(35 days)
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No
The summary describes a standard soft-tissue biopsy needle with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
No.
The device is described as a biopsy needle, which is used for diagnostic purposes (obtaining tissue samples) rather than treating a disease or condition.
No
Explanation: This device is a biopsy needle used to collect tissue samples. While the collected samples may be used for diagnostic purposes, the device itself is a tool for specimen collection and not a diagnostic device that analyzes or interprets medical data to diagnose a condition.
No
The device description explicitly states it is a "standard soft-tissue biopsy needle," which is a physical hardware device.
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 Daum BiopsyNeedle is a physical instrument used to obtain a tissue sample from the body. It is a tool for collecting the specimen, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use clearly states it's for "percutaneous or open surgical biopsies," which is the process of taking a tissue sample. It doesn't mention any analysis or testing of the sample itself.
The biopsy needle is a crucial part of the diagnostic process, as the collected tissue sample will likely be sent to a laboratory for in vitro diagnostic testing (e.g., histology, pathology). However, the needle itself is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.
Product codes
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Device Description
The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
breast, lung, kidney, liver, lymph nodes, and prostate.
Indicated Patient Age Range
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
POB
K961185
APR 3 0 1996
Image /page/0/Picture/5 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.
916-342-4133 FAX: 916-343-4541
23 April 1996
510(K) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- A. Classification name: Set, biopsy needle and needle, gastroenterology, instrument, or blopsy
Common/usual name: Biopsy needle
Proprietary name: Daum BiopsyNeedle
- B. Substantial eguivalence: Baxter ( Pharmaseal ) TruCut (K813338), MD Tech Ultra-Core B1opsy Needle, and others.
- C. Device description: The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.
- Intended use: ענ The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.
- E. Technological characteristics: The Daum BiopsyNeedle 1s 81milar to predicate devices
3407 Bay Avenue · Chico, California 95973 · USA
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ここで K961185
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SMDA Summary 23 April 1996
in its design, function, and intended use.
is different than many The proposed device hiopsy needles in that the Daum device has components manufactured of titanium and titanium alloys, rather than from stainless steel.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frank Lee
Prank Ferguson Official Correspondent