HandyDop™ is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, by means of continuous wave (doppler) echoscopy. The device is indicated for use to detect the flow of blood within the body.

When using it with the 2 MHz probe, HandyDop™ is indicated for use for the early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well being.

When using it with the 4 MHz or 8 MHz probes, HandyDop™ is indicated for use for detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.

Device Description

The Handydop is a handheld, unidirectional, continuous wave (CW) Doppler with three changeable probes. 2MHz CW probe for foetal heartbeat detection, 4MHz CW probe and 8 MHz CW probe for peripheral vascular applications. You can hear the blood flow from a vein as a modulated noise on the speaker of the handydop. The Handydop works cordless with two 9V Battery's or Accumulators. The housings of the Handydop and the probes are made of ABS-plastics. The quartz crystals where encapsulated with Araldit-D (a Duroplastic). As control panel there are only the ON/OFF switch and the loudness wheel.

AI/ML Overview

The provided document is a 510(k) summary for the HANDYDOP, a continuous wave (CW) Doppler device. It primarily focuses on demonstrating substantial equivalence to a predicate device and discussing its intended use and classification.

Critically, the document does not contain information about acceptance criteria, the study design, or device performance against specific metrics. It is a regulatory submission for market clearance, not a clinical study report. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance data.

Specifically, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: This document only describes the device and its intended uses. It does not provide any performance metrics or acceptance criteria that would typically be found in a study report (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.).
Sample size used for the test set and the data provenance: There is no mention of a test set, sample size, or data provenance (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no discussion of ground truth establishment or expert involvement.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: No adjudication method is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a standalone Doppler, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be applicable or present.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is a human-operated Doppler; it doesn't have an "algorithm only" performance that would be separated from human interaction in this context. Its function is to transmit and receive ultrasonic energy, with interpretation done by the user.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study details are provided, there is no mention of the type of ground truth.
The sample size for the training set: This device does not appear to involve machine learning or AI, so there would be no "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary of what is available: The device's intended use.

The document primarily focuses on the intended use of the HANDYDOP device for which substantial equivalence is being claimed:

When using it with the 2 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, and general indication of fetal well-being.
When using it with the 4 MHz or 8 MHz probes: Detection of blood flow in the peripheral vascular system for assisting in the detection of peripheral vascular disease.

The FDA's letter (pages 2-3) indicates that the device has been found substantially equivalent to the predicate device (Medasonics' Cadence Doppler Ultrasound System, 510k #K991441). This "substantial equivalence" is the primary "proof" for market clearance, rather than a detailed performance study against explicit acceptance criteria in the vein of a novel AI device. The FDA also requests specific post-clearance information regarding acoustic output measurements based on production line devices, which suggests that safety and technical specifications, rather than diagnostic accuracy metrics, were the focus of evaluation for this type of device.

Summary

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SEP 1 2 2003

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name: Elcat GmbH

1-Submitter Name:	Eleat GmbH
2-Address:	Schießstättstraße 29D-82515 WolfratshausenGermany
3-Phone:	011 49 8171 4214-0
4-Fax:	011 49 8171 4214-47
5-Contact Person:	Mr Bernd Marquardt (General Manager)
6-Date summary prepared:	January 30th, 2003
7- Official Correspondent:	Mansour Consulting LLC
8- Address:	1308 Morningside Park DrAlpharetta, GA 30022 USA
9- Phone:	(770) 908-8180
10- Fax:	(425) 795-9341
11- Contact person:	Jay Mansour, president
12-Device Trade or Proprietary Name:	HANDYDOP
13-Device Common or usual name:	Doppler
14-Device Classification Name:	MONITOR, ULTRASONIC, FETAL
15-Substantial Equivalency is claimed against the following device:	Medasonics' Cadence Doppler Ultrasound System, 510k #K991441 (referto Appendix 2 for FDA website printout)This notification for HANDYDOP is of the ABBREVIATED type as perthe declaration of conformity included in this summary

16-Description of the Device:

17-Intended use of the device: (Indications for use typed on a separate FDA form)

PAGE 2

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

SEP 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ELCAT Gmbh % Mr. Jay Mansour President Mansour Consulting, LLC 1308 Morningside Park Dr. ALPHARETTA GA 30022

Re: K030466

Trade Name: HandyDop™ Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: July 23, 2003 Received: July 28, 2003

Dear Mr. Mansour:

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 HandyDop™, as described in your premarket notification:

Transducer Model Number

2MHz
4MHz
8MHz

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

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Page 2 - Mr. Mansour

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 (OS) 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 (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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".

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Page: 3 – Mr. Mansour

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

117

, i

Sincerely yours,

Yamila Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure ﻧ

ﺎ

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: HANDY DOT IS DESIGNED TO TRANSMIT AND RECEIVE ULTRASOUNDENERGY INTO & THRU THE PREGNANT WOMAN BY MEANS OF CONTINUOUS WAVE (DOPPLER)(IDENTIFY TO DETECT FLOW OF BLOOD WITHIN THE BODY2 MHZ PROBE IS FOR USE FOR EARLY DETECTION OF FETAL LIFE, DETECTION OFMULTIPLE PREGNANCIES, FETAL SCREENING FROM EARLY GESTATION THRU

Prescription Use (Per 21 CFR 801.109)

Nancy Higdon

(Division Sign-Off) / Division of Reproductive, Abdor and Radiological Devices 540(k) Number _

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SUBJECT	Siok # K030466
DATE	07/23/03

CONTINUATION OF COMMENTS

DELIVERY, AND GENERAL INDICATION OF FETAL WELL BEING.
4 MHZ & 8 MHZ PROBES ARE FOR USE FOR DETECTION
of BLOOD FLOW IN THE PERIPHERAL VASCULAR SYSTEM
OF THE BODY FOR ASSISTING IN THE DETECTION OF
PERIPHERAL VASCULAR DISEASE.
PAGE 55

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal					N
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 2 MHz Probe is indicated for use forThe early detection of fetal life, detection ofmultiple pregnancies, fetal screening from earlygestation through delivery, and general indicationof fetal well being.

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Legum
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

F-3

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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	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: 4 MAZ PROBE IS INDICATED FOR USE FOR DETECTION OF BLOOD FLOW IN THE PERIPHERAL VASCULAR SYSTEM OF THE BODY FOR ASSISTING IN THE DETECTION OF PERIPHERAL VASCULAR DISEASE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

ca Evaluation (ODE)
David G. Lynn
(Division Sign Off)

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

Prescription Use (Per 21 CFR 801.109)

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic utrasound 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)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments: 8 MHZ PROBE IS INDICATED FOR USE FOR DETECTION OF BLOOD FLOW IN THE PERIPHERAL VASCULAR SYSTEM OF THE BODY FOR ASSISTING IN THE DETECTION of PERIPHERAL VASCULAR DISEASE

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Lipton

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

Prescription Use (Per 21 CFR 801.109)

F-3

Regulation Number and Section

§ 884.2660 Fetal ultrasonic monitor and accessories.

(a)
Identification. A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.(b)
Classification. Class II (performance standards).