(15 days)
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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "SenoRx Introducer." This type of document is for regulatory clearance and does not contain information about acceptance criteria or a study proving device performance in the manner typically described for AI/ML devices.
The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is standard for clinical performance studies of AI/ML-driven medical devices.
This document, however, is for a physical medical device (an introducer) and its clearance is based on demonstrating "substantial equivalence" to a legally marketed predicate device, not on achieving specific performance metrics in a clinical study as would be required for an AI algorithm.
Therefore, I cannot extract the requested information from this document. The document primarily focuses on:
- Confirming the device name and regulation details.
- Stating that the device is substantially equivalent to a predicate device.
- Listing the indications for use.
- Outlining regulatory compliance requirements.
There is no mention of acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, or any of the elements related to evaluating an algorithm's performance.
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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.
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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. 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
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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 |
|---|---|
| --------------- | ---------- |
§ 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.