(241 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a manual bone marrow biopsy and aspiration system, with no mention of AI or ML.
No
The device is described as a biopsy system designed to obtain samples for histological examinations, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is designed to obtain biopsy samples from bone marrow which are then used for histological examinations. These examinations are performed to identify abnormalities in blood cells and signs of diseases, which is a diagnostic purpose.
No
The device description explicitly states it is composed of "single use devices intended to obtain biopsy samples from bone," indicating a physical, hardware-based medical device. The performance studies also focus on physical characteristics and sterilization, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for bone marrow aspiration and biopsy procedures to obtain samples. It does not mention analyzing these samples or providing diagnostic information based on the analysis of the samples in vitro.
- Device Description: The description reinforces that the device is used to obtain biopsy samples for histological examinations. It's the tool for collecting the sample, not for performing the diagnostic test on the sample.
- IVD Definition: An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to collect the specimen, not to examine it.
The bone marrow samples collected using this device would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., histological examination, flow cytometry, genetic testing), but the needle itself is not the IVD.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac crest, sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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) |
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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. |
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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.
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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 | |
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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 |
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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.