(241 days)
Not Found
No
The summary describes a mechanical biopsy system and does not mention any AI or ML components or functionalities.
No
The device is a biopsy system used for obtaining tissue samples for diagnostic purposes (histological examinations), not for treating a condition.
Yes
Explanation: The device is a biopsy system used to obtain tissue samples for histological examinations, which is a diagnostic procedure to identify diseases.
No
The device description explicitly states it is composed of "single use devices intended to obtain biopsy samples from soft tissue for histological examinations" and describes physical components like needles and cannulas. The performance studies also focus on physical characteristics and testing of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain histological biopsy samples from soft tissues and lymph nodes. This means the device is used to collect tissue for examination, not to perform a diagnostic test on a sample in vitro (outside the body).
- Device Description: The description details a biopsy system with needles and mechanisms for obtaining tissue samples. This aligns with a device used for tissue collection, not for performing a diagnostic test.
- No Mention of In Vitro Testing: The document describes in vitro bench testing to evaluate the device's performance and comparability to predicate devices, but this is testing of the device itself, not diagnostic testing using the device.
- No Mention of Analyzing Samples: The description focuses on the process of obtaining the sample, not on any subsequent analysis or diagnostic interpretation of the sample by the device.
IVD devices are typically used to perform tests on samples (like blood, urine, tissue) in vitro to diagnose diseases or conditions. This device is a tool for obtaining the sample that will then be analyzed in vitro by other means (e.g., in a pathology lab).
N/A
Intended Use / 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.
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.
Product codes
KNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues (such as breast, kidney, liver, prostate and various soft tissue masses), lymph nodes and other superficial non-vascular lumps.
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 testing was performed to support a determination of substantial equivalence 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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)
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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.
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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 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 |
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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.
| 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.
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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 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.