Who is the manufacturer of Medone Ultra, Medextra?

Medax Srl Unipersonale filed the 510(k) submission for Medone Ultra, Medextra (K192101).

What is the FDA product code for Medone Ultra, Medextra?

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

What is the regulatory pathway for Medone Ultra, Medextra?

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

What are the predicate devices for Medone Ultra, Medextra?

Achieve® Programmable Automatic Biopsy Systems (K141552); Velox 2 (K181803).

Who can help prepare an FDA 510(k) submission like Medone Ultra, Medextra?

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.

Medone Ultra, Medextra

K192101 · Medax Srl Unipersonale · KNW · Apr 2, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K192101
Device Name	Medone Ultra, Medextra
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

MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy. MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy.

Device Story

Medax Soft Tissue Biopsy System consists of single-use, spring-loaded, guillotine-style biopsy devices (MEDONE ULTRA and MEDEXTRA). MEDONE ULTRA is a programmable automatic system; MEDEXTRA is a semi-automatic system with a rectangular cannula and adjustable penetration depth. Devices are used by clinicians in clinical settings to obtain soft tissue core samples for histological examination. Operation involves single-hand automatic activation to advance the needle/cannula into the target tissue. The mechanical action captures tissue within the sample notch. The output is a tissue core sample retrieved for pathology analysis, aiding in the diagnosis of soft tissue abnormalities. Benefits include minimally invasive tissue acquisition for diagnostic purposes.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical in vitro bench testing, including performance/functional testing (ISO 9626), biocompatibility (ISO 10993), bioburden/sterility testing (ISO 11737), and packaging validation (ISO 11607).

Technological Characteristics

Materials: AISI 304 stainless steel cannula and mandrel. Principle: Spring-loaded, guillotine-style mechanical biopsy. Sterilization: Ethylene Oxide (EO) per ISO 11135-1. Form factor: Disposable, single-use, hand-held. No software or electronic components.

Indications for Use

Indicated for individuals requiring histological biopsy of soft tissues, including breast, kidney, liver, prostate, spleen, lymph nodes, and superficial non-vascular lumps. Contraindicated for use in bone, deep visceral structures (for MEDEXTRA), and breast (for MEDEXTRA).

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

Achieve® Programmable Automatic Biopsy Systems (K141552)
Velox 2 (K181803)

