The Cadence Fetal Monitor , model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartum period. It performs what is commonly called the non stress test.

The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.

Device Description

The Cadence Fetal monitor is a perinatal monitoring system for non-invasively measuring, displaying and printing out in graphic form on a strip chart recorder maternal abdominal contractions and fetal heart rate for either a singleton fetus or twin fetuses during the last trimester. A manual hand held pushbutton marker for patient identification of contractions is also part of the monitor. The Cadence Fetal monitor uses one or two ultrasound transducers for monitoring the fetal heart rate (FHR) depending on whether there is a singleton or twin pregnancy. The multi crystal , broad band ultrasound transducer operates at a frequency of 2 mHz. The ultrasound transducer or transducers are placed on the maternal abdomen by means of one or two belts and transmits the ultrasound signal to the fetal heart(s). The transducer(s) also receive the echo from the fetal heart(s) and processes the echoes determining the fetal heart rate(s) The TOCO transducer is also placed on the maternal abdomen with a belt and it detects the forward displacement of the maternal abdominal muscles during a contraction. The TOCO transducer is a tocotonometer which operates on the strain gauge principle to measure displacement. The central section of the TOCO transducer is depressed by the forward displacement of the abdominal muscles during a contraction. It is used for assessing frequency and duration of uterine contractions. It gives an indication of contractions pressure.

The fetal heart rate(s) and TOCO percent contractions pressure are displayed on numerical readouts and printed out on a strip chart recorder in graphic form.

A fetal event marker pushbutton is also available for the patient to identify contractions manually by pushing the button on the fetal event marker.

AI/ML Overview

The Cadence Fetal Monitor device was deemed substantially equivalent to predicate devices (Sonicaid 820 and Corometrics 171/172) based on

principles of operation
specifications
performance

This means that the device meets the same acceptance criteria as the predicate devices. The submission indicates that "Extensive safety, performance testing, and validation" were performed to ensure the device met "all of its functional requirements and performance specifications" and complied with safety standards. However, specific acceptance criteria and detailed performance results from this testing are not explicitly reported in the provided text.

Based on the information provided, here's a summary:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criteria (Derived from Predicate Comparison)	Cadence 2001/2002 Performance
Fetal Heart Detection: Pulsed Doppler With Auto-Correlation	Yes
Fetal Heart Rate Display Units: 1 BPM	1 BPM
Fetal Heart Rate Range: 50-210 BPM (Predicate ranges 30-240 BPM / 50-210 BPM)	50-210 BPM
Ultrasound Frequency: 2 MHz (Predicate ranges 1.15-2.0 MHz)	2 MHz
Fetal Heart Rate Alarms: Yes	Yes
Toco Transducer Type: Strain gauge	Strain gauge
Toco Range (relative units): 0-100	0-100
Toco Resolution (relative units): 1	1
Chart Recorder: Yes	Yes
Numeric Display Of Results: Yes	Yes
Ultrasound Power (ISPTA): < 100 mW/sq.cm (Predicate values 5 ISATA / Less than 100 ISPTA)	6.972 ISPTA
Safety and Effectiveness: Equivalent to predicates	Demonstrated (through testing and validation)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance tests. It generically mentions "Extensive safety, performance testing, and validation" but provides no details on these aspects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not provided in the document. The Cadence Fetal Monitor is a hardware device for monitoring, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be applicable in this context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not explicitly stated. The device itself is designed for continuous monitoring and provides numerical and graphical readouts to be used by trained medical personnel. Its "standalone" performance would refer to its ability to accurately detect FHR and TOCO measurements, which is implied by the performance testing mentioned, but no specific standalone study details are given.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document does not explicitly describe the type of ground truth used for validating the device's measurements. For a fetal monitor, ground truth would typically involve comparing the device's FHR and TOCO readings against established medical standards or other validated monitoring equipment, but the details of this comparison are not provided.

8. The Sample Size for the Training Set

This information is not provided in the document. As this is a hardware device based on established principles of operation (Pulsed Doppler with auto-correlation and strain gauge for TOCO), it would likely not involve a "training set" in the sense of machine learning algorithms. Its design and calibration would be based on engineering principles and preclinical testing.

9. How the Ground Truth for the Training Set Was Established

As noted above, this information is not applicable in the context of a "training set" for a traditional hardware medical device like a fetal monitor.

Summary

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CADENCE 510k SUBMISSION -

Cadence Fetal Monitor Edan Instruments, Inc.

SUMMARY

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

Submitters name, address, phone number, contact person and 1. preparation date:
Name:

Edan Instruments, Inc. 4/F, New Energy Building 2009 Nanyou Road Nanshan, Shenzhen, Guangdong 5188054 China Phone: 86 755 26062059 86 755 26062022 Fax: Responsible person: Xie Xicheng

Official Correspondent:

William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 914 376 5565 Fax:

Date of Preparation: 4/2/04

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040903

2. Device:
Proprietary Name: Cadence Ante partum Fetal Monitor model 2001 (Singleton) and model 2002 (Twins)
Common Name: Fetal Monitor
Classification Name: 21 CFR 884.2740 System, Monitoring, Perinatal
Product Code: HGM
Manufactured By: Edan instruments, Inc. China
2. Predicate Devices: Comparison of the Cadence Fetal monitor to the Predicate Devices
DEVICE	CADENCE 2001,2002	SONICAID 820	COROMETRICS 171 AND 172
ATTRIBUTE
510k Number	K040903	K002150	K991905
Singleton (model 2001)	yes	yes	yes
Twins (model 2002)	yes	yes	yes
Fetal Heart Detection: Pulsed Doppler With Auto-Correlation	yes	yes	yes
Fetal Heart Rate Display Units	1 BPM	1 BPM	1 BPM
Fetal Heart Rate Range	50-210 BPM	30-240 BPM	50-210 BPM
Ultrasound Frequency	2 MHz	1.5 MHz and 2.0 MHz	1.15 MHz
Ultrasound	6.972 ISPTA	less than 100 ISPTA	5 ISATA

