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. Modes of Operation: B, M, PW D, CW D, Color Doppler, Amplitude Doppler, Combined (B + M, B + PWD, Color Doppler + PWD, Amplitude Doppler + PWD).

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), 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 Kontron Medical Sigma 5000 series, Imagic ultrasound system is a medical diagnostic ultrasound imaging system.

Here's an analysis of the provided text regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria or quantifiable performance metrics for the device. Instead, the acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Kontron Medical Sigma 110/330, K002239) and compliance with relevant safety and quality standards.

The reported device performance is broadly stated as conformant with applicable medical device safety standards and consistent with traditional clinical practice and FDA guidelines.

Acceptance Criteria Category	Description of Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Substantial equivalence to predicate device (Kontron Medical Sigma 110/330, K002239).	The technological characteristics of the new device are the same as those of the predicate device.
Acoustic Output	Conformity with applicable medical device safety standards.	Device has been evaluated and found conformant. A post-clearance special report with acoustic output measurements from production line devices is required.
Biocompatibility	Conformity with applicable medical device safety standards.	Device has been evaluated and found conformant.
Thermal Safety	Conformity with applicable medical device safety standards.	Device has been evaluated and found conformant.
Electrical Safety	Conformity with applicable medical device safety standards.	Device has been evaluated and found conformant.
Mechanical Safety	Conformity with applicable medical device safety standards.	Device has been evaluated and found conformant.
Quality System	Conformity with 21 CFR 820 Quality System Regulation and ISO13485 quality system standards.	Manufacturer's design and development process conforms to these standards.
Intended Use	Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines.	Confirmed.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or data provenance (country of origin, retrospective/prospective) is described for the clinical performance of the device. The submission explicitly states: "Clinical tests: Since the Sigma 5000 series Imagic uses the same technology and principles as existing devices, clinical tests are not required."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since clinical tests were not required, there is no mention of a test set, experts, or ground truth establishment in this context.

4. Adjudication Method for the Test Set

Not applicable, as no external test set with expert adjudication was used for clinical performance.

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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in this device. This is a conventional diagnostic ultrasound imaging system.

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

This is not applicable as the device is a diagnostic ultrasound system, not an AI algorithm. Its performance is intrinsically linked to human operation and interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the purpose of demonstrating substantial equivalence, the "ground truth" implicitly relies on the established safety and effectiveness of the predicate device (Kontron Medical Sigma 110/330, K002239) and general clinical consensus regarding the safe and effective performance of ultrasound technology. No new ground truth specific to this device's clinical performance was established via studies mentioned in this document.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware and software system, not a machine learning model that requires a training set in this context. Its "training" or development likely involved engineering design, testing against specifications, and conformity to standards, rather than data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set (in the context of machine learning) is mentioned or implied for this device.

Summary

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K050099

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

Image /page/0/Picture/2 description: The image shows the logo for Kontron Medical. The logo has a stylized letter K on the left, followed by the word "KONTRON" in all caps. Below "KONTRON" is the word "MEDICAL", also in all caps. The font is sans-serif.

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c)

1. Submitter Information JAN 2 8 2005 Kontron Medical SAS a. Submitter: 52, rue Pierre Curie 78373 Plaisir, Yveline France b. Contact Person: Ms. Georgina Fabian Kontron Medical LLC. 9j Brookside Heights Wanaque, NJ 07465 Phone: 973-839-8669 c. Date Prepared: 15 September 2004 2. Name of device a. Trade name: Sigma 5000 series, Imagic b. Common name: Medical Diagnostic Ultrasound Imaging System and transducers Ultrasonic Pulsed Doppler Imaging System 21 CFR 892.1550 c. Classification name: 90-IYN Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560 90-IYO Diagnostic Ultrasonic Transducer 21 CFR 892.1570 90-ITX

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), 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

{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, followed by the word "KONTRON" in bold, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a smaller font size. The logo is simple and professional, and the use of bold letters makes it easily recognizable.

5. Intended use

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).

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.

