SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM

K053084 · Kontron Medical Systems Sas · IYN · Nov 16, 2005 · Radiology

Device Facts

• Record ID: K053084
• Device Name: SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
• Applicant: Kontron Medical Systems Sas
• Product Code: IYN · Radiology
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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).

Device Story

Sigma 5000 series, Imagic is a mobile ultrasound console (60x95x130 cm) featuring a keyboard, TFT screen, and various transducers. It performs B-mode, M-mode, PW/CW Doppler, Color Flow Mapping, and Color Time motion. Operated by clinicians in clinical settings, it processes ultrasound signals to produce real-time diagnostic images and flow data. Output is displayed on the integrated screen for physician interpretation to aid in clinical decision-making and patient diagnosis. The system supports image storage and hard-copy output.

Clinical Evidence

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

Technological Characteristics

Mobile ultrasound console with TFT display. Modalities: B-mode, M-mode, PW/CW Doppler, CFM, CM mode. Transducers: 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. Conforms to 21 CFR 892.1550, 892.1560, 892.1570. Design conforms to 21 CFR 820 and ISO 13485.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal, abdominal, pediatric, small organs (thyroid, breast, testicle), cardiac, transesophageal, peripheral vascular, and musculoskeletal (conventional and superficial) applications. Prescription use only.

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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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 SAS<br>52, rue Pierre Curie<br>78373 Plaisir, Yveline<br>France |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| b. Contact Person: | Mr. Larry Walker<br>Fukuda Denshi USA INC.<br>17725 N.E. 65th Street Bldg. C<br>Redmond, WA 98052-4911<br>Phone:[phone]<br>Fax: [phone] |
| 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 892.1550<br>90-IYN<br>Ultrasonic Pulsed Echo Imaging System 21 CFR 892.1560<br>90-IYO<br>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 (CW Doppler), Color Flow Mapping (CFM) and Color Time motion (CM mode).

The submission also includes the transducers necessary for these procedures.

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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, 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

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.

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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

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

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

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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 | 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 | P | P | P | P | | P | P | | P | |
| Abdominal | P | P | P | P | | P | P | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>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-skeletal<br>Conventional | P | P | P | P | | P | P | | P | |
| Musculo-skeletal Super-<br>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

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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 | 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 | | P | P | P | | P | P | | P | |
| Abdominal | | P | P | P | | P | P | | P | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>logical | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| 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 Brogdon |
|---------------|--------------------------------------|
| | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, |
| | and Radiological Devices |
| 510(k) Number | K053024 |

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 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 | 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 | | 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-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)

(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 | 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 | | P | P | P | P | P | P | | P | |
| Transesophageal | | P | P | P | P | P | P | | P | |
| 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 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

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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" 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 | 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 | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neuro-<br>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-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:

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

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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

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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 | 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) | | 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-skeletal<br>Conventional | | P | P | P | | P | P | | P | |
| Musculo-skeletal Super-<br>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) | <i>Nancy C Brogdon</i> |
|--------------------------------------------------------|---------------------------------------------------------------|
| | (Division Sign Off) |
| Prescription Use (Per 21 CFR 801.109) | Division of Reproductive, Abdominal, and Radiological Devices |
| | K053084 |
| | 510(k) Number |

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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 | 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) | | 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-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) | |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | (Division Sign-Off)<br>Division of Reproductive, Abdominal,<br>and Radiological Devices<br>510(k) Number |
| Sigma 5000 series, IMAGIC : Summary of Safety and Effectiveness | 19.09.05 |

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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 | 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 | | | | P | P | | | | | |
| 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: .........................................................................................................................................................

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

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

- ..............................................................................................................................................................................
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 | 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 | | | | P | P | | | | | |
| 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)

Prescription Use (Per 21 CFR 801.109)

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