(88 days)
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No
The description focuses on image visualization, preplanning, and tracking based on imported CT/MRI data. There is no mention of AI or ML algorithms for image analysis, decision support, or automated functions. The system appears to be a traditional image guidance system.
No.
The device is used for image guidance and preplanning in neurosurgical procedures, it does not directly treat or cure a disease or condition. Its purpose is to assist the surgeon during the procedure, not to provide therapy itself.
No
Explanation: The device is described as an image guidance surgical system used to provide guidance based on preoperative images during neurosurgical procedures. Its function is to assist in surgical navigation rather than to diagnose medical conditions or diseases.
No
The device description explicitly lists hardware components such as a measurement system (infra-red detection system with locators, detectors, probe, and processing unit) and tool support systems (Standard Floor Stand Microscope Support and SurgiScope Integrated Tool Support System).
Based on the provided information, the Leksell Image Guidance Surgical System (LIGS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LIGS Function: The LIGS system is used during surgical procedures to provide image guidance based on preoperative images (CT, MRI). It helps the surgeon navigate and plan surgical paths within the patient's body. It does not analyze biological specimens.
The LIGS system is a surgical guidance system, falling under the category of medical devices used for surgical planning and navigation.
N/A
Intended Use / Indications for Use
The Leksell Image Guidance Surgical System (LIGS) is intended for use in neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.
Product codes
Not Found
Device Description
The Leksell Image Guidance Surgical System (LIGS) device provides image guidance in surgical procedures. The LIGS System imports CT/MRI images and provides a visual display of the images for preplanning surgical paths which are used for guidance during the surgical procedures.
The LIGS System is a modular system which includes an interface with a measurement system used with a manual microscope (ViewScope) or with a motorized microscope tool support system (SurgiScope).
The main components of the LIGS System are:
- ScopePlan .
ScopePlan provides surgical preplanning based on Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or other current 2D and 3D modalities, retrieval of preplanning studies and imaging during the surgical procedure, image correlation with a defined point and image retrieval subsequent to the surgical procedure.
The ScopePlan is to be used with specified commercially available surgical microscopes and accessories.
- Measurement System .
The measurement system is an infra-red detection system which is comprised of locators attached to the patient and tool, infra red detectors, a probe and a processing unit. The locators and the probe contain infra red emitting LED's. The system accurately locates and continually tracks the patient and the tool (typically a microscope).
Tool Support System
.
There are two types of tool support systems which are used with the LIGS System:
· Standard Floor Stand Microscope Support
- · SurgiScope Integrated Tool Support System
The SurgiScope Integrated Tool Support System is a motorized manually operated, computer-monitored device module which is mounted on the ceiling of the operating room. The device holds in place surgical tools, typically a surgical microscope, during operative procedures. The Surgeon, or other medical expert, activates electromechanical components to position and adjust the microscope during an operation. The user has complete control of the microscope tool during all phases of the procedure and must initiate activation and continuously activate by depressing a push button on the microscope handle in order for the system to operate.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or other current 2D and 3D modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Validation and verification studies were conducted to evaluated the performance characteristics of the Leksell Image Guidance Surgical System. The results of these studies demonstrated that the Leksell Image Guidance Surgical System is capable of safely and accurately performing the stated intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K943468, K920689, K954276, K942233
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
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
ORIGINAL 510(k) SUBMISSION LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM
JUL 26 1996
SECTION 20
SUMMARY OF SAFETY AND EFFECTIVENESS
1
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ORIGINAL 510(k) SUBMISSION LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM
SECTION 20: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 20.1
- A. Company Name: Elekta Instrument AB
- B. Company Address: Birger Jarlsgatan 53
- C. Company Phone: (011) 46 8 402 54 00
D. Contact Person:
Sverker Glans Vice President Quality and Regulatory Affairs Elekta Instrument AB
Stockholm, Sweden S-103 93
E. Date Summary Prepared: April 26, 1996
20.2. DEVICE IDENTIFICATION
| A. Trade/Proprietary Name: | Leksell Image Guidance Surgical System |
|---|---|
| B. Classification Name: | Stereotactic Accessory |
・
2
20.3 IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date |
|---|---|---|---|
| Cleared | |||
| Elekta Instruments AB | SurgiPlan | K943468 | 1-20-95 |
| DeeMed Internations | Microscope Support | K920689 | 11-12-93 |
| System (MSS) | |||
| Surgical Navigation | Stealth System | K954276 | 1-24-96 |
| Technology | |||
| Zeiss | Zeiss Multiple Coordinate | K942233 | 7-1-94 |
| Manipulator System (MKM) |
20.4. DEVICE DESCRIPTION
The Leksell Image Guidance Surgical System (LIGS) device provides image guidance in surgical procedures. The LIGS System imports CT/MRI images and provides a visual display of the images for preplanning surgical paths which are used for guidance during the surgical procedures.
The LIGS System is a modular system which includes an interface with a measurement system used with a manual microscope (ViewScope) or with a motorized microscope tool support system (SurgiScope).
The main components of the LIGS System are:
- ScopePlan .
ScopePlan provides surgical preplanning based on Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or other current
3
2D and 3D modalities, retrieval of preplanning studies and imaging during the surgical procedure, image correlation with a defined point and image retrieval subsequent to the surgical procedure.
The ScopePlan is to be used with specified commercially available surgical microscopes and accessories.
- Measurement System .
The measurement system is an infra-red detection system which is comprised of locators attached to the patient and tool, infra red detectors, a probe and a processing unit. The locators and the probe contain infra red emitting LED's. The system accurately locates and continually tracks the patient and the tool (typically a microscope).
Tool Support System
.
There are two types of tool support systems which are used with the LIGS System:
· Standard Floor Stand Microscope Support
- · SurgiScope Integrated Tool Support System
The SurgiScope Integrated Tool Support System is a motorized manually operated, computer-monitored device module which is mounted on the ceiling of the operating room. The device holds in place surgical tools, typically a surgical microscope, during operative procedures. The Surgeon, or other medical expert, activates
4
ORIGINAL 510(k) SUBMISSION LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM
electromechanical components to position and adjust the microscope during an operation. The user has complete control of the microscope tool during all phases of the procedure and must initiate activation and continuously activate by depressing a push button on the microscope handle in order for the system to operate.
INTENDED USE 20.5
The Leksell Image Guidance Surgical System (LIGS) is intended for use in neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.
20.6 TECHNOLOGICAL CHARACTERISTICS
The fundamental technical characteristics are similar to those of the predicate devices and are listed on the comparison chart provided in this 510(k) submission. Differences that exist between these systems relate to physical appearance and materials which do not affect the relative safety or effectiveness of the device.
20.7 PERFORMANCE DATA
Validation and verification studies were conducted to evaluated the performance characteristics of the Leksell Image Guidance Surgical System. The results of these studies demonstrated that the Leksell Image Guidance Surgical System is capable of safely and accurately performing the stated intended use.
20.8 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. a completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.