LONGPORT MODEL LDS -1

{0}------------------------------------------------ JUN 2 3 1999 ### PREMARKET NOTIFICATION [510(K)] SUMMARY - SRS International® Corporation 1. Submitted by: Suite 1000, 1625 K Street, NW Washington, D.C. 20006 Telephone: 202-223-0157 202-835-8970 Fax: - 2. Contact Person: Michael G. Farrow, Ph.D. #### 3. Name of the Device - Longport™ Model LDSTM-1 a. Trade Name: - b. Common Name: Ultrasound Scanner c. Classification Name: Class II 90 IYO System, Imaging, Pulsed Echo, Ultrasonic #### 4. Legally Marketed Device for which we are claiming substantial equivalence: DermaScan C® ver. 3 Cortex Technology Textilvaenget 1 9560 Hadsund, Denmark Telephone 45-9857-4100 Fax 45-9857-2223 The USA Representative for DermaScan is: cyberDERM, inc. 275 New Darlington Road Media, PA 19063-5607 Telephone 610-544-7868 The 510(k) number for DermaScan is: K89-4834 #### 5. Description of the Device: The Longport™ LDSTM-1 is a proprietary, non-invasive medical device for performing ultrasound scanning of the upper layers of the dermis. It is a portable, high frequency (20 MHz) ultrasound device which captures and reproduces images of soft tissue up to 1.5 inches below the skin at a high resolution utilizing a laptop computer. {1}------------------------------------------------ #### PAGE 2 of 2 K- 940-636 ### 6. Intended Use of the Device: Current indication for use: **high resolution ultrasound imaging" ### 7. Summary of Tcchnological Characteristics compared to Predicate Device: Technological characteristics of this device which are similar to those of the predicate include: - Transducer type: focused, single element a. - Transducer stand-off medium: water b. - Water reservoir retention: membrane c. - d. Operating system: windows - Operator control: keyboard/ mouse e. - Processor: Pentium f. - Data format: digital g. - h. Data Storage: Hard/ floppy disk - i. Distance Measurement - Split Screen Features j. - k. Palettes: Gray scale and color Technological characteristics of this device which are different than the predicate include: - Transducer Center Frequency: a. Longport 20MHz; Predicate 10, 20, 30 MHz - b. Scan Rate: Longport 1 scan/ second: Predicate up to 6 scans/ second - c. Safety: Longport: IEC 601-1 & EMI: EN55011, Class A Predicate: IEC 601 & UL 544 - d. Power Requirements Longport: 100-200 V, 50-60 Hz Predicate 110/220 VAC +/- 20% - Power Consumption: e. Longport: 250 W Predicate 350 W - Operating Temperature and Humidity: f. Longport 0-55ºC; 10-90% rel. non-condensing Predicate: 10-40ºC; 5-95% non-condensing {2}------------------------------------------------ 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 stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Food and Drug Administratic 9200 Corporate Boulevard Rockville MD 20850 JUN 2 3 1999 Longport, Inc. c/o Michael G. Farrow, Ph.D. Official Correspondent SRS International Corporation Suite 1000 1625 K Street, NW Washington, DC 20006-1604 RE: K990238 Longport Model LDS-1 (Ultrasound Skin Scanner) Regulatory Class: II Product Code: 90 IYO 21 CFR 892.1560 Dated: June 10, 1999 Received: June 10, 1999 Dear Dr. Farrow: 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 Longport Model LDS-1, as described in your premarket notification: > Transducer Model Number 20 MHz Transducer If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such Existing major regulations affecting your device can be additional controls. 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 QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. 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. {3}------------------------------------------------ Page -2- Dr. Farrow This determination of substantial equivalence is granted on the condition that prior to shipping the first 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 Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains 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 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 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree 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 Paul M. Gammell, Ph.D. at (301) 594-1212. Sincerely yours, Harriet C. Ingram 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 (s) {4}------------------------------------------------ Page_1___of_1__ 510(k) Number (if known): _K-99-0238 Device Name:_Longport_Model_LDS=1_____________________________________________________________________________________________________________________________________________ Indications For Use: high resolution ultrasound imaging (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |--------------------------------------------------------------------|---------| | Division of Reproductive, Abdominal, ENT, and Radiological Devices | | | 510(k) Number | K990238 | | Prescription Use | <div> <img alt="checkbox" src=""/> </div> | OR | Over-The-Counter Use | <div> <img alt="checkbox" src=""/> </div> | |----------------------|-------------------------------------------|----|----------------------|-------------------------------------------| | (Per 21 CFR 801.109) | | | | | (Optional Format 1-2-96) {5}------------------------------------------------ ### (990238 ## LDS-1 Ultrasound System . Appendix F #### Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | <b>Mode of Operation</b> | | | | | | | | | | |-------------------------------|--------------------------|----------|----------|------------|------------|----------------------|--------------------------|-------------------------------|---------------------------|------------------------| | <b>Clinical Application</b> | <b>A</b> | <b>B</b> | <b>M</b> | <b>PWD</b> | <b>CWD</b> | <b>Color Doppler</b> | <b>Amplitude Doppler</b> | <b>Color Velocity Imaging</b> | <b>Combined (specify)</b> | <b>Other (specify)</b> | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | SKIN | N | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Track 1 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David G. Legon (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Prescription Use (Per 21 CFR 801.109) F-3 510(k) Number {6}------------------------------------------------ ### K990238 # 20 MHz Transducer for use with the LDS-1 Ultrasound System Appendix F ### Diagnostic Ultrasound Indications for Use Form Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Clinical Application | Mode of Operation | | | | | | | | | | |-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | • | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | • | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) SKIN | | N | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Track 1 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices Prescription Use (Per 21 CFR 801.109) Prescription Use (Per 21 CFR 801.109) 的一个人的一个人的 ﻟﻤﺴﺎ F-3 510(k) Number K990238