High resolution ultrasound imaging for wounds, superficial musculoskeletal diagnosis and assessment, plastic/reconstructive surgery planning and assessment, dematological assessment and diagnosis, and aesthetic application

Device Description

The Episcan I-200 has been developed to examine the human skin and the first few centimeters of underlying soft tissue using ultrasound of center frequency 20 MHz. The system displays the information obtained in the form of brightness or B-scans, which are presented either color-coded or grayscale images. These images can be stored on magnetic media, printed or transferred electronically for archive or analysis. Physically, the system consists of two main components: the hand-held ultrasound probe and the portable instrument/computer body with its monitor and keyboard. Operation of the Episcan I-200 is similar to that of most medical diagnostic ultrasound systems in clinical use today. The near real-time imaging of the scanner allows you to view the scanner's screen as you reposition the probe and alter the scanner's parameters. The image can be saved to a disk, printed, forwarded via a network or modem to a remote location or discarded. The Episcan I-200 contains enhancements or new features including short cut menus; adjust and move measurements and annotations; copy and paste measurements and annotations, tidy and repair databases, and new analysis functions.

AI/ML Overview

This FDA 510(k) premarket notification (K062571) describes the Longport Episcan I-200 ultrasound system. The document focuses on demonstrating substantial equivalence to predicate devices and detailing the intended uses for various transducers. It does not present a study with acceptance criteria and reported device performance data in the way typically seen for AI/ML device submissions. Instead, it's a traditional 510(k) for an ultrasound imaging system.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document as it does not contain a performance study against specific acceptance criteria.

However, I can extract information related to the device's intended use and the transducers.

Here's a breakdown of the available information relevant to your request, and where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria and reported device performance for a study. This is a premarket notification for a medical device (an ultrasound system), which typically focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a clinical performance study with predefined acceptance criteria for a specific diagnostic task.

2. Sample Size Used for the Test Set and Data Provenance

This information is not available in the provided document. The document describes a medical imaging device (ultrasound system) and its intended uses, but it does not detail any specific clinical performance studies that involved a "test set" of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available in the provided document. As there is no described performance study with a test set, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

This information is not available in the provided document. As there is no described performance study with a test set, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

This information is not available in the provided document. This type of study is common for evaluating AI/ML systems' impact on human reader performance, but this submission is for a traditional ultrasound device and does not describe such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not available in the provided document. The Episcan I-200 is an ultrasound imaging system operated by a clinician ("human-in-the-loop"). The document does not describe an "algorithm only" or standalone performance study in the context of AI/ML.

7. The Type of Ground Truth Used

This information is not available in the provided document. Since no specific performance study is detailed, no ground truth method is described. The device inherently generates images for clinical assessment, where clinicians interpret the images without a pre-established "ground truth" provided by an algorithm.

8. The Sample Size for the Training Set

This information is not available in the provided document. This device is an imaging system and not described as an AI/ML device that would undergo a training phase on a dataset.

9. How the Ground Truth for the Training Set was Established

This information is not available in the provided document. As there is no mention of a training set, there is no method described for establishing ground truth for it.

Summary of Available Information from the Provided Text:

The provided document (K062571) is a 510(k) premarket notification for the Longport Episcan I-200 Ultrasound System. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Device Description:
The Episcan I-200 is an ultrasound system with a center frequency of 20 MHz, designed to examine human skin and the first few centimeters of underlying soft tissue. It produces brightness (B-scans) images in color-coded or grayscale, which can be stored, printed, or transferred. It consists of a hand-held ultrasound probe and a portable instrument/computer body with a monitor and keyboard. Its operation is similar to other medical diagnostic ultrasound systems, offering near real-time imaging. Enhancements include shortcut menus, adjustable measurements and annotations, and new analysis functions.

Intended Use (across various transducers):
"High resolution ultrasound imaging for wounds, superficial musculoskeletal diagnosis and assessment, plastic/reconstructive surgery planning and assessment, dematological assessment and diagnosis, and aesthetic application."

More specific indications for various transducer models (e.g., 1030-20, 0931-12, 0931-10, 0931-07, 1248-07, 1248-10, 1248-12) include:

Superficial Musculo-skeletal (indicated as 'N' for New Indication for some transducers)
Skin and underlying soft tissue
Wound management and assessment
Detection and assessment of pressure ulcers, detection of deep tissue injury, burn depth assessment, differentiation of edema from lymphedema
Clinical Dermatology, skin lesion assessment, aesthetics

Substantial Equivalence:
The device is deemed substantially equivalent based on similar technological characteristics to predicate devices (Longport LDS-1, Hudson 2020/2040/2060, Diasus P75LHF, Cortex DermaScan C). Similar characteristics include transducer center frequency, scanning mode, scan field/length, transducer stand-off medium, water reservoir retention, Windows Operating System, operator control, data format, data storage, distance measurement, split screen features, palettes, safety, power requirement, power consumption, and operating temperature/humidity. Differences noted are transducer type and scan rate.

