ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6

K092997 · Edan Instruments, Inc. · KNG · Nov 10, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K092997
• Device Name: ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
• Applicant: Edan Instruments, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Nov 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

The Ultrasonic TableTop Doppler is intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate 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.

Device Story

Ultrasonic TableTop Doppler (Models SD5, SD6) uses continuous wave (CW) Doppler transducers (2MHz or 3MHz) to detect fetal heart rate (FHR); device records and plays back 240 seconds of fetal heart sound. Operated by healthcare professionals (nurses, midwives, technicians, PAs) in hospitals, clinics, and private offices; not for ICU, OR, or home use. SD6 model features wireless probe with Li-ion battery and infrared communication. Output provides FHR data to clinicians for assessment of fetal well-being and viability. Benefits include non-invasive, real-time fetal monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including software, hardware, safety, and environmental testing, alongside risk analysis and final validation.

Technological Characteristics

Continuous wave (CW) Doppler fetal monitor. Models SD5 (wired) and SD6 (wireless probe). 2MHz and 3MHz transducers. Ni-MH battery (main unit), Li-ion battery (SD6 probe). Infrared communication (SD6). Class II device. Software-based signal processing for FHR detection.

Indications for Use

Indicated for detection of fetal heart rate from early gestation through delivery, general indication of fetal well-being, and verification of fetal heart viability following trauma.

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

• IMEXDOP CT+ (K942441)
• Sonotrax series pocket doppler (K080087)

Submission Summary (Full Text)

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C092997

Section 1

### 510(k) Summary of Safety and Effectiveness

This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92

| Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>shekou, Nanshan Shenzhen.<br>518067 P.R. China<br>Tel: [phone]<br>Fax:[phone]<br>Contact person: Jiang Yucai | NOV 10 2009 |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|

William Stern Official correspondent: Multigon Industries,Inc. l Odell Plaza Yonkers, N.Y. 10701 Phone: [phone] X27 914 376 6111 Fax:

2009-9-23

KNG

Date of Preparation: Proprietary Name: Classification Name: Product code: Predicate Devices:

| Predicate devices | IMEXDOP CT+ | Sonotrax series pocket<br>doppler |
|-------------------|------------------------------|-----------------------------------|
| Manufacturer | Imex Medical<br>Systems, Inc | Edan Instruments, Inc |
| K # | K942441 | K080087 |

Device Description:

Ultrasonic TableTop Doppler provides the following primary features:

Ultrasonic TableTop Doppler (Models SD5, SD6)

21 CFR 884.2660 Fetal ultrasonic monitor and accessories

- · Basic parameters: FHR
- · 240 seconds fetal heart sound record and playback
- · Infrared communication(for SD6 only)
- · Ni-MH battery for 20 hours continuous working of main unit
- · Li-ion battery for 2.5 hours continuous working of SD6 probe
- · Charge the SD6 probe battery by main unit
- · Continuous wave Doppler transducer for FHR detection

#### Comparison with predicate device

The Ultrasonic TableTop Doppler models including SD5 and SD6

3

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. '.'

have the same device characteristics as the predicate devices mentioned above, the 2MHz, 3MHz probes for heart rate detection uses the same technology and circuitry as the cleared Sonotrax series pocket Doppler under K080087. The Ultrasonic TableTop Doppler is also similar and comparable to the IMEXDOP CT+ cleared under K024197. Hence Ultrasonic TableTop Doppler above is substantially equivalent to the predicate devices cited.

The Ultrasonic TableTop Doppler is intended to be used by health Intended Use: care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

> The 2 MHz and/or 3 MHz probes are indicated for the detection of fetal heart rate 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.

It is not intended for use in intensive care units, operating rooms or Contraindications: for home use.

Test Summary:

The following quality assurance measures were applied to the development of the Ultrasonic Doppler

- · Software testing
- · Hardware testing
- · Safety testing
- · Environment test
- · Risk analysis
- Final validation

Conclusion:

Verification and validation testing was done on the Ultrasonic TableTop Doppler. This premarket notification submission demonstrates that Ultrasonic TableTop Doppler is substantially equivalent to the predicate device.

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Image /page/2/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the bird. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Edan Instruments, Inc. % Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701

## NOV 1 0 2009

Re: K092997

Trade/Device Name: Ultrasonic TableTop Doppler (Models SD5 and SD6) Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: September 25, 2009 Received: September 28, 2009

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 Ultrasonic TableTop Doppler (Models SD5 and SD6) as described in your premarket notification:

Transducer Model Number

2MHz CW fetal probe - model: SD5 3MHz CW fetal probe - SD5 2MHz CW wireless fetal probe - model: SD6 3MHz CW wireless fetal probe - model: SD6

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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 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 go to http://www.fdagov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

Sincerely vours.

Janine M. Morris

to Janine M. Morris Acting Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 2MHz CW fetal probe- model: SD5

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

| Clinical Application | | Mode Operation | | | | | | | | |
|------------------------------|---|----------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheraln Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E The above is a 2MHz CW transducer for the fetal heart rate detection. Additional Comments:

> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

Jose M. Perez

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

6

Prescription Use
(Per 21 CFR 801.109)

(Per 21 CFR 801.109)

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## Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 3MHz CW fetal probe- model: SD5

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

| Clinical Application | | Mode Operation | | | | | | | | |
|------------------------------|---|----------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E N=1iew multanon, - I =previously vicured of FDT, OW transducer for the fetal heart rate detection.

> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrb, Office of Device Evaluation (ODE)

Aom Mhz

7

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

**Prescription Use**
(Per 21 CFR 801.109)

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

## Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 2MHz CW wireless fetal probe- model: SD6

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

| Clinical Application | | Mode Operation | | | | | | | | |
|------------------------------|---|----------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E The above is a 2MHz CW transducer for the fetal heart rate detection. Additional Comments: __

> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrb, Office of Device Evaluation (ODE)

Arzu M. Whang
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal and Radiogical Devic 510(k) Number

8

Prescription Use
(Per 21 CFR 801.109)

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

## Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 3MHz CW wireless fetal probe- model: SD6

Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows

| Clinical Application | | Mode Operation | | | | | | | | |
|------------------------------|---|----------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | 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 | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |

N=new indication; P=previously cleared by FDA; e=ADDED UNDER appendix E The above is a 3MHz CW transducer for the fetal heart rate detection. Additional Comments: __

> PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division a Reproductive, Abdominal, and Radio gical Devices 510(k) Number.

9

Prescription Use. (Per 21 CFR 801.109)