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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the SenoSonix Ultrasound Breast Biopsy System. It describes the device, its intended use, and argues for substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or a study that presents performance data for the SenoSonix device itself.

The document discusses the device's indications for use and compares them to predicate devices, stating that the SenoSonix System's indications are a "sub-set of the predicate devices" and that the design changes are limited to integrating existing functionalities into a single console. This suggests that the device's performance is inherently linked to the performance of its predicate components (SenoRx Control Module, Vacuum System, and Sonix Ultrasound Scanner), which were previously cleared.

The information provided outlines the indications for use of the ultrasound module and transducers, which detail the clinical applications and modes of operation for which they are intended. These are descriptive rather than quantitative performance criteria for the biopsy system's accuracy or efficacy.

Therefore, I cannot provide the requested table or detailed study information for the SenoSonix Ultrasound Breast Biopsy System based on the input text. The document focuses on demonstrating substantial equivalence to pre-existing, cleared devices rather than providing new performance studies for the integrated system.

Here's a breakdown of why the requested information cannot be fully extracted and what can be inferred:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the overall biopsy system (e.g., biopsy success rate, diagnostic accuracy). The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning the device should perform "as well as" or "not worse than" the predicates.
Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, number of successful biopsies, etc.) for the SenoSonix system is reported in the provided text.

2. Sample size used for the test set and data provenance:

Test Set Size: Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

4. Adjudication method for the test set:

Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC study is mentioned. The submission is based on demonstrating substantial equivalence to predicate devices, not on a comparative effectiveness study of the integrated system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is a medical device for tissue biopsy and ultrasound imaging, not an AI algorithm.

7. The type of ground truth used:

Not applicable, as no dedicated performance study for the SenoSonix integrated system is described.

8. The sample size for the training set:

Not applicable, as no "training set" in the context of an algorithm is discussed.

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided document is a regulatory submission focused on substantial equivalence, not a clinical study report. It states that the SenoSonix System "has the same intended use," "uses the same operating principle," "incorporates the same biopsy and ultrasound probes," and "has the same manufacturing materials and processes" as its predicate devices. This implies that the performance of the integrated system is expected to be equivalent to the known performance of its component predicate devices, rather than being demonstrated through a new, independent performance study with defined acceptance criteria and collected data within this document.

Summary

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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 ColumbiaAliso Viejo, CA 92656P. 949.362.4800 F. 949.362.3200
Contact person	Eben Gordon
Device name	SenoSonix Ultrasound Breast Biopsy System
Common name	Biopsy deviceUltrasound Imaging System
Classification name	Gastroenterology-urology biopsy instrument 876.1075 KNW
	Diagnostic Ultrasound ModuleUltrasonic Pulsed Doppler Imaging System 892.1550 TYNUltrasonic Pulsed Echo Imaging System 892.1560 IYODiagnostic Ultrasound Transducer 892.1570 ITX
Review category	Tier II
Regulatory class	II
Predicate device	K023923 SenoCor 360 Circumferential Vacuum-AssistedBiopsy DeviceK040842 SenoRx Biopsy Device IIK061827 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 inproviding breast tissue samples for diagnostic sampling of breastabnormalities.
	The SenoSonix System integrates the functions of the existingSenoRx Control Module (K023923) and Vacuum System(K023923) into a single console. An added feature of theSenoSonix System is the integration of Ultrasonix Medical'sSonix Ultrasound Scanner (K061827).
	The SenoSonix System has 2 flat panel displays. One displaysthe ultrasound image and the other is for user operation and

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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 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.

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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

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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)

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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)

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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

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র্বা INDICATIONS FOR USE

510(k) Number (if known):

SenoSonix Ultrasound Breast Biopsy System 510(k) Submission Device Name:

Indications for Use:

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.

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

Regulation Number and Section

§ 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.