SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
Device Facts
| Record ID | K080087 |
|---|---|
| Device Name | SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR |
| Applicant | Edan Instruments, Inc. |
| Product Code | KNG · Obstetrics/Gynecology |
| Decision Date | Mar 11, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2660 |
| Device Class | Class 2 |
Indications for Use
The 2 mHz and/ or 3 mHz obstetrical probes are indicated for the detection of fetal life from early gestation thru delivery. They can also be used to verify fetal heart viability. The 4 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. The Sonotrax series of pocket dopplers are to be used 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.
Device Story
Handheld pocket Doppler device; uses continuous wave (CW) ultrasound to detect fetal heart rate and peripheral blood flow. Input: ultrasound signals via 2/3 MHz (fetal) or 4/8 MHz (vascular) split-D piezoelectric transducers. Operation: high-frequency oscillator drives transmitter; reflected waves from moving blood cells/fetal heart received by second transducer; signal amplified, filtered, and converted to baseband audio Doppler signal; output via loudspeaker/headphone jack. Fetal heart rate calculated and displayed on LCD. Used in hospitals, clinics, and private offices by healthcare professionals. Provides audible feedback and heart rate data to assist clinicians in assessing fetal well-being and vascular health.
Clinical Evidence
Bench testing only. Device subjected to performance testing and validation under design control procedures to ensure functional requirements and safety standards compliance. No clinical data presented.
Technological Characteristics
Handheld pocket Doppler; split-D piezoelectric transducers (2, 3, 4, 8 MHz); continuous wave (CW) ultrasound; battery-powered; LCD display (except Lite model); audio output via speaker/headphone jack. No complex software/AI mentioned; signal processing is analog/baseband filtering.
Indications for Use
Indicated for detection of fetal life from early gestation through delivery, verification of fetal heart viability, and detection of blood flow in veins and arteries to assist in peripheral vascular disease diagnosis. 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.
Predicate Devices
Submission Summary (Full Text)
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X 510K SUBMISSION
K080087
pg. 1 of 4
510k Submission , SONOT Ultrasonic Fetal And Vascular Pocket Doppler Edan Instruments,Inc.
# SUMMARY
MAR 1 1 2008
This summary of 510k safety and effectiveness information is being submitted in Accordance with 21CFD part 807.92
- Submitters name, address, phone number, contact person and preparation 1. date:
- Name: Edan Instruments.Inc 3/F-B ,Nanshan Medical Equipments Park, Nanhai Road #1019 Shekou, Nanshen, Shenzhen 518067 P.R. China Tel: 86 755 2689 9197 Fax:86 755 2688 2223 Responsible person: Liu Yongying
Official Correspondent:
William Stern
Multigon Industries, Inc.
1 Odell Plaza
Yonkers, N.Y. 10701
Phone: 914 376 5200 x27 Fax: 914376 6111
Date of Preparation: 1/9/08
- 2. Device:
Proprietary Name: Sontotrax Ultrasonic Fetal and Vascular Pocket Doppler Models: Sonotrax Lite, Sonotrax Basic,
> Sonotrax Basic A, Sonotrax Pro, Sonotrax II, Sonotrax II Pro,
Sonotrax Vascular
{1}------------------------------------------------
SONOTRAX 510K SUBMISSION
K080087
pg. 2 of 4 6
Common Name: Handheld Fetal and Peripheral Vascular Doppler
Classification name: Fetal Ultrasonic Monitor and Accessories Ultrasonic Bloodflow Monitor Diagnostic ultrasonic transducer
Product Code:
KNG HEP
Manufactured By: Edan Instruments, Inc., China
Predicate Devices: 3.
K040480 Sonotrax Ultrasonic Pocket Doppler, manufactured by Edan Instruments, Inc.
K024197 LifeDop Doppler Ultrasound System , manufactured by Summit Doppler Systems,
5350 Vivian St., Suite A, Arvada, CO 80002
4. Classification Names :
> Class II as per 21CFR 884-2660, Fetal Ultrasonic Monitor and accessories.(KNG)
Class II as per 21CFR 884-2660, Ultrasonic Bloodflow Monitor (HEP)
5. Description:
> The Sonotrax fetal Dopplers enumerated in their various models in 2. above use the tried and true principle of Dopplershift of an ultrasound signal to detect the fetal heartbeat using the 2 mHz and pr 3 mHz probes and for blood flow detection in veins and artefies using the 4 mHz and 8 mHz probes.
> The Sonotrax Fetal Dopplers uses a split D piezoelectric transducer. A high frequency oscillator supplies a continuous high frequency voltage to one half of the split D transmitter transducer. The high frequency voltage is converted to an ultrasound acoustic wave by the transducer and is transmitted to biophysical objects thru an applied coupling water based medium and moves thru biophysical objects. The acoustic ultrasound is
Image /page/1/Picture/17 description: The image contains handwritten text that appears to be notes or calculations. The text includes numbers such as 2, 3, 4, and 8, followed by the symbols 'mHz' and 'H2'. Additionally, the word 'Heartbeat' is written in a cursive style. The overall impression is that the image captures a snapshot of someone's notes related to measurements or observations, possibly in a scientific or medical context.
{2}------------------------------------------------
### SONOTRAX 510K SUBMISSION
reflected by moving blood cells and moving objects such as the fetal heart. The reflected ultrasound is received by the second split D receiver transducer and is converted via the piezoelectric effect into a high frequency electronic signal. The received electronic signal is amplified and detected. The result is a base band audio Doppler shifted signal which is filtered , and converted to audio via a loud speaker. At the same time the fetal heart rate is applied to and displayed on a liquid crystal counter display.