۰۰:

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

JAN 2 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kontron Medical S.A.S. % Mr. Robert Mosenkis President CITECH Medical Device Testing and Consulting 5200 Butler Pike PLYMOUTH MEETING PA 19462-1298

Re: K050099

Trade Name: Sigma 5000 Series, Imagic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: January 17, 2005 Received: January 18, 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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a list of items with numbers and abbreviations. The first item is "5-12 LA", followed by "3-8 PA" and "3-8 TEM". The last two items are "2 MHz Pen" and "8 MHz Pen", with MHz likely referring to megahertz.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your de vice is elassified (360 acre) arols. Existing major regulations affecting your device and including the subject to such it inay be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Feactis concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I feast be advised that I Drisones or our device complies with other requirements of the Act that I DA has made a acteriminations administered by other Federal agencies. You must of ally it cochar statutes and regulations, but not limited to: registration and listing (21 Compry with an the Hec STOQuenters)01); good manufacturing practice requirements as set CFN i at 607), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that prior to shipping I ms device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers In Appendix U, (cheroood) of the Sixinostic Ultrasound Systems and Transducers." If the special Secking Manteling Orcalians unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket I mis lotter will and in your ding of substantial equivalence of your device to a legally marketed nonicate 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 conact 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

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

Page 3 - Mr. Mosenkis

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

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

Sincerely yours,

Nancy C Brogdon

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

Enclosure(s)

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

Image /page/5/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, sans-serif letters. Below "KONTRON" is the word "MEDICAL" in a thinner, sans-serif font. The overall design is simple and modern.

System: Sigma 5000 series, Imagic

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

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

што такшини и и примении и и причини и и причини и и присини и и присини и пристични и принисимии и принистични и принистични при п ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy Brogdon

(Division Sign Division of Reproductive, and Radiological Devic

KITNEMber Sigma 5000 series, IMAGIC : Summary of Safety and Effectiven

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

Image /page/6/Picture/1 description: The image contains 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 a thinner, uppercase font. The overall design is simple and professional.

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	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	N	N	N	N	N	N	N		N
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 Brogdon

15 Sept 04

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number ..

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 consists of a stylized letter 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. The logo is black and white.

System: Sigma 5000 series, Imagic

Transducer: 2-5 CA

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
Abdominal		N	N	N		N	N		N
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric		N	N	N		N	N		N
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 Hodgdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050090

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

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

Image /page/8/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 overall design is simple and professional.

System: Sigma 5000 series, Imagic

Transducer: 5-12 LA

Dysteint Digital 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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		N
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric		N	N	N		N	N		N
Small organs (specify)		N	N	N		N	N		N
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N
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 Devices
510(k) Number	2050099

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness 15 Sept 04 Page 6Sigma 5000 series, IMAGIC : Summary of Safety and Effectivencss

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

Image /page/9/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, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a smaller, uppercase font. The overall design is simple and professional.

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		N	N	N	N	N	N		N
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N
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. Bogdan

15 Sept 04

(Division Sian-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

Page 7

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

Image /page/10/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, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a smaller font size, also in uppercase letters. The overall design is simple and professional, suggesting a company in the medical technology field.

System: Sigma 5000 series, Imagic

Transducer: 3-8 TEM

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
Abdominal
Intraoperative (specify)
Intraoperative Neuro-logical
Pediatric
Small organs (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		N	N	N	N	N	N		N
Transesophageal		N	N	N	N	N	N		N
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

この他にある

.............................................................................................................................................................................. ..............................................................................................................................................................................

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

ance (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 5 ! Olk) Number ______________________________________________________________________________________________________________________________________________________________

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

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

Image /page/11/Picture/1 description: The image shows the logo for Kontron Medical. The logo features a stylized letter "K" on the left, followed by the word "KONTRON" in bold, uppercase letters. Below "KONTRON" is the word "MEDICAL" in a smaller, non-bold 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				N	N
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)

Nancy Choydon

15 Sept 04

Prescription Use (Per 21 CFR 801.109)

(Division Sigh-Off) Division of Reproductive, Abdor ana Radiological Devices 510(k) Number

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

Page 9

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

Image /page/12/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 a smaller font size, also in uppercase letters. The overall design is simple and professional.

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				N	N
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)

Nancy C. Swogdon

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Padiological Devices 2050094 51 Jan Number _

Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness

15 Sept 04

Regulation Number and Section

N/A