(63 days)
No
The summary describes a mechanical biopsy needle with a modified sample notch and a CT spacer. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML. The performance studies focus on the physical characteristics of the needle and the quality of the tissue sample.
No
The device is a biopsy needle, used for obtaining tissue samples for diagnosis, not for treating a disease or condition.
Yes
The device is used to obtain biopsies from soft tissues, and biopsies are a fundamental part of diagnosing diseases and conditions.
No
The device description clearly describes physical biopsy needles and a computed tomography spacer, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to obtain biopsies from soft tissues. This is a procedure to collect a sample of tissue from a living organism.
- Device Description: The device is a biopsy needle, designed for the physical act of extracting tissue.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's primary function is the collection of the specimen, not the analysis of it.
While the collected tissue sample might subsequently be used in an IVD process (e.g., examined under a microscope or tested for biomarkers), the biopsy needle itself is a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer are single-use biopsy needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
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)
Testing confirms that the quality of the samples obtained with the modified notch needles are equivalent to the samples obtained from the standard sample notch needles.
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.
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
§ 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
JUL 30 1996
Bard Radiology Division 13183 Harland Dr., N.E. Covington, GA 30209
Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, stylized font. The letters are thick and have a slightly rounded appearance. The word is presented in all capital letters and is the central focus of the image.
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VI. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Submitter Information:
| Submitter's Name:
Address: | C. R. Bard, Inc., Radiology Division
13183 Harland Drive North East
Covington, Georgia 30209 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------|
| Phone Number: | (770) 784-6411 or 1-800-526-4455
extension 6411 |
| Fax Number: | (770) 784-6419 |
| Contact Person:
Contact Person's Address: | Carol Vierling
8195 Industrial Blvd.
Covington, Georgia 30209 |
| Date of Preparation: | May 13, 1996 |
| Device Name: | |
| Trade Name: | Bard® Biopty-Cut® Biopsy Needle and
Bard® Biopty-Cut® Biopsy Needle with |
Spacer
Common/Usual Name:
Biopsy Needle
Classification Name:
Gastroenterology-urology biopsy instrument, needle
Predicate Device Name:
Trade Name:
Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Biopsy Needle with Spacer
Device Description:
The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer are single-use biopsy needles.
Intended Use:
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
1
K962077
Technological Characteristics Summary:
The Bard® Biopty-Cut® Biopsy Needle and Bard® Biopty-Cut® Needle with Spacer which are the subject of this Premarket Notification, have a modified sample notch. They are available in various gauges and lengths. The Bard® Biopty-Cut® Needle with Spacer is packaged with a computed topography spacer.
Performance Data Summary:
Testing confirms that the quality of the samples obtained with the modified notch needles are equivalent to the samples obtained from the standard sample notch needles.
2
SECTION V1 - TABLE 1 Characteristics of Equivalent Devices Type of Instrument
| Characteristic | CURRENT | PROPOSED | |
|---|---|---|---|
| Bard® Biopty-Cut® Biopsy | |||
| Needle | |||
| 510(k) #K871390 | Bard® Biopty-Cut® Needle | ||
| with and without Spacer | |||
| 510(k) #K910720 | Bard® Biopty-Cut® Needle | ||
| with and without Spacer | |||
| Indications for Use | Percutaneous biopsy of the liver, | ||
| kidney, prostate, spleen, lymph | |||
| nodes and different tumors. | Obtaining core biopsy, of various | ||
| organs and tissues.1 | Obtaining biopsies from soft | ||
| tissues such as liver, kidney, | |||
| prostate, spleen, lymph nodes | |||
| and various soft tissues. It is not | |||
| intended for use in bone.1 | |||
| Needle Type | Sterile, non-pyrogenic, 2-part | ||
| cannula/stylet, stainless steel | |||
| with plastic hubs. | Sterile, non-pyrogenic, 2-part | ||
| cannula/stylet, stainless steel with | |||
| plastic hubs. | Sterile, non-pyrogenic, | ||
| 2-part cannula/stylet, | |||
| stainless steel with plastic hubs. | |||
| Reuse Status | Disposable, not intended for re- | ||
| use. | Disposable, not intended for re- | ||
| use. | Disposable, not intended for | ||
| re-use. | |||
| Available Needle Diameters | 14,18, 20 gauge | 12,14,16,18,20 gauge | 12,14,16,18,20 gauge |
| Available Needle Lengths | 16, 20cm | 10, 16, 20cm (all gauges) | |
| 25, 30cm (16, 18 gauge) | 10, 16, 20cm (all gauges) | ||
| 25, 30cm (16, 18 gauge) | |||
| Sample Notch Length | 17mm for 18 gauge | ||
| 20mm for 14 gauge | 17mm2 | 17mm for 12, 16, 18, 20 gauge | |
| 19mm for 14 gauge | |||
| Configuration of | |||
| Sample Notch Ends | proximal = radius | ||
| distal = radius | proximal = radius | ||
| distal = radius | proximal = radius | ||
| distal 3= angled | |||
| Centimeter Gradations | |||
| on Cannula | None | Optional | Optional |
| Spacer Component | None | Optional | Optional |
| Etched Tip | None | Optional | Optional |
| 1. Indications for use were very general in #K910720. A subsequent 510(k) for biopsy needles, #K922939, included DFUs with more specific indications. These | |||
| indications were used in the Biopty-Cut Biopsy needle line. | |||
| 2. #K910720 noted that the sample notch length was 17mm for all needles. It should have noted that the notch length is 17 or 19mm, depending on gauge size. | |||
| 3. distal = angled is the only change proposed. Test results and report presented in Appendix B of this submission show no significant difference could be | |||
| detected between the samples collected by a needle with an angled distal sample notch and samples collected by a needle with a radius distal sample notch | |||
| Characteristic | Bard® Biopty-Cut® Biopsy Needle | ||
| 510(k) #K871390 | CURRENT | ||
| Bard® Biopty-Cut® Needle | |||
| with and without Spacer | |||
| 510(k) #K910720 | PROPOSED | ||
| Bard® Biopty-Cut® Needle | |||
| with and without Spacer | |||
| Number of Samples | 1 per fire | 1 per fire | 1 per fire |
| Mechanics of Action | Automatic, spring - driven | Automatic, spring - driven | Automatic, spring - driven |
| Mode of Action | Single puncture and sample | Single puncture and sample | Single puncture and sample |
3
SECTION V1 - TABLE 1 Characteristics of Equivalent Devices Type of Instrument
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