(15 days)
No
The summary describes a vacuum-assisted biopsy device integrated with an ultrasound scanner. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of these technologies. The focus is on the mechanical and imaging components for tissue sampling and visualization.
No
The device is described as an "Ultrasound Breast Biopsy System" intended for "diagnostic sampling of breast abnormalities" and "histologic examination." Its purpose is to aid in diagnosis and evaluation by generating images, not to provide therapy or treatment.
Yes
The device is described as aiding in the "diagnosis and evaluation of soft tissues" and providing "breast tissue samples for diagnostic sampling of breast abnormalities."
No
The device description clearly states it is a "percutaneous ultrasound-guided, vacuum-assisted biopsy device" that integrates hardware components like a control module, vacuum system, ultrasound scanner, and flat panel displays. It is a physical system, not solely software.
Based on the provided information, the SenoSonix Ultrasound Breast Biopsy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes.
- SenoSonix Function: The SenoSonix system is a device used in vivo (within the body) to obtain tissue samples for subsequent diagnostic examination. It also provides ultrasound imaging for guidance during the biopsy procedure.
- Intended Use: The intended use clearly states it's for providing breast tissue samples for diagnostic sampling and aiding in the diagnosis and evaluation of soft tissues through imaging. It's not performing the diagnostic test on the tissue itself.
- Device Description: The description focuses on the biopsy mechanism and the integrated ultrasound for guidance, not on analyzing the tissue sample within the device.
While the tissue samples obtained by the SenoSonix system will likely be used for in vitro diagnostic testing (histologic examination), the SenoSonix device itself is the tool for acquiring the sample and guiding the procedure, not the diagnostic test itself.
N/A
Intended Use / Indications for Use
The SenoSonix Ultrasound Breast Biopsy 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 ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The SenoSonix System is a percutaneous ultrasound-guided, vacuum-assisted biopsy device which is intended for use in providing breast tissue samples for diagnostic sampling of breast abnormalities.
The SenoSonix System integrates the functions of the existing SenoRx Control Module (K023923) and Vacuum System (K023923) into a single console. An added feature of the SenoSonix System is the integration of Ultrasonix Medical's Sonix Ultrasound Scanner (K061827).
The SenoSonix System has 2 flat panel displays. One displays the ultrasound image and the other is for user operation and control. The biopsy module will be controlled by the small window on the touch screen when the biopsy tab is selected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast, abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified physician, obstetrics/gynecology and general radiology examinations.
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.
K023923 SenoCor 360 Circumferential Vacuum-Assisted Biopsy Device, K040842 SenoRx Biopsy Device II, K061827 Sonix Ultrasound Scanner
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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
K07254/
Image /page/0/Picture/1 description: The image shows the word "SENORx" in a stylized font. The letters are black and the word is centered. The "O" in the word is replaced by a ribbon.
SEP 2 5 2007
5. 510(K) SUMMARY
| Prepared date | August 21, 2007 |
|---|---|
| 510(k) owner | SenoRx, Inc. |
| 11 Columbia | |
| Aliso Viejo, CA 92656 | |
| P. 949.362.4800 F. 949.362.3200 | |
| Contact person | Eben Gordon |
| Device name | SenoSonix Ultrasound Breast Biopsy System |
| Common name | Biopsy device |
| Ultrasound Imaging System | |
| Classification name | Gastroenterology-urology biopsy instrument 876.1075 KNW |
| Diagnostic Ultrasound Module | |
| Ultrasonic Pulsed Doppler Imaging System 892.1550 TYN | |
| Ultrasonic Pulsed Echo Imaging System 892.1560 IYO | |
| Diagnostic Ultrasound Transducer 892.1570 ITX | |
| Review category | Tier II |
| Regulatory class | II |
| Predicate device | K023923 SenoCor 360 Circumferential Vacuum-Assisted |
| Biopsy Device | |
| K040842 SenoRx Biopsy Device II | |
| K061827 Sonix Ultrasound Scanner | |
| Decision date | 12/11//2002 (K023923) |
| 4/30/2004 (K040842) | |
| 8/4/2006 (K061827) | |
| Device description | The SenoSonix System is a percutaneous ultrasound-guided, |
| vacuum-assisted biopsy device which is intended for use in | |
| providing breast tissue samples for diagnostic sampling of breast | |
| abnormalities. | |
| The SenoSonix System integrates the functions of the existing | |
| SenoRx Control Module (K023923) and Vacuum System | |
| (K023923) into a single console. An added feature of the | |
| SenoSonix System is the integration of Ultrasonix Medical's | |
| Sonix Ultrasound Scanner (K061827). | |
| The SenoSonix System has 2 flat panel displays. One displays | |
| the ultrasound image and the other is for user operation and |
1
Image /page/1/Picture/0 description: The image shows the word "SenORx" in a stylized font. The letters are large and bold, with a slight serif. There is some noise or distortion in the middle of the word, between the "N" and the "O". The overall impression is of a logo or brand name.
Indications for use
Summary of substantial equivalence
control. The biopsy module will be controlled by the small window on the touch screen when the biopsy tab is selected.
The SenoSonix Ultrasound Breast Biopsy 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 ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
The indications for use for the SenoSonix System are a sub-set of the predicate devices. The design changes that have occurred to the SenoRx Biopsy System and the Sonix Ultrasound System are limited to those to take advantage of a shared console, keyboard, and display.
The software is only changed to integrate the functionality of the control module, vacuum system, and ultrasound module into a common console.
