(90 days)
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No
The device description and performance studies focus on the physical characteristics and biocompatibility of the needle, with no mention of AI or ML for analysis or guidance.
No.
The device is used to obtain samples for diagnostic evaluation, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is used to obtain samples "to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment," which directly indicates a diagnostic purpose.
No
The device description clearly states it is comprised of a cannula and stylet assembly, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. While the FNA needle obtains the sample, the diagnostic evaluation of the cells is performed after the sample is collected, likely in a laboratory setting using other methods (e.g., microscopy, staining).
- The description focuses on the device's function of obtaining the sample. It describes the physical components and how it's used to aspirate fluid containing cells.
- The performance studies mentioned are related to the biocompatibility and safety of the device materials, not the diagnostic performance of analyzing the cells.
- There is no mention of any analytical or diagnostic function performed by the device itself.
The FNA needle is a medical device used for sample collection, which is a crucial step in the diagnostic process, but it is not the diagnostic device itself. The diagnostic evaluation happens downstream from the use of this needle.
N/A
Intended Use / Indications for Use
FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.
Product codes
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Device Description
The FNA needles are comprised of a cannula and stylet assembly connected to a handle for ease of insertion into soft tissues of the body.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissues such as breast, liver, kidney, pancreas and lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The materials used in the fabrication of the FNA needles are evaluated through biological qualification safety tests as outlined 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 guidance and found to be acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Baxter Skinny Chiba Needle, Hart Enterprises, Inc. Soft Tissue Needles
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Surgical Group
OCT 23 1996
Baxter Healthcare Corporation
1500 Waukegan Road McGaw Park, Illinois 60085 USA
1
847.473.1500 FAX: 847.785.2460
Baxter
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FINE NEEDLE ASPIRATION NEEDLE
| Manufacturer: | Baxter Healthcare Corporation
Surgical Group
400 East Foster Road
Mannford, OK 74044 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | July, 1996 |
| Common Name: | Fine Needle Aspiration Needle |
| Classification: | Class II per 21CFR § 876.1075 |
| Predicate Devices: | Baxter Skinny Chiba Needle
Hart Enterprises, Inc. Soft Tissue Needles |
| Description: | The FNA needles are comprised of a cannula and
stylet assembly connected to a handle for ease
of insertion into soft tissues of the body. |
1
Surgical Group
Baxter Healthcare Corporation 500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460
Baxter
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FINE NEEDLE ASPIRATION NEEDLE
Intended Use:
FNA needles are devices that are used to obtain samples through the aspiration of fluid (containing cells) from soft tissues such as breast, liver, kidney, pancreas and lung, etc. to analyze size, shape and structure of cells for diagnostic evaluation or monitor treatment.
Substantial Equivalence:
The Baxter FNA Needles are substantially equivalent to Baxter's Skinny Chiba Needles and to the Hart Enterprises Soft Tissue Biopsy Needle 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 FNA needles are evaluated through biological qualification safety tests as outlined 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 guidance and found to be acceptable for the intended use.