Diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continous wave Doppler (CW Doppler), Color Flow Mapping (CFM) adn Color Time motion (CM mode).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small organs (Thyroid, Breast, Testicle), Cardiac, Transesophageal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

Device Description

The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode). The submission also includes the transducers necessary for these procedures. The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from Kontron Medical for their Sigma 5000 series, Imagic ultrasound system. It is a declaration of substantial equivalence to a predicate device (Kontron Medical Sigma 110/330, K002239), and not a study proving the device meets specific performance criteria through clinical trials. The document explicitly states:

"Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."

Therefore, the device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting pre-defined acceptance criteria through a specific study with a test set of data.

Given this, I cannot extract the requested information regarding acceptance criteria and performance from a study because such a study was not conducted or reported in this document.

However, I can summarize the non-clinical tests that were performed and the basis for the substantial equivalence claim.

Summary based on the provided document:

Table of Acceptance Criteria and Reported Device Performance: Not applicable. The submission asserts substantial equivalence based on technological characteristics being the same as the predicate device, not on meeting specific quantitative performance metrics from a clinical study.
Sample size used for the test set and the data provenance: Not applicable. No test set of data from clinical studies was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from a clinical test set.
Adjudication method for the test set: Not applicable. No test set or expert adjudication was performed.
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: Not applicable. This document predates widespread AI in medical imaging and focuses on ultrasound system equivalence, not AI effectiveness.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm-only performance study was conducted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The equivalence is based on the technological characteristics of the device being the same as the predicate device.
The sample size for the training set: Not applicable. No machine learning algorithm training was mentioned or evaluated.
How the ground truth for the training set was established: Not applicable. No machine learning algorithm training was mentioned or evaluated.

Information that can be extracted regarding device acceptance:

The device's acceptance is based on its substantial equivalence to Kontron Medical Sigma 110/330 (K002239). The reasoning provided is that:

The technological characteristics of the new device (Sigma 5000 series, Imagic) are the same as those of the predicate device.
The device has been evaluated for non-clinical tests: acoustic output, biocompatibility, and thermal, electrical, and mechanical safety, and has been found to conform to applicable medical device safety standards.
The design and development process conforms with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards.
Compliance is verified through independent evaluation with ongoing factory surveillance.
Diagnostic ultrasound has a long history of safe and effective performance.

Therefore, the acceptance criteria implicitly rely on the predicate device's established safety and effectiveness through conformity to standards and regulations, rather than new clinical performance data for this specific device.

Summary

{0}------------------------------------------------

Kontron Medical 52, rue Pierre Curie F-78373 Plaisir, Yvelines

NOV 1 6 2005

Image /page/0/Picture/2 description: The image shows the logo for Kontron Medical. The logo features a stylized "K" on the left, followed by the word "KONTRON" in bold, sans-serif font. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. Below the logo is the text "K 053084".

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c)

1. Submitter Information

a. Submitter:	Kontron Medical SAS52, rue Pierre Curie78373 Plaisir, YvelineFrance
b. Contact Person:	Mr. Larry WalkerFukuda Denshi USA INC.17725 N.E. 65th Street Bldg. CRedmond, WA 98052-4911Phone:800-365-6668Fax: 425-869-2018
c. Date Prepared:	02 September 2005
2. Name of device
a. Trade name:	Sigma 5000 series, Imagic
b. Common name:	Medical Diagnostic Ultrasound Imaging System and transducers
c. Classification name:	Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.155090-IYNUltrasonic Pulsed Echo Imaging System 21 CFR 892.156090-IYODiagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX

1. Equivalent Legally-Marketed Devices:
  Kontron Medical Sigma 110/330, K002239

The technological characteristics of the predicate device are the same as those of the new device.

1. Description
  The Sigma 5000 series, Imagic is an ultrasound instrument intended to perform the following diagnostic ultrasound investigations: Imaging (B-mode), Time motion (M-mode), Pulsed wave Doppler (PW Doppler), Continuous wave Doppler (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode).

The submission also includes the transducers necessary for these procedures.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter "K" on the left, with the word "KONTRON" in bold, sans-serif font above the word "MEDICAL" in a thinner, sans-serif font. The letter "K" is made up of a combination of vertical lines and diagonal lines, with a small circle in the center.

The system is a mobile console approximately 60 cm wide, 95 cm deep and 130 cm high equipped with a keyboard control panal, a large TFT screen, assorted transducers and image storage or hard-copy devices

Intended use

6. Performance Data

a. Non-clinical tests: The device has been evaluated for acoustic output, biocompatibility and thermal, electrical and mechanical safety, and has been found conform with applicable medical device safety standards.
b. Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required.
c. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Kontron Medical that the Sigma 5000 series Imagic is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health and Human Services (HHS) in the USA. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines representing hair or clothing. The overall design is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Kontron Medical Systems SAS % Mr. Robert Mosenkis CITECH 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K053084

Trade Name: Sigma 5000 Series Imagic Ultrasound System Regulation Number: 21 CFR 892.1550; 892.1560; 892.1570 Regulation Name: Ultrasonic Pulsed Doppler Imaging System; Ultrasonic Pulsed Echo Imaging System; Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: IYN; IYO; ITX Dated: October 31, 2005 Received: November 2, 2005

Dear Mr. Mosenkis:

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 Sigma 5000 Series Imagic Ultrasound System, as described in your premarket notification:

Transducer Model Number

2-4 PA; 2-5 CA; 3-8 PA; 3-8 TEM; 4-9EC; 5-12 LA; 5-12 L50; 2 MHz Pen; 8 MHz Pen

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

{3}------------------------------------------------

Page 2 - Mr. Mosenkis

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 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/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Nancy brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" on the left, with the word "KONTRON" in bold, sans-serif letters to the right of the "K". Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The logo is black and white.

