K Number
K993501
Device Name
3D1 MICROPOSITIONING HEADSTAGE
Date Cleared
1999-11-22

(38 days)

Product Code
Regulation Number
882.4560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.
Device Description
The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.
More Information

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Not Found

No
The summary describes a mechanical device for precise positioning and does not mention any software, algorithms, or data processing that would indicate AI/ML.

No
The device is described as an accessory that allows for precise positioning of a neurosurgical instrument during procedures, but it does not directly provide a therapeutic effect itself.

No

The device is described as a micropositioning headstage used for precise movement of a surgical instrument. Its function is to aid in surgical procedures, not to diagnose medical conditions or analyze data to identify a disease, condition, or health status.

No

The device description explicitly states it is a "device that allows for precise positioning of a neurosurgical instrument along three axes" and "comes with a mounting adaptor." This indicates a physical hardware component, not a software-only device.

Based on the provided information, the 3D1 Micropositioning Headstage 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 3D1 Micropositioning Headstage is a surgical instrument used during a neurosurgical procedure to precisely position other instruments within the body. It does not analyze samples taken from the body.
  • Intended Use: The intended use clearly states it's for precise movement of a surgical instrument during neurosurgery.
  • Device Description: The description reinforces its role as an accessory to a stereotactic head frame for positioning instruments.

Therefore, the 3D1 Micropositioning Headstage is a surgical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.

Product codes

HAW

Device Description

The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

qualified neurosurgeon

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.)

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Predicate Device(s)

Not Found

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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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).

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K99350f

510(k) Summary

3D1 Micropositioning Headstage

Common/Classification Name: Stereotactic Instrument, 21 CFR 882.4560

Scientific Tools, Inc. 2932 Ross Clark Circle, #165 Dothan, AL 36301

334-708-0653 334-702-0653

Contact: Doug Real, Prepared: September 17, 1999

A. LEGALLY MARKETED PREDICATE DEVICES

The 3D1 Micropositioning Headstage is an accessory to currently marketed stereotactic headframes, which are Class II devices under the responsibility of the Neurological Devices Panel. FDA has assigned the product code 84HAW to stereotactic instruments.

B. DEVICE DESCRIPTION

The 3D1 Micropositioning Headstage is a device that allows for precise positioning of a neurosurgical instrument along three axes. The device is used in neurosurgical procedures in conjunction with a conventional stereotactic head frame and serves as an accessory to those devices. The 3D1 device comes with a mounting adaptor that is specific for the particular stereotactic head frame being used.

C. INTENDED USE

The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when precise movement of a surgical instrument is needed along any of three axes. The 3D1 Micropositioning Headstage is intended to be used with a standard stereotactic headframe system.

D. SUBSTANTIAL EQUIVALENCE SUMMARY

The 3D1 Micropositioning Headstage is a medical device, and it has similar, though slightly different, indications for use as the legally marketed predicate devices. However, the differences do not alter

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the intended therapeutic effect. The 3D1 Micropositioning Headstage has the same technological characteristics as the predicate devices for which it is an accessory. This premarket notification has described the characteristics of the 3D1 Micropositioning Headstage in sufficient detail to assure substantial equivalence. In summary, this pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

TECHNOLOGICAL CHARACTERISTICS E.

Both the 3D1 Micropositioning Headstage and the predicate devices employ precision mechanical positioning systems to guide neurosurgical instruments. Both the 3D1 Micropositioning Headstage and the predicate devices are purely manually operated and serve as an aid in positioning to the neurosurgeon.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 22 1999

Scientific Tools, Inc. c/o T. Whit Athey, Ph.D. C. L. McIntosh & Associates 12300 Twinbrook Parkway Suite 625 Rockville, Maryland 20852

Re: K993501

Trade Name: 3D1 Micro Positioning Headstage Regulatory Class: II Product Code: HAW Dated: October 14, 1999 Received: October 15, 1999

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,

Stephen Rhodes

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

K993501 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The 3D1 Micropositioning Headstage is indicated for use by a qualified neurosurgeon when The JD Micropobitioning rical instrument is needed along any of three axes. The 3D1 process intovement of a belginanded to be used with a standard stereotactic headframe system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hosta Durkin

(Division Sign-Off) Division of General Restorative Devices K993501 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use --------

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