(241 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the Medax Bone Marrow Biopsy and Aspiration System. It seeks to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than proving that a new device meets specific, novel acceptance criteria through a clinical study.
Therefore, the document does not contain the kind of information requested in the prompt, which typically relates to the performance validation of a new, often AI-driven, medical device against a defined set of clinical acceptance criteria. Specifically, it does not include:
- A table of acceptance criteria and reported device performance based on clinical outcomes.
- Sample sizes used for test sets, data provenance (country, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- Sample sizes or ground truth establishment for training sets.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of:
- Intended Use and Indications for Use: The devices are stated to be identical to predicate devices in these aspects.
- Technological Characteristics: Detail is provided on aspects like regulation number, device description, target population, mechanics of operation (all manual instruments), available models (gauge and length), patient/tissue contact materials (Stainless steel AISI 304), biocompatibility requirements (ISO 10993), and sterilization methods (Ethylene Oxide).
- Performance Testing (Non-clinical/Bench Tests): This primarily refers to in vitro tests carried out according to FDA guidance and applicable ISO/ASTM standards (e.g., ISO 9626 for stainless steel needle tubing, ISO 10993 for biocompatibility, ISO 11607-1 for packaging, ISO 11737-1 for sterility, and tests for EtO residuals). The document states that "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." However, it does not list these specific acceptance criteria in a quantitative manner or provide the raw performance data from these tests.
In summary, the provided document does not support a response to the prompt's specific questions regarding acceptance criteria and performance study details, as it is a 510(k) submission based on substantial equivalence to existing devices through comparison of design and non-clinical performance, not a clinical performance study with defined quantitative acceptance criteria against a ground truth on a test set.
{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) | |
|---|---|
| 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}------------------------------------------------
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/APoggio Rusco Mantova, ITALY 46025 |
| EstablishmentRegistration Number | 3007648417 |
| Summary PreparationDate | March 30th 2020 |
| Contact Person | Stefano CavalieriQuality 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 thedevice | Medax Bone Marrow Biopsy and Aspiration System(MED-B, MED-I, MED-J, MED-L, MED-S). |
| Classification Nameand class | Instrument, BiopsyDevice Class: IIProduct Code: KNWRegulation Number 21 CFR 876.1075 |
| Performance Standard | ISO 9626:2016 Stainless steel needle tubing for the manufacture ofmedical devices - Requirements and test methodsASTM F899-12b Standard Specification for Wrought StainlessSteels for Surgical InstrumentsISO 10993:2009 series and FDA Guidance on Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process ",Date:06/16/16ISO 11607-1:2006 Packaging for terminally sterilized medicaldevices -- Part 1: Requirements for materials, sterile barriersystems and packaging systemsISO 11737-1:2006 Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a populationof microorganisms on products |
| DESCRIPTION of thedevice: | Medax Bone Marrow Biopsy and Aspiration System portfolio is composedby single use devices intended to obtain biopsy samples from bone forhistological examinations.Devices are available in different gauge dimensions (identified by differentcolors) and needle length. |
| Indications for Use | MED-I Bone Marrow Aspiration Needle: MED-I biopsy system has beendesigned to be used in bone marrow aspiration procedures from iliac crestor sternum.MED-S Bone Marrow Aspiration Needle: MED-S biopsy system has beendesigned to be used in bone marrow aspiration procedures from sternum oriliac crest. |
| MED-L Bone Marrow Biopsy and Aspiration System: MED-L biopsysystem has been designed to be used inbone marrow aspiration and the posterior iliac crest biopsy.MED-B Bone Marrow Biopsy and aspiration System: MED-B biopsysystem has been designed to be used in bone marrow aspiration and theposterior iliac crest biopsy.MED-J Bone Marrow Biopsy and Aspiration System: MED-J biopsysystem has been designed to be used in bone marrow aspiration and theposterior iliac crest biopsy. Note: Do not use in sternal procedure. | |
| Comparison ofTechnologicalCharacteristics | Documental comparisons were performed to support a determination ofsubstantial equivalence (refer to performance testing below) betweenMedax Bone Marrow Biopsy and Aspiration System portfolio andpredicate devices.The results of these evaluation provide reasonable assurance that proposeddevices have been designed and tested to assure conformance to therequirements for its intended use and perform comparably to the existingpredicate devices. |
| Performance Testing(non-clinical) | In vitro bench tests were carried out, according to the requirements ofFDAs document Guidance for Industry and FDA Staff: Format forTraditional 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 FDAGuidance on Use of International Standard ISO 10993-1, "Biologicalevaluation of medical devices - Part 1: Evaluation and testing withina risk management process "- Bioburden and Sterility tests;- Validation of the EtO Sterilization process,- Packaging validation,- Labelling evaluation,- EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol accordingto EN ISO 10993-7.Results from these performances evaluation demonstrated that the MedaxBone Marrow Biopsy and Aspiration System devices met the acceptancecriteria defined in the product specification and performed comparably tothe 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.