Power (mw/sq.cm)

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KOYO903

Fetal HeartRate Alarms	yes	yes	yes
DEVICE	CADENCE	SONICAID 820	COROMETRICS171/172
ATTRIBUTE
TocoTransducerType	strain gauge	strain gauge	strain gauge
Toco Range(relative units)	0-100	0-100	0-100
Toco Resolution(relative units)	1	1	1
Chart Recorder	yes	yes	yes
Numeric DisplayOf Results	yes	yes	yes

Conclusion: The Cadence model 2001 singleton and 2002 twin monitors are Similar and equivalent to the two predicate devices , the Sonicaid 820 and the Corometrics 171/172 in principles of operation, specifications, and performance.

3. Classification Names:

Class II as per 21 CFR 884.2740 System., Monitoring,Perinatal

Description ഗ
The Cadence Fetal monitor is a perinatal monitoring system for non-invasively measuring, displaying and printing out in graphic form on a strip chart recorder maternal

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abdominal contractions and fetal heart rate for either a singleton fetus or twin fetuses during the last trimester. A manual hand held pushbutton marker for patient identification of contractions is also part of the monitor. The Cadence Fetal monitor uses one or two ultrasound transducers for monitoring the fetal heart rate (FHR) depending on whether there is a singleton or twin pregnancy. The multi crystal , broad band ultrasound transducer operates at a frequency of 2 mHz. The ultrasound transducer or transducers are placed on the maternal abdomen by means of one or two belts and transmits the ultrasound signal to the fetal heart(s). The transducer(s) also receive the echo from the fetal heart(s) and processes the echoes determining the fetal heart rate(s) The TOCO transducer is also placed on the maternal abdomen with a belt and it detects the forward displacement of the maternal abdominal muscles during a contraction. The TOCO transducer is a tocotonometer which operates on the strain gauge principle to measure displacement. The central section of the TOCO transducer is depressed by the forward displacement of the abdominal muscles during a contraction. It is used for assessing frequency and duration of uterine contractions. It gives an indication of contractions pressure.

The fetal heart rate(s) and TOCO percent contractions pressure are displayed on numerical readouts and printed out on a strip chart recorder in graphic form.

A fetal event marker pushbutton is also available for the patient to identify contractions manually by pushing the button on the fetal event marker.

Indications for Use. 6.
The Cadence Fetal Monitor, model 2001 for singletons and model 2002 for twins, is a fetal monitor for monitoring fetal well being during the antepartum period. It performs what is commonly called the non -stress test.

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k 640903

The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals, clinics, physicians offices and in the patients home by prescription or doctors orders. -

1. Contra-Indications.
  None known at this time
Comparison to Predicate Devices. 8.
The Cadence Fetal Monitor has the same device characteristics of all of the approved predicate devices listed in item 3 above with the commonality of ultrasound transducer(s) principles of operation, TOCO transducer principle of operation, ultrasound fetal heart detection and display, contraction detection and display and fetal event marker and display, and graphic recording and display available.
ರು. Test Data:
The Cadence Fetal monitor device has been subjected to Extensive safety, performance testing, and validation before release. Final testing of the Cadence Fetal monitor included various performance tests designed to ensure that the device met all of its functional requirements and performance specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards.

The Cadence fetal monitor device labeling includes instructions for safe and effective use, warnings, cautions, and guidance for use. It has been shown there fore to be safe and effective.

1. Literature Review:
  A review of the literature pertaining to the safety of the Cadence Fetal monitor has been conducted and appropriate safeguards have been incorporated in the design of the Cadence Fetal monitor.
1. Conclusions:
  The conclusion drawn from these tests is that the Cadence

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K040903

Fetal monitor is equivalent in safety and efficacy to the predicate devices listed in # 3. above.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2004

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

Re: K040903

Trade/Device Name: Cadence Antepartum Fetal Monitor; Model 2001 -Cadence (singleton) and Model 2002 -- Cadence Dual (twin) Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: 85 HGM Dated: August 4, 2004 Received: August 10, 2004

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 Cadence Antepartum Fetal Monitor as described in your premarket notification:

Transducer Model Number

2 MHz PW Doppler 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 may of cable of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish

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Page 2 - Mr. William Stern

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 r you added office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Mr. Slade Stratton at (301) 594-1212.

Sincerely yours.

David An. Syzomm

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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CADENCE MODEL 2001 CADENCE MODEL 2002 DUAL 510K SUBMISSION

Appendix F

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer. เกิโคที่มีสินธุรีส์ โดยสิทธิริโทรทัศน์ PROBE: - เปรีย สิทธิประเร็ง of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	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-skeletaiConventional
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 Pulsed Wave Transducer for fetal heart rate detection

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Darrel R. Larson

(Division Sian-Off) Division of Reproductive, Abdom and Radiological Devic 510(k) Number

Prescription Use (Per 21 CFR 801.109)

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CADENCE MODEL 2001 CADENCE MODEL 2002 DUAL 510K SUBMISSION

Indications for Use

510(k) Number (if known):

K040903

Device Name:

Fietal Monitor 2001/2002 Cadence

Indications For Use:

The Cadence Fetal Monitor 2001/2002 is to be used by trained medical personnel in hospitals clinics, physicians offices, and in the patients home by prescription or doctors orders.

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ No (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) 14

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Dev 510(k) Number

Page 1 of 2

Regulation Number and Section

§ 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).