(241 days)
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.
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.
Disposable programmable automatic spring-loaded guillotine style biopsy system for histological biopsy on soft tissue.
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.
The Medax Soft Tissue Biopsy System (MEDONE ULTRA and MEDEXTRA) has been deemed substantially equivalent to its predicate devices based on non-clinical performance testing. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list distinct "acceptance criteria" values in the traditional sense (e.g., a specific sensitivity or specificity percentage). Instead, it states that the devices met the acceptance criteria defined in the product specification and performed comparably to the predicate devices. The overall acceptance criterion for this submission is demonstrating substantial equivalence to legally marketed predicate devices.
The reported device performance is based on the results of the non-clinical bench tests demonstrating that the devices designed and tested to assure conformance to the requirements for its intended use and perform comparably to the existing predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Conformance to performance and functional requirements | MEDONE ULTRA: Needle cannula from 14G to 20G, Length from 60 mm to 200 mm. Cannula and mandrel made of AISI 304 stainless steel. Biocompatible according to ISO 10993. Sterilized by Ethylene Oxide (EO).MEDEXTRA: Needle cannula 4.6mm x 2.10mm, Single length 100mm. Adjustable penetration depth from 12 or 22 mm, Max sample notch size 20 mm. Cannula and mandrel made of stainless steel AISI 304. Biocompatible according to ISO 10993. Sterilized by Ethylene Oxide (EO).The tests 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. Differences in needle range for MEDONE ULTRA (14G-20G vs 12G-20G for predicate) and MEDEXTRA (single length 100mm vs 80mm-300mm for predicate) were considered to fall within the predicate's range or not affect safety and effectiveness. |
| Biocompatibility | Biocompatible according to ISO 10993 applicable parts. |
| Sterilization effectiveness | Sterilized by Ethylene Oxide (EO), validated according to ISO 11135-1. Demonstrates compliance with bioburden and sterility tests, and EtO Residual, Ethylene Chlorohydrin and Ethylene Glycol according to EN ISO 10993-7. |
| Packaging integrity | Packaging validation performed according to ISO 11607-1.2006. |
| Labeling compliance | Labeling evaluation performed. |
2. Sample Size Used for the Test Set and Data Provenance
The document details in vitro bench tests for performance evaluation. It does not mention a "test set" in the context of clinical studies with patients or human data.
- Sample Size for Test Set: Not applicable as it was an in vitro bench testing for physical and functional characteristics, biocompatibility, and sterility validation, not a clinical trial with a patient test set.
- Data Provenance: The testing was "in vitro bench testing," indicating laboratory-based tests. The country of origin for the data (where the tests were conducted) is not explicitly stated, but the submitter is MEDAX S.R.L. UNIPERSONALE based in Mantova, Italy. The tests were done as part of a 510(k) submission to the FDA. The data provenance is effectively non-clinical, laboratory-based, and retrospective (done to support current submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical, bench testing study. The "ground truth" was established by engineering specifications, regulatory standards (e.g. ISO, ASTM), and the validated performance of the predicate devices. Experts involved would be engineers, quality assurance personnel, and regulatory affairs specialists, not clinical experts establishing a medical "ground truth."
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication from medical experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
No. This device is a biopsy instrument, not an AI-powered diagnostic tool, and therefore, an MRMC study related to AI assistance for human readers is not relevant or applicable to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This device is a manual biopsy instrument and does not involve any algorithms or AI for standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on adherence to:
- Engineering and product specifications for the biopsy devices.
- International and national standards (e.g., ISO 9626, ASTM F899-12b, ISO 10993 series, ISO 11607-1, ISO 11737, ISO 11135-1, EN ISO 10993-7).
- Functional performance comparable to the legally marketed predicate devices.
Essentially, the ground truth is compliance with established regulatory standards and verifiable performance metrics for medical devices of this type, as demonstrated through bench testing.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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: 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
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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
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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)
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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 | |||||
| EstablishmentRegistration Number | 3007648417 | ||||
| Summary PreparationDate | 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 thedevice | Medax Soft Tissue Biopsy System (MEDONE ULTRA, MEDEXTRA) | ||||
| Classification Nameand 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 ofmedical devices -- Requirements and test methods- ASTM F899-12b Standard Specification for Wrought StainlessSteels for Surgical Instruments- ISO 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:06/16/16- ISO 11607-1.2006 Packaging for terminally sterilized medicaldevices -- Part 1: Requirements for materials, sterile barriersystems and packaging systems- ISO 11737:2006 Sterilization of medical devices --Microbiological methods -- Part 1: Determination of a populationof microorganisms on products | ||||
| DESCRIPTION of thedevice: | Medax Soft Tissue Biopsy System portfolio is composed by single usedevices 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.
