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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the fetal monitoring transducers, formatted as requested:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Acoustic Output < 20mW/cm² average	Acoustic output testing shows power is less than 20mW/cm² average.
Assembly design equivalent to predicate device	AIV assembly design is equivalent to predicate device assembly design.
Performance as intended and equivalent to predicate device assemblies	Bench Testing demonstrates that the AIV devices perform as intended and are equivalent to predicate device assemblies.
Biocompatibility	AIV plastics have conformed to consensus standards relating to Biocompatibility.
Does not raise new issues of safety and effectiveness	"These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices."
Does not alter fundamental technology of predicate devices	"These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices."
Intended Use: Measure fetal heart rate and uterine contractions in the gravid patient (same as predicate)	The AIV 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, which is "Same" as the predicate devices.
Anatomical Sites (same as predicate)	The ultrasound transducer is placed on the maternal abdomen aimed at the fetal heart; the TOCO transducer is placed on the maternal abdomen over the fundal area of the uterus (Same as predicate).
Target Patient Population (same as predicate)	Gravid patients, especially during labor (Same as predicate).
FHR Range (same as predicate: dependent upon monitor specifications)	Dependent upon monitor specifications (Same as predicate).
Uterine Activity Range (same as predicate: dependent upon monitor specifications)	Dependent upon monitor specifications (Same as predicate).
Patient Use/Reuse: Reusable (same as predicate)	Reusable (Same as predicate).
Sterility: Non-sterile (same as predicate)	Non-sterile (Same as predicate).
Description of Patient Attachment (same as predicate)	These devices attach to the gravid patient with elastic straps around the waist (Same as predicate).
Cable Length: 10 feet (predicate varied)	10 feet (predicate varied, e.g., Epic had 8 feet). This is a point of minor difference but not flagged as non-equivalent.
Accessories (same as predicate)	Transducer belts and ultrasonic gel (Same as predicate).
Connector Design (same as predicate)	Transducer cable connectors are color-coded and keyed to fit the appropriate fetal monitors (Same as predicate).
Operational Characteristics (Pulsed Doppler)	AIV FM10835 = Pulsed Doppler; AIV FM10836 = Pulsed Doppler (Same as predicate).
Ultrasound Center Frequency (approx. 1.0 MHz)	AIV FM10835 = 1.0 MHz; AIV FM10836 = 1.0 MHz (predicate 5700LAX = 1.151 MHz, EFU200-20 = 1.0 MHz). The AIV devices match one predicate directly and are close to the other.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set. This was a 510(k) premarket notification for a replacement accessory, focusing on equivalence to predicate devices rather than a new clinical study with a test set of patients.
- Data Provenance: Not applicable in the context of a clinical test set. The data presented is from bench testing and conformity to standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with ground truth established by experts. The determination of substantial equivalence relies on comparison to existing, legally marketed devices and specified technical performance.
Adjudication method for the test set:
- Not applicable. No test set requiring adjudication is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (transducer) for measuring physiological signals, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is an accessory transducer, not a standalone algorithm. The "performance" assessment is based on physical and technical characteristics and its ability to function as a direct replacement for predicate transducers.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the performance and specifications of the predicate devices (Corometrics, Epic, Hewlett Packard transducers) and established consensus standards (e.g., for biocompatibility, acoustic output limits). The AIV transducers aim to meet or be equivalent to these.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this device is not an AI algorithm.

Summary

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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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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) 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 (800) 638-2041 or (301) 443-6597 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	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-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.

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: 410-787-1300 ext. 131 Fax:: 410-787-1337 e-mail: gfalk@aiv-inc.com

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:

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 uterinecontractions in the gravid patient.	Same	Same
Anatomical Sites	The ultrasound transducer is placed onthe maternal abdomen aimed at the fetalheart; the TOCO transducer is placed onthe maternal abdomen over the fundalarea of the uterus.	Same	Same
Target PatientPopulation	Gravid patients, especially during labor.	Same	Same
FHR Range	Dependent upon monitor specifications.	Same	Same
Uterine ActivityRange	Dependent upon monitor specifications.	Same	Same
Patient Use/Reuse	Reusable.	Same	Same
Sterility	Non-sterile	Same	Same
Description ofPatient Attachment	These devices attach to the gravid patientwith 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-coded and keyed to fit the appropriatefetal monitors.	Same	Same
Acoustic Output	<20mW/cm2 average	Same	Same
OperationalCharacteristics	AIV FM10835 = Pulsed DopplerAIV FM10836 = Pulsed Doppler	5700LAX =Pulsed Doppler	EFU200-20 =Pulsed Doppler
Specifications(Ultrasound CenterFrequency)	AIV FM10835 = 1.0 MHzAIV FM10836 = 1.0 MHz	5700LAX =1.151 MHz	EFU200-20 =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.

Regulation Number and Section

§ 884.2720 External uterine contraction monitor and accessories.

(a)
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.(b)
Classification. Class II (performance standards).