This submission is a regulatory filing for marketing clearance, not a clinical study report with performance metrics against acceptance criteria.

Summary

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K06251

PREMARKET NOTIFICATION 510(k) SUMMARY

1. Submitted by:	Michael G. Farrow, Ph.D., Consultant4239 32nd Road, SouthArlington, VA 22206Telephone: (202) 285-2626E-mail: farrow002@yahoo.com
------------------	--------------------------------------------------------------------------------------------------------------------------------------------------

NUV 2 1 2006

1. Contact Person: Michael G. Farrow, Ph.D. (Official Correspondent)

3. Name of the Device:

Longport™ Episcan 1-200 a. Trade Name: b. Common Name: Ultrasound Scanner c. Classification Name: Class II 90 IYO
System, Imaging, Pulsed Echo, Ultrasonic

4. Legally Marketed Device(s) for which we are claiming substantial equivalence:

Longport LDS-1 Longport Inc. Spring Valley Business Park 2 Braxton Way, Suite 111 Glen Mills, PA 19342

Hudson 2020, 2040, 2060 Ultrasound Scanner Hudson Diagnostic Imaging, LLC 610 Boulevard Elmwood, NJ

Diasus, Diagnostic Ultrasound System P75LHF, 5-12MHz Ultra wideband Linear Array Probe Dynamic Imaging Limeted 9 Cochrane Square, Brucefield Industrial Part Livingston EH 54 9DR, Scotland, UK

Corte> DermaScan C Ultrasonic Transducer Cortex DermaScan C Ultrasonic System Textilvaeget 1 9560 Hadsund, Denmark

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5. Description of the Device:

6. Intended Use of the Device: Current indication for use:

"High resolution ultrasound imaging for wounds, superficial musculoskeletal diagnosis and assessment, plastic/reconstructive surgery planning and assessment, dematological assessment and diagnosis, and aesthetic application"

7. Summary of Technological Characteristics compared to Predicate Device:

Technological characteristics of this device which are similar to those of the predicates are:

1. Transducer Center Frequency
1. Scanning Mode
1. Scan Field/Length
1. Transducer stand-off medium
1. Water Reservoir retention
1. Windows Operating System
1. Operator Control
1. Data Format
1. Data Storage
1. Distance Measurement
1. Split Screen Features

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Palattes 13) Safety
Power Requirement
Power Consumption
Operating Temperature and Humidity

Technological characteristics of this device which are different than those of the predicates are:

Transducer type
Scan rate

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is oriented diagonally, facing upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Longport, Inc. % Michael Farrow, Ph.D. Consultant 4239 32" Road, South ARLINGTON VA 22206

NOV 2 1 2006

Re: K062571

Trade Name: Longport Model Episcan I-200, Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYO and ITX Dated: November 13, 2006 Received: November 13, 2006

Dear Dr. Farrow:

We have reviewed your Section 510(k) premarket 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 Episcan I-200, Ultrasound System as described in your premarket notification:

Transducer Model Number

1030-20, 20 MHz (10-30MHz) 0931-12, 20MHz (9-31MHz)

Image /page/3/Picture/13 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906 - 2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font, followed by three stars. The logo is surrounded by a circular border with text that is difficult to read due to the image quality.

Protecting and Promoting Public Health

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0931-10, 20MHz (9-31MHz)
0931-07, 20 MHz (9-31MHz)
1248-07 30 MHz (12-48MHz)
1248-10, 30 MHz (12-48MHz)
1248-12, 30 MHz (12-48MHz)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled,

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Page 3 - Dr. Farrow

"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Andrew Kang at (240) 276-3666.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

The EPISCAN I-200 high resolution ultrasound system is a specialized system for imaging the skin and underlying soft tissue. It is intended for use by clinicians, or under the direction of physicians for imaging and analysis in research environments as well as clinical settings including medical/surgical dermatology assessment and diagnosis (aesthetic and therapeutic), plastic/reconstructive surgical planning, wound assessment and management, skin assessment for pressure ulcer detection and prevention, and superficial musculoskeletal diagnosis.

Nancy C. Hogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices R06257 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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K 062571

Transducer Model Number 1030-20 High Resolution Probe 20mm focus transducer Scan Length 15mm Nominal frequency 20 MHz (10-30MHz)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human hody as follows;

Clinical Application	A	B
Ophthalmic
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial	N	N
Other (Specify)	P

N=New Indication: P=previously cleared by FDA; E=addcd under Appellclix E

Additional Comments: P= skin and underlying soft tissue.

