(154 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as equivalent to a predicate device from 1980, which predates widespread AI/ML use in medical devices.
Yes
The device is described as an ultrasonic surgical instrument intended to cut or fragment tissue, bone, or organs, which describes a therapeutic function.
No
The device is described as an ultrasonic surgical instrument intended to cut or fragment tissue, bone, or organs, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is an "ultrasonic surgical instrument," which is a hardware device. The comparison to the predicate device, also an ultrasonic surgical aspirator, further confirms it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to cut or fragment tissue, bone, or organs in orthopedic surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description reinforces its use as a surgical instrument for cutting and fragmenting tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The Ultracut 2000 and CUSA are both ultrasonic surgical instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
Product codes
Not Found
Device Description
The Ultralase Ultracut 2000 is an ultrasonic surgical instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue, bone, or organs in orthopedic surgery
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUN 2 8 1996
APPENDIX C
SUMMARY OF SAFETY AND EFFECTIVENESS
The Ultralase Ultracut 2000 is equivalent to the predicate device Cavitron Corporation's Cavitron Ultrasonic Surgical Aspirator (CUSA). The Ultracut 2000 has the same general intended use, similar principles of operation, and similar technological characteristics as The Ultracut 2000 and CUSA are both ultrasonic surgical the predicate device. instruments intended for use to cut or fragment tissue, bone, or organs in orthopedic surgery.
Comparison Chart
Ultracut 2000
CUSA (Model 200H)
EtO or Steam
510(k) K801623 Applied For Console Dimensions (in) 4.5 x 12.25 x 11.125 76 x 23 x 26 Power Specifications 115VAC; 50/60 Hz 115VAC; 50/60 Hz Footswitch Control Yes Yes Intended Use Ultrasonic Surgery Ultrasonic Surgery Frequency 40kHz 37kHz Vibration Amplitude Variable, 0-500μ Variable, 0-355u Variable, 0-70 watts Power Variable, 0-100 watts Yes (0 - 99 min) Timer Yes (1 sec - 100 min) Aspiration Yes Yes Irrigation Yes Yes Modes of Operation Continuous Continuous Pulsed On/Off Pulsed On/Off Handpiece Frequency 37kHz 40kHz Dimensions (inches) L 5.75 x D 1.25 L 6.75 Removable Surgical Tips Yes Yes Tip Material Titanium or Stainless Steel Titanium Transducer Piezoelectric Magnetostrictive
Autoclave
Sterilization