(48 days)
Not Found
Not Found
No
The summary does not contain any explicit mentions of AI, ML, deep learning, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices (like training/test sets, AUC, sensitivity/specificity). The description focuses on "auto-registration and localization" which can be achieved through traditional image processing algorithms.
No
The device is described as an accessory to aid in auto-registration and localization for image-guided surgery, not as a device that directly treats a medical condition. Its purpose is to assist in surgical procedures.
No
Explanation: The device is described as a stereotactic system accessory to aid in auto-registration and localization for image-guided surgery, not for diagnosing medical conditions. It aids in surgical procedures by localizing anatomical structures, which is a therapeutic or assistive function, not a diagnostic one.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended use describes a stereotactic system accessory, which often involves hardware components for tracking and localization. Without a description of the device itself, it's impossible to definitively say if it's purely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The intended use describes the device 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." This involves using imaging data (CT or MR) to guide surgical procedures directly on the patient's body.
- No Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device works with imaging data of the patient's anatomy.
Therefore, this device falls under the category of a surgical guidance or navigation system accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HAW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT or MR-based model
Anatomical Site
rigid patient anatomical structures
Indicated Patient Age Range
Adult, Child, and Infant
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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
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
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