(29 days)
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Not Found
No
The summary provides no information suggesting the use of AI or ML. It describes a biopsy device for tissue sampling, which is a mechanical process.
No.
The device is used for diagnostic sampling of breast abnormalities, not for treatment or therapy.
Yes
The device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities, implying its use in diagnosis.
No
The device is described as a "Biopsy Device," which strongly implies a physical instrument used for tissue sampling, not a software-only application. The intended use also describes a physical action ("provide breast tissue samples").
Based on the provided information, the SenoRx Biopsy Device II is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide breast tissue samples for diagnostic sampling of breast abnormalities." This describes a device used to obtain a sample from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The description indicates the device is used to collect the tissue sample, not to perform a diagnostic test on the sample itself.
The tissue samples collected by this device would then likely be sent to a laboratory for in vitro diagnostic testing (e.g., pathology examination). The SenoRx Biopsy Device II is the tool used to acquire the sample for those subsequent IVD tests.
N/A
Intended Use / Indications for Use
The SenoRx Biopsy Device II is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is intended to provide breast tissue samples for the purpose of histologic examination. It can be used to sample breast abnormalities under mammographic guidance. It can be used to sample breast abnormalities for biopsy purposes where there is 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 abnormality should not be used to interpret the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not completely removed histologically, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Product codes
KNW
Device Description
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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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized depiction of an eagle, with its wings spread and head turned to the side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K040842
Trade/Device Name: SenoRx Biopsy Device II Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: KNW Dated: March 31, 2004 Received: April 1, 2004
Dear Ms. Boucly:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 commerce prior to May 28, 1976, the cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labcling (21 CFR Part 801); good manufacturing practice requirements as set forth 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milkerem
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
Device Name:
SenoRx Biopsy Device II
Indications for Use:
The SenoRx Biopsy Device II is indicated to provide breast tissue samples for The Sellorx Diopsy Devrest abnormalities. It is intended to provide breast tissue thaghostic sampling of ere with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its The extent of insterears ase. Therefore the extent of removal of the imaged mailmographic upportuitor. The extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not ablormanty, org, maily it is essential that the tissue margins be examined for mstologically 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)
Mark A. Milkerson
I. Restorative, and Neurological Devices
510(k) Number.