(70 days)
Not Found
No
The document describes image processing and algorithms for image-guided surgery planning, but does not mention AI, ML, or related concepts like neural networks or deep learning. The modifications are focused on the operating system and wireless components.
No
The device provides guidance and localization during surgery for presurgical planning and intra-operative procedures, but it does not directly treat or cure any condition.
No
The device is intended for surgical planning and guidance, not for diagnosing medical conditions. It uses diagnostic images but does not perform the diagnosis itself.
No
The device description explicitly mentions hardware components like the "MAYFIELD®/ ACCISS™ Operating Arm System," "MAYFIELD® Optical ACCISS™ System," "Wireless Probe," and "Wireless Dynamic Reference Frame." While software is a key part of the modification, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system uses diagnostic images of the patient to assist the surgeon with presurgical planning and provide orientation and reference information during intra-operative procedures. This is a surgical guidance and navigation system, not a device that performs tests on biological specimens in vitro (outside the body).
- Device Description: The description reinforces its role in image-guided surgery, utilizing tracking for 3-D digitizing and displaying reformatted images for planning and guidance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests. The "diagnostic images" are the input data for the surgical guidance function, not the output of an in vitro diagnostic test.
In summary, the device's function is to assist in surgical procedures using pre-acquired diagnostic images, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Systems are intended for use as: • devices that, by the use of diagnostic images of the patient, acquired specifically to assist the surgeon with presurgical planning, provide orientation and reference information during intra-operative procedures.
The Systems are indicated for use in: • Guidance and localization in open craniotomies, and for surgeries that are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies, and electrode implants. The Systems may also be used to review medical images in a neurosurgical context.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The MAYFIELD®/ ACCISS™ System with Windows NT® for Cranial Surgery and MAYFIELD® Optical ACCISS™ System with Windows NT® for Cranial Surgery and with the Wireless Probe/Dvnamic Reference Frame involve: a) conversion of the operating system software for both Systems to Windows NT (hereafter "Windows") from DOS, and b) addition of a battery-powered Wireless Probe and battery-powered Wireless Dynamic Reference Frame [hereafter Wireless Probe/DRF] for use with the Optical System. Wireless Probe/DRF each carries a sterile battery for their power. When coupled with the Optical System, the wireless models function in the same way as the wired versions by allowing preoperative and operative planning surgical procedures using CT or MR images. "Windows" allows the user to select and simultaneously display and/or keep on the screen a number of images of interest, "zoom" images to larger sizes and move images to different locations on the monitor screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR images
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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
Tests simulating cranial surgery planning were performed using the Arm System with "Windows" and the Optical System with "Windows" and with the Wireless Probe/DRF. The results were compared to the results of the same tests performed with the DOS-based Systems and with the wired Probe and DRF.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The comparison demonstrated that the functions of the Arm and Optical Systems were unchanged.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image shows a logo for Ohio Medical Instrument Company Inc. located in Cincinnati, Ohio 45227. The image also contains the text "II 510(k) SUMMARY" and the date "NOV - 2 1999". The logo features a medical symbol with a snake wrapped around a staff.
Summary of Safety and Effectiveness
MAYFIELD®/ ACCISS™ System with Windows NT® for Cranial Surgery and MAYFIELD® Optical ACCISS" System with Windows NT® for Cranial Surgery and with the Wireless Probe/Dvnamic Reference Frame
This Summary is submitted pursuant to Section 513(i) of the Federal Food, Drug and Cosmetics Act, as amended by the Safe Medical Devices Act [SMDA] of 1990, and in accordance with the requirements of 21 C.F.R. § 807.92.
-
- This Summary was prepared on August 20, 1999. The Submitter's Name and Address & the name of the Contact Person are: Ohio Medical Instrument Company, Inc. 4900 Charlemar Drive Cincinnati, Ohio 45227 U.S.A. Fax: (513) 561-0195 Phone: (513) 561-2241 Kenneth B. Miller, Director, Regulatory Affairs and Quality Assurance
- This Premarket Notification describes modifications to the MAYFIELD® ACCISS" System 2 [hereafter Arm System] and to the MAYFIELD®/ Optical ACCISS™ System [hereafter Optical System]. The common name of these Systems is Computer-Based Image-Guided Stereotactic Surgery Planning Systems, and the classification name is Stereotactic Instrumentation.
