(86 days)
The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece).
The Surgical Lightstic™ 180 is indicated for use in laser medicine and surgery with 980-1064 nm wavelength laser energy in the following surgical specialties: general surgery, cardiothoracic surgery(recommended 980nm), plastic surgery and dermatology.
Expanded for: Coagulation of Cardiac Tissue
These are additional indications to the already cleared indications for market release in K993834.
Not Found
The provided text ("Surgical Lightstic™ 180" 510(k) Summary) explicitly states "Performance Data: None required." (Section 1). This means that a specific study proving the device meets acceptance criteria was not conducted or submitted for this 510(k) premarket notification.
The FDA's review for this device (K011988), as indicated in the correspondence (Section 2 and 3), determined it to be "substantially equivalent" to predicate devices (K993834 and K980668). Substantial equivalence means that the device has the same intended use as legally marketed predicate devices and the technological characteristics do not raise different questions of safety and effectiveness.
Therefore, since no performance data or study was required or provided, the following information cannot be extracted from the given text:
- A table of acceptance criteria and the reported device performance: Not applicable as no performance data was required.
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
- If a standalone study was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) clearance for the Surgical Lightstic™ 180 was based on a finding of substantial equivalence to existing devices, not on new performance data demonstrating its ability to meet specific acceptance criteria through a dedicated study.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.