(53 days)
Not Found
No
The description focuses on mechanical guidance and alignment, with no mention of AI/ML terms or data processing/analysis that would typically indicate AI/ML involvement.
No
The device is a needle guide that assists in precise needle placement during ultrasound-guided procedures. It does not directly treat or diagnose a disease or condition itself.
No
Explanation: This device is a needle guide used during ultrasound-guided procedures to assist in precise needle placement. Its function is to guide a needle, not to diagnose a condition.
No
The device description explicitly states that the components for the Needle Guides are "all single use disposable" and "delivered sterile," indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The described device is a needle guide used during ultrasound-guided procedures. Its purpose is to physically guide a needle or other interventional device into the body, not to analyze samples from the body.
- Intended Use: The intended use clearly states it provides guidance for needles during a procedure, not for analyzing samples after they are collected.
Therefore, this device falls under the category of a surgical or procedural accessory rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
510(k) Summary continue
| Biopsy guides in this submission | K043425 | |
|---|---|---|
| Intended Use | Needle Guide for BK Medical transducer 88xx" | |
| Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy. | The Needle Guide provides guidance for a needle, catheter, biopsy apparatus or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform biopsy or precise needle placement. | |
| Indications for use | Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy. | The Needle Guide provides guidance for a needle, catheter, biopsy apparatus or other interventional device by positioning it relative to the ultrasound transducer and the resulting image during a diagnostic ultrasound procedure in order to perform biopsy or precise needle placement. |
| Needle Guide angle | Fixed and Various | Various |
| Pre-sterilized | Yes | Yes |
| Removable options for Ultrasonic probe | Yes | Yes |
| For use with variety of Needles | Yes | Yes |
| Materials | MABS (incl. BaSO4) | |
| MABS (incl. BaSO4) and stainless steel | Nylon and ABS | |
| Single Use / Disposable | Yes | Yes |
| Device description | The Needle Guide system consists of 3-4 primary components (depending on the intended transducer) which are used to provide alignment with an ultrasound transducer, in order to guide a needle in relation to the ultrasound image | The Needle Guide system consists of 4 primary components which are used to provide alignment with an ultrasound transducer, in order to guide a needle in relation to the ultrasound image. |
78814; 8815; 8824
ﺘﺮ ﺗﻘ
Conclusion: The needle guides in this application have same intended use and the same characteristics as the predicate device.
B-K Medical therefore believes that the devices in this submission are substantially equivalent to the device in K043425.
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510(k) Summary
K083667
Page 2 of 2
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 +45 44528199 Fax: Establishment registration number: 9680269
Contact person: Lars Oksby Hansen Date prepared: 08 December 2008
Trade name: Needle Guide for 8814 (UA1335), for 8815 (UA1336), for 8824 (UA8824).
Common name: Needle Guide
Classification:
Diagnostic Ultrasound Transducer ITX (21 CFR 892.1570) Class II
Identification of predicate, legally marketed device:
Sheathes Needle Guide System (K043425)
Device description:
The BK Medical Needle Guides described are designed to be used with BK Medical' Ultrasound system to provide alignment with an ultrasound intra-operative transducer, in order to guide a needle (biopsy device, or other interventional device) in relation to the ultrasound image. The components for the Needle Guides are all single use disposable, and delivered sterile. Note! The needle guides are delivered without needles.
Intended use.
Purpose:
Needle Guide for BK Medical transducer 88xx * Needle guide 88XX" provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures that require precise needle placement or biopsy.
The device is for use by medical professionals in a physician office or Intended environment: hospital environment.
*8814; 8815; 8824
Technological characteristics compared to the predicate device.
The predicate device has the same major technological characteristics as the subject device, see comparison below.
Comparison with Sheathes Needle Guide System (K043425) �
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is arranged vertically, with 'Public Health' on the first line and 'Service' on the second line. The font appears to be a serif typeface, and the text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard
FEB - 2 2009
Rockville MD 20850
Mr. Lars Oksby Hansen Regulatory Manager B-K Medical APS Mileparken 34, DK-2730, Herlev DENMARK
Re: K083667
Trade/Device Name: Needle guide for 8814 (UA1335). Needle guide for 8815 (UA1336), and Needle guide for 8824 (UA1337)
Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: ITX Dated: December 8, 2008 Received: December 11, 2008
Dear Mr. Hansen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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 os 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDH's Office of Surveillance and Biometrics' (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 Manufactures, 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.suppot/index.html.
Sincerely yours,
Janine M. Morris
anine M. Morri Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) k 083667
Needle guide for 8814 (UA1335), Needle guide for 8815 (UA1336), Device Name: Needle guide for 8824 (UA1337).
Indications For Use:
Needle guide(s) provides guidance for needles or other interventional devices during an ultrasound-guided procedure. It positions the needle relative to the transducer, so that the needle image is in a specified position in the ultrasound image during procedures. that require precise needle placement or biopsy.
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)
signature
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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