(59 days)
Not Found
None
No
The device description and intended use describe a mechanical biopsy needle, and there is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a biopsy needle for diagnostic evaluation, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used "for diagnostic evaluation." The device itself (a biopsy needle) is used to obtain samples, which are then analyzed to provide a diagnosis.
No
The device description clearly states it is comprised of a cannula and stylet assembly connected to a handle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce a cannula into soft tissue for diagnostic evaluation. This means the device is used to obtain a sample from the body.
- Device Description: The description details a physical needle used for tissue collection.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside of the body (in vitro) to provide information for diagnosis. This device is used inside the body to collect the specimen.
The diagnostic evaluation mentioned in the intended use would likely be performed on the tissue sample obtained by this needle, using separate IVD devices or laboratory procedures. The needle itself is a tool for obtaining the sample, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.
Product codes
Not Found
Device Description
The 18 gauge Tru-Cut Biopsy needle is comprised of a cannula and stylet assembly connected to a handle for ease of insertion into the soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue such as breast, lungs, lymph nodes and prostate, etc.
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
All materials used in the fabrication of this 18 gauge Tru-Cut Biopsy Needle were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of of Medical Devices". biocompatibility tests performed were USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization as required. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s):
Not Found
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
APR - 4 1992
Surgical Group
Baxter Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA
847.473.1500 FAX: 847.785.2460
N = 4
Baxter
APR - 4 1996
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 18 GAUGE TRU-CUT BIOPSY NEEDLE
| Manufacturer: | Baxter Healthcare Corporation
Surgical Group
400 East Foster Road
Mannford, OK 74044 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Richter
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | January, 1996 |
| Common Name: | 18 Gauge Tru-Cut Biopsy Needle |
| Classification: | Class II per 21CFR § 876.1075 |
| Predicate Device: | Baxter 14 Gauge Tru-Cut Biopsy Needle |
| Description: | The 18 gauge Tru-Cut Biopsy needle is
comprised of a cannula and stylet assembly
connected to a handle for ease of insertion
into the soft tissue. |
1
XII. SMDA REQUIREMENTS (continued)
ーン・イン
スーパー
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 18 GAUGE TRU-CUT BIOPSY NEEDLE
| Intended Use: | The 18 gauge Tru-Cut Biopsy Needle is a
device that introduces a cannula into the soft
tissue such as breast, lungs, lymph nodes and
prostate, etc. for diagnostic evaluation. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Baxter 18 gauge Tru-Cut Biopsy Needle is
substantially equivalent to Baxter's 14 gauge
Tru-Cut Biopsy Needle in that: |
| | - the intended use is the same
- the performance attributes are the
same |
| Summary of testing: | All materials used in the fabrication of this 18
gauge Tru-Cut Biopsy Needle were evaluated
through biological qualification safety tests as
outlined in in ISO 10993 Part-1 "Biological
Evaluation of of Medical Devices".
biocompatibility tests performed were USP Plastics
Class VI, Implant, Hemolysis, Tissue Culture,
Pyrogenicity, Ocular Irritation, and Guinea Pig
Maximization as required. These materials have
met the requirements of the guidance and were
found to be acceptable for the intended use. |
13