(79 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard physiological monitoring parameters and features without mentioning any AI/ML capabilities.
No
The device is a monitor used for non-invasive and invasive monitoring of a fetus during antepartum examination, labor, and delivery. It detects and displays physiological parameters (FHR, TOCO, IUP/DECG) but does not provide treatment or modify bodily functions.
Yes
The device is described as a "Fetal & Maternal Monitor" intended for "non-invasive and invasive monitoring of fetus" and provides features like monitoring "FHRs using ultrasound and uterine activity" and "Internal parameters: IUP/DECG." Monitoring physiological parameters to assess the health status of a patient is a diagnostic function.
No
The device description explicitly lists multiple hardware components, including transducers, a built-in wireless module, a lithium battery, probe and wall mounting racks, and an optional fetal stimulator. It also mentions hardware testing in the performance studies summary.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Fetal & Maternal Monitor is used for monitoring physiological parameters (FHR, TOCO, IUP, DECG) of the fetus and mother directly within the body (non-invasive and invasive monitoring). It uses ultrasound and other transducers applied to or inserted into the patient.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It measures signals generated by the body.
Therefore, the Fetal & Maternal Monitor falls under the category of a medical device used for monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
1 MHz PW fetal probe- model F9
Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application: Fetal
Mode Operation: PWD (N)
1 MHz PW fetal probe- model F6
Intended use : Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Clinical Application: Fetal
Mode Operation: PWD (N)
Product codes
HGM
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
- 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
Transducers intended for use with the Fetal and Maternal Monitor (Models F6 and F9):
- 1 MHz PW fetal probe - model F6
- 1 MHz PW fetal probe - model F9
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, DECG, TOCO, IUPC
Anatomical Site
Fetus, Uterine
Indicated Patient Age Range
Pregnant women from the 28th week of gestation.
Intended User / Care Setting
Trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
It is not intended for use in intensive care units, operating rooms or for home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: 86-755-26882220
Fax:86-755-26882223
Responsible person: Jiang Yucai |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official correspondent: | William Stern
Multigon Industries, Inc.
1 Odell Plaza
Yonkers, N.Y. 10701
Phone: 914 376 5200 X27
Fax: 914 376 6111 |
| 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
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
1
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
Monitor | CADENCE II | Corometrics 120 series
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
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. | | |
| Contraindications: | It is not intended for use in intensive care units, operating rooms or for home
use. | | |
| Test Summary: | 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 | | |
| 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. | | |
2
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.
3
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 Glenn Bell, Ph.D., at (240) 276-3666.
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
4
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
5
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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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 | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (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