System: Sigma 5000 series, Imagic

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
Abdominal	P	P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric	P	P	P	P		P	P		P
Small organs (specify)	P	P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal	P	P	P	P	P	P	P		P
Transrectal	N	N	N	N		N	N		N
Transvaginal	N	N	N	N		N	N		N
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P
Laparascopic
Musculo-skeletalConventional	P	P	P	P		P	P		P
Musculo-skeletal Super-ficial	P	P	P	P		P	P		P
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

· Small organs: Thyroid, Breast, Testicle
Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Broadlon

Division of Reproductive, Abdominal,
and Radiological Devices

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" on the left, with a series of vertical lines and a dot. To the right of the "K" is the word "KONTRON" in bold, sans-serif font, and below that is the word "MEDICAL" in a thinner, sans-serif font.

System: Sigma 5000 series, Imagic

Transducer: 2-4 PA

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PW D	CW D	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neuro- logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletal Conventional
Musculo-skeletal Super- ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

• Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

1 (ODE)

(Division Sigh-Off)

Division of Bened
brin
on

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053084

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter "K" on the left, followed by the words "KONTRON" and "MEDICAL" stacked on top of each other. The letter "K" is made up of a combination of vertical lines and diagonal lines, with a small circle in the center.

System: Sigma 5000 series, Imagic

Transducer: 2-5 CA

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
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

· Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)

	Nancy C Brogdon
	(Division Sign-Off)
	Division of Reproductive, Abdominal,
	and Radiological Devices
510(k) Number	K053024

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

...

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Kontron Medical. The logo features a stylized "K" on the left, with a series of vertical lines and a dot. To the right of the "K" is the word "KONTRON" in bold, sans-serif font, and below that is the word "MEDICAL" in a thinner, sans-serif font.

System: Sigma 5000 series, Imagic

Transducer: 3-8 PA

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric		P	P	P	P	P	P		P
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

· Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0530

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter K on the left, followed by the words "KONTRON" in bold, sans-serif font on the top line, and "MEDICAL" in a thinner, sans-serif font on the bottom line. The letter K is made up of a series of vertical lines on the left side, a circle in the middle, and two diagonal lines on the right side.

System: Sigma 5000 series, Imagic

Transducer: 3-8 TEM

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal		P	P	P	P	P	P		P
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

· Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C Broadson
(Division Sign-Off)

19.09.05

Division of Reproductive, Abo and Radiological Devices 510(k) Number

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

Page 7

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" on the left, with vertical lines and a dot, followed by the word "KONTRON" in bold, sans-serif font. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The overall design is simple and modern.

System: Sigma 5000 series, Imagic

Transducer: 4-9EC

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		N	N	N		N	N		N
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		N	N	N		N	N		N
Transvaginal		N	N	N		N	N		N
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

· Small organs: Thyroid, Breast, Testicle
Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

. www.aaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa

. Worldwood and would and would are would and would are and our waard and armany waa a
の中の時間の時間が出来ません。 (1990年)10月10日には1990年には1990年には、1990年には、1990年には、1990年には199

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

E)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
4053084

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

19.09.05

510(k) Number

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter K on the left, followed by the word "KONTRON" in bold, uppercase letters. Below "KONTRON" is the word "MEDICAL" in uppercase letters. The letter K is made up of vertical lines and a diagonal line, with a dot in the center.

System: Sigma 5000 series, Imagic

Transducer: 5-12 LA

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)	P	P	P		P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P
Laparascopic
Musculo-skeletalConventional	P	P	P		P	P	P
Musculo-skeletal Super-ficial	P	P	P		P	P	P
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

· Small organs: Thyroid, Breast, Testicle
Combined modes: B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD

Concurrence of CDRH, Office of Device Evaluation (ODE)	Nancy C Brogdon
	(Division Sign Off)
Prescription Use (Per 21 CFR 801.109)	Division of Reproductive, Abdominal, and Radiological Devices
	K053084
	510(k) Number

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized letter K on the left, with the word "KONTRON" in bold, uppercase letters to the right of the K. Below "KONTRON" is the word "MEDICAL" in uppercase letters, with a thinner font. The logo is black and white.

System: Sigma 5000 series, Imagic

Transducer: 5-12 L50

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)		N	N	N		N	N		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		N	N	N	N	N	N		N
Laparascopic
Musculo-skeletalConventional		N	N	N		N	N		N
Musculo-skeletal Super-ficial		N	N	N		N	N		N
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:

· Small organs: Thyroid, Breast, Testicle

Combined modes:	B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD
-----------------	--------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)	(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices510(k) Number
Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness	19.09.05

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" on the left, with a series of vertical lines and a dot, followed by the word "KONTRON" in bold, sans-serif font. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font.

System: Sigma 5000 series, Imagic

Transducer: 2 MHz Pen

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac				P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: .........................................................................................................................................................

..............................................................................................................................................................................
Concurrence of CDRH, Office of Device Evaluation (ODE)

Narena Brogdon

(Division Sign Division of Reproduct ve. Abdon and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Sigma 5000 series, IMAGIC : Truthful and Accurate Statement

19.09.05

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the logo for Kontron Medical. The logo consists of a stylized "K" symbol on the left, followed by the word "KONTRON" in bold, sans-serif font. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The logo is black and white.

System: Sigma 5000 series, Imagic

Transducer: 8 MHz Pen

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular				P	P
Laparascopic
Musculo-skeletalConventional
Musculo-skeletal Super-ficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: .........................................................................................................................................................

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K053084

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.