FETAL & MATERNAL MONITOR, MODEL F6, F9

K082602 · Edan Instruments, Inc. · HGM · Nov 26, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K082602
• Device Name: FETAL & MATERNAL MONITOR, MODEL F6, F9
• Applicant: Edan Instruments, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Intended Use

The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Device Story

Fetal & Maternal Monitor (Models F6/F9) performs non-invasive/invasive fetal monitoring; inputs include ultrasound signals (FHR), TOCO transducer data (uterine activity), DECG, and IUPC. Device processes signals to provide real-time waveform display, FHR limit alarms, and data storage (12-hour playback). Used in antepartum/labor/delivery rooms by trained clinicians. Features include optional wireless module, fetal stimulator, and PC data transmission. Output assists clinicians in assessing fetal status during labor and delivery; supports Non-Stress testing. Benefits include continuous fetal heart rate and uterine activity monitoring to guide clinical management.

Clinical Evidence

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

Technological Characteristics

Perinatal monitoring system; 1 MHz PW fetal ultrasound transducers; TOCO, DECG, and IUPC sensors. Features lithium battery, wireless module, and PC connectivity. Software-based waveform processing and alarm management. Class II device.

Indications for Use

Indicated for pregnant women from the 28th week of gestation for non-invasive and invasive fetal monitoring during antepartum examination, labor, and delivery. Contraindicated for use in intensive care units, operating rooms, or home use.

Regulatory Classification

Identification

A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

Predicate Devices

• CADENCE II (K073221)
• Corometrics 120 series maternal/fetal monitor (K991739)

Submission Summary (Full Text)

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#### NOV 2 6 2008 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>Responsible person: Jiang Yucai |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | William Stern<br>Multigon Industries, Inc.<br>1 Odell Plaza<br>Yonkers, N.Y. 10701<br>Phone: [phone] X27<br>Fax: [phone] |
| Date of Preparation: | Jul 17, 2008 |
| Proprietary Name: | Fetal & Maternal Monitor (Models F6 and F9) |
| Classification Name: | 21 CFR 884.2740 Perinatal monitoring system and accessories |
| Product code: | HGM |
| Predicate Devices: | |

| Predicate devices | CADENCE II | Corometrics 120 series<br>maternal/ fetal monitor |
|-------------------|------------------------|---------------------------------------------------|
| Manufacturer | Edan Instruments, Inc. | GE Healthcare |
| K # | K073221 | K991739 |

Device Description:

The Fetal & Maternal Monitor provides the following primary features that can be available for the multiple configurations:

- Basic parameters: FHR, TOCO, Event Mark, AFM
- · Optional Dual FHR monitoring
- · Optional Internal parameters: IUP/DECG

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#### Fetal & maternal monitor 510K Submission

- 12 hours waveforms playback
- · Optional Built-in wireless module
- · Software for data transmission to PC
- · Quick printing for stored waveform
- · Lithium battery for 4 hours continuous working
- Probe rack and wall mounting rack
- Optional Fetal Stimulator
- FHR limit alarm
- Pulse wave Doppler waterproof transducer for FHR detection

#### Comparison with predicate device

| Monitoring Mode | Fetal & Maternal<br>Monitor | CADENCE II | Corometrics 120 series<br>maternal/ fetal monitor |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------------------------------------------|
| FHR/Dual FHR | yes | yes | yes |
| TOCO | yes | yes | yes |
| Fetal ECG, IUP | yes | yes | yes |
| Intended Use: | The Fetal & Maternal Monitor is intended for non-invasive and invasive<br>monitoring of fetus during antepartum examination, labor and delivery. It is<br>intended to be used only by trained and qualified personnel in antepartum<br>examination rooms, labor and delivery rooms. | | |
| | Fetal & Maternal Monitor provides Non-Stress testing for pregnant women<br>from the 28th week of gestation. It can externally monitor the FHRs using<br>ultrasound and uterine activity via a TOCO transducer. Alternatively, it can<br>internally monitor one of the FHRs with DECG and uterine activity with an<br>IUPC. | | |
| Contraindications: | It is not intended for use in intensive care units, operating rooms or for home<br>use. | | |
| Test Summary: | The following quality assurance measures were applied to the development<br>of the Fetal & Maternal Monitor | | |
| | • Software testing | | |
| | • Hardware testing | | |
| | • Safety testing | | |
| | • Environment test | | |
| | • Risk analysis | | |
| | • Final validation | | |
| Conclusion: | Verification and validation testing was done on the Fetal & Maternal Monitor.<br>This premarket notification submission demonstrates that Fetal & Maternal<br>Monitor is substantially equivalent to the predicate device. | | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

NOV 2 6 2008

Rc: K082602

Trade/Device Name: Fetal and Maternal Monitor (Models F6 and F9) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal Monitoring System and Accessories Regulatory Class: Class II Product Code: HGM Dated: November 4, 2008 Received: November 5, 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 Fetal and Maternal Monitor (Models F6 and F9), as described in your premarket notification:

> 1 MHz PW fetal probe - model F6 1 MHz PW fetal probe - model F9

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 [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 Glenn Bell, Ph.D., at [phone].

Sincerely yours,

loquítm Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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Fetal & maternal monitor 510K Submission

### Indication for Use

K0826002

510(k) Number (if known):

Device Name:

Fetal & Maternal Monitor (Models F6 and F9)

The Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.

Prescription Use (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

---

(Division Sign-Off)

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

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# Diagnostic Ultrasound indications for Use Form

## Fill out one form for each ultrasound system and each transducer. 1 MHz PW fetal probe- model F9

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 | | | | | | | | | | |

Additional Comments: ___ The above is a 1 mHz PW transducer for the fetal heart rate detection.

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

Imri In Whan

(Division Sign-Off) Divisior Regraductive, Abdominal, and Radiological Devic

510(k) Number

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

# Diagnostic Ultrasound indications for Use Form

## Fill out one form for each ultrasound system and each transducer. 1 MHz PW fetal probe- model F6

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 | | | | | | | | | | |
| Peripheraln Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal | | | | | | | | | | |
| Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other | | | | | | | | | | |
| N=new indication; P=previously cleared by FDA: e=ADDED UNDER appendix E | | | | | | | | | | |

ਦ

Additional Comments: _ The above is a 1 mHz PW transducer for the fetal heart rate detection.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE I FNEEDED

CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)

Irmu In Whay
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

(k) Number K082662