(139 days)
These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.
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 Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.
The provided document is a 510(k) Summary for a medical device (Transducers for Ultrasound Fetal Monitoring) and does not contain detailed information about a clinical study or specific acceptance criteria for performance metrics beyond general functional equivalence.
However, I can extract the relevant information that is present and indicate where specific details you requested are not available in this document.
Here's an attempt to answer your request based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from comparison to predicate) | Reported Device Performance (from "Performance Data and Conclusions") |
|---|---|
| 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. |
| Biocompatibility (Conforms to consensus standards) | AIV plastics have conformed to consensus standards relating to Biocompatibility. |
| Perform as intended (measure fetal heart rate) | Alv assembly design is equivalent to producted by devices perform as intended and are equivalent to predicate device assemblies. |
| Does not raise new safety or effectiveness issues, nor 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. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document primarily focuses on demonstrating equivalence through design and testing of fundamental characteristics rather than a clinical trial with a defined test set of patients.
- Data Provenance: Not specified. Given the nature of the tests (acoustic output, biocompatibility, assembly design comparison), it's likely laboratory-based. No patient data or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for these types of engineering and material tests would be established through accredited laboratory methods and technical specifications, not expert clinical consensus.
4. Adjudication method for the test set
Not applicable. There's no indication of an adjudication method used. The "performance data" describes physical and material properties rather than clinical outcomes requiring expert review.
5. 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 device is a passive transducer for fetal monitoring, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-assistance evaluation is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is hardware (transducer) and does not involve an algorithm for standalone performance evaluation in the context of an AI device.
7. The type of ground truth used
- Acoustic Output: Likely established through standardized acoustic power measurement techniques and equipment.
- Assembly Design: Established by expert engineering comparison against the predicate device's design and specifications.
- Biocompatibility: Established by adherence to recognized consensus standards (e.g., ISO 10993 series) through laboratory testing.
- Performance as Intended: Inferred equivalence based on the above tests and similarity to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable (no training set).
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AUG 1 6 2004
Image /page/0/Picture/1 description: The image shows the logo for AIV, which is a company that supports clinical engineering worldwide. The logo consists of a star above the letters "aiv" in a stylized font. Below the logo is the text "Supporting Clinical Engineering Worldwide".
Appendix C Page 1 of 2
510(k) Summary
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:
March 26, 2004
Product Name:
Classification Name: Perinatal Monitoring System Accessories Common Name: Transducers for ultrasound fetal monitoring Proprietary Name: Transducers for ultrasound fetal monitoring
Predicate Device:
These AIV devices are equivalent to the following legally marketed devices: Corometrics Models 5700LAX (Ultrasound) K982651
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 Doppier shift technology. These transducers are intended to be a direct replacement for the Corometrics transducers.
Intended Use:
These devices are intended to be used as replacement transducer accessories for Corometrics monitors, for use in measuring fetal heart rates.
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Kujira 10x
| AIV | Corometrics | |
|---|---|---|
| Intended Use | Measure fetal heart rate and uterinecontractions in the gravid patient. | 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 |
| Target PatientPopulation | Gravid patients, especially during labor. | Same |
| FHR Range | Dependent upon monitor specifications. | Same |
| Uterine ActivityRange | Dependent upon monitor specifications. | Same |
| Patient Use/Reuse | Reusable. | Same |
| Sterility | Non-sterile | Same |
| Description ofPatient Attachment | These devices attach to the gravid patientwith elastic straps around the waist. | Same |
| Cable Length | 10 feet | |
| Accessories | Transducer belts and ultrasonic gel | Same |
| Connector Design | Transducer cable connectors are color-coded and keyed to fit the appropriatefetal monitors. | Same |
| Acoustic Output | <20mW/cm2 average | Same |
| OperationalCharacteristics | AIV FM10833 = Pulsed DopplerAIV FM10834 = Pulsed DopplerAIV FM10835 = Pulsed Doppler | 5700LAX =Pulsed Doppler |
| Specifications(Ultrasound CenterFrequency) | AIV FM10833 = 1.151 MHzAIV FM10834 = 1.151 MHzAIV FM10835 = 1.0 MHz | 5700LAX =1.151 MHz |
Comparison to Predicate Device:
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. .
- Al v assembly design is oquivalent to producted by devices perform as intended and are equivalent . to predicate device assemblies.
- to prodiouts do not accembility.
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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/3 description: The image shows the date August 16, 2004. The text is in a simple, bold font. The date is written in the format of month, day, and year. The text is black and the background is white.
Mr. Gregory Falk Engineering Manager American IV Products, Inc. 7485 Shipley Avenue HANOVER MD 21076
Rc: K040819
Trade/Device Name: Transducers for Ultrasound Fetal Monitoring Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories
Regulatory Class: II Product Code: 85 HGM Dated: July 9, 2004 Received: July 12, 2004
Dear Mr. Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section - 10(t) production is substantially equivalent (for the indications ferenced above and nave decemblied the enclosed devices marketed in interstate for use stated in the encrosure) to tegars mannel date of the Medical Device Americal Developments, or to commerce prof to May 26, 1970, the cliaving with the provisions of the Federal Food, DNA devices that have been recalismed in accordance approval of a premarket approval application (PMA). and Cosmelle Act (Ret) that do not require approvince the general controls provisions of the Act. The Y ou may, therefore, market the device, backed requirements for annual registration, listing of general controls provisions of the received in the readulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (SCC above) into elthir elass regulations affecting your device can
may be subject to such additional controls. Existing major regulations of th may be subject to such additional ochironal ons. Little 21, Parts 800 to 898. In addition, FDA may be found in the Code of I outstal reg.
publish 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 experience that FIFA has made a decermination that your as receed by other Federal agencies. You must comply of CEP Part of any regeral statutes and regulations and limited to: registration and listing (2) CFR Part with an the Act STEquirements, including, cartice requirements as set forth in the 807), labeling (21 C.FR Part 820), 5000, and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820), and if applicable, 1980, 1958, quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to oegin manteang your device of your device to a legally premarket notification. The PDA instification 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 If you desire specific advice for your de tot to to to to to to to 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 Additionally, for questions 01) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanos at (21CFR Part 807.97) you may obtain. Other general of Yelector to premarked notified in the Act may be obtained from the Division of Small information on your responsibility of the many 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,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K040819 510(k) Number (if known):
Transducers for Ultrasound Fetal Monitoring Device Name:
Indications For Use:
These devices are intended to be used as replacement accessories to Corometrics Monitors, to measure fetal heart rate in the gravid patient.
AIV Transducer Model Numbers: FM10833 and FM10834. These devices are direct replacements for the Corometric's 5700LAX.
Intended for use with Corometrics Fetal monitor models: 116,118,120 Series,150,151,155 and 340
Required information for the ultrasound transducers, relating to their indications for use, is attached.
Prescription Use (Part 21 CFR 801 Subpart D) ADDIOR
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)
Daniel h. Lyman
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
Page 1 of
§ 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).