(374 days)
Not Found
No
The device description and intended use focus on standard ultrasound Doppler and strain gauge technology for fetal monitoring, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for monitoring and charting Fetal Heart Rate and maternal uterine activity, which are diagnostic purposes, not therapeutic.
No.
The device is a replacement accessory for fetal monitor transducers that monitor and chart Fetal Heart Rate and maternal uterine activity, rather than providing a diagnosis based on that data. It obtains signals, but does not diagnose.
No
The device description explicitly states that the devices are "Transducers for Ultrasonic and Tocodynamometer fetal monitoring" and describes their physical components and how they function using ultrasound and strain gauge technology. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these devices are replacement accessories for fetal monitor transducers. They are used to monitor and chart Fetal Heart Rate and maternal uterine activity by obtaining signals from the patient's abdomen.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body to acquire physiological signals.
Therefore, since the device does not perform tests on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device. It is a medical device used for physiological monitoring.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
85 HGM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
The ultrasound transducer is placed on the patient's abdomen aimed at the fetal heartbeat. The Toco is placed on the patient's abdomen at the top of the uterus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing demonstrates that the devices perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K891595, K852076, K900480, K852518, K940898
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Trade
| 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 IM76 |
| and AM 66 | |
| ULTRASONIC Transducer Model 8031010-02 | AMS/Spacelabs US91 for FM Model 1M76 |
| and AM 66 | |
| TOCO Transducer Model 8032008-04 | AMS/Spacelabs TD84 for FM Model IM77 |
| and AM 67 | |
| ULTRASONIC Transducer Model 8031011-02 | AMS/Spacelabs US915 for FM Model IM77 |
| and 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.
1
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 | Coro
174 | Coro
145 | HP
1356 | AMS
IM-76 | AMS
IM-77 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|------------|--------------|--------------|
| Intended Use
(Ultrasound) | To detect, measure and record
fetal heart rate and the duration
and frequency of uterine
contractions during labor. | Same | Same | Same | Same | Same |
| Intended Use
(Toco) | To detect, measure and record
uterine pressure to determine
timing of contractions. | Same | Same | Same | Same | Same |
| Target
Patient
Population | Gravid patients, particularly during
labor. | Same | Same | Same | Same | Same |
| Anatomical
sites | The ultrasound transducer is
placed on the patient's abdomen
aimed at the fetal heartbeat. The
Toco is placed on the patient's
abdomen at the top of the uterus. | Same | Same | Same | Same | Same |
| FHR Range | As to monitor system specifications | Same | Same | Same | Same | Same |
| Uterine
Activity
Range | As to monitor system specifications | Same | Same | Same | Same | Same |
| Patient | Reusable | Same | Same | Same | Same | Same |
Predicate Comparison (Substantial Equivalence)
2
| Use/Reuse | ||||||
|---|---|---|---|---|---|---|
| Sterility | Non-sterile | Same | Same | Same | Same | Same |
| Patient | ||||||
| Attachment | These devices attach to the | |||||
| patient with elastic belts strapped | ||||||
| to the patient | Same | Same | Same | Same | Same | |
| Cable Length | Eight feet | Same | Same | Same | Same | Same |
| Accessories | Transducer belts and Ultrasonic | |||||
| Gel | Same | Same | Same | Same | Same | |
| Connector | ||||||
| Design | Transducers are color coded and | |||||
| designed to fit into the | ||||||
| appropriate monitoring system. | Same | Same | Same | Same | Same | |
| Acoustic | ||||||
| Output | ||||||
| (Ultrasound | ||||||
| Transducer) |