LIFEDOP DOPPLER

K024197 · Summit Doppler Systems, Inc. · KNG · Jan 3, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K024197
• Device Name: LIFEDOP DOPPLER
• Applicant: Summit Doppler Systems, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Device Story

Handheld, battery-powered audio Doppler ultrasound system; used in clinical settings by healthcare providers. Device utilizes interchangeable continuous wave (CW) probes (2.1/3.2 MHz for fetal; 4.0/8.0 MHz for vascular) to detect motion via Doppler shift. Input signals processed to produce audible audio output via speaker or headphones; LCD displays heart rate, battery status, and waveform information. Includes optional built-in audio recorder. Clinicians use audio and visual outputs to assess fetal viability or identify peripheral vascular blood flow patterns, aiding in clinical diagnosis and patient management.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Handheld, battery-powered Doppler ultrasound system. Uses continuous wave (CW) transducers at 2.1, 3.2, 4.0, and 8.0 MHz. Features include LCD display, speaker, headphone jack, and optional audio recorder. Operates as a standalone device.

Indications for Use

Indicated for fetal heart beat detection to determine fetal viability (using 2.1 or 3.2 MHz probes) and for blood flow detection in veins and arteries to assist in peripheral vascular disease detection (using 4.0 or 8.0 MHz probes).

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

• Dopplex II Pocket Doppler (K930200)
• Cadance Doppler Ultrasound System (K991441)

Submission Summary (Full Text)

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K024197

# JAN 0 3 2003

#### SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. LifeDop Doppler Ultrasound System

Name and Address:

Summit Doppler Systems, Inc. 5350 Vivian St. Suite A Arvada, CO 80002-1957

Phone: [phone] Fax: [phone]

Ken Jarrell - President

November 4, 2002

LifeDop Doppler Ultrasound System

Handheld Fetal and Peripheral Vascular Doppler

| Class II per: | FR Number | Product Code |
|--------------------------------|-----------|--------------|
| Monitor, Ultrasonic, Fetal | 884.2660 | KNG |
| Monitor, Bloodflow, Ultrasonic | 884.2660 | HEP |

Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.

Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

The LifeDop is a hand-held, battery powered, audio Doppler device used for detecting fetal heart beats and for blood flow detection in veins and arteries. The product includes four interchangeable probes (OB Late Term, OB Early Term, Vascular pencil probe, Vascular flat face probe) and user replaceable batteries. The user interface includes an on/off button, play/record button, volume control, single 2-1/4" speaker, headphone jack and LCD display for heart rate, battery and waveform information.

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

Medasonics Incorporated Newark, California Cadance Doppler Ultrasound System K991441 cleared 12/28/99

Doppler ultrasound technology is the same as substantially equivalent device shown above. New technology included in the LifeDop is an optional built-in audio recorder.

None provided

Based on comparisons of device features, materials, intended use and performance, the LifeDop Doppler is shown to be substantially equivalent to the commercially available and legally marketed device indicated above.

Contact:

Preparation Date:

Device Name:

Common Name:

Classification:

Indications for Use:

Description:

Substantial Equivalence:

Technologies Summary:

Clinical Testing:

Conclusion:

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Image /page/1/Picture/14 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which are likely meant to represent a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Summit Doppler Systems, Inc. % Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW Suite 104 NEW BRIGHTON MN 55112-1891

JAN 0 3 2003

Re: K024197

Trade Name: LifeDop Doppler Ultrasound System Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG and HEP Dated: December 19, 2002 Received: December 20, 2002

Dear Mr. Job:

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 LifeDop Doppler Ultrasound System, as described in your premarket notification:

Transducer Model Number

2.1 MHz CW Fetal Probe 3.2 MHz CW Fetal Probe 4.0 MHz CW Peripheral Vascular Probe 8.0 MHz CW Peripheral Vascular Probe

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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 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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Page 3 – Mr. Job

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

Sincerely yours,

Daniel A. Ingerson

for

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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### Attachment C - Indication for Use

### Diagnostic Ultrasound Indications for Use Form

LifeDop Doppler Ultrasound System

Main unit fetal system with either 2.1 MHz CW or 3.2 MHz CW

Main unit peripheral vascular system with either 4.0 MHz CW or 8.0 MHz CW

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 | | | | | | | | | | |
| Pedlatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: ___ The system consists of main unit plus either a 2.1 MHz CW or a

3.2 MHz CW transducer for fetal applications, and either a 4.0 MHz CW

or a 8.0 MHz CW transducer for peripheral vascular applications.

Only one transducer can be used with the main unit at a time.

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

David A. Severson

Prescription Use (Per 21 CRF 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K024197
510(k) Number C-

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#### 2.1 MHz CW Fetal Probe

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 | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

The above is for a 2.1 MHz CW transducer for fetal heart detection Additional Comments: __

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

\Prescription Use (Per 21 CRF 801.109)

Daniel C. Simpson

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

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

#### 3.2 MHz CW Fetal Probe

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 | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

Concurrence of CDRH, Office of Device of Device Evaluation (ODE)

Prescription Use (Per 21 CRF 801.109)

Daniel K. Ingram

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

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

#### 4.0 MHz CW Peripheral Vascular Probe

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 | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: ____The above is for a 4.0 MHz CW transducer for peripheral vascular

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

V Prescription Use (Per 21 CRF 801.109)

Daniel A. Symm

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

{8}------------------------------------------------

## 8.0 MHz CW Peripheral Vascular Probe

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 | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | N | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

The above is for a 8.0 MHz CW transducer for peripheral vascular Additional Comments: __

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

Prescription Use (Per 21 CRF 801.109)

Daniel R. Sayre
(Division Sign-Off)

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

C-5