(85 days)
The SenoRx Biopsy Device System 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.
The SenoRx Biopsy Device is a percutaneous electrosurgical biopsy device which is indicated for use in providing breast tissue samples for diagnostic sampling of breast abnormalities under ultrasound guidance.
The provided text is a 510(k) summary for the SenoRx Biopsy Device System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study.
Therefore, the document does not contain the requested information regarding acceptance criteria or a study proving the device meets them.
The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that it does not raise new questions of safety and effectiveness and is as safe and effective as the predicate device.
Here's what can be inferred from the document regarding the information requested, and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not define specific performance acceptance criteria for the SenoRx Biopsy Device System, nor does it report performance metrics against such criteria. The focus is on comparing its intended use, design, construction, materials, and technology to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document does not describe any clinical study or test set data. It's a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Missing. As no clinical study or test set is described, there's no mention of experts or ground truth establishment for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No test set or related adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Missing. This type of study is entirely irrelevant to biopsy devices that provide tissue samples for diagnostic sampling. It's a concept typically associated with diagnostic imaging AI tools. The SenoRx device is for tissue acquisition, not image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The SenoRx Biopsy Device System is a percutaneous electrosurgical biopsy device, a physical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. No ground truth is mentioned because no clinical study data is presented. The device's purpose is to provide tissue for histologic examination (pathology), which would then establish the diagnostic ground truth for the patient, but this is an outcome of using the device, not a metric by which the device itself is proven to meet acceptance criteria in this document.
8. The sample size for the training set
- Missing. As this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" is not applicable in this context.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of Document Content:
The document (510(k) K013641) states the following:
- Device Name: SenoRx Biopsy Device System
- Intended Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, with partial or complete removal of the imaged abnormality.
- Predicate Devices: Mammotome® Biopsy System (Ethicon Endo-Surgery) and Easy Guide™ Electrosurgical Access Device (SenoRx Inc.).
- Basis for Equivalence: The document asserts that the "intended use, design, construction, materials and technology are comparable to the predicate devices."
This is a standard 510(k) submission, where the primary goal is to demonstrate substantial equivalence to previously cleared devices, not to present a clinical study proving specific performance acceptance criteria for the new device.
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SenoRx Inc. Premarket Notification SenoRx Biopsy Device System
JAN 2 9 2002
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
KO13641
1/2
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | SenoRx Inc. |
|---|---|
| b. Company Address: | 11 Columbia, Suite A |
| c. Telephone:Facsimile: | (949) 362-4800(949) 362-3519 |
| d. Contact Person: | Amy BouclyDirector, Regulatory Affairsand Quality Assurance |
e. Date Summary Prepared:
DEVICE IDENTIFICATION 2.
SenoRx Biopsy Device a. Trade/Proprietary Name: SenoRx Driver SenoRx Control Module SenoRxVacuum System
Biopsy Device, 876.1075 b. Classification Name:
IDENTIFICATION OF PREDICATE DEVICES 3.
Mammotome® Biopsy System
Ethicon Endo-Surgery (K991980, K003297)
Easy Guide™ Electrosurgical Access Device
SenoRx Inc. (K012004)
SI
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013641 2/2
SenoRx Inc. Premarket Notification SenoRx Biopsy Device System
DESCRIPTION OF THE DEVICE 4.
The SenoRx Biopsy Device is a percutaneous electrosurgical biopsy device which is indicated for use in providing breast tissue samples for diagnostic sampling of breast abnormalities under ultrasound guidance.
STATEMENT OF INTENDED USE ડ.
The SenoRx Biopsy Device System 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.
COMPARISON WITH PREDICATE DEVICES 6.
The intended use, design, construction, materials and technology are comparable to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of flowing lines that suggest movement and dynamism. The bird is positioned to the right of the text, which is arranged in a circular fashion around the left side of the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2002
Ms. Amy Boucly Director, Regulatory Affairs and Quality Assurance SenoRx, Inc. 11 Columbia, Suite A Aliso Viejo, California 92656
Re: K013641
Trade/Device Name: SenoRx Biopsy Device Regulation Number: 878.4400, 876.1075 Regulation Name: Electrosurgical cutting and coagulation device and accessories Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: GEI, KNW Dated: October 30, 2001 Received: November 5, 2001
Dear Ms. Boucly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined 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 clorosure) to regars and ment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, as centrance with the provisions of the Federal Food, Drug, devices that have been rocussions in asse approval of a premarket approval application (PMA). and Costictle Act (110) that to not required to the general controls provisions of the Act. The r ou may, mercere, maniev of the Act include requirements for annual registration, listing of general voltrold profice, 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 rr your de rice is onabilional 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 r rouse of actived 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 or any I vature utates and see and see and the bet not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 6077, accems (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) This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of your premarket notification. The PDA Inding of subsantial equivalier by .
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 and If you desire specific advice for your dovice diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices, please contac additionally 21 CFR Part 809.10 In Vitto unable as on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and adverti Compliance at (301) 594-4059. Additionally, 16. question of S94-4639. Also, please note the your device, please colliact the Office of Compiller natification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket not may be obtained from t regulation entitled, "Misoranding of receive to production at may be obtained from the Other general information on your responsional 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,
uriam C. Provost
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. Premarket Notification SenoRx Biopsy Device System
FDA Indications for Use Page 2
510(k) number (if known): K013641
Device Name:
SenoRx Biopsy Device
Indications for Use:
The SenoRx Biopsy Device System 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 The extent of insteasing 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013641
§ 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.