(170 days)
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.
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.
This 510(k) premarket notification (K013428) for the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System is a submission for a revised indication for use for an already cleared device. Therefore, it does not contain a new study that proves the device meets specific acceptance criteria related to performance metrics (e.g., accuracy, sensitivity, specificity).
The core of this submission is a claim of substantial equivalence to previously cleared devices (K981686, K003699, K001153, K005389) and a revision to the Indications for Use statement. It explicitly states: "The devices are not changed either in hardware or software. This notification only relates to a revision of the Indications for Use..."
As such, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, because a new study demonstrating such performance was not conducted or submitted with this specific 510(k). This particular submission leverages the performance established in the predicate devices and focuses on broadening the scope of its clinical utility.
Therefore, most of the sections of your request are not applicable to this document. I will fill in the information that is available.
Acceptance Criteria and Device Performance Study for K013428: MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System
This 510(k) submission (K013428) is for a revised indication for use of an existing device, the MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®/Optical ACCISS™ System. The document explicitly states: "The devices are not changed either in hardware or software." and "This notification only relates to a revision of the Indications for Use..."
Therefore, this submission does not include a new study with specific acceptance criteria and reported device performance metrics (such as accuracy, sensitivity, specificity, detection rate, etc.) for a novel or modified device. The substantial equivalence is based on the previously cleared predicate devices and the unchanged hardware/software.
Table of Acceptance Criteria and Reported Device Performance:
Since no new performance study was conducted or presented in this 510(k), this table cannot be populated with new device performance against acceptance criteria. The device's performance is assumed to be consistent with the predicate devices and its prior clearances (K955397, K982244, K991267, and K992843).
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable, as this submission is for a revised indication for use, not a new performance study. | Not applicable, as this submission is for a revised indication for use, not a new performance study. |
1. A table of acceptance criteria and the reported device performance:
- Not applicable. This 510(k) does not present new performance data or acceptance criteria as it's for a revised indication of an existing, unchanged device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data was provided or generated for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No new ground truth establishment was described for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new adjudication method was described for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. The device described is a computer-based image-guided stereotactic planning system, not an AI-assisted diagnostic device where "human readers improve with AI vs without AI assistance" would be a relevant metric. Furthermore, no MRMC study was mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission focuses on a revision of indications for use for an existing surgical navigation system. Standalone algorithm performance, in the context of typical AI/diagnostic devices, is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No new ground truth establishment was described for this submission. For surgical navigation systems, the 'ground truth' often relates to the physical accuracy of the navigation relative to anatomical landmarks, but no new study measuring this was presented.
8. The sample size for the training set:
- Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.
9. How the ground truth for the training set was established:
- Not applicable. As this is not a submission for a new algorithm requiring a training set, this information is not relevant or provided.
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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.
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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.
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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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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
§ 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).