TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

K040392 · American I.V. Products, Inc. · HFM · Sep 14, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040392
• Device Name: TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
• Applicant: American I.V. Products, Inc.
• Product Code: HFM · Obstetrics/Gynecology
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2720
• Device Class: Class 2

Intended Use

These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

Device Story

AIV transducers (ultrasound and tocodynamometer) serve as replacement accessories for Corometrics and Hewlett Packard fetal monitors. Ultrasound transducers utilize Doppler shift technology to detect fetal heart rate; tocodynamometer transducers utilize strain gauges to detect uterine contractions. Devices are placed on the maternal abdomen and secured with elastic straps. Output is transmitted via cable to the host monitor, which processes the signals for clinical display. Healthcare providers use this data to monitor fetal status and labor progression. Benefits include continuous, non-invasive monitoring of fetal heart rate and uterine activity during pregnancy and labor.

Clinical Evidence

Bench testing only. Acoustic output testing confirmed power levels <20mW/cm2 average. Biocompatibility of plastics confirmed via consensus standards. No clinical data provided.

Technological Characteristics

Ultrasound transducers use pulsed Doppler technology (1.0 MHz center frequency). Tocodynamometer transducers use strain gauge sensors. Devices are non-sterile, reusable, and connect to host monitors via keyed, color-coded cables. Biocompatible plastics used. Acoustic output <20mW/cm2.

Indications for Use

Indicated for gravid patients, especially during labor, for the measurement of fetal heart rate and uterine contractions.

Regulatory Classification

Identification

An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.

Predicate Devices

• Corometrics Models 2264LAX (TOCO) (K982651)
• Corometrics 5700LAX (Ultrasound) (K982651)
• Epic Models EFT200-20 (TOCO) (K992811)
• Epic Models EFU200-20 (Ultrasound) (K992811)
• Hewlett Packard Models 1355 (TOCO) (K992811)
• Hewlett Packard Models 1356 (Ultrasound) (K992811)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2004

Mr. Gregory C. Falk American IV Products, Inc. 7485 Shipley Avenue HANOVER MD 21076

Re: K040392

Trade/Device Name: Transducers for Ultrasound and Tocodynamometer Fetal Monitoring Regulation Number: 21 CFR 884.2720 Regulation Name: External uterine contraction monitor and accessories Regulation Number: 21 CFR 884.2960 Regulation Name: Obstetric ultrasonic transducer and accessories Product Code: 85 HFM and HGL Dated: July 8, 2004 Received: July 12, 2004

Dear Mr. Falk:

This letter corrects our substantially equivalent letter of September 14, 2004 regarding the transducers for ultrasound and tocodynamometer fetal monitoring. The letter listed only the ultrasound transducers (FM10835, FM10836) to which the determination of substantial equivalence applies. However, the determination of substantial equivalence applies to all five transducers described in your premarket notification, i.e. FM10835, FM 10839, FM 10840, and FM 10841.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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. 1

This letter will allow you to continue marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Daniel A. Segerson

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

Enclosure

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Appendix B Page 1 of 3 Rev_6-28-04

# Indications for Use

510(k) Number (if known): K040392

Transducers for Ultrasound and Tocodynamometer Fetal Device Name: Monitoring

Indications For Use:

These devices are intended to be used as replacement accessories to Corometrics and Hewlett Packard Monitors, to measure fetal heart rate and uterine contractions in the gravid patient.

AIV Transducer Model Numbers: FM10835 and FM10836. These devices are a direct replacement for the EPIC EFU200-20, Ultrasound Transducer for measuring fetal heart rate.

AIV Transducer Model Numbers: FM10839 and FM10840. These devices are a direct replacement for the Corometric's 2264LAX. TOCO Transducer for measuring uterine contractions.

AIV Transducer Model Number: FM10841. This device is a direct replacement for the EPIC EFT200-20, TOCO Transducer for measuring uterine contractions.

Required information for the ultrasound transducers, relating to their indications for use, is attached.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Damilh Grayson

(Division Sign-Off)

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

Page 1 of

7485 Shipley Avenue · Hanover, MD · 21076 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com

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Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer

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

AIV Transducer Model Number: FM10835 Replacement for Epic Model Number EFU200-20 (also HP Model 1356)

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | 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 | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N = New indication
P = previously cleared by FDA
E = added under Appendix E
Intended for use with Philips Medical (HP) M1350A and Viridia Series 50 XM monitors.

Additional Comments: This device is a direct replacement for the EPIC EFU200-20 (and Hewlett Packard Model 1356, by Epic Substantial Equivalence K992811) Ultrasound Transducer for measuring fetal heart rate.

David A. Lagrone

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices

510(k) Number

Prescription Use_

7485 Shipley Avenue · Hanover, MD · 21076 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com

04033

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Appendix B Page 3 of 3 Rev_6-28-04

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer

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

AIV Transducer Model Number: FM10836 Replacement for Epic Model Number EFU200-20 (also HP Model 1356)

| | Mode of Operation | | | | | | | | | |
|-------------------------------|-------------------|---|---|-----|-------------------------------|------------------|----------------------------|------------------------------|-----------------------|--------------------|
| Clinical Application | 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 | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| N = New indication | | | | | P = previously cleared by FDA | | E = added under Appendix E | | | |

Intended for use with Philips Medical (HP) M1350A and Viridia Series 50 XM · monitors.

