PD-100 SERIES ULTRASONIC POCKET DOPPLER

K111934 · Advanced Instrumentations, Inc. · KNG · Sep 22, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K111934
• Device Name: PD-100 SERIES ULTRASONIC POCKET DOPPLER
• Applicant: Advanced Instrumentations, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Sep 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 3 MHz obstetrical 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 Story

PD-100 Series Ultrasonic Pocket Doppler is a handheld diagnostic device; utilizes ultrasonic transducers (2, 3, 4, 5, 8 MHz) to emit and receive ultrasound signals; processes reflected signals to detect fetal heart rate or blood flow velocity in peripheral vasculature; provides audible output for clinician interpretation; used in hospitals, clinics, and private offices by healthcare professionals; assists in clinical assessment of fetal well-being and peripheral vascular disease detection; aids in rapid viability verification following trauma.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Handheld ultrasonic Doppler device; utilizes interchangeable 2, 3, 4, 5, and 8 MHz probes; battery-powered; provides audible output; non-invasive; class II device under 21 CFR 884.2660.

Indications for Use

Indicated for detection of fetal heart rate from early gestation through delivery, assessment of fetal well-being, and verification of fetal viability post-trauma (using 2/3 MHz probes); detection of blood flow in veins and arteries to assist in peripheral vascular disease diagnosis (using 4/5/8 MHz probes). Intended for use by healthcare professionals (nurses, midwives, technicians, PAs) via physician prescription.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

SEP 22 2021

Re: K111934

Trade/Device Name: PD-100 Series Ultrasonic Doppler (models PD-100B, PD-100A, PD-100Plus, PD-100Pro, PD-1000, PD-1000Plus, and PD-1000Pro) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG and HEP Dated: September 13, 2011 Received: September 15, 2011

Dear Dr. Millan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This Jetter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

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

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## Indications for Use

## 510(k) Number (if known):

Device Name: PD-100 Series Ultrasonic Pocket Doppler (models PD-100B, PD-100A, PD-100Plus, PD-100Pro, PD-1000, PD-1000Plus and PD-1000Pro)

## Indications for Use:

The PD-100 series Ultrasonic Pocket Doppler are intended for use by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physicians' assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and 3 MHz obstetrical 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.

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)

Mary Sastle

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

510K K11934

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