(374 days)
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to obtain signals to monitor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor.
Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.
The provided text is a 510(k) summary for Cetro America, Inc.'s Transducers for Ultrasonic and Tocodynamometer fetal monitoring. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not describe a study involving detailed acceptance criteria and reported device performance metrics in the way that would typically be associated with AI/ML device validation. This is a clearance for replacement medical transducers based on substantial equivalence to existing devices, not a study evaluating an AI algorithm's performance.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by demonstrating substantial equivalence to predicate devices and conformity to consensus performance standards. The "reported device performance" is not quantified with specific metrics like sensitivity, specificity, or AUC, but rather by stating that "Bench testing demonstrates that the devices perform as intended."
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use (Ultrasound) | To detect, measure and record fetal heart rate and the duration and frequency of uterine contractions during labor. | "Same" as predicate devices (Corometrics 174 & 145, HP 1356, AMS IM-76 & IM-77). Implicitly, the device successfully detects, measures, and records FHR and uterine contractions as intended. |
| Intended Use (Toco) | To detect, measure and record uterine pressure to determine timing of contractions. | "Same" as predicate devices. Implicitly, the device successfully detects, measures, and records uterine pressure as intended. |
| Target Patient Population | Gravid patients, particularly during labor. | "Same" as predicate devices. |
| Anatomical sites | Ultrasound on abdomen aimed at fetal heartbeat; Toco on abdomen at top of uterus. | "Same" as predicate devices. |
| FHR Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same FHR range as the monitors it's compatible with. |
| Uterine Activity Range | As per monitor system specifications. | "Same" as predicate devices. Implicitly, it operates within the same uterine activity range as the monitors it's compatible with. |
| Patient Use/Reuse | Reusable. | "Same" as predicate devices. |
| Sterility | Non-sterile. | "Same" as predicate devices. |
| Patient Attachment | Attaches with elastic belts strapped to the patient. | "Same" as predicate devices. |
| Cable Length | Eight feet. | "Same" as predicate devices. |
| Accessories | Transducer belts and Ultrasonic Gel. | "Same" as predicate devices. |
| Connector Design | Color-coded and designed to fit appropriate monitoring system. | "Same" as predicate devices. |
| Acoustic Output (Ultrasound) | <20mW/cm² average. | "Same" as predicate devices. Implicitly, the acoustic output is <20mW/cm² average. |
| Operational Characteristics | Pulsed Doppler for Ultrasonic transducers. | Cetro 8031010-02, 8031011-02, 8031012-02 are Pulsed Doppler. Compared to specific predicate models (HP 1356, AMS IM-76, AMS IM-77), "Same" where applicable. |
| U/S Center Frequency | Specific frequencies for each model: 1.536 MHz (8031010-02), 1.024 MHz (8031011-02), 0.9984 MHz (8031012-02). | Confirmed frequencies listed for each model. Compared to specific predicate models (HP 1356, AMS IM-76, AMS IM-77), "Same" where applicable. |
| General Performance | Conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility. | "The company declares conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility." "Bench testing demonstrates that the devices perform as intended." This implies successful demonstration of safety, electrical, mechanical, biocompatibility, and functional performance consistent with the intended use and predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A). This document describes a 510(k) submission for medical device transducers. The "study" mentioned is bench testing for substantial equivalence, not a clinical trial with a defined test set of patient data, data provenance, or retrospective/prospective nature as one would find for an AI/ML diagnostic device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. Ground truth from experts is not a concept applied in this type of substantial equivalence submission for transducers. The performance is assessed against technical specifications and comparison to predicate devices, not expert human interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is described because there are no human interpretations of a test set to adjudicate.
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
- N/A. This is not an AI/ML device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML device. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the technical specifications and established performance characteristics of the predicate devices and relevant consensus performance standards (Electrical/Mechanical/Thermal Safety, Biocompatibility). The device's performance is deemed acceptable if it meets these technical specifications and shows equivalence.
8. The sample size for the training set
- N/A. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- N/A. Not an AI/ML device.
