(661 days)
to be used for histological biopsy on soft tissues. to retrieve bone marrow and bone samples from illac crest. to retrieve bone marrow and bone samples from iliac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues. histological biopsy on soft tissues. aspiration bone marrow from sternum or illac crest. histological biopsy on soft tissues histological biopsy on soft tissues histological and cytological biopsies of soft tissue Aspiration needle for cyto - histological biopsies on soft tissue. histological biopsy on soft tissues histological biopsy on soft tissues histological biopsy on soft tissues
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This document is a 510(k) premarket notification for the "Medax Biopsy System - Guns and Needles" and related devices. It is largely a regulatory approval letter and a list of intended uses for various biopsy devices.
Unfortunately, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
Specifically, the requested information about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in this regulatory notice.
The document primarily focuses on:
- The FDA's decision that the device is "substantially equivalent" to predicate devices.
- Regulatory requirements and contact information.
- A list of various Medax biopsy device names and their intended uses (e.g., "histological biopsy on soft tissues," "retrieve bone marrow and bone samples").
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a design validation report, or a clinical study report.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 7 2511
Medax Unipersonale SRL % Pekato Medical Supplies, Inc. Mr. Flavio Tomassini 3016 N.W. 82nd Avenue Miami, Florida 33122
Re: K092338
Trade/Device Name: Medax Biopsy System - Guns and Needles Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: May 23, 2011 Received: May 27, 2011
Dear Mr. Tomassini:
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
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Page 2 - Mr. Flavio Tomassini
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely, yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K092338
Section 4 Indication for use and Statement
4.1 Indication for use
510(k) Number: K092338
Device name: Universal Duo. Intended use: to be used for histological biopsy on soft tissues. Device name: Neoxus. Intended use: to retrieve bone marrow and bone samples from illac crest. Intended use: to retrieve bone marrow and bone samples from iliac crest. Device name: Cage. Device name: Velox. Intended use: histological biopsy on soft tissues Device name: Velox 2. Intended use: histological biopsy on soft tissues Device name: Universal Plus. Intended use: histological biopsy on soft tissues. Device name: Universal. Intended use: histological biopsy on soft tissues. Device name: Perfectus. Intended use: aspiration bone marrow from sternum or illac crest. Device name: Lux. Intended use: histological biopsy on soft tissues Device name: Lux 2. Intended use: histological biopsy on soft tissues Intended use: histological and cytological biopsies of soft tissue Device name: Hepax. Device name: FNA (Chiba /Quincke /Turner/ Westcott / Franseen). Intended use: Aspiration needle for cyto - histological biopsies on soft tissue. Device name: Facile. Intended use: histological biopsy on soft tissues Device name: Cesar. Intended use: histological biopsy on soft tissues Device name: Nextage. Intended use: histological biopsy on soft tissues
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Nil R.P. Dyke for mxn
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(K)
(Division sign-off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K092338
Section 4 - Page 1
§ 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.