- The predicate devices are the MAYFIELD® ACCISS" Image-Guided Stereotactic 3. Workstation (K955397) and the MAYFIELD®/ Optical ACCISS "Image-Guided Stereotactic Workstation [OASYS™] (K982244).
-
- The modifications apply to cranial surgery and involve; a) conversion of the operating system software for both Systems to Windows NT (hereafter "Windows") from DOS, and b) addition of a battery-powered Wireless Probe and battery-powered Wireless Dynamic Reference Frame [hereafter Wireless Probe/DRF] for use with the Optical System.
- ട്. "Windows" is operating system software that, in conjunction with the Arm and Optical Systems, allows the user to select and simultaneously display and/or keep on the screen a number of images of interest, "zoom" images to larger sizes and move images to different locations on the monitor screen. "Windows" replaces and is substantially equivalent to the DOS operating system software used by the predicate Systems. Changes to the overall design of the screens and to the way the Systems are used have been minimized to make the transition easy for the user.
Windows NT is a registered trademark of Microsoft Corp.
1
II 510(k) SUMMARY (continued)
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The Wireless Probe/DRF each carries a sterile battery for their power. When coupled with 6. the Optical System, the wireless models function in the same way as the wired versions by allowing preoperative and operative planning surgical procedures using CT or MR images.
K992843 -
The addition of "Windows" and the Wireless Probe/DRF has not changed the Intended Use of 7. the Arm System and the Optical System. The Arm and Optical Systems are intended for use as devices that use diagnostic images of the patient, acquired specifically to assist the surgeon with presurgical planning, to provide orientation and reference information during intra-operative procedures. There are no operational differences between "Windows" and DOS or between the Wireless Probe/DRF and the wired Probe/DRF. All phases of preoperative and operative planning for cranial surgery remain the same.
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"Windows" is operating system software that replaces the predicate DOS operating system 8. software. It does not introduce any technological changes to the Systems other than the ability to display and/or keep a number of images simultaneously on the monitor screen, "zoom" the images to larger sizes and move the images to different locations on the monitor screen. With the exception of the power source, the technological characteristics of the Wireless Probe/DRF are the same as or similar to those of the predicate wired devices where LED-based systems and infrared signals are used to provide tracking information as an aid to surgery.
-
ഗ് Tests simulating cranial surgery planning were performed using the Arm System with "Windows" and the Optical System with "Windows" and with the Wireless Probe/DRF. The results were compared to the results of the same tests performed with the DOS-based Systems and with the wired Probe and DRF. This comparison demonstrated that the functions of the Arm and Optical Systems were unchanged.
-
- Based upon the above points, OMI has concluded that for cranial surgery, the Arm System with "Windows" and the Optical System with "Windows" and with the Wireless Probe/DRF do not raise any new unresolved issues relating to safety and effectiveness. Ohio Medical Instrument Company, Inc. therefore considers the Arm System with "Windows" and the Optical System with "Windows" and with the Wireless Probe/DRF, to be substantially equivalent to the predicate Systems.
2
II 510(k) SUMMARY (continued)
| FEATURE | MAYFIELD®/ ACCISS™ Operating Arm
and Optical ACCISS™ Systems
[K955397, K982244] | MAYFIELD®/ ACCISS™ System with
"Windows" for Cranial Surgery and
MAYFIELD® Optical ACCISS™ System
with "Windows" for Cranial Surgery
and with the Wireless Probe/DRF |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Systems are intended for use as:
• devices that, by the use of diagnostic
images of the patient, acquired
specifically to assist the surgeon with
presurgical planning, provide
orientation and reference information
during intra-operative procedures. | The Systems are intended for use as:
• Same. |
| Indications for
Use | The Systems are indicated for use in:
• Guidance and localization in open
craniotomies, and for surgeries that are
traditionally performed with a
stereotactic apparatus, such as
biopsies, thalamotomies, and electrode
implants. The Systems may also be
used to review medical images in a
neurological context. | The Systems are indicated for use in:
• Same. |
| Design | • Arm or Optical tracking for 3-D
digitizing.