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Appendix A Section E - 510 K Summary
APR 1 0 2006
Applicant Information
Applicant Information: Cetro America, Inc. 925 Sherman Avenue Hamden, CT 06514 Phone: (203) 248-0500 Fax: (203) 288-9032 E-mail: admin@cetroamerica.com
Establishment Registration Number: 3004167720
Contact Information:
Maya Cianciolo Cetro America 925 Sherman Avenue Hamden, CT 06514 Phone: (203) 248-0500 Fax: (203) 288-9032 E-mail: admin@cetroamerica.com
Date Prepared: March 14, 2005 Device Name Device Trade Name:
| Cetro America Replacement Device TradeName | OEM Equivalent Device Name |
|---|---|
| TOCO Transducer Model 8032009-04 | HP Toco 1355A for 1350+ Series and morerecent model monitors |
| ULTRASONIC Transducer Model 8031012-02 | HP Ultrasound 1356 A for 1350 SeriesMonitor |
| TOCO Transducer Model 8032010-04 | Corometrics Toco for all model monitors |
| TOCO Transducer Model 8032007-04 | AMS/Spacelabs TD84 for FM Model IM76and AM 66 |
| ULTRASONIC Transducer Model 8031010-02 | AMS/Spacelabs US91 for FM Model 1M76and AM 66 |
| TOCO Transducer Model 8032008-04 | AMS/Spacelabs TD84 for FM Model IM77and AM 67 |
| ULTRASONIC Transducer Model 8031011-02 | AMS/Spacelabs US915 for FM Model IM77and AM 67 |
Device Common Name: Transducers for Ultrasonic and Tocodynamometer fetal monitoring
Device Classification: Class II (performance standards) Regulation Description: Perinatal monitoring system and accessories.
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Regulation Numbers: 21 CFR 884.2740 Product Codes: 85 HGM Predicate Device
Predicate Device: These devices are equivalent to the following legally marketed devices:
- Corometrics 174 (U/S 5700 and TOCO 2260) K891595 .
- Corometrics 145 K852076 .
- HP 1356 (U/S 1356A and TOCO 1355A) K900480 .
- . AMS IM-76 (U/S US91 and TOCO TD84) K852518
- AMS IM-77 (U/S US915 and TOCO TD84) K940898 .
Device Description
Cetro America, Inc. Transducers for Ultrasonic and Tocodynamometer fetal monitoring will be used as replacements for similar transducers manufactured by Corometrics (currently GE), Hewlett Packard Medical (currently Phillips Medical) and Advanced Medical Systems (currently Spacelabs Medical) and their respective fetal monitors. The ultrasound transducer is used to detect Fetal Heart Rate (FHR) using the ultrasound Doppler shift technology. Ultrasound transducers operate in a pulsed Doppler mode with around a 33% Duty Cycle. The Tocodynamometer transducer uses a strain gauge to detect uterine contraction frequency and duration during labor.
Intended Use
These devices are replacement accessories for the original manufacturer's fetal monitor transducers and are intended to monitor and chart Fetal Heart Rate and maternal uterine activity.
