(208 days)
The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician.
It is not indicated for use near non-intact skin or the eyes.
It is not intended for home use.
IMEXLAB 9100 Diagnostic Ultrasound Device
The provided document is a 510(k) premarket notification approval letter for the IMEXLAB 9100 Diagnostic Ultrasound Device, dated April 15, 1998. It primarily focuses on regulatory approval and indications for use, and does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen in modern AI/ML device submissions.
Therefore, I cannot provide the requested information in the format of acceptance criteria and reported device performance. The details you're looking for (sample sizes, expert qualifications, adjudication methods, MRMC studies, effect sizes, standalone performance, ground truth types, training set details) are characteristic of recent regulatory submissions for AI-powered medical devices, which involve rigorous performance testing.
The document indicates that the IMEXLAB 9100 was found "substantially equivalent" to legally marketed predicate devices prior to May 28, 1976. This means its regulatory approval relied on demonstrating that it performs as safely and effectively as existing, legally marketed ultrasound devices for its stated indications: "assisting in the detection of peripheral vascular diseases."
Here's a summary of what can be extracted from the provided text, related to the device and its intended use:
- Device Name: IMEXLAB 9100 Diagnostic Ultrasound Device
- Regulatory Class: II (21 CFR 892.1550)
- Procode: 90 IYN
- Indications for Use: "The IMEXLAB 9100 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use."
- Transducers cleared: 5 MHz CW and 8 MHz CW
- Intended Use Mode of Operation (from Appendix F for both 5MHz and 8MHz transducers): Amplitude Doppler for:
- Intraoperative (general)
- Musculo-skeletal Conventional
- Other listed clinical applications for diagnostic ultrasound (but not explicitly marked for IMEXLAB 9100 in the provided forms): Ophthalmic, Fetal, Abdominal, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Musculo-skeletal Superficial.
No study data, performance metrics, or specific acceptance criteria are detailed in this regulatory approval letter. Such information would typically be found in the manufacturer's 510(k) submission itself, not in the FDA's approval letter, especially for devices cleared via substantial equivalence over two decades ago.
§ 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.