• Interfaces to computer graphics
workstation.
• Displays reformatted CT or MR images
in variety of configurations.
• Algorithms for image-guided surgery
planning.
• Software to show body part undergoing
surgery - head. | • Same-with Wireless Probe/DRF for
Optical System.
• Same
• Same-with ability to simultaneously
display and/or keep multiple images
on screen, "zoom" images to larger
sizes, and move images on screen
• Same
• Same |
| Materials | • Aluminum 6061 [anodized] for tracking
probe [K853627 for use of anodized
aluminum].
• Stainless steel ASTM F899, passivated
QQ-P-35 Type 2 for sterile probe-tips. | • Same
• Same |
| FEATURE | MAYFIELD®/ ACCISS™ Operating Arm
and Optical ACCISS™ Systems
[K955397, K982244] | MAYFIELD®/ ACCISS™ System with
"Windows" for Cranial Surgery and
MAYFIELD® Optical ACCISS™ System
with "Windows" for Cranial Surgery
and with the Wireless Probe/DRF |
| Sterilization | • Systems shipped non-sterile. User
cleans and sterilizes prior to use.
• Steam sterilization method validated for
metal components and accessories. | • Same-except for the packaged sterile
batteries for the Wireless Probe/DRF
that are shipped separately.
• Same-includes wireless Probe/DRF. |
| Type of Detector | • Optically encoded signals from joints of
articulated arm.
• A 3-camera Sensor Assembly detects
infrared signals emitted from LEDs on
hand-held probe handle. The Sensor
Assembly is mounted on a dedicated,
mobile stand.
• The Probe handle and DRF each have
LEDs that are electrically powered by a
wire from workstation. | • Same
• Same-with Transmitter for Wireless
Probe/DRF mounted with Sensor
Assembly.
• Same-except the Wireless Probe/DRF
each carries a sterile battery for power. |
| Registration
Technique | • Scanned Fiducials
• Anatomical Fiducials | • Same
• Same |
| Operating
Software | • Structure: MS-DOS, with two major
functions: Image Importation, and
Surgical Applications [navigation].
• Uses a Graphical User Interface to
facilitate interaction with users.
• Image Manipulation: Unreformatted,
reformatted, 3-D surface rendering. | • Structure: "Windows", with same two
major functions.
• Uses Modified Graphical User Interface
with similar functionality.
• Same-with multiple images displayed,
"zoom" of image, able to move images
on screen. |
| Accessories | • BUDDE® Halo Retractor System
[K830332] | • Same |
Summary of Substantial Equivalence - Comparison Table
3
II 510(k) SUMMARY (continued)
Summary of Substantial Equivalence - Comparison Table
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Mr. Kenneth B. Miller Director, Regulatory Affairs/Quality Assurance Ohio Medical Instrument Company, Inc. 4900 Charlemar Drive Cincinnati, Ohio 45227
Re: K992843
Trade Name: MAYFIELD®/ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and MAYFIELD®/Optical ACCISS™ System (OASYS™) with Windows NT® for Cranial Surgery and with the Wireless Probe/Dynamic Reference Frame
Regulatory Class: II Product Code: HAW Dated: August 20, 1999 Received: August 24, 1999
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. Kenneth B. Miller
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known):
Device Name: MAYFIELD®/ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and MAYFIELD® Optical ACCISS™ System with Windows NT® for Cranial Surgery and with Wireless Probe/Dynamic Reference Frame
Indications for Use:
The MAYFIELD® / ACCISS™ Operating Arm System with Windows NT® for Cranial Surgery and the MAYFIELD®/Optical ACCISS™ System (OASYS™) with Windows NT® for Cranial Surgery and with Wireless ProberDynamic Reference Frame are indicated for use in guidance and localization in open craniotomies, and for surgeries that are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies, and electrode implants. The Systems may also be used to review medical images in a neurosurgical context.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
colle
on,
Prescription Use of (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
(Optional Format - 1 - 2 - 96)