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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 cannulaand adjustable penetration depth: is intended for use in obtaining biopsiesfrom lymph nodes and other superficial non-vascular lumps. It is notintended for use in bone or deep visceral structures. | ||||
|---|---|---|---|---|
| Comparison ofTechnologicalCharacteristics | In vitro bench testing was performed to support a determination ofsubstantial equivalence (refer to performance testing below) betweenMedax Soft Tissue Biopsy System portfolio and predicate devices.The results of these tests 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 FDA- Guidance 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 MedaxSoft Tissue Biopsy System devices met the acceptance criteria defined inthe product specification and performed comparably to the predicatedevice. | |||
| SUBSTANTIALEQUIVALENCE: | Medax Soft Tissue Biopsy System devices are identical to the predicatedevice in terms of intended use, indications for use and medical technique.Equivalence has been identified as follows: | |||
| Medax SoftTissue BiopsySystem Device | Name | Predicate DeviceManufacturer | 510(k) ID | |
| MEDONEULTRA Softtissueprogrammableautomaticdisposablebiopsy system | Achieve®ProgrammableAutomaticBiopsySystems | MERITMEDICAL | K141552,cleared byFDA on June10, 2014 | |
| MEDEXTRAlymph nodebiopsy systemwith rectangularshaped cannula | Velox 2 | Medax s.r.l. | K181803,cleared byFDA onOctober 18,2018 |
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Rev.04 – March 30th 2020
Table 1 - Comparison of the Medax Soft tissue Biopsy System to the predicate Soft tissue Biopsy System devices.
| 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 automaticspring-loaded guillotine style biopsysystem for histological biopsy on softtissue. | Disposable programmable automaticspring-loaded guillotine style biopsysystem for histological biopsy on softtissue. |
| Indication for Use | MEDONE ULTRA intended for usein obtaining core biopsy samplesfrom soft tissue such as kidney, liver,prostrate, spleen, lymph nodes, andvarious soft tissue masses. Notintended for use in bone | intended for use in obtaining corebiopsy samples from soft tissue suchas kidney, liver, prostrate, spleen,lymph nodes, and various soft tissuemasses. Not intended for use in bone |
| Target Population | Individuals requiring biopsy forsampling of soft tissue abnormalities | Same as current device |
| Mechanics ofOperation | Single hand automatic activation | Same as current device |
| Model Available(Needle, Cannula(S),And Stylet Size:Diameter, Gauge andLength) | Needle cannula from 14G to 20GLength from 60 mm to 200 mm | Needle cannula from 12G to 20GLength from 60 mm to 200 mm |
| Patient/TissueContact Materials | Cannula and mandrel are made out ofAISI 304 stainless steel.Only Stainless steel is in directsurgical contact with all soft tissuesof the patient. | Cannula and mandrel are made out ofstainless steel.Only Stainless steel is in directsurgical contact with all soft tissues ofthe patient. |
| BiocompatibilityRequirements | Biocompatible according to ISO10993 applicable parts | Biocompatible according to ISO 10993applicable parts |
| Description of TheSterilization 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.
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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 DeviceMEDEXTRA | Predicate deviceVELOX 2 (K181803) | |
|---|---|---|
| Regulation Number | 21 CFR §876.1075 | Same |
| Device Description | Disposable semi-automatic spring-loaded guillotine style biopsy systemwith adjustable penetration depth andrectangular shaped cannula forhistological biopsy on lymph nodesand other superficial non-vascularlumps. | Disposable semi-automatic spring-loaded guillotine style biopsy systemwith adjustable penetration depth forhistological biopsy on soft tissue. |
| Indication for Use | MEDEXTRA is intended for use inobtaining biopsies from soft tissuessuch as lymph nodes and othersuperficial non-vascular lumps.It is not intended for use in bone,deep visceral structures and breastbiopsy. | The device is intended for use inobtaining biopsies from soft tissuessuch as liver, kidney, prostate, breast,spleen, lymph nodes and various softtissue masses. It is not intended for usein bone biopsy. |
| Target Population | Individuals requiring biopsy forsampling of soft tissue abnormalities | Individuals requiring biopsy forsampling 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 ofOperation | Single hand automatic activation | Single hand automatic activation |
| Model Available(Needle, Cannula(S),And Stylet Size:Diameter, Gauge andLength) | Needle cannula 4,6mm x 2.10mmSingle length 100mm | Needle cannula from 14G (2.1mm) to20G (0.8mm)Length from 80 mm to 300 mm |
| Patient/TissueContact Materials | Cannula and mandrel are made ofstainless steel AISI 304. OnlyStainless steel AISI 304 is in directsurgical contact with all soft tissuesof the patient. | Cannula and mandrel are made ofstainless steel AISI 304. Only Stainlesssteel AISI 304 is in direct surgicalcontact with all soft tissues of thepatient. |
| BiocompatibilityRequirements | Biocompatible according to ISO10993 applicable parts | Biocompatible according to ISO 10993applicable parts |
| Description of TheSterilization Method | Sterilized by Ethylene Oxide (EO) Inaccordance with ISO 11135-1 | Sterilized by Ethylene Oxide (EO) Inaccordance 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.
§ 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.