(15 days)
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Not Found
No
The 510(k) summary describes a physical introducer device used for breast biopsy under image guidance, with no mention of AI or ML in its function or description.
No
The device is used to create a passageway for diagnostic biopsy, not for treating a disease or condition.
Yes
Explanation: The device is used to facilitate a diagnostic biopsy, which is a diagnostic procedure.
No
The device description and intended use clearly describe a physical introducer used for breast biopsy, which is a hardware device. There is no mention of software as the primary component or function.
Based on the provided information, the SenoRx Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed." This describes a device used in vivo (within the body) to facilitate a procedure.
- IVD Definition: IVDs are devices used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples or any diagnostic testing performed on specimens.
The SenoRx Introducer is a surgical or procedural device used to access tissue for a biopsy, which is then typically sent to a laboratory for in vitro diagnostic testing. The introducer itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The SenoRx Introducer is indicated for use to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
Product codes
GEI
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
image guidance
Anatomical Site
breast
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance Senorx, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K042098
Trade/Device Name: SenoRx Introducer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 3, 2004 Received: August 4, 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 enactment 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 either 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 Code 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); labeling (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.
1
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. Milliken
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
SenoRx Inc. Special 510(k) Device Modification SenoRx Introducer
Indications for Use Statement
| 510(k) Number (if known) | K042098 |
|---|---|
| Device Name | SenoRx Introducer |
| Indications for Use | The SenoRx Introducer is indicated for use to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Prescription Use (Per 21 CFR 801. 109) | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ---------------------------------------- | --- | ---- | ---------------------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K04 2098 |
|---|---|
| --------------- | ---------- |