(132 days)
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.
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.
The Cortex DermaScan C Ultrasonic System did not undergo a clinical study to prove it meets acceptance criteria for this 510(k) submission.
The document states:
- Acceptance Criteria & Device Performance: Not provided, as clinical tests were deemed not required.
- Sample size for the test set and data provenance: No test set was used for clinical performance evaluation.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set was used.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted.
- Standalone (algorithm only) performance: Not applicable, as this is an ultrasound system, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Reasoning for lack of clinical studies:
The application states, "Since the DermaScan C is identical to a previously-cleared device, clinical tests are not required." (Page A 4, Section 6b). The predicate device is identified as the "DermaScan C Ultrasonic 3D skin scanner, K894834".
The submission focuses on non-clinical tests:
- Software revalidation.
- Ultrasonic emission tests by an outside laboratory.
- Electrical safety tests.
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3/17/99
Derma Scan C
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 201-727-1703 Fax 201-727-1708
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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle's head with three parallel lines extending from the back of the head, symbolizing growth and progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central emblem.
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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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 (301) 594-1212.
.. . . . . .
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.
| CLINICALAPPLICATION | A | B | M | PWD | CWD | COLORDOPPLER | POWER(AMPLITUDE)DOPPLER | COLORVELOCITYIMAGING | COMBINED(SPECIFY) | OTHER(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 | (Per 21 CFR 810.109) |
|---|---|
| ------------------ | ------------------------------------ |
| (Division Sign-Off) | |
|---|---|
| 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.
| CLINICALAPPLICATION | A | B | M | PWD | CWD | COLORDOPPLER | POWER(AMPLITUDE)DOPPLER | COLORVELOCITYIMAGING | COMBINED(SPECIFY) | OTHER(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 | ✓ (Per 21 CFR 810.109) |
|---|---|
| ------------------ | ------------------------------------------------------------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983945 |
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.