CORTEX DERMASCAN C ULTRASONIC SYSTEM

K983945 · Cortex Technology Aps · IYO · Mar 17, 1999 · Radiology

Device Facts

• Record ID: K983945
• Device Name: CORTEX DERMASCAN C ULTRASONIC SYSTEM
• Applicant: Cortex Technology Aps
• Product Code: IYO · Radiology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

Device Story

Ultrasonic scanning system for dermatology; utilizes 20 MHz transducer. Inputs: ultrasonic signals; transforms via B-scan, M-scan, and A-scan processing. Outputs: real-time 2D B-scan, M-scan, and frozen A-scan images. Used in clinical settings for skin layer and blood vessel visualization and measurement. Healthcare providers use visual output to assess skin structures and dimensions. Benefits include non-invasive diagnostic visualization of dermal layers.

Clinical Evidence

No clinical data; device is identical to a previously cleared predicate.

Technological Characteristics

Ultrasonic imaging system; 20 MHz transducer; visualization modes include 2D B-scan, M-scan, and A-scan. Electrical safety and ultrasonic emission testing performed.

Indications for Use

Indicated for dermatological applications to visualize skin layers and blood vessels and perform approximate dimensional measurements.

Regulatory Classification

Identification

An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• DermaScan C Ultrasonic 3D skin scanner (K894834)

Submission Summary (Full Text)

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3/17/99
Derma Scan C

K983945

Page A 4

# Cortex Technology 510(k) Submission DermaScan C Ultrasound System

510(k) Summary

# (1) Submitter Information

Name: Cortex Technology

Address:

Textilvaenget 1 9560 Hadsund Denmark

Telephone Number: 45-9857-2223

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 5, 1998

(2) Name of Device

Trade Name: Cortex DermaScan C Ultrasonic System Common Name: Ultrasound Scanning System for Dermatological Applications Classification name: System, Imaging, Pulsed-Echo, Ultrasonic, 90IYN.

(3) Equivalent legally-marketed devices.

The Derma-Scan C is identical to the version currently cleared in the United States, the DermaScan C Ultrasonic 3D skin scanner, K894834, assigned to the Brymill Corporation.

(4) Description

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The DermaScan C provides the following visualization modes:

a. 2-dimensional B-scan, displayed in real time

b. M-scan, displayed in real time

c. A-scan, as a "frozen" image derived from a B-scan line.

(5) Intended Use

The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

(6) Performance Data

(a) Non-clinical tests

The software has all been revalidated for this submission. The system has had ultrasonic emission tests conducted by an outside laboratory. Electrical safety tests have been conducted on the device.

(b) Clinical tests

Since the DermaScan C is identical to a previously-cleared device, clinical tests are not required.

(c) Conclusions

The Derma-Scan C is equivalent in safety and efficacy to the legally-marketed predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

George H. Myers, Sc.D. Official Correpondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, N.J. 07604

Re: K983945 Cortex DermaScan C Ultrasonic System Regulatory Class: II/ 21 CFR 892.1560 Product Code: 90 IYO Dated: February 3, 1999 Received: February 8, 1999

Dear Dr. Myers:

We have reviewed your Section 510(k) 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 Cortex DermaScan C Ultrasonic System, as described in your premarket notification:

#### Transducer Model Number

#### 20 MHz

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic OS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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.

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Page 2 - George H. Myers, Sc.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html": >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

.. . . . . .

Sincerely yours,

11 . . . .

Thind h. Slegman

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Diagnostic Ultrasound Indications for Use Form

Page _________________________________________________________________________________________________________________________________________________________________________

# 510(k) Number (if known):K983945

# Device Name: Cortex DermaScan C Ultrasonic Transducer

Intended Use: The DermaScan C ultrasonic transducer is intended to be used with the Cortex DermaScan C, an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|-------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| (specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | X | X | X | | | | | | | |

#### Mode of Operation

# Additional Comments:

*Clinical Application is "Dermatology"

# (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> (Per 21 CFR 810.109) |
|------------------|------------------------------------|
|------------------|------------------------------------|

| (Division Sign-Off) | <span></span> |
|---------------------|--------------------------------------------------------------------|
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K983945 |

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

#### Diagnostic Ultrasound Indications for Use Form

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):K983945

### Device Name: Cortex DermaScan C Ultrasonic System

Intended Use: The DermaScan C is an ultrasonic scanning system intended to be used to visualize the layers of the skin, including blood vessels, and to make approximate measurements of dimensions in the layers of the skin and blood vessels, by ultrasonic means.

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|-------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| (specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ | | | | | | | | | | |
| (Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral | | | | | | | | | | |
| Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | X | X | X | | | | | | | |

## Mode of Operation

# Additional Comments:

*Clinical Application is "Dermatology"

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <div style="display: flex; align-items: center;"> ✓ (Per 21 CFR 810.109) </div> |
|------------------|-------------------------------------------------------------------------------------------------------------|
|------------------|-------------------------------------------------------------------------------------------------------------|

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983945 |