MEDONE Soft tissue automatic disposable biopsy system: MEDONE biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

MEDCUT automatic disposable biopsy system : MEDCUT biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest.

MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy.

MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.

Device Description

Medax Biopsy Systems II portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue or bone (depending on product family) for histological examinations. Devices are available in different gauge dimensions (identified by different colors) and needle length.

AI/ML Overview

This document, K172344, describes MEDAX S.R.L. Unipersonale's Medax Biopsy Systems II. It is a 510(k) summary for new biopsy systems. The information provided is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, number and qualifications of experts, adjudication methods, and MRMC studies, are not applicable here.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria juxtaposed with quantitative device performance metrics in the way a diagnostic AI study would. Instead, it states that the devices met acceptance criteria defined in their product specification and performed comparably to predicate devices based on in vitro bench testing.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to ISO 9626:2016 (Stainless steel needle tubing requirements)	Met requirements and test methods of ISO 9626
Conformance to ISO 10993 series and FDA Guidance (Biocompatibility)	Biocompatibility tests performed according to ISO 10993 series and FDA Guidance
Bioburden and Sterility tests	Tests performed to confirm appropriate bioburden and sterility
Validation of EtO Sterilization process	Validation performed
EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7	Residue levels met requirements
Packaging validation	Validation performed
Labeling evaluation	Labeling evaluated for compliance
Performance comparable to predicate devices	Results from performance evaluation demonstrated comparable performance to predicate device

2. Sample Sizes used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable as this is not a diagnostic AI study. The "test set" here refers to physical devices undergoing bench testing. The specific number of devices tested for each performance characteristic is not detailed.
Data Provenance: Not applicable. The "data" comes from physical, in vitro bench tests of the devices, not patient data.

3. Number of Experts used to establish the ground truth for the test set and qualifications

Not applicable. "Ground truth" in this context refers to the physical and chemical properties of the biopsy devices as measured by standard engineering and biocompatibility tests, not a diagnostic interpretation by medical experts.

4. Adjudication method

Not applicable. This is not a study involving human readers or diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This document concerns the regulatory clearance of a physical medical device (biopsy systems), not an AI-powered diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone (algorithm only without human-in-the-loop performance) Study

Not applicable. This is not an AI algorithm. The performance evaluation is for the physical biopsy systems themselves (e.g., strength of material, sterility, biocompatibility).

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation of these biopsy systems is based on established international standards and regulatory guidance for medical device manufacturing, material properties, sterility, and biocompatibility. This includes:

ISO 9626:2016 for stainless steel needle tubing requirements.
ISO 10993 series and FDA Guidance for biocompatibility.
ISO 11607-1.2006 for packaging.
ISO 11737:2006 for microbiological methods.
ASTM F899-12b for wrought stainless steels.
EN ISO 10993-7 for EtO residuals.

8. Sample Size for the Training Set

Not applicable. This is not an AI-powered device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2017

MEDAX S.R.L. Unipersonale % Mr. Mario Gennari Regulatory Consultant Gemar S.R.L. Via G. Puccini 1 Medolla, I-41036 Italy

Re: K172344

Trade/Device Name: Medax Biopsy Systems II Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: August 28, 2017 Received: August 31, 2017

Dear Mr. Gennari:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172344

Device Name

Medax Biopsy Systems II

Indications for Use (Describe)

MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest.

MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy.

MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.

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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Image /page/3/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. Below the word "medax" is the phrase "medical devices" in smaller letters.

510(k) Summary - Traditional 510(k) Medax Biopsy Systems II - K172344 Rev.03 – October 27th 2017

510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92

I. SUBMITTER

MEDAX S.R.L. UNIPERSONALE Via R. Piva 1/A Poggio Rusco, 46025 Mantova, ITALY Phone: +39.0535.1813915 Fax: +39.0535.1812744

Contact Person:

Telephone Number Fax Number

Mario Gennari, Regulatory Consultant +39.0535.731216 +39.0535.731216

Date Prepared:

October 27th, 2017

II. DEVICE

Name of the Device: Common name of the device: MEDEM, MEDBONE, MEDLOCK) Classification Name: Regulatory Class: Product Code:

Medax Biopsy Systems II Medax Biopsy Systems II (MEDONE, MEDCUT,

Instrument, Biopsy Device Class: II KNW

III. PREDICATE DEVICE

Substantial equivalence has been identified as follows:

MedaxSystems II Device	Predicate DeviceName	Manufacturer	510(k) ID
MEDONE Automaticdisposable BiopsySystem	Avangarde BiopsySystem	MEDAX S.R.L.UNIPERSONALE	K142125 - NewMedax biopsysystem
MEDCUT Automaticdisposable BiopsySystem	Monopty DisposableCore BiopsyInstrument	Bard PeripheralVascular, Inc	K133948 - Bard-Monopty disposablecore biopsyinstrument
MEDEM Mallarmebone marrowaspiration system	PERFECTUS Bonemarrow biopsydevice	MEDAX S.R.L.UNIPERSONALE	K092338 - Medaxbiopsy system
MEDBONE bonemarrow biopsy system	NEO OXUS Bonemarrow biopsysystem	MEDAX S.R.L.UNIPERSONALE	K092338 - Medaxbiopsy system
MEDLOCK Bonemarrow biopsy andaspiration system	TOTALLYREMOVE: Needlefor bone-marrowbiopsy	BIOPSYBELL S.R.L.	K130616-MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-

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Image /page/4/Picture/1 description: The image shows the 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.

510(k) Summary - Traditional 510(k) Medax Biopsy Systems II - K172344 Rev.03 - October 27th 2017

MedaxSystems II Device	BiopsyName	Predicate DeviceManufacturer	510(k) ID
			AUTOMATIC-BIOPSY-NEEDLES,AUTOMATIC-BIOPSY-NEEDLES

Medax Biopsy Systems II devices are identical to the predicate device in terms of intended use, indications for use and medical technique.

Based on the safety and performance testing, technological characteristics and the indications for use, the devices proposed Medax Biopsy Systems II, have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to the identified predicate device.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

It is not intended for use in bone biopsy.

MEDCUT automatic disposable biopsy system: MEDCUT biopsy system is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue masses.

It is not intended for use in bone biopsy.

MEDEM Mallarmé bone marrow aspiration needle: MEDEM biopsy needle must be used for bone marrow aspiration from sternum or iliac crest.

MEDBONE Bone marrow biopsy system: MEDBONE biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy.

MEDLOCK Bone marrow biopsy and aspiration system: MEDLOCK biopsy system must be used for bone marrow aspiration and the posterior iliac crest biopsy.

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Image /page/5/Picture/1 description: The image shows the logo for MEDAX medical devices. The logo is in 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. The logo is simple and modern, and it is likely used to represent the company's brand.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

In vitro bench testing were performed to support a determination of substantial equivalence (refer to performance testing below) between Medax Biopsy Systems II portfolio and predicate devices. The results of these tests 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.

VII. PERFORMANCE DATA

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, -
EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7. -
-Packaging validation,
Labelling evaluation. -

Applicable standards for Medax Biopsy Systems II portfolio are the following:

ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices --Requirements and test methods;
-ISO 10993-1:2009 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 11737:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products;
-ASTM F899-12b Standard Specification for Wrought Stainless Steels for Surgical Instruments.

Results from these performances evaluation demonstrated that the Medax Biopsy Systems II devices met the acceptance criteria defined in the product specification and performed comparably to the predicate device.

VIII. CONCLUSIONS

Regulation Number and Section

§ 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.