The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability following patient trauma.

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Device Description

Ultrasonic TableTop Doppler provides the following primary features:

Basic parameters: FHR, blood flow
240 seconds fetal heart sound record and playback
Infrared communication(for SD6 only)
Ni-MH battery for 20 hours continuous working of main unit
Li-ion battery for 2.5 hours continuous working of SD6 probe

AI/ML Overview

The provided text is a 510(k) summary for the Edan Instruments, Inc. Ultrasonic TableTop Doppler (Models SD5 and SD6). It lists device information, predicate devices, and indications for use, but does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared devices. It includes forms for "Diagnostic Ultrasound indications for Use" for various probes (5MHz, 4MHz, 8MHz vascular probes, and 5MHz, 4MHz, 8MHz CW wireless vascular probes), indicating their intended use for blood flow detection in peripheral vascular applications. However, these forms do not detail performance metrics, acceptance criteria, or study results.

Therefore, I cannot provide the requested information from the given text.

The following information is NOT present in the provided text:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
If a standalone (algorithm only without human-in-the-loop performance) study was done.
The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
The sample size for the training set.
How the ground truth for the training set was established.

The document is a regulatory submission focused on establishing substantial equivalence for an ultrasonic doppler device, not a performance study report with detailed acceptance criteria and results.

Summary

{0}------------------------------------------------

Section 1

510(k) Summary of Safety and Effectiveness

OCT 2 8 2010

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

Submitter:	Edan Instruments, Inc3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,shekou, Nanshan Shenzhen,518067 P.R. ChinaTel: 86-755-26882220Fax:86-755-26882223Contact person: Yue Qiuhong
Official correspondent:	William SternMultigon Industries, Inc..1 Odell PlazaYonkers, N.Y. 10701Phone: 914 376 5200 X27Fax: 914 376 6111
Date of Preparation:	2010-7-20
Proprietary Name:	Ultrasonic TableTop Doppler (Models SD5, SD6)
Classification Name:	21 CFR 884.2660 Fetal ultrasonic monitor and accessories21 CFR 884.2660 Ultrasound Blood Flow Monitor
Product code:	MAA/JAF

Predicate Devices:

Predicate devices	IMEXDOP CT+	Sonotrax series pocketDoppler	Ultrasonic TableTopDoppler
Manufacturer	Imex MedicalSystems, Inc	Edan Instruments, Inc	Edan Instruments,Inc
K #	K942441	K080087	K092997

Ultrasonic TableTop Doppler provides the following primary features: Device Description:

· Basic parameters: FHR, blood flow
· 240 seconds fetal heart sound record and playback
· Infrared communication(for SD6 only)
Ni-MH battery for 20 hours continuous working of main unit
· Li-ion battery for 2.5 hours continuous working of SD6 probe

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure embracing another person. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Yue Qiuhong Certification Engineer Edan Instruments. Inc. 3/F - B, Nanshan Medical Equipment Park Shenzhen, Guangdong 518067 CHINA

OCT 2 8 2010

Re: K102138

Trade/Device Name: Ultrasonic TableTop Doppler (models SD5 and SD6) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: MAA and JAF Dated: September 29, 2010 Received: October 4, 2010

Dear Ms. Qiuhong:

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 Ultrasonic TableTop Doppler (models SD5 and SD6), as described in your premarket notification:

Transducer Model Number

5MHz CW Vascular Probe-model: SD5 4MHz CW vascular probe-model SD5 8MHz CW vascular probe-model SD5 5MHz CW wireless vascular probe-model: SD6 4MHz CW wireless vascular probe-model: SD6 8MHz CW wireless vascular probe-model SD6

{2}------------------------------------------------

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 895. 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Jana Delfino at (301) 796-6503.

Sincerely yours,

Signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

{3}------------------------------------------------

1741

Ultrasonic TableTop Doppler Traditional 510K Submission

Indication for Use

510(k) Number (if known):

OCT 2 8 2010

Section

Device Name: Ultrasonic TableTop Doppler (models SD5 and SD6)

The 4 MHz, 5 MHz and/or 8 MHz vascular probes are indicated for the detection of blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

× Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K102138

{4}------------------------------------------------

											.

