OB1 OBSTETRICAL DOPPLER

K033156 · D. E. Hokanson, Inc. · KNG · Dec 9, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K033156
• Device Name: OB1 OBSTETRICAL DOPPLER
• Applicant: D. E. Hokanson, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Intended Use

This product will be used to detect fetal heartbeats to help determine fetal viability.

Device Story

OB1 Obstetrical Doppler is a handheld, internally-powered ultrasound device; utilizes 2.25 MHz CW fetal probe to detect fetal heart motion; processes Doppler audio signals via recursive filter techniques to calculate fetal heart rate; outputs audio via integrated loudspeaker and displays heart rate on digital LCD; operated by clinicians; provides real-time fetal heart rate monitoring to assist in viability assessment.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics and performance features to legally marketed predicate devices.

Technological Characteristics

Handheld fetal Doppler; 2.25 MHz continuous wave (CW) transducer; internally powered; digital LCD display; integrated loudspeaker; recursive filter algorithm for heart rate calculation.

Indications for Use

Indicated for detection of fetal heartbeats to determine fetal viability in pregnant patients.

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)
• LifeDop Doppler Ultrasound System (K024197)

Submission Summary (Full Text)

{0}------------------------------------------------

:

# 510(k) Summary of safety and effectiveness information for equivalence determination.

| Device | OB1 Obstetrical Doppler |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Handheld Fetal Doppler |
| Manufacturer | D. E. Hokanson, Inc.<br>12840 NE 21st Place<br>Bellevue, WA 98005<br>Phone: [phone]<br>Fax: [phone] |
| Establishment<br>Registration Number | 3019130 |
| Contact | D. Eugene Hokanson, President |
| Preparation Date | September 26, 2003 |
| Classification | Class II per FR 884.2660, Fetal Ultrasonic Monitor |
| Indications for Use | This product will be used to detect fetal heartbeats to help<br>determine fetal viability. |
| Description | OB1 Obstetrical Doppler is a handheld, internally-powered<br>Doppler audio instrument used for detecting fetal heart beats.<br>There are only four user controls; Up and Down audio<br>volume, Freeze Display, and Power On/Off. A three inch<br>loudspeaker provides good Doppler audio. A digital LCD<br>readout shows the fetal heart rate when it is stable for three<br>or four seconds. |
| Substantial Equivalence<br>to Predicate Devices | Huntleigh Technologies, Manalapan, NJ<br>Dopplex II Pocket Doppler, K930200, cleared 6/24/94<br>Medasonics Incorporated, Newark, CA<br>Cadance Doppler Ultrasound System, K991441, cleared<br>12/28/99<br>Summit Doppler Systems, Inc., Arvada, CO<br>LifeDop Doppler Ultrasound System, K024197, cleared<br>1/03/03 |
| Technology Summary | Doppler ultrasound technology in the OB1 is substantially<br>equivalent to that in the predicate devices listed above.<br>Recursive filter techniques are used to detect the fetal heart<br>rate displayed on the digital readout. This achieves similar<br>results as the techniques (not published) in the predicate<br>devices. |
| Conclusion | Based on comparisons of device features, materials,<br>intended use and performance, the OB1 Obstetrical Doppler<br>is substantially equivalent to the commercially available and<br>legally marketed devices listed above. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 2003

Mr. D. Eugene Hokanson President D. E. Hokanson. Inc. 12840 Northeast 21st Place BELLEVUE WA 98005

Re: K033156

Trade Name: OB1 Obstetrical Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: 85 KNG Dated: November 11, 2003 Received: November 17, 2003

Dear Mr. Hokanson:

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 OB1 Obstetrical Doppler, as described in your premarket notification:

## Transducer Model Number

## 2.25 MHz CW Fetal Probe

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.

{2}------------------------------------------------

Page 2 - Mr. Hokanson

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".

{3}------------------------------------------------

Page 3 – Mr. Hokanson

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

Sincerely yours,

David A. Lyman

fr

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

Enclosure(s)

{4}------------------------------------------------

#### Diagnostic Ultrasound Indications for Use Form

#### 2.25 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<br>Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | | |
| Conventional | | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Although the transducer can be disconnected from the main unit there is only a 2.25MHz probe available for the OB1 at this time.

(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 CFR 801.109) ✔

David G. Hanson

(Division Sion-C Division of and Radio 510(k) Nu

Page 14 of 17