(48 days)
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.
Not Found
This 510(k) summary does not contain the detailed study information required to fill out the table and answer all questions. It primarily focuses on the FDA's determination of substantial equivalence for the Spherz™ stereotaxic instrument based on its indications for use and comparison to a predicate device.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test sets or training sets.
- Details on ground truth establishment (number/qualifications of experts, adjudication method, type of ground truth).
- Whether a standalone or MRMC comparative effectiveness study was done, or any associated effect sizes.
- Data provenance.
Therefore, most of the requested information cannot be extracted from the provided text.
Based on the information given, here's what can be inferred or stated:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document. Substantial equivalence for 510(k) usually implies performance similar to a predicate device, but specific quantitative criteria are not provided here.
- Reported Device Performance: Not detailed in this document. The FDA's letter only states that the device is substantially equivalent to a legally marketed predicate device.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided in the document.
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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 provided in the document.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the document.
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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 provided in the document. This device (Spherz™) is described as a "stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures." It's not an AI-driven diagnostic reader, so an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant to this product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not provided in the document. Given it's an "accessory to aid in auto-registration and localization," it functions with human intervention as part of an image-guided surgery system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in the document.
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The sample size for the training set:
- Not provided in the document.
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How the ground truth for the training set was established:
- Not provided in the document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES .
Image /page/0/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 three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
Ms. Helen Zinreich Chief Executive Officer I.Z.I. Corporation 7020 Tudsbury Road Baltimore, Maryland 21244
Re: K022074
Trade/Device Name: SpherzTM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: June 17, 2002 Received: June 26, 2002
Dear Ms. Zinreich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 – Ms. Helen Zinreich
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
L. Supt Rhodes
2 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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Page 1 of 1
510(K) Number (if known):
Spherz™ Product Name:
Indications for Use.
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structures in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of sterotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure can be identified relative to a CT or MR-based model of the anatomy.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Target Population: Adult, Child, and Infant
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stuart Rurka
× Prescription Use
DRof General, Restorative Counter Use and Neurological Devices
510(k) Number K022074
SK-33
FD/01
23
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16
§ 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).