(149 days)
high resolution ultrasound imaging
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: SKIN
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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information for the Longport™ Model LDS™-1 device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Longport™ Model LDS™-1 does not explicitly state specific acceptance criteria or report device performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device (DermaScan C® ver. 3 Cortex Technology).
Instead of performance metrics, the document highlights:
- Intended Use: "high resolution ultrasound imaging"
- Technological Characteristics Compared to Predicate Device:
- Similarities: Transducer type (focused, single element), stand-off medium (water), water reservoir retention (membrane), operating system (windows), operator control (keyboard/mouse), processor (Pentium), data format (digital), data storage (hard/floppy disk), distance measurement, split screen features, palettes (gray scale and color).
- Differences: Transducer Center Frequency (Longport 20MHz; Predicate 10, 20, 30 MHz), Scan Rate (Longport 1 scan/second; Predicate up to 6 scans/second), Safety (Longport: IEC 601-1 & EMI: EN55011, Class A; Predicate: IEC 601 & UL 544), Power Requirements, Power Consumption, Operating Temperature and Humidity.
Therefore, a table of acceptance criteria and reported device performance directly from this document cannot be created in the way typically found for algorithm performance. The basis for clearance here is substantial equivalence of technological characteristics for the stated intended use.
2. Sample size used for the test set and the data provenance
The 510(k) summary does not provide information on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). Because the submission is for substantial equivalence based on technological characteristics and intended use, rather than a clinical performance study, such details are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. Given the nature of a 510(k) for an ultrasound scanner based on substantial equivalence, a formal ground truth establishment process with experts for a clinical dataset is not described.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) submission. The document focuses on the device's technical specifications and intended use in comparison to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The Longport™ Model LDS™-1 is an ultrasound imaging system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI devices was not conducted and is not applicable in this context. The device is a tool intended to be used by a human operator (human-in-the-loop).
7. The type of ground truth used
The concept of "ground truth" as typically applied to performance studies (e.g., pathology, outcomes data) is not discussed in this 510(k) because it's a submission for an imaging device based on substantial equivalence, not a clinical efficacy study requiring a definitive ground truth for diagnostic accuracy. The "truth" in this context is that the device produces "high resolution ultrasound imaging" consistent with its intended use and is technically comparable to a legally marketed predicate device.
8. The sample size for the training set
This information is not provided in the 510(k) summary. As an ultrasound imaging device, it does not involve the concept of a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This information is not provided in the 510(k) summary, as it's not relevant for an ultrasound imaging device that does not utilize a training set in the AI/machine learning context.
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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:
-
- 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.
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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
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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.
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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)
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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)
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(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
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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)
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F-3
510(k) Number K990238
§ 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.