(69 days)
Not Found
No
The description focuses on mechanical components and image guidance based on traditional stereotactic principles, with no mention of AI or ML.
No
The device is described as a guide used for instrument positioning during surgical procedures, which is a supportive role rather than directly providing therapy.
No
The device is described as a guide for positioning instruments during surgical procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the device consists of physical components: a base ring, targeting swivel with instrument channel, and locking ring. It is a hardware accessory used in conjunction with a surgical system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: The Elekta Stereotactic Guide is a surgical accessory used for guiding and positioning instruments during open cranial procedures. It interacts directly with the patient's skull and is used in conjunction with imaging and other surgical tools.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is purely mechanical guidance during surgery.
Therefore, based on the provided information, the Elekta Stereotactic Guide falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elekta Stereotactic Guide is indicated for the guidance and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Elekta Stereotactic Guide is an accessory to the Leksell Image Guidance Surgical (LIGS) System. The device consists of a base ring, targeting swivel with instrument channel, and locking ring. The guide and the LIGS are used for guidance and stereotactic instrument positioning during open cranial procedures and surgeries normally performed with traditional stereotactic apparatus. Once the target and entry point is determined during the presurgical planning phase, the craniotomy is made and the Elekta Stereotactic Guide is screwed into the patient's skull at the point of entry. The LIGS probe is placed into the guide and the orientation toward the target is determined using the intra-operative images. The guide is then locked into place and classic stereotactic instruments may then be placed into the channel of the guide for the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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)
The Elekta Stereotactic Guide has been evaluated for performance characteristics using a mechanical accuracy study and a clinical evaluation. Mechanical accuracy was performed on a phantom model with biopsy needle measurements and compared to stereotactic frames. A clinical evaluation of 31 procedures, using the Elekta Stereotactic Guide as an accessory to the Leksell Image Guidance Surgical System was documented. Both studies show that the Elekta Stereotactic Guide performs as intended.
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
UUL 20 1999
Elekta Stereotactic Guide Original Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 16.1
| a. Company Name: | Elekta Instruments, AB | |
|---|---|---|
| b. Company Address: | Birger Jarlsgatan 53, S-103 93 | |
| Stockholm, Sweden | ||
| c. Company Phone: | ||
| Company Facsimile: | (011) 46 8 5872 54 00 | |
| (011) 46 8 5872 55 00 | ||
| d. Contact Person: | Sverker Glans | |
| Vice President | ||
| Quality and Regulatory Affairs | ||
| e. Date Summary Prepared: | May 7, 1999 |
DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | Elekta Stereotactic Guide
Accessory to the Leksell Image Guidance
Surgical System |
|----------------------------|-----------------------------------------------------------------------------------------|
| b. Classification Name: | Stereotaxic Instrument |
| | 21 CFR 882.4560 |
16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Ohio Medical | Mayfield-ACCISS Workstation | K955397 | 04/30/96 |
| Ad-Tech | DAP II Biopsy Guide | K830999 | 07/12/83 |
| Elekta, AB | Leksell Stereotactic System | K972324 | 03/02/98 |
1
11991636
Elekta Stereotactic Guide Original Premarket 510(k) Notification
DEVICE DESCRIPTION 16.4
The Elekta Stereotactic Guide is an accessory to the Leksell Image Guidance Surgical (LIGS) System. The device consists of a base ring, targeting swivel with instrument channel, and locking ring. The guide and the LIGS are used for guidance and stereotactic instrument positioning during open cranial procedures and surgeries normally performed with traditional stereotactic apparatus. Once the target and entry point is determined during the presurgical planning phase, the craniotomy is made and the Elekta Stereotactic Guide is screwed into the patient's skull at the point of entry. The LIGS probe is placed into the guide and the orientation toward the target is determined using the intra-operative images. The guide is then locked into place and classic stereotactic instruments may then be placed into the channel of the guide for the surgical procedure.
16.5 SUBSTANTIAL EQUIVALENCE
The Elekta Stereotactic Guide, as an Accessory to the Leksell Image Guidance Surgical System, is substantially equivalent to Ohio Medical Instruments Mayfield-ACCISS Workstation, Ad-Tech's DAP II Biopsy Guide and Elekta Instruments' Leksell Stereotactic System.
The fundamental technical characteristics of the Elekta Stereotactic Guide are similar to those of the predicate devices. The design of guide and affixation to the patient is equivalent to the Ad-Tech predicate device. The materials used in the Elekta Stereotactic Guide is equivalent to those used in all three predicate devices. The image guidance capabilities are equivalent to that of the Ohio Medical Instruments predicate device.
The Indications for Use for the Elekta Stereotactic Guide is equivalent to the
2
predicate devices in terms of precise stereotactic instrument positioning and image guidance capabilities.
16.6 INTENDED USE
The Elekta Stereotactic Guide is indicated for the guidance and stereotactic instrument positioning in open cranial procedures and surgeries normally performed with traditional stereotactic apparatus.
16.7 TECHNOLOGICAL CHARACTERISTICS
The Elekta Stereotactic Guide is affixed to the patient's cranium. The device consists of a base ring, targeting swivel with instrument channel and locking ring. The base ring provides a rigid fixation for the locking ring and targeting swivel. The instrument channel can accommodate Elekta stereotactic instruments and an Leksell Image Guidance Surgical System probe. A navigational probe is used for determination of the orientation of the target using the intra-operative images of the LIGS system. The guide is locked into place when the correct orientation is obtained. A stop is attached to the stereotactic instrument prior to insertion into the channel. Comparison of the technological characteristics to those of the predicate devices has been provided in this submission.
16.8 PERFORMANCE DATA
The Elekta Stereotactic Guide has been evaluated for performance characteristics using a mechanical accuracy study and a clinical evaluation. Mechanical accuracy was performed on a phantom model with biopsy needle measurements and compared to stereotactic frames. A clinical evaluation of 31 procedures, using the Elekta Stereotactic Guide as an accessory to the Leksell Image
3
K99/636
Guidance Surgical System was documented. Both studies show that the Elekta Stereotactic Guide performs as intended.
510(K) CHECKLIST 16.9
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer ls Checklist is provided in this submission.
4
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three overlapping profiles, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 1999
Elekta Instruments, AB c/o Ms. Carol Patterson Patterson Consulting Group, Inc. 18140 Smokesignal Drive San Diego, California 92127
Re: K991636 Trade Name: Elekta Stereotactic Guide Regulatory Class: II Product Code: HAW Dated: May 7, 1999 Received: May 12, 1999
Dear Ms. Patterson:
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 (QS) 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 - Ms. Carol Patterson
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 vour 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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