(71 days)
Not Found
No
The description focuses on a physical biopsy guide providing a predetermined path for a needle, with no mention of AI/ML terms or image processing capabilities.
No
Explanation: The device is a biopsy guide used to assist in taking biopsies, which is a diagnostic procedure. It does not provide treatment or therapy.
No
The device is a biopsy guide that helps with the physical procedure of taking tissue samples. While these samples are used for diagnosis, the device itself is a tool for specimen collection, not for analyzing or interpreting information to determine a medical condition.
No
The device description explicitly states it is a physical biopsy guide that is fixed to an ultrasound probe, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The device described is a biopsy guide. Its function is to physically guide a needle during an ultrasound-guided biopsy procedure. It is a tool used during the collection of a sample, not a test performed on the sample itself.
- Intended Use: The intended use is "Performing ultrasound guided biopsies of the prostate." This describes a procedure for obtaining a tissue sample, not a diagnostic test performed on a sample.
The device is a surgical accessory or instrument used in a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Purpose: Performing ultrasound guided biopsies of the prostate.
Indications for Use: Performing ultrasound guided biopsies of the prostate
Product codes (comma separated list FDA assigned to the subject device)
FCG
Device Description
The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate and similar soft tissue.
Indicated Patient Age Range
The intended population is adult patients.
Intended User / Care Setting
The device is for use by medical professionals in a physician office or hospital environment.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary:
This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.
Submitters name: B-K Medical Address: Mileparken 34, DK2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Establishment registration number: 9680269
JUL 2 2 2008
Contact person: Jens Rasmussen, Director of Quality Date prepared: 9 May 2008
Trade name: Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), Dual biopsy guide for 8818 (UA1329-S).
Common name: Biopsy needle guide
Classification:
Kit, needle biopsy FCG (CFR 876.1075) Class II
Identification of predicate, legally marketed device:
Targetscan biopsy kit, Targetscan biopsy needle guide (K073399)
Device description:
The biopsy guides are designed to be used with B-K Medical's ultrasound systems to guide needles for taking biopsies of the prostate and similar soft tissue. The biopsy guides are fixed to the ultrasonic probe, and provide a predetermined path for a biopsy needle. The biopsy guides are similar to previously used biopsy guides delivered non sterile. The new biopsy guides are delivered sterile.
Intended use.
Purpose: Performing ultrasound guided biopsies of the prostate. Intended patient population: The intended population is adult patients. Intended environment: The device is for use by medical professionals in a physician office or hospital environment.
Technological characteristics compared to the predicate device.
The predicate device has the same major technological characteristics as the subject device, see comparison below.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 2 2 2008
Mr. Jens Rasmussen Director of Quality B-K Medical Mileparken 34, DK-2730 Herlev DENMARK
Re: K081323
Trade/Device Name: Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), and Dual biopsy guide for 8818 (UA1329-S)
Regulation Number: 21 CFR 876.1075
Regulation Name: Gastroenterology-urology biopsy instrument
Regulatory Class: II Product Code: FCG Dated: June 30, 2008 Received: July 7, 2008
Dear Mr. Rasmussen:
We have reviewed your Section 510(k) premarket notification of intent to market the device w ferenced 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Approvally, it ifal) of coole of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/13 description: The image is a black and white circular logo. The logo contains the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are in a bold, stylized font in the center of the logo. The logo is surrounded by a dotted border and stars.
Protecting and Promoting Public Health
2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Hoalth's (CDRH 3) Office of Compliance at Une of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K081323 __
Device Name:
Biopsy guide for 8808 (UA1257S17E), Biplane biopsy guide for 8818 (UA1322-S), Endfire biopsy guide for 8818 (UA1323-S), Dual biopsy guide for 8818 (UA1329-S)
Indications for Use:
Performing ultrasound guided biopsies of the prostate
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helena Roman
(Division Sign-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number