Qther No mound management, and assessment, detection and pressure ulcers, detection of

deen tissue injury, burn depth assessment differentints edema from Lymphedema

(Grevel: DO ADLE ARKAR BEFOW IIHR THAF-COMITANT OD ADDITIEN TIME DEDICO)

Concurrence of CDRII, Office of Device Evaluation (ODB)

Prescription Use (Per 21 CFR 801 . 109)

Nancy Morgan
(Division Sign-Off)
Division of Reproductive, Abdominal,

and Radiological Devices

510(k) Number _

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K062571

Transducer Model Number 0931-12 High Resolution Probe 12mm focus transduccr Scan Length 15mm Nominal frequency 20 MHz (9-31 MHz)

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	COLORDOPPLER	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
PediatricSmall Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial	N	N
Other (Specify)	N	N

dication; P-previously cicared by FDA: E=added under Appendix E

Assessment, clinical dermately management, and assessment, and assessment, and any and excludes to a

assessment, clinical dermatology, skin lesion assessment, acathetics

THE WE CONSEMBER OF CONTINES FINE-CONTINATE ON ANOTHER FACTORIAL AND FREATED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Proscription Use (Per 21 CFR 801.109)

Nancy C. Bergdon
(Division Sign-Off)

Division of Reproductive, Ab and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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K062571

Transducer Model Number 0931-10 High Resolution Probe 10mm focus transducer Scan Length 15mm Nominal frequency 20 MHz (9-31 MHz)

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	A	B
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)	N	N
Mode of Operation

N=New Indication; P=previously cleared by FDA; E=added under Appendix E

Additional Comments: Other N= wound management and assessment superficial musculoskeletal

assessment. clinical dermatology, seatherics

Circuse do not meme berow. This that that continue on violher sode it vietided

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Braga
(Division Sign-Off)

9 Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

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K062571

Appendix F

Transducer Model Number 0931-07 Migh Resolution Prohe 12mm focus transducer Scan Length 15mm Nominal frequency 20 MHz (9-31 MHz)

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	COLORDOPPLER	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)	N	N

Indication: P-previously cleared by FDA: E-added under Appendly E

Additional Comments: Qther News a

ตรารังลัย อิต คุณา พิหามพิธีทุกพ. โคเพ เจ้าพิพิธ อัตราคารเล่นวันเทพ อังค์เป็นพระอิตภาพ Concurrence of CDRII. Office of Device Evaluation (ODE)

Prescription Usc (Pcr 21 CFR 80)، 109 801، 801، 801، 801، 80

Nancy C. Snoddon
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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K062571

Transducer Model # 1248-07 Very High Resolution Probe 7.25mm focus transducer Scan Length = 15mm Nominal Frequency = 30 MHz (12 - 48 MHz)

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	COLORDOPPLER	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal
ConventionalMusculo-skeletalSuperficial
Other (Specify)	N	N

N=New Indication; P=previously cloared by FDA; E=added under Appendix E

Additional Comments:

QTHER = Clinical Dermatology

Aesthetics

SEE ATTACHED DETAILS FOR INDICATIONS FOR USE

Concurrence of CDRH, Office of Device Evaluation (OPE)

Prescription Use (Per 21 CFR 801.109)

Evaluation (ODE)

(Division Sign-Off)
Nancy/Broydon

Appendix F

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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K062571

Transducer Model # 1248-10 Very High Resolution Probe 10mm focus transducer Scan Length = 15mm Nominal Frequency = 30 MHz (12 - 48 MHz)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	COLORDOPPLER	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopio
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)	N	N

Intended Use: Diagnostic ultrasound imaging or fluid flow aualysis of the human body as follows:

N=New Indication; P=previously cleared by FDA; E=added under Appendix E

Additional Commonts:

QTHER = Cilnical Dermatology

Aesthetics

SEE ATTACHED DETAILS FOR INDICATIONS FOR USE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Usc (Pet 21 CFR 801.109)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number _

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K062571

Transducer Model # 1248-12 Very High Resolution Probe 12mm focus transducer Scan Length = 15mm Nominal Frequency = 30 MHz (12 - 48 MHz)

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	COLORDOPPLER	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ(specify)
Adult Cephalic
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intervascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (Specify)	N	N

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N=New Indication; Pepreviously cleared by FDA; E=added under Appendix E

Additional Comments:

OTHER = Clinical Dermatology

Acathofics

SEE ATTACHED DETAILS FOR INDICATIONS FOR USE

Conourrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy K. Broadon

IDivision Sint Off Division of Reproductive, Abde and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.