| MedaxBoneMarrowBiopsyandAspirationSystemsDevice | Name | Predicate DeviceManufacturer | 510(k) ID |
|---|---|---|---|
| MED-IBonemarrowaspirationneedle | HANDLEXBone marrowaspirationneedle | MEDAX S.R.L.UNIPERSONALE | K181803 - MedaxBiopsy SystemIII, cleared byFDA on10/18/2018 |
| MED-SBonemarrowaspirationneedle | PERFECTUSBone marrowaspirationneedle | MEDAX S.R.L.UNIPERSONALE | K181803 - MedaxBiopsy SystemIII, cleared byFDA on10/18/2018 |
| MED-LBonemarrowbiopsy andaspirationsystem | MEDLOCKBone marrowbiopsy andaspirationsystem | MEDAX S.R.L.UNIPERSONALE | K172344 - MedaxBiopsy System II,cleared by FDAon 11/13/2017 |
| MED-BBonemarrowbiopsy andaspirationsystem | MEDBONEBone marrowbiopsy system | MEDAX S.R.L.UNIPERSONALE | K172344 - MedaxBiopsy System II,cleared by FDAon 11/13/2017 |
| MED-JBoneMarrowBiopsy andAspirationSystem | BD/Carefusion,OriginalJamshidi™bone marrowbiopsyaspirationneedle | Carefusion | K171531 -Jamshidi BoneMarrowBiopsy/AspirationNeedle, clearedby FDA on9/11/2017 |
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-IBone Marrow Aspiration Needle | HANDLEX Bone Marrow AspirationNeedle (K181803) | |||
| Regulation Number | 21 CFR §876.1075 | Same | ||
| Device Description | Disposable bone marrow aspiration needle,used to aspirate bone marrow from sternumor iliac crest. The device is comprised of anouter cannula with handle and inner stylet. | Disposable bone marrow aspiration needle,used to aspirate bone marrow from sternumor iliac crest. The device is comprised of anouter cannula with handle and inner stylet. | ||
| Indication for Use | The device is intended for aspiration of bonemarrow from sternum or iliac crest. | The device is intended for aspiration of bonemarrow from sternum or iliac crest. | ||
| Target Population | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | ||
| Mechanics of Operation | Manual instrument | Manual instrument | ||
| Model Available(Needle, cannula(S),And Stylet Size:Diameter, GaugeAnd Length) | Needle cannula from 14G to 18GAvailable with aspiration tip andexplant/transplant tip - Length from30 mm to 110 mm | Needle cannula from 14G to 18GAvailable with aspiration tip andexplant/transplant tip - Length from30 mm to 110 mm | ||
| Patient/TissueContact Materials | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | ||
| BiocompatibilityRequirements | Biocompatible according to ISO 10993applicable parts | Biocompatible according to ISO 10993applicable 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-SBone Marrow Aspiration Needle | PERFECTUS Bone Marrow AspirationNeedle (K181803) | |||
| Regulation Number | 21 CFR §876.1075 | Same | ||
| Device Description | Disposable bone marrow aspiration needlewith adjustable depth setter, used to aspiratebone marrow from sternum or iliac crest. | Disposable bone marrow aspiration needlewith adjustable depth setter, used to aspiratebone marrow from sternum or iliac crest. | ||
| Indication for Use | The device is intended for aspiration of bonemarrow from sternum or iliac crest. | The device is intended for aspiration of bonemarrow from sternum or iliac crest. | ||
| Target Population | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | ||
| Mechanics ofOperation | Manual instrument | Manual instrument | ||
| Model Available(Needle, cannula(S),And Stylet Size:Diameter, GaugeAnd Length) | Needle cannula from 14G to 18GAvailable with aspiration tip andexplant/transplant tip - Length from20 mm to 150 mm | Needle cannula from 14G to 18GAvailable with aspiration tip andexplant/transplant tip - Length from20 mm to 150 mm | ||
| Patient/TissueContact Materials | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | ||
| BiocompatibilityRequirements | Biocompatible according to ISO 10993applicable parts | Biocompatible according to ISO 10993applicable 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-LBone Marrow Aspiration System | MEDLOCK Bone Marrow Biopsy AndAspiration System K172344 | |
| Regulation Number | 21 CFR §876.1075 | Same |
| Device Description | Disposable device, was designed for bone-marrow biopsy from the iliac crest. Thedevice consists of an outer cannula withhandle and an inner stylet. The needle isequipped with a universal Luer-Lockconnector for eventual cytologicalaspiration. | Disposable MEDLOCK device wasdesigned for bone-marrow biopsy from theiliac crest. The device consists of an outercannula with handle and an inner stylet. Theneedle is equipped with a universal Luer-Lock connector for eventual cytologicalaspiration. |
