(87 days)
No
The summary describes a mechanical biopsy system and needle, with no mention of AI, ML, or any computational analysis of images beyond "imaging control" for guidance.
No
The device is described as being "intended for obtaining biopsies from breast tissues for diagnostic purposes" and "is not intended for therapeutic excision of tissue."
Yes
The device is intended for obtaining biopsies from breast tissues for diagnostic purposes.
No
The device description explicitly mentions a "Breast Biopsy System" and a "Biopty-Cut® Needle," which are hardware components used for obtaining tissue samples. The summary does not indicate that the device is solely software.
Based on the provided text, 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 diagnosis. This device is used to obtain the specimen (breast tissue) from the body.
- The intended use explicitly states it's for "obtaining biopsies from breast tissues for diagnostic purposes." This describes a procedure to collect a sample, not to perform a diagnostic test on the sample itself.
- The device description focuses on the mechanism for obtaining the tissue sample. It compares it to another biopsy needle, which is also a device for tissue collection.
While the tissue obtained by this device will likely be used for in vitro diagnostic testing later, the device itself is a tissue acquisition device, not an IVD.
N/A
Intended Use / Indications for Use
Like the Bard Biopsy Needle (K871390), the Auto Suture* ABBI* Breast Biopsy System is intended for obtaining biopsies from breast tissues for diagnostic purposes. The device is not intended for therapeutic excision of tissue.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Both the Auto Suture* ABBI* Breast Biopsy System, and Bard® Biopty® Instrument Biopty-Cut® Needle (K871390) are indicated for obtaining soft tissue samples under imaging control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast tissues
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)
Both the Auto Suture* ABBI* Breast Biopsy System and the Bard Biopsy Needle (K871390) are effective in removing a sample of tissue for biopsy.
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.
Bard® Biopty® Instrument Biopty-Cut® Needle (K871390).
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.
Not Found
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
Dec. 20, 1995 K963825 510(k) SUMMARY OF INFORMATION:
| SUBMITTER: | United States Surgical Corporation
150 Glover Avenue
Norwalk, CT 06856
(203) 845-1000 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Curtis Raymond |
| DATE PREPARED: | December 18, 1996 |
| CLASSIFICATION NAME: | Manual Surgical Instrument for general use |
| COMMON NAME: | Biopsy Device |
| PROPRIETARY NAME: | Auto Suture* ABBI* Breast Biopsy System |
| PREDICATE DEVICE: | Bard® Biopty® Instrument Biopty-Cut® Needle
(K871390). |
| DEVICE DESCRIPTION: | Both the Auto Suture* ABBI* Breast Biopsy System,
and Bard® Biopty® Instrument Biopty-Cut® Needle
(K871390) are indicated for obtaining soft tissue
samples under imaging control. |
| INTENDED USE: | Like the Bard Biopsy Needle (K871390), the Auto
Suture* ABBI* Breast Biopsy System is intended for
obtaining biopsies from breast tissues for diagnostic
purposes. The device is not intended for
therapeutic excision of tissue. |
| MATERIALS: | All component materials of the Auto Suture* ABBI*
Breast Biopsy System are comprised of materials
which are in accordance with ISO Standard #109931. |
| PERFORMANCE: | Both the Auto Suture* ABBI* Breast
Biopsy System and the Bard Biopsy Needle (K871390)
are effective in removing a sample of tissue for biopsy. |
mange .. . . . . .