Additional Comments: This device is a direct replacement for the EPIC EFU200-20 (and Hewlett Packard Model 1356, by Epic Substantial Equivalence K992811) Ultrasound Transducer for measuring fetal heart rate.

David A. Snyam

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040392

Prescription Use_

7485 Shipley Avenue · Hanover, MD · 21076 · USA · p 800.990.2911 · f 410.787.1337 · www.aiv-inc.com

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SEP 1 4 2004

Image /page/5/Picture/1 description: The image contains the logo for AIV, which is a black star above the letters "aiv" in a stylized font. Below the logo is the text "Supporting Clinical Engineering Worldwide". The text is in a smaller font than the logo.

Appendix C Page 1 of 3 Rev 6-28-04

# 510(k) Summary (Ref:K040392)

## Submitter Information:

American IV Products, Inc. 7485 Shipley Avenue Hanover, MD 21076

### Contact:

Gregory Falk Engineering Manager Telephone: [phone] ext. 131 Fax:: [phone] e-mail: [e-mail]

#### Date Prepared:

February 13, 2004

#### Product Name:

Classification Name: Perinatal Monitoring System Accessories Common Name: Transducers for ultrasound and tocodynamometer fetal monitoring Proprietary Name: Transducers for ultrasound and tocodynamometer fetal monitoring

#### List of Submitted Devices:

| TOCO | Ultrasound |
|---------|------------|
| FM10839 | FM10835 |
| FM10840 | FM10836 |
| FM10841 | |

#### Predicate Device:

These AIV devices are equivalent to the following legally marketed devices: Corometrics Models 2264LAX (TOCO) K982651 5700LAX (Ultrasound) K982651

Epic Models EFT200-20 (TOCO) K992811 EFU200-20 (Ultrasound) K992811

Hewlett Packard Models 1355 TOCO) (by Epic equivalence reference K992811) 1356 (Ultrasound) (by Epic equivalence reference K992811)

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### Description:

AIV's ultrasound (US) and tocodynamometer (TOCO) transducers are replacements for similar transducers manufactured by Corometrics and Hewlett Packard for their respective monitors. The AIV transducers are also a replacement for similar transducers manufactured by Epic for use on Corometrics and Hewlett Packard monitors.

The US transducers are used to detect the fetal heart rate using Doppler shift technology. The TOCO transducers detect uterine activity using a strain gauge for evaluating contractions. These transducers are intended to be a direct replacement for the Corometrics, Hewlett Packard and Epic transducers.

#### Intended Use:

These devices are intended to be used as replacement transducer accessories for Corometrics and Hewlett Packard monitors, for use in measuring fetal heart rates and uterine contractions.

| | AIV | Corometrics | Epic |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-------------------------------|
| Intended Use | Measure fetal heart rate and uterine<br>contractions in the gravid patient. | Same | Same |
| Anatomical Sites | The ultrasound transducer is placed on<br>the maternal abdomen aimed at the fetal<br>heart; the TOCO transducer is placed on<br>the maternal abdomen over the fundal<br>area of the uterus. | Same | Same |
| Target Patient<br>Population | Gravid patients, especially during labor. | Same | Same |
| FHR Range | Dependent upon monitor specifications. | Same | Same |
| Uterine Activity<br>Range | Dependent upon monitor specifications. | Same | Same |
| Patient Use/Reuse | Reusable. | Same | Same |
| Sterility | Non-sterile | Same | Same |
| Description of<br>Patient Attachment | These devices attach to the gravid patient<br>with elastic straps around the waist. | Same | Same |
| Cable Length | 10 feet | | 8 feet |
| Accessories | Transducer belts and ultrasonic gel | Same | Same |
| Connector Design | Transducer cable connectors are color-<br>coded and keyed to fit the appropriate<br>fetal monitors. | Same | Same |
| Acoustic Output | <20mW/cm2 average | Same | Same |
| Operational<br>Characteristics | AIV FM10835 = Pulsed Doppler<br>AIV FM10836 = Pulsed Doppler | 5700LAX =<br>Pulsed Doppler | EFU200-20 =<br>Pulsed Doppler |
| Specifications<br>(Ultrasound Center<br>Frequency) | AIV FM10835 = 1.0 MHz<br>AIV FM10836 = 1.0 MHz | 5700LAX =<br>1.151 MHz | EFU200-20 =<br>1.0 MHz |

#### Comparison to Predicate Device:

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# Performance Data and Conclusions:

- . Acoustic output testing shows power is less than 20mW/cm2 average.
- AIV assembly design is equivalent to predicate device assembly design. .
- . Bench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies.
- . AIV plastics have conformed to consensus standards relating to Biocompatibility.
- These devices do not raise new issues of safety and effectiveness, nor do they alter the . fundamental technology of the predicate devices.