(11 days)
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No
The provided text describes a biopsy device for tissue sampling and does not mention any AI or ML capabilities, image processing, or data analysis features typically associated with AI/ML in medical devices.
No
Explanation: The device is indicated for diagnostic sampling of breast abnormalities to obtain tissue samples for histologic examination, not for treating a disease or condition.
Yes
This device is used to obtain breast tissue samples "for diagnostic sampling of breast abnormalities," and the purpose of taking these samples is "for histologic examination." This process directly aids in diagnosis.
No
The device description is not available, but the intended use clearly describes a "Biopsy Device" which is a physical instrument used to collect tissue samples. This indicates a hardware component, not a software-only device.
Based on the provided information, the SenoRx EnCor Biopsy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is used to obtain breast tissue samples for diagnostic sampling. It is a tool for collecting the sample, not for performing the diagnostic test on the sample itself.
- Intended Use: The intended use is to "provide breast tissue samples for diagnostic sampling" and "provide breast tissue for histologic examination." This indicates the device's role is in the collection phase, not the analysis phase. The tissue samples collected by this device would then be sent to a laboratory for in vitro diagnostic testing (histologic examination).
Therefore, the SenoRx EnCor Biopsy Device is a medical device used for tissue collection, which is a step prior to in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SenoRx EnCor Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes
KNW
Device Description
EnCor Biopsy Device 7 Gauge
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
mammographic
Anatomical Site
breast
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird symbol with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
MAY 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K051158
Trade/Device Name: EnCor Biopsy Device 7 Gauge Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: May 4, 2005 Received: May 5, 2005
Dear Ms. Boucly:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or 10 conninered pror to may 20, 1978, tive excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Free (110) 2100 market the device, subject to the general controls provisions of the Act. The r ou may, arerers, aniers, and include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to such additional controls. Existing major regulations affecting your device it may be basily of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA oun of found in the conouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of acrised that I be mination that your device complies with other requirements of the Act that I Director statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Crth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Amy Boucly
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'ls ough finding of substantial equivalence of your device to a legally premarket notification "Te results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at 100 101 - 100 - 240) 276-0120 . Also, please note the regulation entitled, Connact the Office of Comptallers are the notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SenoRx Inc. Special 510(k) Device Modification EnCor Biopsy Device 7 Gauge
Indications for Use
510(k) Number (if known):
01156
Device Name:
EnCor Biopsy Device 7 Gauge
Indications for Use:
The SenoRx EnCor Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tive
KOS1158
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