The Sonotrax product includes four interchangeable probes (2mHz and 3 mHz Obstetrical probes and 4mHz and 8mHz vascular probes).
The user interface includes an on/off button, a play /record button (only in the Sonotrax Pro model), a loud speaker, headphone jack, LCD display for heartrate (all models except Sonotrax lite), and a battery.
#### Indications for use: 6.
The 2 mHz and/ or 3 mHz obstetrical probes are indicated for the detection of fetal life .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 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.
The Sonotrax series of pocket dopplers are to be used 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.
- 7. Contraindications: None known at this time.
Comparison to Predicate Device.
The Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler models in 2. above including the Lite, Basic, Pro, II, and Vascular models have the same device characteristics as all the predicate approved devices in item 3 above. All of these above models use the same technology and circuitry as the already approved Sonotrax Doppler cleared under K040480. In this application we have added a 3 mHz probe frequency for fetal use, and a 4 mHz and 8 mHz vascular probes for vascular use. These Sonotrax models are also similar and comparable to the Lifedop Doppler cleared under K024197. Hence the Sonotrax Fetal and Vascular Pocket Doppler models in paragraph 2 above are substantially equivalent to the predicate devices cited.
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### SONOTRAX 510K SUBMISSION
2080087
pg. 4 of 48
#### Test Data: 9.
The Sonotrax Ultrasonic Fetal and Vascular Doppler devices have been designed under design control procedures in the company's QSR system as enumerated in the Cerctificate of Conformance and subjected to extensive safety, performance testing and validations before release. Final testing of the Sonotrax Ultrasonic Fetal and Vascular Dopplers includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complies with applicable industry and safety standards.
The Sonotrax Ultrasonic Fetal and Vascular Doppler device labeling includes instructions for safe and effective use, warnings cautions and guidance for use.
- 10. Literature Review:
A review of the literature pertaining to the safety of Doppler Blood flowmeters has been conducted and appropriate safeguards have been incorporated in the design of the Sonotrax Ultrasonic Fetal and Vascular Fetal Dopplers.
10. Conclusions:
> The conclusion drawn from these tests is that the Sonotrax Ultrasonic Fetal and Vascular Dopplers described herein are equivalent in safety and efficacy to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2008
Edan Instruments, Inc. c/o Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701
Re: K080087
Trade/Device Name: Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler Regulation Number: 21 CFR §884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: January 9, 2008 Received: January 23, 2008
Dear Mr. Stern:
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 Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler, as described in your premarket notification:
### Transducer Model Number
| 8 mHz CW Vascular Probe | 4 mHz CW Vascular Probe |
|-------------------------|-------------------------|
| 3 mHz CW Fetal Probe | 2 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.
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Page 2 - Mr. William Stern
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 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 Gamal Akabani, Ph.D. at (240) 276-3666.
Sincerely yours,
Arnthethly
NANCY C. BENDER
ancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{6}------------------------------------------------
## Indication for Use
510(k) Number (if known):
Device Name:
Sonotrax Ultrasonic Fetal and Vascular Pocket Doppler
Indication for Use:
The 2 mHz and/ or 3 mHz obstetrical probes are indicated for the detection of fetal life from early gestation thru delivery. They can also be used to verify fetal heart viability.
The 4 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.
The Sonotrax series of pocket dopplers are to be used 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 model includes Sonotrax Lite, Sonotrax Basic. Sonotrax Pro, Sonotrax Basic A, Sonotrax II, Sonotrax II Pro, Sonotrax Vascular.
Prescription Use _ Yes (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use No (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Aonhnh
ive. Abdominal ision of Reproduc Radiological Devic 510(k) Number
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SONOTRAX
Appendix F
08008
510(k) Number
### Diagnostic Ultrasound Indications for Use Form
# Fill out one form for each ultrasound system and each transducer.
> FETAL - PROBE - - MODEL : - SONOTRAX
Diagnostic ultrasound imaging or fluid flow analysis of the human bod
| | | Mode of Operation | | | | | | | | |
|-------------------------------|---|-------------------|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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 Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The above is a 3 mHz CW transducer for FETAL HEART RATE DETECTION MODEL CD3.0-MS3
(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)
F-3
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
K080087
{8}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
# Fill out one form for each ultrasound system and each transducer, 8 mHz CW VASCLR PROBE - MODEL - SONOTRAX
Internet CW VASCLR PROBE - MODEL - SONOTRAX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the hu
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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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 Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The above is a 8 mHz CW transducer for
detection of blood flow in veins and arteries
MODEL CD8.0-MS3
(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)
lom m why
(Division Sign-Off)
Division of Reproductive, Abdominal, F-3 and Radiological Devi 510(k) Number.
{9}------------------------------------------------
SONOTRAX
Appendix F
### Diagnostic Ultrasound Indications for Use Form
# Fill out one form for each ultrasound system and each transducer, 4 mHz CW VASC one for for facil and assembly system and each transfucer,
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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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 Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The above is a 4 mHz CW transducer for
DETECTION OF BLOOD FLOW IN VEINS AND ARTERIES
MODEL CD4.0-MS3
MODEL CD4.0-MS3
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
escription Use (Per 21 CFR 801.109)___________________________________________________________________________________________________________________________________________
Tony M. White
(Division Sign-Off)
E-3 Division of Reproductive, Abdominal, and Radiological Device.
510(k) Number K080087
{10}------------------------------------------------
SONOTRAX
Appendix F
### continious wave Diagnostic Ultrasound Indications for Use
#
tended 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 | | | | | | |
| 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 Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: The above is a 2 mHz CW transducer for fetal heart rate detection. MODEL CD2.0-MS3
(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) --
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number.
F-3
