(129 days)
Not Found
No
The device description focuses on mechanical guidance and physical design features, with no mention of AI or ML capabilities.
No
The device is a needle guide used for ultrasound-guided procedures (biopsy, aspiration, catheter placement), not a device that directly treats a condition.
No
The device is a needle guide used with diagnostic ultrasound; it does not perform diagnosis itself.
No
The device is a physical, mechanical needle guide that attaches to an ultrasound transducer. It is described as a "mechanical means" and a "single, disposable component" made of materials that undergo biocompatibility testing. It does not appear to be software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Function of this device: This device is a mechanical guide used during ultrasound-guided procedures. It helps healthcare workers accurately position needles or instruments within the body. It does not analyze or examine any specimens from the body.
- Intended Use: The intended use clearly states it provides a "mechanical means for performing needle / instrument guided procedures." The procedures listed (tissue biopsy, fluid aspiration, catheter placement, and treatment) are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The description focuses on the physical design and function of the guide in relation to the ultrasound transducer and the needle/instrument. It does not mention any components or processes related to analyzing biological samples.
In summary, this device is a surgical accessory or a procedural guide used in conjunction with an ultrasound system. Its purpose is to facilitate accurate placement of instruments within the body, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Intended Uses: This device provides a mechanical means for performing needle / instrument guided procedures with the use of the diagnostic ultrasound endocavity transducer. Needle guide is attached over endocavity transducer I probe / scanhead instruments. This device provides a fixed path for the needle or instrument that when coupled by the ultrasound system software corresponds to on-screen imaging quidelines for visualizing guided instrument placement procedures. CIVCO Endocavity Ultrasound Needle / Biopsy Guides are furnished sterile; single use patient / procedure, The single use, disposable feature helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Indications for Use: Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The subject device provides a fixed path by which to allow needle / instrument guidance in relationship to a specific ultrasound transducer geometry. Various sizes and shapes of endocavity needle guides are engineered and manufactured by CIVCO - each is designed to fit to a specific OEM ultrasound transducer or family of transducers.
The endocavity guide design integrates the mounting bracket and cannula into a single, disposable The endocavity guloc design mogration the transducer with a clip-on action. The removal process is complished by pulling the needle guide off the transducer in a reverse method from the application.
Design variables address the mounting features / dimensional characteristics / presentation angle necessary to accommodate differences in transducer geometries, and the cannula size (gauge) as required by the needle / instrument to be guide configurations are essentially the same in appearance and function. All guides are designed for conformal fit with locator features for secure alignment to the transducer. Exterior shapes of the needle guide are contoured for patient comfort.
The device is furnished sterile; and the entire quide is single use patient / procedure, The single use, disposable feature helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Product categories / models include:
Disposable Endocavity Needle Guide (sterile)
Disposable Transrectal Needle Guide (sterile)
Disposable Transvaginal Needle Guide (sterile)
Endocavity needle quides are individually packaged in sterile "procedure kit" form for single patient / procedure, disposable use. "Procedure kits" are also available with Poly and Latex transducer covers combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
transvaginal and transrectal
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)
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
Image /page/0/Picture/0 description: The image shows the logo for CIVCO Medical Instruments. The logo features a stylized globe on the left, with curved lines representing the continents and meridians. To the right of the globe is the company name, "CIVCO MEDICAL INSTRUMENTS," in a bold, sans-serif font. The overall design is clean and professional, conveying a sense of global reach and medical expertise.
Solutions for Ultrasound
B2 of B5
L970514
June 20, 1997
Disposable Endocavity Ultrasound Needle / Biopsy Guide 510(k) Summary -
Date Summary Prepared: 31 January 1997
This summary of the safety and effectiveness information upon which the substantial equivalence determination is based is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Name: Address: Telephone No.: Contact Person:
CIVCO Medical Instruments Company, Inc. 102 First Street South, Kalona, IA 52247 fax: (319) 656-4451 (319) 656-4447 J. William Jones, Manager - Regulatory Affairs
Establishment Registration Number: 1937223
CIVCO Medical Instruments is registered as a medical device manufacturer.
| Device Trade / Proprietary Name: |
|---|
| Device Common / Usual Name: |
| Device Classification Name: |
Disposable Endocavity Ultrasound Needle / Biopsy Guide Ultrasound Transducer Needle / Instrument Guide Ultrasonic Diagnostic Transducer Accessories
| Classification: | Class II under 21 CFR 892.1570 |
|---|---|
| Classification Panel: | 90 Radiology |
| Classification Procode: | ITX |
Description of Predicate Device(s): The CIVCO Disposable Endocavity Ultrasound Needle / Biogsv Guide is equivalent to CIVCO's currently, legally marketed Transrectal Needle/Biopsy Guide, 510(k) reference number K875128/A, and Transvaginal Needle/Biopsy Guide, 510(k) reference number K875240/A.
