(158 days)
No
The description focuses on image correlation and localization using a physical probe and articulated arm, with no mention of AI or ML algorithms for image analysis, planning, or guidance.
No
The device is described as a system designed to assist in planning and performing surgery by correlating patient medical image data with anatomy, acting as a localizing device for guidance. It does not directly treat a condition.
No
The device is described as an image-guided surgery system used for guidance and localization during surgical procedures. It does not perform diagnoses or identify diseases.
No
The device description explicitly lists hardware components such as a workstation, probe assembly, and stereotactic system, in addition to the software.
Based on the provided information, the Mayfield-ACCISSTM Workstation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ACCISS Function: The description clearly states that ACCISS is used for guidance and localization during surgical procedures (open craniotomies, biopsies, etc.) by correlating pre-operative imaging data (CT/MRI) with the patient's anatomy in the operating room. It acts as a navigation tool for the surgeon.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is entirely based on processing and displaying medical images and tracking the position of a probe relative to the patient's anatomy.
Therefore, the Mayfield-ACCISSTM Workstation falls under the category of a surgical navigation system or image-guided surgery system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ACCISS is to be used both for quidance and localization in open craniotomies and for surgeries which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.
Product codes
Not Found
Device Description
The Mayfield-ACCISSTM Workstation is a computer-based system designed for use in the OR. It has a compact design, sterilizable keyboard cover and electrical isolation for patient safety. Completely self-contained on a cart, the system transfers easily between OR and offices for use not only as a clinical tool but as a desk-top based clinical research tool and image-review workstation as well. A simple yet direct user interface screen with easy-to understand graphics displays the images.
The Mayfield-ACCISSTM Workstation is intended to correlate a patient's preoperative Computed Tomography (CT) and/or Magnetic Resonance (MRI) data with a patient's anatomy to assist in planning and performing surgery. The system is composed of a medical imaging workstation and position-sensing articulated arm with a probe that acts as a localizing device. The workstation computer is loaded with the patient's CT or MRI data. The image data set is correlated to the patient on the OR table by physically matching points such as scanned fiducial markers, anatomical features or surface points with corresponding points on the imaged data set. After the correlation, the indication of the probe orientation appears on the screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.
The Mayfield-ACCISSTM Workstation consists of the following" :
- A. Workstation
- B. Software
- C. Probe Assembly
- D. Pelorus Stereotactic System
Training Accessories E.
1 Plastic Skull 50 CT/MR Skin Markers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
MRI
Anatomical Site
Cranium (implicitly, for neurosurgical procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
OR (Operating Room)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ISG Allegro Viewing Wand (K911783), Pelorus Arc Carrier (K851659A), CORITechs CORITaxic I Workstation (K915791), Cordis Micra Microosurgical Instruments (K862971)
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.
BRW/CRW (K811452)
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
955397
Image /page/0/Picture/1 description: The image shows the date "APR 30 1996" in bold, black font. The letters and numbers are slightly distorted, giving them a handwritten appearance. The date is likely extracted from a document or photograph.
Section B - Summary & Certification
Summary of Safety and Effectiveness Mayfield-ACCISS Workstation
Pursuant to Section 513(i) of the Federal Food, Druq, and Cosmetic Act
l. General Information:
Classification Name: Stereotactic Instruments
Common/Usual Name: Computer-based stereotactic surgical planning system
Trade/Proprietary Name: Mayfield-ACCISS Workstation
Applicant's Name and Address:
Marvin L. Sussman, Ph. D., Vice President, Administration and Regulatory Affairs NOMOS Corporation 2591 Wexford Bavne Road Sewickley, PA 15143
II. Name of predicate device(s):
ISG Allegro Viewing Wand (K911783) Pelorus Arc Carrier (K851659A) CORITechs CORITaxic I Workstation (K915791) Cordis Micra Microosurgical Instruments (K862971) - for use of Titanium in contact with Brain Tissue
III. Classification:
Neurosurgical stereotactic instruments and accessories are Class II (21 CFR 882.4560 Neurological Devices Panel).
