(273 days)
No
The 510(k) summary describes a mechanical biopsy device and does not mention any AI or ML components or functionalities.
No.
The device is intended to obtain diagnostic samples for histological examination, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended to obtain diagnostic samples for histological examination, which directly contributes to diagnosis.
No
The device description explicitly lists multiple physical components (handle, cannula, stylet, etc.), indicating it is a hardware device, not software-only.
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 diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure." This describes a procedure to collect a sample from the body.
- Device Description: The device is a "semiautomatic percutaneous soft tissue biopsy system" with components like a cannula and stylet. This is a tool for physically extracting tissue.
- Lack of IVD Characteristics: An IVD device is typically used in vitro (outside the body) to examine specimens (like blood, urine, or tissue samples) to provide information about a patient's health. This device's function is to collect the specimen, not to analyze it.
The histological examination that will be performed on the collected sample is an in vitro diagnostic process, but the biopsy device itself is a tool for sample collection, not for the diagnostic analysis.
N/A
Intended Use / Indications for Use
The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.
Product codes
KNW
Device Description
The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the proposed devices will be delivered with a protective tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, CT-Guidance, Magnetic Resonance Imaging (MRI)
Anatomical Site
Soft tissues
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)
Biocompatibility, sterility, packaging and MRtesting demonstrate the safety and effectiveness of the proposed devices.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for SOMATEX Medical Technologies GmbH. Above the company name is the number k/02771. The SOMATEX logo has a registered trademark symbol next to it.
Rheinstraße 7d | D-14513 Teltow
JUN 2 4 2011
510(k) SUMMARY
Biopsy Handy / MRI Biopsy Handy
Submitter:
Somatex Medical Technologies GmbH Rheinstrasse 7d 14513 Teltow Germany Phone: +49 3328 3076 13 +49 3328 3076 99 Fax:
Official Correspondent: Susanne Raab
Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, MA 02139 Phone: 617 547 0628 Fax: 617 520 2136 e-mail: sbraab@comcast.net
Biopsy Handy / MRI Biopsy Handy Trade Name:
Common Name: Semiautomatic Biopsy System
II
Biopsy Instrument, 21 C.F.R. 876.1075 Classification Name:
Regulatory Class:
Product Code: KNW
Device Description: The Biopsy Handy and the MRI Biopsy Handy are sterile, single use, semiautomatic percutaneous soft tissue biopsy systems each consisting of the following major components: a device handle, a cannula, a stylet button, a stylet with a specimen chamber, a hub of the cannula, a guide bush, a slide and a pressure spring. In addition, the cannulas of the
1
Image /page/1/Picture/0 description: The image shows the logo for SOMATEX Medical Technologies GmbH. The logo is in black and white and features the word "SOMATEX" in large, bold letters. Below the word "SOMATEX" is the phrase "MEDICAL TECHNOLOGIES GMBH" in smaller letters.
einstraße 7d | D-1451 3328 30 76-0 | Fax +49 (0) 3328 30 76 @somatex.com | www.somatex.com
proposed devices will be delivered with a protective tube.
The Biopsy Handy and MRI Biopsy Handy are intended to Intended Use: obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.
The Biopsy Handy and MRI Biopsy Handy are substantially equivalent to the Speedybell manufactured by Biopsybell S.A.S., which has been cleared by FDA on August 17, 2001 (K010735), and the Daum Biopsygun manufactured by Daum Corp., which has been cleared by FDA on March 6, 1998 (K974576). Specifically, the proposed devices and the predicate devices are all intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. In addition, the proposed devices and the predicate device Speedybell are indicated to be used with ultrasound or CT-Guidance techniques. Finally, both the MRI Biopsy Handy and the predicate device Daum Biopsygun are indicated to be used with magnetic resonance imaging (MRI) techniques.
Furthermore, the Biopsy Handy and MRI Biopsy Handy are identical or similar in technology, design and material to the
Substantial Equivalence:
2
Image /page/2/Picture/0 description: The image shows the logo for SOMATEX Medical Technologies GmbH. The word "SOMATEX" is in large, bold, sans-serif font, with a registered trademark symbol to the right of the "X". Below the main wordmark, "MEDICAL TECHNOLOGIES GMBH" is printed in a smaller, sans-serif font.
MADE IN GERM.
Rheinstraße 7d | 0-14513 Teltow Tel +49 [0] 3328 30 76-0 | Fax +49 [0} 3328 30 76-95 info@somatex.com | www.somatex.co
predicate devices. Both the proposed and the predicate devices consist of the same primary components and the component materials of the proposed device and the predicate devices are substantially equivalent.
Based on the same intended use and the similiarities in technolgy, design and materials, the Biopsy Handy and MRI Biopsy Handy are substantially equivalent to their predicate devices. The minor technological differences between the proposed devices and the predicate devices do not raise new questions of safety and effectiveness.
Finally, biocompatibility, sterility, packaging and MRtesting demonstrate the safety and effectiveness of the proposed devices.
Date Prepared:
February 24, 2011
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Somatex Medical Technologies GmbH % Ms. Susanne Raab Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, Massachusetts 02139
JUN 2 4 2011
Re: K102771
Trade/Device Name: Biopsy Handy/MRD Biopsy Handy Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: June 23, 2011 Received: June 24, 2011
Dear Ms. Raab:
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
4
Page 2 - Ms. Susanne Raab
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 (OS) 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,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known):
Device Name: Biopsy Handy / MRI Biopsy Handy
Indications for Use:
The Biopsy Handy and MRI Biopsy Handy are intended to obtain diagnostic samples of soft tissues for histological examination during a percutaneaous biopsy procedure. Both devices are indicated to be used with ultrasound or CT-Guidance techniques. Only the MRI Biopsy Handy is indicated to be used with magnetic resonance imaging (MRI) techniques.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OL
Nil RP Qyle fortkn
ivision Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102771
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