiration tip and explant/transplant tip - Length from 20 mm to 150 mm | | | Patient/Tissue Contact Materials | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | | Biocompatibility Requirements | Biocompatible according to ISO 10993 applicable parts | | Biocompatible according to ISO 10993 applicable parts | | | Sterilization | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for Medax medical devices. The logo is red with white text. The word "medax" is in large, bold letters on the top line, and the words "medical devices" are in smaller letters on the bottom line. Summary - Traditional 510(k) Medax Bone Marrow Biopsy and Aspiration System Rev.05 – March 30th 2020 | | Subject Device | Predicate Device | |--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Medax MED-L Bone Marrow Aspiration System | MEDLOCK Bone Marrow Biopsy And Aspiration System K172344 | | Regulation Number | 21 CFR §876.1075 | Same | | Device Description | Disposable device, was designed for bone- marrow biopsy from the iliac crest. The device consists of an outer cannula with handle and an inner stylet. The needle is equipped with a universal Luer-Lock connector for eventual cytological aspiration. | Disposable MEDLOCK device was designed for bone-marrow biopsy from the iliac crest. The device consists of an outer cannula with handle and an inner stylet. The needle is equipped with a universal Luer- Lock connector for eventual cytological aspiration. | | Indication for Use Including Specific Target Organs | biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. | biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. | | Target Population | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | Mechanics of Operation | Manual instrument | Manual instrument | | Model Available (Needle, Cannula(S), And Stylet Size: Diameter, Gauge And Length) | Needle cannula from 7G to 13G "MED-L ": Needle length from 100 mm to 150 mm | Needle cannula from 8G to 13G "MEDLOCK ": Needle length from 70 mm to 150 mm | | Patient/Tissue Contact Materials | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | Biocompatibility Requirements | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | | Sterilization | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | | Subject Device | Predicate Device | | | Medax MED-B Bone Marrow Aspiration System | MEDBONE Bone Marrow Biopsy System (K172344) | | Regulation Number | 21 CFR §876.1075 | Same | | Device Description | Disposable bone marrow biopsy needle Is comprised of an outer cannula with an inner stylet. The needle has an ergonomic handle at whose base a Luer lock cone is fitted. | Disposable bone marrow biopsy needle Is comprised of an outer cannula with an inner stylet. The needle has an ergonomic handle at whose base a Luer lock cone is fitted. | | Indication for Use | The device is intended to retrieve bone marrow and bone samples from the iliac crest. | The device is intended to retrieve bone marrow and bone samples from the iliac crest. | | Target Population | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | Mechanics of Operation | Manual instrument | Manual instrument | | Model Available (Needle, Cannula(S), And Stylet Size: Diameter, Gauge And Length) | Needle cannula from 7G to 13G Available with Explant Transplant version - length from 70 mm to 150 mm | Needle cannula from 8G to 13G Available with Explant Transplant version "MED-B ": Needle length from 100 mm to 150 mm | | Patient/Tissue Contact Materials | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | | Biocompatibility Requirements | Biocompatible according to ISO 10993 | Biocompatible according to ISO 10993 | | | Subject Device | Predicate Device | | | Medax MED-B | MEDBONE Bone Marrow Biopsy | | | Bone Marrow Aspiration System | System (K172344) | | Sterilization | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | | | Subject Device | BD/Carefusion, Original Jamshidi™ | | | Medax MED-J | Bone Marrow Biopsy Aspiration Needles | | | Bone Marrow Aspiration System | (K171531) | | Device Description | Disposable bone marrow manual biopsy needle is used to retrieve bone marrow aspirate and core biopsy samples from bone and/or bone marrow. The devices are comprised of an outer cannula with a handle and an inner stylet. The specimen is contained within the cradle during withdrawal from the cannula. | The Jamshidi devices are manual, sterile, disposable needles intended to obtain bone marrow aspirate and core biopsy samples from bone and/or bone marrow. The devices are comprised of an outer cannula with a handle and an inner stylet. The specimen is contained within the cradle during withdrawal from the cannula. | | Indication for Use | Med-J biopsy system has been designed to be used in bone marrow aspiration and the posterior iliac crest biopsy. | The device is intended to use in aspirating bone marrow and obtaining biopsy from posterior iliac crest | | Target Population | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | Individuals requiring biopsy for bone marrow sampling for abnormality in blood cells and signs of diseases | | Mechanics of Operation | Manual instrument | Manual instrument | | Model Available (Needle, cannula(S), And Stylet Size: Diameter, Gauge And Length) | Needle cannula from 8G to 13G MED-J bone marrow biopsy/aspiration system ": Needle length from 50 mm to 150 mm | Needle cannula from 8G to 13G "Jamshidi bone marrow biopsy/aspiration needle ": Needle length from 50 mm to 152 mm | | Patient/Tissue Contact Materials | Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | Stainless steel is in direct surgical contact with all soft tissues of the patient. | | Biocompatibility Requirements | Biocompatible according to ISO 10993 applicable parts | Biocompatible according to ISO 10993 applicable parts | | Sterilization | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | Supplied sterile via Ethylene Oxide (EO), according to ISO 11135-1 | {8}------------------------------------------------ Image /page/8/Picture/1 description: The image is a logo for MEDAX medical devices. The logo is white text on a red background. The word "MEDAX" is in large, bold letters on the top line. The words "medical devices" are in smaller letters on the bottom line. Summary - Traditional 510(k) Medax Bone Marrow Biopsy and Aspiration System Rev.05 – March 30th 2020 ### Conclusion ### Conclusion Medax Bone Marrow Biopsy and Aspiration System devices are identical to predicate devices in terms of intended use, indications for use and medical technique. Based on the safety and performance testing, the comparison with technological characteristics and the indications for use, the devices proposed Medax Bone Marrow Biopsy and Aspiration System, have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to the identified predicate device.