K Number

Device Name

LONGPORT MODEL LDS -1

Manufacturer

LONGPORT, INC.

Date Cleared

1999-06-23

(149 days)

Product Code

IYO

Regulation Number

892.1560

Intended Use

high resolution ultrasound imaging

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K89-4834

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound imaging device and does not mention any AI or ML components or functionalities.

Therapeutic

No
The device is described as an imaging device for diagnostic purposes, specifically for performing ultrasound scanning to capture and reproduce images of soft tissue. It does not mention any therapeutic function.

Diagnostic

Yes
The device is described as performing ultrasound scanning and reproducing images of soft tissue, which falls under the definition of diagnostic imaging.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "portable, high frequency (20 MHz) ultrasound device" which captures images, indicating it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The Longport™ LDSTM-1 is described as a "non-invasive medical device for performing ultrasound scanning of the upper layers of the dermis." It uses ultrasound to create images of tissue within the body, not to analyze samples taken from the body.
Intended Use: The intended use is "high resolution ultrasound imaging," which is a diagnostic imaging technique performed directly on the patient.

Therefore, the Longport™ LDSTM-1 falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

high resolution ultrasound imaging
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: SKIN

Product codes (comma separated list FDA assigned to the subject device)

90 IYO

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Skin, upper layers of the dermis

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K89-4834

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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:
1. 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:

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

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.

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)

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		OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(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:

	Mode of Operation
Clinical Application	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)

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

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)

的一个人的一个人的

ﻟﻤﺴﺎ

F-3

510(k) Number K990238