(170 days)
No
The document explicitly states that the devices are unchanged in hardware or software and refers to previous 510(k) submissions from the late 1990s and early 2000s, a time when AI/ML in medical devices was not prevalent. The description focuses on traditional image correlation and locating methods. There are no mentions of AI, ML, or related concepts.
No
The device is described as an operating arm system used for stereotactic surgery to assist with navigation and planning during procedures, not to directly treat or cure a disease.
No
Explanation: The device is described as an "Operating Arm System" used for "stereotactic surgery" to aid in "plan[ning], and/or complete[ing], the intended procedure." It uses CT or MRI data for navigation during surgical procedures, not for diagnosis.
No
The device description explicitly states that the devices are not changed in either hardware or software and refers to previous K numbers which describe systems that include hardware components (Operating Arm System, Optical System). The description also mentions "various locating methods (mechanical, optical or ther concluded to the potware)", indicating hardware involvement.
Based on the provided information, this device 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.
- Device Function: The description clearly states that this device is a surgical navigation system that uses pre- or intra-operative CT or MRI data to guide surgical procedures on rigid anatomical structures (skull, long bone, vertebra). It is used during surgery to assist the surgeon, not to analyze samples outside the body.
- Intended Use: The intended use is for surgical procedures (open and percutaneous) where stereotactic surgery is considered appropriate. This is a surgical tool, not a diagnostic test.
The device's function and intended use fall squarely within the realm of surgical guidance and navigation, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.
Product codes
HAW
Device Description
The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843. This notification only relates to a revision of the Indications for Use to a closer alignment for the devices shown above to which Substantial Equivalence is claimed. All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI
Anatomical Site
rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers. Representative uses would be for cranial, spinal and ENT procedures.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
K981686, K003699, K001153, K005389
Reference Device(s)
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
APR 0 4 2002
510(k) Summary MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System Revised Indication
Contact:
Kenneth B. Miller Manager, Regulatory Ohio Medical Instrument Company, Inc. 4900 Charlemar Drive Cincinnati, OH 45227
Telephone: 513-561-2241
Prepared by:
K. M. Associates 10 Oak Point Wrentham, MA 02093
Contact: Don Lincoln
Telephone: 508-384-2546
Trade Names:
MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System
Computer-based Image-guided Stereotactic Planning Common Name: System
Instrument, Stereotaxic (84HAW) Classification Name:
Substantial Equivalence
K981686 StealthStation® System, is claimed to: K003699 Medivision IGS System K001153 StealthStation® Generation 3 System K005389 VectorVision2
1
Device Description: The devices are not changed either in hardware or software. They remain as shown in K955397, K982244, K991267, and K992843.
This notification only relates to a revision of the Indications for Use to a closer alignment riflis notinoution only rolatoo to a rothfor the devices shown above to which Substantial Equivalence is claimed.
All of these devices use CT or MRI data gathered prior to, or during, a surgery that is then correlated to the patient by way of various locating methods (mechanical, optical or ther concluded to the potware. This then allows the user to plan, and/or complete, the intended procedure.
Indication for Use: The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open or percutaneous procedures for any medical condition where reference to a rigid anatomical structure, proooderoo for uny mourbarcenor vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotaxic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ohio Medical Instrument Company, Inc. Mr. Kenneth B. Miller Manager, Regulatory 4900 Charlemar Drive Cincinatti, Ohio 45227
APR 0 4 2002
Re: K013428
Re: K015428
Trade Name: Mayfield®/Acciss™ Operating Arm System and Mayfield®/Optical Acciss™ System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 28, 2002 Received: January 31, 2002
Dear Mr. Miller:
We have reviewed your Section 510(k) premarket notification of intent to market the we have forlowed your books betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate (101 the maneations for abs base of the enactment date of the Medical Device commence prior to May 20, 1970, the been reclassified in accordance with the provisions Amendinents, or to doviets and Cosmetic Act (Act) that do not require approval of a of the Pederal I ood, Drug, and Obmit). You may, therefore, market the device, subject to promarket approval approvations of the Act. The general controls provisions of the Act the general connois provisions or aistration, 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 (PMA), it may be subject to such additional controls. Existing major regulations (I will in they con be found in the Code of Federal Regulations, Title 21, Parts affecting your do for the may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does I louse be that FDA has made a determination that your device complies with other not moun that I DTP has or any Federal statutes and regulations administered by other requirements on the Provet comply with all the Act's requirements, including, but not 1 oderal agencies: "100 and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Kenneth Miller
This letter will allow you to begin marketing your device as described in your Section a This letter will anow you to begin manoming of substantial equivalence of your JTV(K) premiation noticate 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 II you desire specific ad 150 for in vitro diagnostic devices), please contact the allt additionally 21 OFF Fur 8091106659. Additionally, for questions on the promotion Other of Compliance at (301), please contact the Office of Compliance at (301) 594and advertising of your the regulation entitled, (Misbranding by reference to premarket 4057. Allso, prease note and rogan. Other general information on your responsibilities nothecation((210) (21 CF R Pat-60197). She Division of Small Manufacturers, International under the Act may be obtained from the member (800) 6382041 or (301) 4436597 or at its anternet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 of · Page
510(k) Number (if known):
MAYFIELD®/ACCISS™ Operating Arm System and Device Name: MAYFIELD®/Optical ACCISS™ System
Indications For Use:
The MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the sku!!, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate. Representative uses would be for cranial, spinal and ENT procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format - 1 - 2 - 96)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013428