(30 days)
Not Found
No
The 510(k) summary describes a simple mechanical device (a screw) used as a reference point in stereotactic surgery. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device is described as a "self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures" and is intended for "establishing fixed reference point(s) in patients requiring stereotactic surgery." It functions as an accessory for navigation systems, which points to a diagnostic or assistive role rather than directly treating or preventing a disease.
No
The device is a physical fixation device used as a reference point during stereotactic surgery, not for diagnosing medical conditions.
No
The device description clearly states it is a "self drilling metallic fixation device," indicating it is a physical hardware component, not software.
Based on the provided information, the Lorenz Fiducial Screw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for establishing fixed reference points in patients for stereotactic surgery. This is an in-vivo application, meaning it's used directly on or within the body.
- Device Description: The device is a metallic fixation device used as a reference point during procedures. This further reinforces its in-vivo use.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Lorenz Fiducial Screw does not involve any of these activities.
Therefore, the Lorenz Fiducial Screw is a surgical accessory used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.
Product codes (comma separated list FDA assigned to the subject device)
84HAW
Device Description
The Lorenz Fiducial Screw is a self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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
MAR 1 5 2001
Summary of Safety and Effectiveness
| Device Name: | Lorenz Fiducial Screw |
|---|---|
| Classification Name: | Stereotaxic Instrument and Accessory |
| Device Product Code: | Neurology: 84HAW (21 CFR 882.4560) |
Intended Use:
The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.
Description:
The Lorenz Fiducial Screw is a self drilling metallic fixation device with a stop used only as a reference point during stereotactic procedures.
Sterility Information:
The Fiducial screw will be marketed as non-sterile, single use devices. Steam Sterilization recommendations are included in the package insert and can be seen in Attachment I.
Substantial Equivalence:
Walter Lorenz considers the Lorenz Fiducial Screw equivalent to the Howmedica Leibinger, Inc. Ost-Reg Marker System for Stereotaxic Navigation, K961120 and Lorenz 1.0mm, 1.5mm, 2.0mm systems, K953385. TAB 3 includes a substantial equivalence comparison table to competitive devices. TAB 4 includes information for Howmedica Leibinger, Inc.
Possible risks:
Lorenz Fiducial Screws should not be used when there is the following:
-
- Bone infection
-
- Skin infection
000011
1
Image /page/1/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 an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2001
Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, Florida 32218
K010427 Re: Trade Name: Lorenz Fiducial Screw Regulatory Class: II Product Code: HAW Dated: February 6, 2001 Received: February 13, 2001
Dear Ms. Reed:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 510(x) notificantalially equivalent (for the indications for above and we have determined this as marketed in interstate commerce prior to use stated in the enclosure) to devices manological Device Amendments, or to devices that May 28, 1970, the ellacinem date of the Frederal Food, Drug, and have been reclassified in accordance with the pro research, subject to the general controls Cosmetic Act (Act). You may, therefore, manor ano of the Act include requirements for
es and provisions of the Act. "The general connects pood 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 (Premarket Approval), it may be subject to satis as a federal Regulations, Title 21, regulations arrecting your device can of roans in the mination assumes compliance with the Parts 600 to 695. A Substantially Squarement, as set forth in the Quality System current Good Manufacturing Practice requiation (21 CFR Part 820) and that, Regulation (QS) for Medical Devices: Sood and Drug Administration (FDA) will verify
through periodic (QS) inspections, the Food and Drug Administration within result to through periodic (Q3) inspections, the I 000 and in regulation may result in regulations such assumptions. Tanufe to comply with the SHE cognification whenice in the action. In addition. PDA may publish farmer and continued on the first on submission does Federal Register. Prease note: this response to Jour pross 31 through 542 of the Act for not allect any obligation you might have and control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Kim Reed
This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow your even finding of substantial equivalence of your device to a premarket notification. THE PDT Intellige or calassification 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 If you desire specific as for in vitro diagnostic devices), please contact the Office of and additionally 009:104-4595. Additionally, for questions on the promotion and Compliance at (301) 591 1595. Practition of Compliance at (301) 594-4639. advertising of your avrievy from entitled, "Misbranding by reference to premarket Also, prease note the regulation online and information on your responsibilities under the nother (21 OF IC 801197). States 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,
for
Miriam. C. Provost
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
3
STATEMENT OF INDICATIONS FOR USE
510(k) Number: K010 427
Device Name: Lorenz Fiducial Screw
Indications For Use:
The Lorenz Fiducial Screw is intended for establishing fixed reference point(s) in patients requiring stereotactic surgery. The Fiducial Screw can be used as an accessory with frameless navigation systems, as appropriate, from other manufacturers.
(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) |
| ------------------------------------------ | -- | ---- | -------------------------------------------------- |
|---|
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K010427 |
|---|---|
| --------------- | --------- |
000001