New Medax Biopsy Systems

K142125 · Medax Srl Unipersonale · KNW · Dec 22, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K142125
• Device Name: New Medax Biopsy Systems
• Applicant: Medax Srl Unipersonale
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Dec 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue. AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues. COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.

Device Story

New Medax Biopsy Systems (BIOFEATHER, AVANGARDE, COX) are manual surgical instruments for soft tissue biopsy. BIOFEATHER and AVANGARDE function as biopsy systems for tissue sampling; COX serves as a co-axial introducer needle to facilitate multiple biopsies. Used in clinical settings by physicians to obtain histological samples for diagnostic purposes. Devices are mechanical; no electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual biopsy instruments and co-axial introducer needles. Mechanical operation. No energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring histological biopsy of soft tissues. COX model indicated for patients requiring multiple soft tissue biopsies.

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.

Submission Summary (Full Text)

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

December 22, 2015

MEDAX Srl Unipersonale % Mrs. Serena Coronati Coronati Consutling Sas Via Luigi Gavioli, 3 Mirandola, 41307 Italy

Re: K142125

Trade/Device Name: New Medax Biopsy Systems Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: November 18, 2015 Received: November 27, 2015

Dear Mrs. Coronati:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

Binita S.Ashar -S

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K142125

### Device Name

New Medax Biopsy Systems (BIOFEATHER, AVANGARDE, COX)

Indications for Use (Describe)

BIOFEATHER: biopsy system must be used for histological biopsy on soft tissue.

AVANGARDE: biopsy system must to be used for histological biopsy on soft tissues.

COX: the Co-Axial introducer needle mod. COX must be used when multiple biopsies of soft tissue are required.

| 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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