(43 days)
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No
The summary describes a mechanical device (needles) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device, a Biopsy Introducer Needle, is used to guide another needle (procedural biopsy needles) to a tissue mass. It does not directly treat or prevent a disease or condition; it is an accessory for a diagnostic procedure.
No
Explanation: The device, a biopsy introducer needle, is used to guide other needles for tissue sampling. While the sampled tissue can then be used for diagnosis, the introducer needle itself does not perform any diagnostic function (e.g., analyzing images, detecting disease markers). Its primary role is mechanical guidance.
No
The device is described as "Biopsy Introducer Needles," which are physical devices used to guide other needles. The performance studies focus on the biocompatibility of the materials, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "guide procedural biopsy needles coaxially to the location of tissue masses or lesions located throughout the body." This describes a device used during a medical procedure to facilitate tissue collection from the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any analysis of samples outside the body. The device's function is purely procedural for sample collection.
Therefore, the Biopsy Introducer Needle is a medical device used in a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Biopsy Introducer Needles are devices that are used to guide procedural biopsy needles coaxially to the location of tissue masses or lesions located throughout the body.
Product codes
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Device Description
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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
throughout the body
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The materials used in the fabrication of the Biopsy Introducer Needles were evaluated through appropriate biological qualification safety tests as identified in ISO 10993, Part 1 - "Biological Evaluation of Medical Devices". The biocompatibility tests performed were Cytotoxicity, Sensitization, irritation or intracutaneous reactivity, acute systemic toxicity, Hemolysis, and Pyrogenicity as required. These materials meet the requirements of the tests and are found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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)
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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
Baxter Healthcare Corporation 1 500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460
OCT 1 0 1996
Baxter
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BIOPSY INTRODUCER NEEDLE
| Intended Use: | Biopsy Introducer Needles are devices that are
used to guide procedural biopsy needles coaxially
to the location of tissue masses or lesions located
throughout the body. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Baxter Biopsy Introducer Needle is
substantially equivalent to the Bard® TruGuide®
Coaxial Needle predicate device in that: |
| | - the intended use is the same
- the performance attributes are the
same |
| Summary of testing: | The materials used in the fabrication of the Biopsy
Introducer Needles were evaluated through
appropriate biological qualification safety tests as
identified in ISO 10993, Part 1 - "Biological
Evaluation of Medical Devices". The biocompatibility
tests performed were Cytotoxicity, Sensitization,
irritation or intracutaneous reactivity, acute systemic
toxicity, Hemolysis, and Pyrogenicity as required.
These materials meet the requirements of the tests
and are found to be acceptable for the intended use. |