(140 days)
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No
The summary focuses on hardware additions (transducer) and software updates for new study types, with no mention of AI, ML, or related performance metrics.
No.
The device is described as an ultrasound imaging system, which is used for diagnostic purposes (imaging), not for therapy.
Yes
The device is an ultrasound imaging system used specifically for obstetrics and gynecology applications, which are diagnostic purposes for examining internal body structures and conditions.
No
The device description explicitly states the addition of an "endovaginal transducer," which is a hardware component. The submission is a modification to an existing ultrasound imaging system, which inherently includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "obstetrics and gynecology applications" using ultrasound imaging. This describes a diagnostic imaging procedure performed on a patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is an "Ultrasound Imaging System" with an "endovaginal transducer." This is consistent with an imaging device used directly on a patient.
- No mention of testing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample.
Therefore, this device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.
Product codes
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Device Description
This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to the HP SONOS 100CF Ultrasound Imaging System.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Attachment D: 510(k) SUMMARY of Safety and Effectiveness
Submitted by: Rob Butler (contact person), Regulatory Approvals Hewlett-Packard Company - Medical Products Group 3000 Minuteman Road Andover, MA 01810 phone (508) 659-2785; fax (508) 687-8284 Summary prepared November 17, 1995.
Device Trade Name: HP 77010CF Ultrasound Imaging System Device Common Name: HP SONOS 100CF Ultrasound Imaging System Classification Name: FDA has classified Ultrasound Imaging Systems as Class II in 21 CFR:
- 870.2100 Cardiovascular Blood Flowmeter 870.2120 Extravascular Blood Flow Probe 870.2330 Echocardiograph 870,2880 Ultrasonic Transducer 870.2890 Vessel Occlusion Transducer 882.1240 Echoencephalograph 884.2225 Obstetric-gynecologic Ultrasonic Imager 884.2960 Obstetric Ultrasonic Transducer and Accessories 892.1550 Ultrasonic Pulsed Doppler Imaging System 892.1560 Ultrasonic Pulsed Echo Imaging System 892.1570 Diagnostic Ultrasonic Transducer
Predicate Devices: In this 510(k) submission, the legally marketed devices to which we claim equivalence are the HP/Philips P800 Ultrasound Imaging System (K935923) and the Sharplan Usight 9010 Laparoscopic Ultrasound System (K945796).
Device Description: This 510(k) submission is to add an endovaginal transducer and a new EV(EndoVaginal)/Pelvic study type to the HP SONOS 100CF Ultrasound Imaging System.
Intended Use: This modification expands the intended use statement for the HP SONOS 100CF Ultrasound Imaging System to include obstetrics and gynecology applications.
Technological Characteristics: This modification includes an OEM endovaginal transducer which is identical to the endovaginal transducer used with the Sharplan Usight 9010 Laparoscopic Ultrasound System. All other technological characteristics of the modification are consistent with the currently marketed (unmodified) HP SONOS 100CF Ultrasound Imaging System.
The safety of this modification is shown by compliance to medical device safety standards (such as IEC 601 and UL 544) and by the acoustic output data provided in this submission. Software safety is verified by hazard analysis and software validation to ensure performance specifications are met. This validation, safety testing, acoustic output testing, and comparison to legally marketed devices demonstrate that this modification is substantially equivalent to the legally marketed predicate devices with regards to safety, effectiveness and intended use.