Medax Biopsy Systems III

K181803 · Medax Srl Unipersonale · KNW · Oct 18, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181803
• Device Name: Medax Biopsy Systems III
• Applicant: Medax Srl Unipersonale
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Oct 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle 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 NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy. FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

Device Story

Medax Biopsy Systems III comprises a range of manual biopsy needles designed for soft tissue sampling and bone marrow aspiration. Needles are used by clinicians to obtain tissue specimens for histological analysis. Operation is manual; device is inserted into target tissue to collect samples. Benefits include diagnostic tissue acquisition for various clinical specialties. No electronic, software, or algorithmic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual biopsy needles. Materials include medical-grade stainless steel. Various configurations for soft tissue and bone marrow access. Non-powered, mechanical devices. Sterilization via standard methods.

Indications for Use

Indicated for patients requiring soft tissue biopsies (liver, kidney, prostate, breast, spleen, lymph nodes, thyroid, abdomen, pancreas, lungs) or bone marrow aspiration/biopsy (sternum, iliac crest). Contraindicated for bone biopsy for soft tissue-specific needles.

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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## October 18, 2018

Medax S.r.l. Unipersonale % Serena Coronati Official Correspondent Coronati Consulting srl Via Luigi Gavioli, 3 I-41307 Mirandola, 41037 Italy

Re: K181803

Trade/Device Name: Medax Biopsy Systems III Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: October 10, 2018 Received: October 15, 2018

Dear Serena 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lona H. Chen -S 2018.10.18 13:00:36 -04'00'

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) K181803

Device Name Medax Biopsy System III

#### Indications for Use (Describe)

MEDEASY, UNIVERSAL DUO, VELOX, VELOX 2, UNIVERSAL PLUS, UNIVERSAL, LUX, LUX 2, FACILE, CAESAR biopsy needle 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

NEO OXUS, HEMAX biopsy needle must be used for bone marrow aspiration and the posterior iliac crest biopsy

PERFECTUS, HANDLEX biopsy needle must be used for bone marrow aspiration from sternum or litac crest

HEPAX biopsy needle is intended for use in obtaining histological biopsies of soft tissues. It is not intended for use in bone biopsy.

FNA (Chiba(Quincke/Turner/Westcott/Fransen) biopsy needles is intended for use in obtaining biopsies from soft tissues such as thyroid, liver, breast, spleen, abdomen, pancreas, lungs, lymph nodes and various soft tissue masses. It is not intended for use in bone biopsy.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span> </div> |
|----------------------------------------------|----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> |

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