Description of Subject Device Submitted for Premarket Notification: - The subject device provides a fixed path by which to allow needle / instrument guidance in relationship to a specific ultrasound transducer geometry. Various sizes and shapes of endocavity needle guides are engineered and manufactured by CIVCO - each is designed to fit to a specific OEM ultrasound transducer or family of transducers.
sheet 1 of 4
ORIGINALS ARE CODED RED
102 First Street South • Kalona, IA 52247 USA Phone: 319/656-4447 · Fax: 319/656-4451 E-mail: info@civcomedical.com
Image /page/0/Picture/18 description: The image shows two quality assurance logos. The first logo on the left is a circular logo with the text "QUALITY ASSURED FIRM" surrounding "ISO 9001" in the center. There is a checkmark below the text. The second logo on the right has a crown on top of a checkmark. Below the checkmark is the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES".
1
83 of 85 510(k) Summary con't. - Disposable Endocavity Ultrasound Needle / Biopsy Guide
Description of Subject Device Submitted for Premarket Notification con't.
The endocavity guide design integrates the mounting bracket and cannula into a single, disposable The endocavity guloc design mogration the transducer with a clip-on action. The removal process is complished by pulling the needle guide off the transducer in a reverse method from the application.
Typical guide designs are illustrated below.
Image /page/1/Picture/4 description: The image shows four different styles of encased cannulas. The cannulas are all black and white and have a similar shape. The text "Encased Cannula Styles" is in the middle of the image. The cannulas appear to be made of metal or plastic.
Open Cannula Styles
Design variables address the mounting features / dimensional characteristics / presentation angle necessary to accommodate differences in transducer geometries, and the cannula size (gauge) as required by the needle / instrument to be guide configurations are essentially the same in appearance and function. All guides are designed for conformal fit with locator features for secure alignment to the transducer. Exterior shapes of the needle guide are contoured for patient comfort.
The device is furnished sterile; and the entire quide is single use patient / procedure, The single use, disposable feature helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
sheet 2 of 4
ORIGINALS ARE CODED RED
ts
2
B4 of B5 510(k) Summary con't. - Disposable Endocavity Ultrasound Needle / Biopsy Guide
Product categories / models include:
Disposable Endocavity Needle Guide (sterile) Disposable Transrectal Needle Guide (sterile)
Disposable Transvaginal Needle Guide (sterile)
Endocavity needle quides are individually packaged in sterile "procedure kit" form for single patient / procedure, disposable use. "Procedure kits" are also available with Poly and Latex transducer covers combined with disposable needle guide devices that CIVCO custom kits for ultrasound OEMs.
Intended Uses: This device provides a mechanical means for performing needle / instrument guided procedures with the use of the diagnostic ultrasound endocavity transducer. Needle guide is attached over endocavity transducer I probe / scanhead instruments. This device provides a fixed path for the needle or instrument that when coupled by the ultrasound system software corresponds to on-screen imaging quidelines for visualizing guided instrument placement procedures. CIVCO Endocavity Ultrasound Needle / Biopsy Guides are furnished sterile; single use patient / procedure, The single use, disposable feature helps to prevent transfer of microorganisms, body fluids, and particulate material to the patient and healthcare worker during reuse of the transducer.
Indications for Use: Diagnostic ultrasound needle / instrument guided procedures - transvaginal and transrectal: tissue biopsy, fluid aspiration, catheter placement, and treatment.
The intended use and indications for use place the CIVCO Disposable Endocavity Ultrasound Needle / Biopsy Guides in device body contact categories as follows:
- a) surface devices, intact skin / mucosal membranes / breached surfaces, limited contact duration ((Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K970514 | |
| Prescription Use (Per 21 CFR 801.109) | | OR Over-The-Counter Use (Optional Format 1-2-96) |