ECHOHEART TRANSVAGINAL DOPPLER PROBE

K060410 · Summit Doppler Systems, Inc. · HEK · Apr 10, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060410
• Device Name: ECHOHEART TRANSVAGINAL DOPPLER PROBE
• Applicant: Summit Doppler Systems, Inc.
• Product Code: HEK · Obstetrics/Gynecology
• Decision Date: Apr 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability.

Device Story

EchoHeart Transvaginal Doppler is an interchangeable probe for the handheld LifeDop Doppler System. It utilizes Doppler ultrasound to detect fetal heart tones. Designed for clinical use by healthcare providers in settings where transabdominal imaging is difficult, such as early pregnancy, obesity, or retroverted uterus. The probe transmits ultrasound waves and processes reflected signals to provide audible fetal heart tones. This output assists clinicians in confirming fetal viability. The device benefits patients by enabling successful monitoring in challenging anatomical or gestational conditions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Interchangeable transvaginal Doppler ultrasound probe. Operates with the handheld LifeDop Doppler System. Technology is based on standard Doppler ultrasound principles. No specific materials or software algorithm classes are detailed beyond standard diagnostic ultrasound transducer specifications.

Indications for Use

Indicated for detection of fetal heart tones via transvaginal approach to determine fetal viability in patients where standard transabdominal probes are insufficient, including early gestations, obese patients, and retroverted uterine positions.

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

• Summit Doppler LifeDop system w/ 3.2 MHz fetal probe (K024197)
• Atlantis Diagnostic International Transvaginal Probe (K961073)

Submission Summary (Full Text)

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KOBO41D

#### 7 2006 APR

## SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. EchoHeart Transvaginal Doppler

Name and Address: Summit Doppler Systems, Inc. 4620 Technology Dr. #100 Golden, CO 80403 Phone: [phone] Fax: [phone] Contact: Ken Jarrell - President Preparation Date: February 10, 2006 Device Name: EchoHeart Transvaginal Doppler Common Name: Transvaginal Doppler Probe Classification: Class II per: FR Number Product Code Transducer, Ultrasonic, Diagnostic 892.1570 ITX Indications for Use: This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability. Description: The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions. Substantial Equivalence: The EchoHeart Transvaginal Doppler probe is substantially equivalent to the currently marketed Summit Doppler LifeDop system w/ 3.2 MHz fetal probe and Atlantis Diagnostic International Transvaginal Probe. Summit Doppler Systems, Inc. Atlantis Diagnostics International, Inc. Golden, Colorado Bothell, WA 98011 LifeDop Doppler w/ 3MHz Probe HDI 1000 Diagnostic w/ Transvaginal Probe K024197, Cleared 1/3/03 K961073, Cleared 2/19/97 Technologies Summary: Doppler ultrasound technology is the same as substantially equivalent devices shown above. Conclusion: Based on comparisons of device features, materials, intended use and performance, and user instructions, the LifeDop Doppler is shown to be substantially equivalent to the commercially available and legally marketed

device indicated above.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or bird, with three wing-like shapes stacked on top of each other.

Public Health Service

7 2006 APR

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ken Jarrell President Summit Doppler Systems, Inc. 4620 Technology Drive, Suite 100 GOLDEN CO 80403

Re: K060410

Trade Name: EchoHeart Transvaginal Doppler Probe Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: HEK and ITX Dated: February 10, 2006 Received: February 16, 2006

Dear Mr. Jarrell:

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 EchoHeart Transyaginal Doppler Probe used with the LifeDop Doppler Ultrasound System, as described in your premarket notification.

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

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Page 2 - Mr. Jarrell

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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

If you have any questions regarding the content of this letter, please contact Ewa Czerska, M.D. at [phone].

Sincerely yours,

David G. Ayres

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

Enclosure(s)

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# Diagnostic Ultrasound Indications for Use Form

# Main unit LifeDop system with EchoHeart Transvaginal Doppler 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 | | | | | P, E | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | N | | | | | |
| Transurethal | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | P, E | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Previously cleared indication is K024197, issued 1/3/03

Additional Comments: ____ The system consists of main unit plus an EchoHeart Transvaginal Probe

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Prescription Use (Per 21 CRF 801.109)

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David G. Ingram
Division Sign Off

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

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# Diagnostic Ultrasound Indications for Use Form

## EchoHeart Transvaginal 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 | | | | | N | | | | | |
| 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: ___The above is for EchoHeart Transvaginal Doppler probe

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

David A. Hyon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Device 510(k) Number

Prescription Use (Per 21 CRF 801.109)