Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and lack of mention of AI/ML terms or performance studies related to learning algorithms indicate no AI/ML is incorporated.

Therapeutic

No
The device is used for detection of fetal heart rate and well-being, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes
The device is used for the detection of fetal heart rate and to verify fetal heart viability, which are diagnostic purposes to assess the health of a fetus.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components such as probes, batteries, and a main unit, indicating it is not solely 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 Function: The Ultrasonic Tabletop Doppler uses ultrasound to detect fetal heart rate. This is a non-invasive method that does not involve testing samples taken from the body.
Intended Use: The intended use is for detecting fetal heart rate and assessing fetal well-being, which is a direct measurement of a physiological process within the body, not an analysis of a biological sample.

Therefore, the function and intended use of this device clearly fall outside the scope of an in vitro diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KNG

Device Description

Ultrasonic Tabletop Doppler provides the following primary features:

Basic parameters: FHR
240 seconds fetal heart sound record and playback
Infrared communication (for TD-6000 only)
Ni-MU1 battery for 20 hours continuous working of main unit
Li-ion battery for 2.5 hours continuous working of TD-6000 probe
Charge the TD-6000 probe battery by main unit
Continuous wave Doppler transducer for FUR detection

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

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)

Clinical testing is not required
Non-clinical test:
The following quality assurance measures were applied to the development of the Ultrasonic Doppler

Software testing
Hardware testing
Safety testing
Environment test
Risk analysis
Final validation

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

Not Found

Predicate Device(s)

K092997

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K112529

Submitter

Advanced Instrumentations, Inc. 6800 N.W. 7710 Court Miami, Fi 33166 Telephone: 305-477-6331 Fax: 305-477-5351

Registration # 1066270

Official correspondent :

Jorge Millan, PhD Email: jmillan@hiatec.org 601 West 20 St Hialeah, FL 33010 Phone : (305) 925-1260

Date Prepared:

August 25, 2011

Device name and classification:

. Device Name: TD-5000 & TD-6000 Ultrasonic Tabletop Doppler
Classification Name: 884.2660 Fetal ultrasonic monitor and accessories . Product code: KNG
Regulatory Class: . II

1

TD-5000 & TD-6000 Ultrasonic Tabletop Doppler

Predicate Device:

SD5 & SD6Ultrasonic Tabletop Doppler. K092997 Manufacturer: EDAN Instruments

Device Description:

Ultrasonic Tabletop Doppler provides the following primary features:

Basic parameters: FHR .
. 240 seconds fetal heart sound record and playback
Infrared communication (for TD-6000 only) .
. Ni-MU1 battery for 20 hours continuous working of main unit
Li-ion battery for 2.5 hours continuous working of TD-6000 probe .
. Charge the TD-6000 probe battery by main unit
. Continuous wave Doppler transducer for FUR detection

Intended Use:

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.

Effectiveness and Safety Contraindications:

Clinical Test

Clinical testing is not required

2

Non-clinical test:

The following quality assurance measures were applied to the development of the Ultrasonic Doppler

Software testing .
Hardware testing .
Safety testing .
. Environment test
Risk analysis .
Final validation .

Comparison to the predicate device:

The subject device has similar technology characteristics and has the same intended use, same design principle, same electrical classification, same measurement mode and same accuracy as the predicate device.

Substantially Equivalent Determination:

Verification and validation testing was done on the TD-5000 & TD-6000 Ultrasonic Tabletop Doppler. This premarket notification submission demonstrates that TD-5000 & TD-6000 Ultrasonic Tabletop Doppler is substantially equivalent to the predicate device.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 2 7 2011

Advanced Instrumentations. Inc. % Jorge Millan, Ph.D. Executive Director Hialeah Technology Center, Inc. 601 West 20 St. HIALEAH FL 33010

Re: K112529

Trade/Device Name: TD-5000 & TD6000 Ultrasonic Tabletop Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: August 26, 2011 Received: September 1, 2011

Dear Dr. Millan:

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 TD-5000 & TD6000 Ultrasonic Tabletop Doppler, as described in your premarket notification:

Transducer Model Number

2MHz CW wireless fetal probe-model: TD-6000 3MHz CW wireless fetal probe-model: TD-6000 2MHz CW fetal probe-model: TD-5000 3MHz CW fetal probe-model: TD-5000

4

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/CDRH/CDRHOffices/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 Joshua Nipper at (301) 796-6524.

Sincerely Yours,

Mahal O'Hara for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

5

Indications for Use

510(k) Number (if known):

Device Name:

TD-5000 & TD-6000 Ultrasonic Tabletop Doppler

Indications for Use:

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

__, and I'm not going to lie, I don't know what to do with this.

Page 1 of ___ -1____________________________________________________________________________________________________________________________________________________________________________

Stuk K112529

6

Diagnostic Ultrasonic Indications for Use Form Fill out one form for each ultrasound system and each transducer 2MHz CW wireless fetal probe- model: TD-6000

Intended Use: Diagnostic Ultrasound imaging or fluid 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					N
Abdominal
Intra-
operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheran
Vascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal
Superficial
Other (specify)

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

Additional comments: The above is a 2MHz CW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

.

(Division Sign. O/B)

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

510K K112529

7

Diagnostic Ultrasonic Indications for Use Form Fill out one form for each ultrasound system and each transducer 3MHz CW wireless fetal probe- model: TD-6000

Intended Use: Diagnostic Ultrasound imaging or fluid 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					N
Abdominal
Intra-
operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheran
Vascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal
Superficial
Other (specify)

N = new indication P=previously cleared by FDA: e=ADDED UNDER appendix E Additional comments: The above is a 3MHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Division Sign-Off

519K K112529

8

Diagnostic Ultrasonic Indications for Use Form Fill out one form for each ultrasound system and each transducer. 2 MHz CW fetal probe- model: TD-5000

Intended Use: Diagnostic Ultrasound imaging or fluid 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					P
Abdominal
Intra-
operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheran
Vascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal
Superficial
Other (specify)

N = new indication P=previously cleared by FDA: e=ADDED UNDER appendix E Additional comments: The above is a 2MHz CW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

510K K112529

9

Diagnostic Ultrasonic Indications for Use Form

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

3MHz CW fetal probe- model: TD-5000

Intended Use: Diagnostic Ultrasound imaging or fluid 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					P
Abdominal
Intra-
operative(Specify)
Intra-operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral
Vascular
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal
Superficial
Other (specify)

N = new indication P=previously cleared by FDA: e=ADDED UNDER appendix E Additional comments: The above is a 3MHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

(Division Sign-Off)

Office of In

510K 5//12539