(90 days)
Not Found
No
The description focuses on a physical electrosurgical device for creating a passageway during biopsy, with no mention of AI/ML in its function or intended use.
No.
This device is designed to create a passageway for diagnostic breast biopsy procedures, which is a diagnostic function, not a therapeutic one.
No
The device is described as an electrosurgical access device used to provide a passageway for a biopsy instrument, not to diagnose. Its intended use is in diagnostic procedures, but it does not perform the diagnosis itself.
No
The device description explicitly states it consists of a monopolar electrosurgical trocar and a cannula, which are physical hardware components.
Based on the provided information, the Easy Guide™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Easy Guide™ Function: The Easy Guide™ is a surgical access device used during a breast biopsy procedure. It helps the physician penetrate the breast tissue and create a path for a biopsy instrument. It does not perform any testing or analysis of a specimen.
- Intended Use: The intended use clearly states it's for "diagnostic breast biopsy procedures to penetrate the breast... and provide a passageway". This describes a procedural tool, not a diagnostic test.
Therefore, the Easy Guide™ is a medical device used in a diagnostic procedure, but it is not an in vitro diagnostic device itself.
N/A
Intended Use / Indications for Use
The Easy Guide™ is indicated for use in diagnostic breast biopsy procedures to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The SenoRx Easy Guide™ Electrosurgical Access Device consists of a monopolar electrosurgical trocar used to penetrate the breast, and a cannula to provide a passageway through which a breast biopsy instrument may be placed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
June 26, 2001
SEP 2 5 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 Boucly |
| Director, Regulatory Affairs | |
| and Quality Assurance | |
| e. Date Summary Prepared: | June 26, 2001 |
| DEVICE IDENTIFICATION | |
| a. Trade/Proprietary Name: | Easy Guide™ Electrosurgical Access |
| Device | |
| b. Classification Name: | Electrosurgical cutting and coagulation |
| device and accessories, 21 CFR |
878.4400
IDENTIFICATION OF PREDICATE DEVICES 3.
Sure Core Biopsy Electrode
Interventional Concepts, Inc. K963813
Accucise Electrosurgical Trocar
Applied Medical Resources K925984
Bovie Hand Control
Sybron Corporation K790187
ਟ I
1
DESCRIPTION OF THE DEVICE 4.
The SenoRx Easy Guide™ Electrosurgical Access Device consists of a monopolar electrosurgical trocar used to penetrate the breast, and a cannula to provide a passageway through which a breast biopsy instrument may be placed.
STATEMENT OF INTENDED USE ડ.
The Easy Guide™ is indicated for use in diagnostic breast biopsy procedures to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
COMPARISON WITH PREDICATE DEVICES 6.
The intended use, design, construction, materials and technology are comparable to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2001
Ms. Amy Boucly Director, Regulatory Affairs And Quality Assurance SenoRx, Inc. 11 Columbia Suite A Aliso Viejo, California 92656
Re: K012004
Trade/Device Name: SenoRx EasyGuide™ Electrosurgical Access Device Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 26, 2001 Received: July 27, 2001
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.
3
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 N. Mikkelson
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
4
2 FDA Indications for Use Page
510(k) number (if known)
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Easy Guide™ Electrosurgical Access Device
Indications for Us
Indications for Use: The Easy Guide™ Electrosurgical Access Device is indicated for use to penetrate the breast under ultrasound guidance and provide a passageway through which a diagnostic biopsy of a breast may be performed.
for Mark N. Mellkuan
ision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number .
(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__________________________________________________________________________________________________________________________________________________________