| Indication for UseIncluding SpecificTarget Organs | biopsy system has been designed to be usedin bone marrow aspiration and the posterioriliac crest biopsy. | biopsy system has been designed to be usedin bone marrow aspiration and the posterioriliac crest biopsy. |
| Target Population | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases |
| Mechanics ofOperation | Manual instrument | Manual instrument |
| Model Available(Needle,Cannula(S), AndStylet Size:Diameter, GaugeAnd Length) | Needle cannula from 7G to 13G"MED-L ": Needle length from 100 mm to150 mm | Needle cannula from 8G to 13G"MEDLOCK ": Needle length from 70 mmto 150 mm |
| Patient/TissueContact Materials | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. |
| BiocompatibilityRequirements | Biocompatible according to ISO 10993applicable parts | Biocompatible according to ISO 10993applicable 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-BBone Marrow Aspiration System | MEDBONE Bone Marrow BiopsySystem (K172344) | |
| Regulation Number | 21 CFR §876.1075 | Same |
| Device Description | Disposable bone marrow biopsy needleIs comprised of an outer cannula with aninner stylet. The needle has an ergonomichandle at whose base a Luer lock cone isfitted. | Disposable bone marrow biopsy needle Iscomprised of an outer cannula with an innerstylet. The needle has an ergonomic handleat whose base a Luer lock cone is fitted. |
| Indication for Use | The device is intended to retrieve bonemarrow and bone samples from the iliaccrest. | The device is intended to retrieve bonemarrow and bone samples from the iliaccrest. |
| Target Population | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases |
| Mechanics ofOperation | Manual instrument | Manual instrument |
| Model Available(Needle,Cannula(S), AndStylet Size:Diameter, GaugeAnd Length) | Needle cannula from 7G to 13GAvailable with Explant Transplant version -length from 70 mm to 150 mm | Needle cannula from 8G to 13GAvailable with Explant Transplant version"MED-B ": Needle length from 100 mm to150 mm |
| Patient/TissueContact Materials | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. |
| BiocompatibilityRequirements | 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 biopsyneedle is used to retrieve bone marrowaspirate and core biopsy samples from boneand/or bone marrow. The devices arecomprised of an outer cannula with a handleand an inner stylet. The specimen iscontained within the cradle duringwithdrawal from the cannula. | The Jamshidi devices are manual, sterile,disposable needles intended to obtain bonemarrow aspirate and core biopsy samplesfrom bone and/or bone marrow. The devicesare comprised of an outer cannula with ahandle and an inner stylet. The specimen iscontained within the cradle duringwithdrawal from the cannula. |
| Indication for Use | Med-J biopsy system has been designed tobe used in bone marrow aspiration and theposterior iliac crest biopsy. | The device is intended to use in aspiratingbone marrow and obtaining biopsy fromposterior iliac crest |
| Target Population | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases | Individuals requiring biopsy for bonemarrow sampling for abnormality in bloodcells and signs of diseases |
| Mechanics ofOperation | Manual instrument | Manual instrument |
| Model Available(Needle, cannula(S),And Stylet Size:Diameter, GaugeAnd Length) | Needle cannula from 8G to 13GMED-J bone marrow biopsy/aspirationsystem ": Needle length from 50 mm to 150mm | Needle cannula from 8G to 13G"Jamshidi bone marrow biopsy/aspirationneedle ": Needle length from 50 mm to 152mm |
| Patient/TissueContact Materials | Stainless steel AISI 304 is in direct surgicalcontact with all soft tissues of the patient. | Stainless steel is in direct surgical contactwith all soft tissues of the patient. |
| BiocompatibilityRequirements | Biocompatible according to ISO 10993applicable parts | Biocompatible according to ISO 10993applicable 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.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.