FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS

K100797 · Edan Instruments, Inc. · HGM · Nov 10, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100797
• Device Name: FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
• Applicant: Edan Instruments, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Nov 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

Indications for Use

The F6 Express and F9 Express fetal & maternal monitor is intended for monitoring physiological parameters of pregnant women during ante-partum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms. F6 Express and F9 Express fetal & maternal monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

Device Story

Fetal & Maternal Monitor (Models F6/F9 Express) monitors physiological parameters during pregnancy, labor, and delivery. Inputs include fetal heart rate (FHR) via 1 MHz PW ultrasound probes, uterine activity (TOCO), internal parameters (IUP, DECG), and maternal vital signs (ECG, SpO2, NIBP, temperature). Device processes signals to provide real-time monitoring and limit alarms. Used in clinical settings (antepartum, labor/delivery rooms) by trained personnel. Output displayed for clinician review to assess fetal well-being and maternal status, supporting clinical decision-making during labor and delivery.

Clinical Evidence

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

Technological Characteristics

Perinatal monitoring system using 1 MHz PW ultrasound transducers for FHR. Parameters include FHR, TOCO, IUP, DECG, MECG, SpO2, NIBP, and temperature. System is a multi-parameter monitor for clinical use. Software-based processing for signal analysis and alarm management.

Indications for Use

Indicated for pregnant women from 28th week of gestation for fetal monitoring, Non-Stress testing, and maternal vital signs 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

• Edan Instruments F9/F6 Maternal/Fetal Monitor (K082602)
• GE Healthcare GE129 Maternal/Fetal Monitor (K991739)

Submission Summary (Full Text)

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#### Attachment 3

### 510(k) Summary

NOV 1 0 2010

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### Date prepared: September 20, 2010

#### 1. Applicant:

Edan Instruments, Inc. 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China Contact person: Randy Jiang

#### 2. Manufacturer:

Edan Instruments, Inc. 3/F - B. Nanshan Medical Equipments Park, Nanhai Rd 1019#, shekou, Nanshan Shenzhen, 518067 P.R. China

#### 3. Submitter:

Mr. Jigar Shah Official Correspondent for Edan Instruments, Inc. mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: [phone] Fax: [phone] [e-mail]

#### 4. Trade/proprietary Name: Fetal & Maternal Monitor (Models F9 Express and F6 Express)

- 5. Classification name: 21 CFR 884.2740 Perinatal monitoring system and accessories.
- 6. Product Code: HGM

7. Predicate Devices:

- Edan Instruments F9/F6 Maternal/Fetal Monitor K082602 .
- GE Healthcare GE129 Maternal/Fetal Monitor K991739 .

#### 8. Device Description

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

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K100797 p. 2 of 3

- Basic parameters: FHR, TOCO, Event Mark, AFM .
- Dual FHR monitoring .
- Internal parameters: IUP, DECG .
- FHR limit alarm

Following facilities are also provided in addition to the above:

- Maternal ECG monitoring .
- Maternal SpO2 monitoring .
- Maternal NIBP .
- Maternal temperature monitoring .

#### 9. Intended Use:

The F9 Express and F6 Express fetal & maternal monitor is intended for monitoring physiological parameters of pregnant women 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.

F9 Express and F6 Express fetal & maternal monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

#### 10. Contraindications:

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

| Monitoring mode | F6 & F9 Express<br>New Device | F6 & F9<br>K082602 | COROMETRICS 120<br>SERIES (129<br>configuration)K991739 |
|-----------------|-------------------------------|--------------------|---------------------------------------------------------|
| FHR/ Dual FHR | Yes | Yes | Yes |
| TOCO | Yes | Yes | Yes |
| Fetal ECG, IUP | Yes | Yes | Yes |
| MECG | Yes | | Yes |
| SpO2 | Yes | | Yes |
| NIBP | Yes | | Yes |

#### 11. Substantial Equivalence Discussion:

#### 12. Summary of Testing:

The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor:

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

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## 13. Conclusion:

・

Verification and validation testing was done on the Fetal & Maternal Monitor. This premarket notification submission demonstrates that Fetal & Maternal Monitor is substantially equivalent to the predicate device.

KID0797

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. The bird is composed of three curved lines that suggest the shape of the wings and body.

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

Edan Instruments, Inc. c/o Mr. Jigar Shah Official Correspondent mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

NOV 1 0 2010

Re: K100797

Trade/Device Name: Fetal and Maternal Monitor (Models F6 Express and F9 Express) Regulation Number: 21 CFR \$884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: November 5, 2010 Received: November 8, 2010

Dear Mr. Shah:

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. Jigah Shah

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 (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 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 Kathy Daws-Kopp, at [phone].

Sincerely vours.

Hebert Semmler

Herbert P. Lerner, MD, Director (Acting) Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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# Indication for Use

NOV 1 0 2010

510(k) Number (if known):_K100797

Device Name: Fetal & Maternal Monitor (Models F6 Express and F9 Express)

F6 Express and F9 Express fetal & maternal monitor is intended for monitoring physiological parameters of pregnant women during ante-partum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

F6 Express and F9 Express fetal & maternal monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.

× 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)

Hula Leun

on of Reproductive, Gastro-Renal, and ogical Devices 0(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 F6 Express

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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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 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)

Hebert Senn

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number .

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

# Diagnostic Ultrasound indications for Use Form Fill out one form for each ultrasound system and each transducer. 1 MHz PW fetal probe- model F9 Express

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 Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (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

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)

Heber Leum

( Division Sign-Off) Di ision of Reproductive, Gastro-Urological Devices 510(k) Number