			Ultrasonic Table Top Doppler 510K Submission
											Diagnostic Ultrasound indications for Use For
											ill out one form for each ultrasound system and each transducer5MHz CW vascular probe- model: SD5imaging or fluid flow analysis of the
				Clinical Application	Intended use : Diagnostic ultrasound		HAM	PWDF	CWD	Color	Mode UperationAmplitude	Color	numan body as followCombine	other
			Ophthalmic Ophthalmic							Doppler	Doppler	Velocity11008 833 6	Specify	Specify
			Abdominal AbdominalIntraoperative(specify) I	- Retal		1888 118 13
			Intraoperative NeurologicalPediatric Pediatric Childer Link	Small Organ(specify)			ン
			Cardiac Cardiac Cardiac	Neonatal Cephalic .		ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
				Transesophageal TransesTransrectalTransvaginal Land Call
			Peripherain Vascular	Transurethral The StIntravascular		ar Pri			. In Bissis -
			Conventional Conventional	Laparoscopic IMusculo-skeletal		11:3	ﺍﻟﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
			Musculo-skeletal Superficial		Other
			، ﻭﻳﺘﻢ ﻣ			100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000		Contraction Comments of			Nenew indication; P-previously cleared by FDA e-ADDED UNDER appendix BAdditional Comments: The above is a 5MHz CW transducer for the blood flow detection,ົນ ແລະ ພິສາຫະກຳລັງ ແລະ ສະຫຼຸບສາຫະກຳ		.
		্রে প্রায়									PERSE PERSONAL CONCURRENCE OF carb, Office of Device Evaluation (ODE I FNEEDED AND AND A			नामुळ	്ചിക്	19
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{5}------------------------------------------------

Ultrasonic Table Top Doppler 510K Submission,

. . Diagnostic Ultrasound indications for Use Form

Fill out one form for each ultrasound system and each transducer. a problem 1 1 4MHz CW vascular probe- model: SD5

Clinical Application	CWD	Mode Operation
Ophthalmic		ColorDoppler	AmplitudeDoppler
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular	N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other

ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤ

ੋ ਸ਼ਹਿਰ

. :

ាន់នៅជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជាជា

ਾ ਸੀ। ਉਸਦੇ ਸ

ी

Additional Comments: The above is a 4MHz CW transducer for the blood flow detection,

Pattern . . . . . . . . . . . . . . . . . . . . . . . . .

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

510K

් පිහිටි විද්‍යා දින දිස්ත්‍රියා දින අධික්‍රියා විද්‍යා පිහිටු බව විසින් විසින් වි

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrts, Office of Device Evaluation (ODE)

: 上海

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

{6}------------------------------------------------

Ultrasonic Table Top Doppler 510K Submission

新闻网

. Diagnostic Ultrasound indications for Use Form

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Clinical Application							Mode Operation
		র ক	MB	CHWDE	SEWO	Color	Amplitude	Color1988 2021 35	Combiner
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
Intraoperative Neurological	. Salaman
Pediatrica
Small Organ (specify)	? - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -	ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
Neonatal Cephalic
Cardiac" """	- રહ્યું	23 : 11 : 14	12, 2017
Transesophageal	・ア
Transrectal Transrectal
Transvaginal
Transurethral + + )			: -
Intravascular mascular		ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ
Peripheraln Vascular
Laparoscopic
Musculo-skeletalConvention
Musculo-skeletal Superficial
. But Burner of Other Barrer

N-liew indication, Tr-previously cleared by FDA, 6-ADDED UNDER appendix B
Additional Comments:

1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

-30 11 2 (Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

的感情 :

510K

PLEASE DO NOT WRITE BEFORETHIS LINE CONTINUE ON ANOTHER PAGE (FNEEDED CONCURRENCE OF carb, Office of Device Evaluation (ODE)

{7}------------------------------------------------

Ultrasonic Table Top Doppler 510K Submission

... Diagnostic Ultrasound indications for Use Rorm

Tillyoutone formifor: each ultrasound: system: and, each transducer.

#5MHz, CW, w/reless vascular, probe, model: SD6
... Intended we : Diegosticultiasond imaging, of fuildflo

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

Clinical Application	Mode Operation
	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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular									N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other

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Ultrasonic TableTop Doppler 510K Submission

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ය පිහිටුද්ද

ﺍﻟﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ

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

AMHz: CW wireless vascular probe-model: SD66
Intended,use: Diggootic illusiond imaging or fuid how analysis

ended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

Clinical Application	CWD	Mode Operation
		Color Doppler	Amplitude Doppler	Color Velocity Imaging
Ophthalmic
Fetal
Abdominal
Intraoperative(specify)
Intraoperative Neurological
Pediatric
Small Organ(specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular	N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E

Additional Comments: The above is a 4MHz CW transducer for the blood flow detection.

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		Ultrasonic Table Top Doppler 51,0K Submission

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Diagnostic Ultrasound indications for Use Form

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વસાય ખેતી

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. "Fill out one form for each ultrasound system and each transducer. 8MHz CW wireless vascular probe- model: SD6

Intended use : Diagnostic ultrasound imaging or fluid flow and your as follows

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

Clinical Application	Mode 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
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheraln Vascular					N
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal Superficial
Other

N=new indication; P=previously cleared by FDA; σ=ADDED UNDER appendix E

Additional Comments: The above is a 8MHz CW transducer for the blood flow detection.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF edrice of Device Evaluation (ODE)

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510K K1622438

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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).