SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

K050099 · Kontron Medical Systems Sas · IYN · Jan 28, 2005 · Radiology

Device Facts

• Record ID: K050099
• Device Name: SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
• Applicant: Kontron Medical Systems Sas
• Product Code: IYN · Radiology
• Decision Date: Jan 28, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

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).

Device Story

The Sigma 5000 series, Imagic is a mobile ultrasound console (approx. 60x95x130 cm) featuring a TFT screen and keyboard control panel. It utilizes various transducers to perform B-mode, M-mode, PW/CW Doppler, Color Flow Mapping, and Color Time motion imaging. Operated by clinicians in a diagnostic setting, the device processes ultrasonic echoes to generate real-time images and flow data. These outputs assist healthcare providers in visualizing internal structures and blood flow, supporting clinical diagnosis and patient management. The system includes image storage and hard-copy capabilities.

Clinical Evidence

No clinical data. The device relies on substantial equivalence to existing, legally marketed ultrasound systems using the same technology and principles. Non-clinical bench testing confirmed compliance with safety standards for acoustic output, biocompatibility, and electrical/mechanical safety.

Technological Characteristics

Mobile ultrasound console with TFT display. Supports B-mode, M-mode, PW/CW Doppler, CFM, and CM modes. Includes various transducers (e.g., 2-4 PA, 2-5 CA, 5-12 LA, 3-8 PA, 3-8 TEM, 2 MHz Pen, 8 MHz Pen). Design conforms to 21 CFR 820 and ISO 13485. Connectivity includes image storage and hard-copy output.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organs (thyroid, breast, testicle), cardiac, transesophageal, peripheral vascular, and musculo-skeletal applications, depending on the specific transducer used.

Regulatory Classification

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.

Predicate Devices

• Kontron Medical Sigma 110/330 (K002239)

Submission Summary (Full Text)

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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: [phone] 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
3. 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.

- 4. 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

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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

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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 [phone]. 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

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Page 3 - Mr. Mosenkis

Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 [phone].

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)

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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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Super-<br>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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | N | N | N | | N | N | | N | |
| Abdominal | | N | N | N | | N | N | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>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

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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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | N | N | N | | N | N | | N | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | | N | N | N | | N | N | | N | |
| Musculo-skeletal Super-<br>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) | <img alt="Nancy Brogdon" src="signature.png"/> |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-skeletal Super-<br>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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>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

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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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organs (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | N | N | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>ficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

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

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

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

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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

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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 | PW<br>D | CW<br>D | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small organs (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | N | N | | | | | |
| Laparascopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Super-<br>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