CADENCE DOPPLER ULTRASOUND SYSTEM

K991441 · Medasonics, Inc. · KNG · Dec 28, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K991441
• Device Name: CADENCE DOPPLER ULTRASOUND SYSTEM
• Applicant: Medasonics, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Dec 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

Using the 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being. Using the 5.1 Mhz probe: Detection of blood flow in the peripheral vascular system of the body

Device Story

The Cadence Doppler Ultrasound System is a handheld diagnostic device used for fetal heart rate monitoring and peripheral vascular blood flow detection. It utilizes the Doppler shift principle of ultrasound signals to detect blood flow. The system comprises a base unit with integrated speaker, volume, and power controls, connected via a coil cord to either a 2.3 MHz or 5.1 MHz continuous wave (CW) transducer. The device is battery-operated (9V). Clinicians operate the device by placing the transducer on the patient; the system converts detected Doppler shifts into audible sound through the speaker. This output allows the clinician to assess fetal well-being or vascular flow, aiding in clinical decision-making regarding pregnancy status or vascular health.

Clinical Evidence

Bench testing only. The device clearance is contingent upon the submission of acoustic output measurements based on production line devices per FDA guidance.

Technological Characteristics

Continuous wave (CW) Doppler ultrasound system. Operates with 2.3 MHz (fetal) and 5.1 MHz (vascular) unfocused transducers. Powered by a 9V battery. Analog signal processing for audible output via speaker. No software or digital processing described.

Indications for Use

Indicated for fetal heart rate detection (2.3 MHz probe) and peripheral vascular blood flow detection (5.1 MHz probe).

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.

Predicate Devices

• Medasonics Models FP3B and BF4B (Preamendment devices)
• Huntleigh Technologies Dopplex II Pocket Doppler (K930200)

Submission Summary (Full Text)

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K991441

DEC 2 8 1999

# SAFETY AND EFFECTIVENESS SUMMARY Medasonics Incorporated Cadence Doppler Ultrasound System

# Name and address of Device Manufacturer submitting 510(k) Notification:

Medasonics Incorporated 38875 Cherry Street Newark, California 94560

### Regulatory Correspondent of Device Manufacturer:

Don Killam Medasonics Incorporated 38875 Cherry Street Newark, California 94560 Phone:[phone]

Date Summary was prepared: April 23,1999 Name of the device: Cadence Doppler Ultrasound System Classification: Class II per 21CFR Monitor, Fetal Doppler Ultrasound 884.2660 Monitor, Blood Flow Class II per 21CFR 884.2660 Indications for Use: Using the 2.3 MHz probe: Early detection of fetal life, detection of multiple pregnancies, fetal screening from early gestation through delivery, general indication of fetal well being. Using the 5.1 Mhz probe: Detection of blood flow in the peripheral vascular system of the body

Description of the device:

The Cadence system utilizes the well understood principle of Doppler shift of an ultrasound signal to detect the flow of blood within the body. The system consists of a base unit that contains the speaker, the volume and on/off controls. The base unit is connected to a 2.3 MHz CW transducer, or to a 5.1 MHz CW transducer via a coil cord. The Cadence operates from a single 9 volt battery.

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### Substantial Equivalence:

The Medasonics Cadence Doppler Ultrasound System is substantially equivalent to the following legally marketed devices:

Medasonics Incorporated 38875 Cherry Street Newark, California Models FP3B and BF4B, Preamendment devices

Huntleigh Technologies Manalapan, New Jersey Dopplex II Pocket Doppler K930200, Cleared 6/24/94

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

DEC 2 8 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medasonics, Inc. C/o William E. McKay President RCMDI 9712 S. Altamont Drive Sandy, Utah 84092

Re: K991441 Cadence Doppler Ultrasound System Dated: December 6, 1999 Received: December 7, 1999 Regulatory Class: II 21 CFR 8842660/Procode: 85 KNG

Dear Mr. McKay:

We have reviewed your Section 510(k) 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 Cadence Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

P338 (2 MHz Fetal) P339 (5 MHz Vascular)

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP requlation may result in assumptions. requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page - 2 - William McKay

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 The FDA finding of substantial equivalence of your premarket notification. 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rod Perez at [phone].

Sincerely yours,

CAPT. Daniel Schultz, M.D.

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Diagnostic Ultrasound Indications for Use Form

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

Stagnoons United Thirdledite 1334 or System with Vascular Probe - Model T335

The system consists of a 5.1 MHz unfocused CW transducer for peripheral Additional Comments: vascular applications, and a 2.3 MHz unfocused CW transducer for fetal heart rate detection. Only one transducer can be used with the speaker unit at a time

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991441

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## Diagnostic Ultrasound Indications for Use Form 2 MHz Fetal Probe - Model P338 (probe only)

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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

The above is a 2.3 MHz unfocused CW transducer for fetal heart Additional Comments: rate detection

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Division Site Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number _

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#### Diagnostic Ultrasound Indications for Use Form 5 MHz Vascular Probe - Model P339 (probe only) 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 | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(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-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: The above is a 5.1 MHz unfocused CW transducer for peripheral vascular applications

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

(Division Sign-Off)
Division

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K991441