(255 days)
No
The description focuses on physical tools and tracking technology for surgical guidance, with no mention of AI or ML algorithms for image analysis, planning, or other functions.
No.
A therapeutic device is intended to treat or cure a disease or condition. This device is described as assisting with "presurgical planning" and providing "orientation and reference information during intra-operative procedures," which are diagnostic and procedural guidance functions, not therapeutic ones.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures." This clearly indicates its role in utilizing diagnostic images for medical purposes.
No
The device description explicitly mentions physical tools (Guide Block, Trackable Awl) that require sterilization and have physical properties (infrared emitting diodes for tracking), indicating it is not solely software.
Based on the provided information, the ViewPoint device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ViewPoint uses diagnostic images of the patient acquired to assist with presurgical planning and provide orientation during intra-operative procedures. This involves using pre-existing patient data (images) for surgical guidance, not analyzing biological samples in vitro to diagnose a condition.
- Device Description: The description focuses on surgical tools (Guide Blocks, Trackable Awl) used for guiding procedures and tracking positions during surgery. This aligns with a surgical navigation or guidance system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests in vitro to determine the presence of a disease or condition.
The ViewPoint is a surgical planning and navigation system that utilizes patient imaging data to assist surgeons during procedures. This falls under the category of medical devices used for surgical guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for use in:
· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
Product codes
HAW
Device Description
Prior to use the ViewPoint tools must be sterilized. Testing has been completed to validate the use of the Sterrad 100 system for this process. The Guide Block (Non-Trackable and Trackable) and the Trackable Awl are three additional tools now available for the ViewPoint. The Guide Blocks guide and track the trajectory of a biopsy needle during a procedure. The Trackable Awl is a standard awl that has been adapted to include infrared emitting diodes so that the tip of the awl can be tracked similar to the standard ViewPoint Y-probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic images
Anatomical Site
Intra-cranial, Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / intra-operative procedures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The use of the Sterrad 100 system adequately sterilizes the ViewPoint tools for intraoperative procedures and does not affect the accuracy or function of the tools.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Repeatability/Resolution: 1mm
Distance measurement: $\pm$ 0.75 mm
3D Localization: $\leq$ 1.57 mm
Fourth Fiducial Checkpoint: $
§ 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
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers 9, 8, 3, 7, 6, and 4. The characters are written in a dark, bold font, and they appear to be slightly slanted.
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
| 1. | General Information |
|---|---|
| Classification: Class II | |
| Image Assisted Surgery Device | |
| Common/Usual Name: Image Assisted Surgery Device Option | |
| Proprietary Name: ViewPoint Tools - Sterrad | |
| Establishment Registration: Picker International, Inc. | |
| World Headquarters | |
| 595 Miner Road | |
| Highland Heights, Ohio 44143 | |
| FDA Owner Number: #1580240 | |
| FDA Registration Number: #1525965 | |
| Performance Standards: No applicable performance standards have been | |
| issued under section 514 of the Food, Drug and | |
| Cosmetic Act. |
Intended Uses 2.
The ViewPoint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The ViewPoint is indicated for use in:
· Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
· Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms.
3. Device Description
Prior to use the ViewPoint tools must be sterilized. Testing has been completed to validate the use of the Sterrad 100 system for this process. The Guide Block (Non-Trackable and Trackable) and the Trackable Awl are three additional tools now available for the ViewPoint. The Guide Blocks guide and track the trajectory of a biopsy needle during a procedure. The Trackable Awl is a standard awl that has been adapted to include infrared emitting diodes so that the tip of the awl can be tracked similar to the standard ViewPoint Y-probe.
PICKER INTERNATIONAL, INC. (STERRAD) 10/22/98 I - 1
1
4. Safety and Effectiveness
The use of the Sterrad 100 system adequately sterilizes the ViewPoint tools for intraoperative procedures and does not affect the accuracy or function of the tools. The Guide Blocks and the Trackable Awl described in this submission are equivalent to the tools described in the 510(k) submissions K963221 and K970604. This equivalence is demonstrated in the following table.
| Parameter | ViewPoint - Sterrad | Predicate Devices |
|---|---|---|
| Tools | • Y-Probe with various tips | |
| • Cable | ||
| • Head Tracker | ||
| • Spine Tracker | ||
| • Drill Guide (Non-Trackable and Trackable) | ||
| • Guide Block (Non-Trackable and Trackable) | ||
| • Trackable Awl | • Y-Probe with various tips | |
| • Cable | ||
| • Head Tracker | ||
| • Spine Tracker | ||
| • Drill Guide (Non-Trackable and Trackable) | ||
| Material Considerations | Same. | Combination of metal and non-metal materials. IREDs on trackable tools are sensitive to heat. |
| Lumens | Same. | Trackable tools have a dead-end lumen in the LEMO Connector. The drill guides have a single-channel stainless steel lumen. |
| Use limits | Same. | None. |
| Accuracy (Y-probe) | Same. | Repeatability/Resolution: 1mm |
| Distance measurement: $\pm$ 0.75 mm | ||
| 3D Localization: $\leq$ 1.57 mm | ||
| Fourth Fiducial Checkpoint: $ |