The SenoSonix System has the following similarities to that of the previously cleared predicate devices:
- . Has the same intended use;
- . Uses the same operating principle and has not altered the fundamental technology:
- . Incorporates the same biopsy and ultrasound probes;
- Incorporates the same patient contacting materials; and
- t Has the same manufacturing materials and processes
In summary, the SenoSonix Ultrasound Breast Biopsy System described in this submission is, in our opinion, substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines that resemble a stylized bird or wing-like shape. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 2007
SenoRx, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K072541
Trade/Device Name: SenoSonix Ultrasound Breast Biopsy System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the SenoSonix Ultrasound Breast Biopsy System, as described in your premarket notification:
Transducer Model Number
C5-2/60 convex 1/5MHz 60mm radius L14-5/38 linear 5/12MHz 38mm L14-5W/60 linear 5/12MHz 60mm L9-4/38 linear 4/9MHz 38mm
3
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.
This letter will allow you to begin marketing your device as described in your 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 market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Paul Hardy at (240) 276-3666.
Sincerely vours.
Ayu Tri Whay
Gr Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
SenoSonix Ultrasound Module
Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | N | N | N | N (a) | N (b) | ||
| Abdominal | N | N | N | N | N | N | N | N (a) | N (b) | |
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | N | N | N | N | N | N | N (a) | N (b) | ||
| Small Organ (specify) | N | N | N | N | N | N | N (a) | N (b) | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N (a) | N (b) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | N | N | N | N | N | N | N (a) | N (b) | ||
| MSK Superficial | N | N | N | N | N | N | N (a) | N (b) | ||
| Other (specify) (c) |
N=new indication; P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Small Organ: breast, thyroid, testicle
Intraoperative: abdominal organs and vascular
(a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
(b) Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
louis K. Whing
(Divisi Division o Radiolog 510(k) Num
5
C5-2/60 convex 1/5MHz 60mm radius transduccr
Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P (a) | P (b) | ||
| Abdominal | P | P | P | P | P | P | P (a) | P (b) | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P (a) | P (b) | ||
| Small Organ (specify) | P | P | P | P | P | P | P (a) | P (b) | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P (a) | P (b) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | P | P | P | P | P | P | P (a) | P (b) | ||
| MSK Superficial | P | P | P | P | P | P | P (a) | P (b) | ||
| Other (specify) |
N=new indication; P=previously cleared by FDA (Ultrasonix Medical Corp. in K061827); B=added under Appendix E
Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) BM, B/PWD, B/CFM/PWD, B/AD/PWD, B/D/PWD, B/CFM/CWD, B/AD/CWD, B/D/D/CWD, B/D/D/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biogry
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aonni M. Whang
(Division Sign Off)
6
L14-5/38 linear 5/12MHz 38mm transducer
Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P (a) | P (b) | ||
| Abdominal | P | P | P | P | P | P | P (a) | P (b) | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P (a) | P (b) | ||
| Small Organ (specify) | P | P | P | P | P | P | P (a) | P (b) | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P (a) | P (b) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | P | P | P | P | P | P | P (a) | P (b) | ||
| MSK Superficial | P | P | P | P | P | P | P (a) | P (b) | ||
| Other (specify) |
N=new indication (previously cleared by Utrasonix Medical Corp. in K061827); P=previously cleared by FDA; E
Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/DPD/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Torgu M. Whan
510(k) N
7
L14-5W/60 linear 5/12MHz 60mm transducer
Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P (a) | P (b) | ||
| Abdominal | P | P | P | P | P | P | P (a) | P (b) | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P (a) | P (b) | ||
| Small Organ (specify) | P | P | P | P | P | P | P (a) | P (b) | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P (a) | P (b) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | P | P | P | P | P | P | P (a) | P (b) | ||
| MSK Superficial | P | P | P | P | P | P | P (a) | P (b) | ||
| Other (specify) |
N=new indication (previously cleared by Ultrasonix Medical Corp. in K061827); P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
(b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Louie M. White
(Division Sign-Off)
Radiol 510(k) Nu
8
L9-4/38 linear 4/9MHz 38mm transducer
Diagnostic Ultrasound Indications for Use Form
Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | P | P | P | P | P | P | P (a) | P (b) | ||
| Abdominal | P | P | P | P | P | P | P (a) | P (b) | ||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | P | P | P | P | P | P | P (a) | P (b) | ||
| Small Organ (specify) | P | P | P | P | P | P | P (a) | P (b) | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P (a) | P (b) | ||
| Laparoscopic | ||||||||||
| MSK Conventional | P | P | P | P | P | P | P (a) | P (b) | ||
| MSK Superficial | P | P | P | P | P | P | P (a) | P (b) | ||
| Other (specify) |
N=new indication (previously cleared by Ultrasonix Medical Corp. in K0618278 K042326); P=previously cleared by FDA; E=added under Appendix E
Additional Comments:
Small Organ: breast, thyroid, testicle
- (a) B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
- (b) Freehand 3D imaging, Directional Power Doppler (DPD), imaging for guidance of biopsy
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Torrie M. Whan
510(k) Nu
9
র্বা INDICATIONS FOR USE
510(k) Number (if known):
SenoSonix Ultrasound Breast Biopsy System 510(k) Submission Device Name:
Indications for Use:
The SenoSonix Ultrasound Breast Biopsy 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 ultrasound module is intended for use in obstetrics/gynecology and general radiology examinations by a qualified physician, to aid in the diagnosis and evaluation of soft tissues, by generating 2 dimensional images, time motion images and biometric studies.
The specific intended uses of the ultrasound system include: abdominal, small parts, peripheral vascular, musculo-skeletal (conventional), musculo-skeletal (superficial), small organ (breast, thyroid, testicle), pediatric and fetal imaging.
Prescription Use X . . .
AND/OR
Over the Counter Use with a
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lone M. Whang
Page of
12