IV. Performance Standards:
No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
app 11 3
1
V. Intended Use and Device Description:
Intended Use: ACCISS is to be used both for quidance and localization in open craniotomies and for surgeries which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.
Introduction: Stereotactic surgical systems superimpose on the patient a coordinate system which can be used to direct a probe or other surgical instrument, based upon diagnostic imaging information, to a predetermined point inside the cranium. When the point is established, surgical instruments are inserted in the instrument holder of stereotactic systems such as the BRW/CRW (K811452) or Leksell (Preamendments device) systems to biopsy and/or remove a lesion. Recently, systems have been developed which allow the determination of surgical paths without the use of a conventional stereotactic frame such as the ISG Viewing Wand (K911783).
The Mayfield-ACCISSTM Workstation is a computer-based system designed for use in the OR. It has a compact design, sterilizable keyboard cover and electrical isolation for patient safety. Completely self-contained on a cart, the system transfers easily between OR and offices for use not only as a clinical tool but as a desk-top based clinical research tool and image-review workstation as well. A simple yet direct user interface screen with easy-to understand graphics displays the images.
The Mayfield-ACCISSTM Workstation is intended to correlate a patient's preoperative Computed Tomography (CT) and/or Magnetic Resonance (MRI) data with a patient's anatomy to assist in planning and performing surgery. The system is composed of a medical imaging workstation and position-sensing articulated arm with a probe that acts as a localizing device. The workstation computer is loaded with the patient's CT or MRI data. The image data set is correlated to the patient on the OR table by physically matching points such as scanned fiducial markers, anatomical features or surface points with corresponding points on the imaged data set. After the correlation, the indication of the probe orientation appears on the screen and moves through the CT or MRI data in correct relation to the probe as manipulated by the surgeon.
The Mayfield-ACCISSTM Workstation consists of the following" :
- A. Workstation
- B. Software
- C. Probe Assembly
- D. Pelorus Stereotactic System
The hardware configuration will be as stated or functionally similar.
2
Training Accessories E.
1 Plastic Skull 50 CT/MR Skin Markers
Supported Modalities
CT MRI
Options:
Color Printer 9-Track Tape Drive
000001
3
VI. Summary of Substantial Equivalence*:
Indications: The indications for the Mayfield-ACCISSTM Workstation are the same as those for the predicate stereotactic devices.
Design: The design of the Mayfield-ACCISS™ Workstation is similar in concept to the predicate stereotactic devices.
Materials: The materials used in the manufacture of the hardware components of the Mayfield-ACCISSTM Workstation are similar to those used in the predicate devices. Material in direct, transient contact with central nervous system (CNS) tissue/fluids is ATSMB398-94 Grade 2 titanium. Titanium has been used in a number of devices which are transiently used in direct contact with CNS tissues/fluids, such as Cordis Micra Microsurgical Instruments (K862971). Therefore, OMI and NOMOS consider the use of titanium for the manufacture of the probe to be the same as the intended use for Microsurgical Instruments used for the direct brain contact. No new biocompatability issues are raised. Differences in structural materials are addressed through labeling.
Manufacturing: The manufacturing processes used in the Mayfield-ACCISS TM Workstation are similar to those used in the manufacture of predicate stereotactic devices.
Specifications: The specifications of the Mayfield-ACCISSTM Workstation are similar to those of the predicate stereotactic device.
Conclusions: The indications, design, materials, manufacturing, and specifications of the Mayfield-ACCISS workstation do not raise any new unresolved issues relating to safety and effectiveness.
NOMOS thus considers the Mayfield-ACCISSTM Workstation substantially equivalent to the predicate devices.
*Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without premarket approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits." 42 Fed. Req. 42,520 et seg. (1977).