Related Devices

K141552 — ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS · Care Fusion · Sep 5, 2014
K160316 — SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles · M.D.L. S.R.L. · Oct 27, 2016
K214063 — Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle · Guangzhou Shengwei Medical Devices Co., Ltd. · Jun 3, 2022
K201166 — Temno Elite Biopsy System · Merit Medical Systems, Inc. · Aug 28, 2020
K172344 — Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK) · Medax Srl Unipersonale · Nov 13, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration". April 2, 2020 MEDAX S.R.L. UNIPERSONALE Stefano Cavalieri Quality Assurance Manager Via R. Piva 1/A Poggio Rusco Mantova, Italy 46025 Re: K192101 Trade/Device Name: Medax Soft Tissue Biopsy System: MEDONE ULTRA and MEDEXTRA 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. 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 {1}------------------------------------------------ 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 (OS) 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) K192101 Device Name Medax Soft Tissue Biopsy System #### Indications for Use (Describe) MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy. MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 shows the logo for MEDAX medical devices. The logo is in a red box 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. ## 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 Soft Tissue Biopsy System | | | | | | | Name of the Device | Medax Soft Tissue Biopsy System | | | | | | Common name of the device | Medax Soft Tissue Biopsy System (MEDONE ULTRA, MEDEXTRA) | | | | | | 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 11737:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | | | | | | DESCRIPTION of the device: | Medax Soft Tissue Biopsy System portfolio is composed by single use devices intended to obtain biopsy samples from soft tissue for histological | | | | | | examinations. | |------------------------------------------------------------------| | MEDONE ULTRA Devices are available in different gauge dimensions | | (identified by different colors) and needle length. | Indications for Use MEDONE ULTRA Soft tissue programmable automatic biopsy system: biopsy system has been designed to be used for histological biopsy of soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses). It is not intended for use in bone biopsy. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for MEDAX medical devices. The logo is in a red box with white text. The word "MEDAX" is in large, bold letters on the top line. Below that, the words "medical devices" are in smaller letters. | MEDEXTRA lymph node biopsy system with rectangular shaped cannula and adjustable penetration depth: is intended for use in obtaining biopsies from lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone or deep visceral structures. | | | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------|---------------------------------------------------------| | Comparison of Technological Characteristics | In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between Medax Soft Tissue Biopsy System 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. | | | | | 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 Soft Tissue Biopsy System devices met the acceptance criteria defined in the product specification and performed comparably to the predicate device. | | | | | SUBSTANTIAL EQUIVALENCE: | Medax Soft Tissue Biopsy System devices are identical to the predicate device in terms of intended use, indications for use and medical technique. Equivalence has been identified as follows: | | | | | | Medax Soft Tissue Biopsy System Device | Name | Predicate Device Manufacturer | 510(k) ID | | | MEDONE ULTRA Soft tissue programmable automatic disposable biopsy system | Achieve® Programmable Automatic Biopsy Systems | MERIT MEDICAL | K141552, cleared by FDA on June 10, 2014 | | | MEDEXTRA lymph node biopsy system with rectangular shaped cannula | Velox 2 | Medax s.r.l. | K181803, cleared by FDA on October 18, 2018 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for "MEDAX medical devices". The word "MEDAX" is in large, bold, white letters on a red background. Below "MEDAX" are the words "medical devices" in smaller, white letters. The logo is simple and clean, and the red and white color scheme is eye-catching. Rev.04 – March 30th 2020 ### Table 1 - Comparison of the Medax Soft tissue Biopsy System to the predicate Soft tissue Biopsy System devices. K192101 | | Subject Device | Predicate device | |-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Medax MEDONE ULTRA | Achieve® Programmable Automatic | | | Programmable Automatic disposable | Biopsy Systems | | | Biopsy System | (K141552) | | Regulation Number | 21 CFR §876.1075 | Same as current device | | Device Description | Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue. | Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue. | | Indication for Use | MEDONE ULTRA intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone | intended for use in obtaining core biopsy samples from soft tissue such as kidney, liver, prostrate, spleen, lymph nodes, and various soft tissue masses. Not intended for use in bone | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Same as current device | | Mechanics of Operation | Single hand automatic activation | Same as current device | | Model Available (Needle, Cannula(S), And Stylet Size: Diameter, Gauge and Length) | Needle cannula from 14G to 20G Length from 60 mm to 200 mm | Needle cannula from 12G to 20G Length from 60 mm to 200 mm | | Patient/Tissue Contact Materials | Cannula and mandrel are made out of AISI 304 stainless steel. Only Stainless steel is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made out of stainless steel. Only 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 | | Description of The Sterilization Method | Sterilized by Ethylene Oxide (EO | Sterilized by Ethylene Oxide (EO) | The lengths of the predicate are exactly equivalent to the lengths range of the proposed device. The predicate device has a larger number of versions in term of diameters of the proposed devices fall within the range of the predicate devices and therefore the substantially equivalence is demonstrated. {6}------------------------------------------------ Image /page/6/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. Below that, the words "medical devices" are in smaller letters. | | Subject Device MEDEXTRA | Predicate device VELOX 2 (K181803) | |-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation Number | 21 CFR §876.1075 | Same | | Device Description | Disposable semi-automatic spring- loaded guillotine style biopsy system with adjustable penetration depth and rectangular shaped cannula for histological biopsy on lymph nodes and other superficial non-vascular lumps. | Disposable semi-automatic spring- loaded guillotine style biopsy system with adjustable penetration depth for histological biopsy on soft tissue. | | Indication for Use | MEDEXTRA is intended for use in obtaining biopsies from soft tissues such as lymph nodes and other superficial non-vascular lumps. It is not intended for use in bone, deep visceral structures and breast biopsy. | The device 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. | | Target Population | Individuals requiring biopsy for sampling of soft tissue abnormalities | Individuals requiring biopsy for sampling of soft tissue abnormalities | | Needle Advancement/ Penetration Depth | From 12 or 22 mm | From 15 mm or 22 mm | | Sample Notch Size | Max 20 mm | Max 20 mm | | Mechanics of Operation | Single hand automatic activation | Single hand automatic activation | | Model Available (Needle, Cannula(S), And Stylet Size: Diameter, Gauge and Length) | Needle cannula 4,6mm x 2.10mm Single length 100mm | Needle cannula from 14G (2.1mm) to 20G (0.8mm) Length from 80 mm to 300 mm | | Patient/Tissue Contact Materials | Cannula and mandrel are made of stainless steel AISI 304. Only Stainless steel AISI 304 is in direct surgical contact with all soft tissues of the patient. | Cannula and mandrel are made of stainless steel AISI 304. Only 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 | | Description of The Sterilization Method | Sterilized by Ethylene Oxide (EO) In accordance with ISO 11135-1 | Sterilized by Ethylene Oxide (EO) In accordance with ISO 11135-1 | The rectangular shape of the subject device Medextra cannula has equivalent functionality if compared with the rounded shape of the predicate cannula. This difference does not affect the safety and effectiveness of the proposed device. The predicate device has a larger number of versions in term of length of the proposed devices falls within the range of the predicate devices and therefore the substantially equivalent is demonstrated. ### CONCLUSION Based on the safety and performance testing, technological characteristics and the indications for use, the devices proposed Medax Soft Tissue Biopsy System, have been demonstrated to be appropriate for their intended use and are considered substantially equivalent to the identified predicate device.