| Category | Cetro America | Coro174 | Coro145 | HP1356 | AMSIM-76 | AMSIM-77 |
|---|---|---|---|---|---|---|
| Intended Use(Ultrasound) | To detect, measure and recordfetal heart rate and the durationand frequency of uterinecontractions during labor. | Same | Same | Same | Same | Same |
| Intended Use(Toco) | To detect, measure and recorduterine pressure to determinetiming of contractions. | Same | Same | Same | Same | Same |
| TargetPatientPopulation | Gravid patients, particularly duringlabor. | Same | Same | Same | Same | Same |
| Anatomicalsites | The ultrasound transducer isplaced on the patient's abdomenaimed at the fetal heartbeat. TheToco is placed on the patient'sabdomen at the top of the uterus. | Same | Same | Same | Same | Same |
| FHR Range | As to monitor system specifications | Same | Same | Same | Same | Same |
| UterineActivityRange | As to monitor system specifications | Same | Same | Same | Same | Same |
| Patient | Reusable | Same | Same | Same | Same | Same |
Predicate Comparison (Substantial Equivalence)
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| Use/Reuse | ||||||
|---|---|---|---|---|---|---|
| Sterility | Non-sterile | Same | Same | Same | Same | Same |
| PatientAttachment | These devices attach to thepatient with elastic belts strappedto the patient | Same | Same | Same | Same | Same |
| Cable Length | Eight feet | Same | Same | Same | Same | Same |
| Accessories | Transducer belts and UltrasonicGel | Same | Same | Same | Same | Same |
| ConnectorDesign | Transducers are color coded anddesigned to fit into theappropriate monitoring system. | Same | Same | Same | Same | Same |
| AcousticOutput(UltrasoundTransducer) | <20mW/cm2 average | Same | Same | Same | Same | Same |
| Category | Cetro America | Coro174 | Coro145 | HP1356 | AMSIM-76 | AMSIM-77 |
|---|---|---|---|---|---|---|
| OperationalCharacteristics | Cetro 8031010-02 - Pulsed DopplerCetro 8031011-02 - Pulsed DopplerCetro 8031012-02 - Pulsed Doppler | -- | -- | --Same-- | Same---- | --Same-- |
| Specifications(U/S CenterFrequency) | Cetro 8031010-02 - 1.536 MHzCetro 8031011-02 - 1.024 MHzCetro 8031012-02 - 0.9984 MHz | -- | -- | ----Same | Same---- | --Same-- |
Conclusion:
Bench testing demonstrates that the devices perform as intended.
The company declares conformity to consensus performance standards relating to Electrical/Mechanical/Thermal Safety and Biocompatibility.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
Ms. Maya Cianciolo Official Correspondent Cetro America 9025 Sherman Avenue HAMDEN CT 06514
Re: K050826
Trade Name: Transducers for Ultrasonic and Tocodynamometer Fetal Monitor Regulation Number: 21 CFR §884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM Dated: March 22, 2006 Received: March 22, 2006
Dear Ms. Cianciolo:
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 Transducers for Ultrasonic & Tocodynamometer Fetal Monitoring, as described in your premarket notification:
Transducer Model Number
TOCO Transducer Model 8032009-04 ULTRASONIC Transducer Model 8031012-02 TOCO Transducer Model 8032010-04 TOCO Transducer Model 8032007-04 ULTRASONIC Transducer Model 8031010-02 TOCO Transducer Model 8032008-04 ULTRASONIC Transducer Model 8031011-02
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Page 2 - Ms. Maya Cianciolo
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.
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 (OS) 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 (301) 443-6597 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 Ms. Michelle Byrne at (301) 594-1212.
Sincerely yours.
Daniel le. Lyman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
- Maps
, "-
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Section D - Indications for Use
Device Name: Cetro America...
TOCO Transducer Model 8032009-04 ULTRASONIC Transducer Model 8031012-02 TOCO Transducer Model 8032010-04 TOCO Transducer Model 8032007-04 ULTRASONIC Transducer Model 8031010-02 TOCO Transducer Model 8032008-04 ULTRASONIC Transducer Model 8031011-02
Indications for Use: These devices are replacement accessories for the original inalCallons.for oso. These thansducers and are intended to obtain signals to manifor and chart Fetal Heart Rate and maternal uterine activity on a fetal monitor. Please refer to the chart below for appropriate replacement pairings:
| Cetro America Replacement Device Name | OEM Equivalent Device Name |
|---|---|
| TOCO Transducer Model 8032009-04 | HP Toco 1355A for 1350+ Series and more recent model monitors |
| ULTRASONIC Transducer Model 8031012-02 | HP Ultrasound 1356 A for 1350 Series Monitor |
| TOCO Transducer Model 8032010-04 | Corometrics Toco for all model monitors |
| TOCO Transducer Model 8032007-04 | AMS/Spacelabs TD84 for FM Model IM76and AM 66 |
| ULTRASONIC Transducer Model 8031010-02 | AMS/Spacelabs US91 for FM Model IM76and AM 66 |
| TOCO Transducer Model 8032008-04 | AMS/Spacelabs TD84 for FM Model IM77and AM 67 |
| ULTRASONIC Transducer Model 8031011-02 | AMS/Spacelabs US915 for FM Model IM77and AM 67 |
David de Segura
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use
§ 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).