(15 days)
No
The description focuses on a computerized brain atlas based on a pre-existing anatomical atlas (Schaltenbrand-Wahren) and does not mention any AI/ML techniques for image processing, analysis, or planning. The update is described as adding a "second generation computerized brain atlas."
No.
The device is intended for planning surgical procedures, not for direct therapeutic intervention.
No
The device is described as being for "planning invasive intra-cranial stereotactic surgical procedures," which indicates a pre-operative planning and guidance function rather than diagnosis. It does not mention identifying, detecting, or assessing a medical condition or disease.
Yes
The device description explicitly states that the submission is for the addition of a "software module" (AtlasSpace) to an existing cleared device (Leksell SurgiPlan). The description focuses on the software update and updated manuals, with no mention of new or modified hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "planning invasive intra-cranial stereotactic surgical procedures." This describes a surgical planning tool used in vivo (within the body) for a medical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces its use in surgical planning and mentions a computerized brain atlas, which is consistent with a surgical planning tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Leksell® SurgiPlan with AtlasSpace™ is a surgical planning software/system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Leksell® SurgiPlan with AtlasSpace™ is intended for use in planning invasive intra-cranial stereotactic surgical procedures.
Product codes
HAW
Device Description
The Leksell® SurgiPlan with AtlasSpace is intended for use in planning invasive intra-cranial stereotactic procedures. The Leksell SurgiPlan was cleared for commercial distribution under K943468 on January 20, 1995. The purpose of this special premarket 510(k) notification is to describe the addition of the AtlasSpace software module. The AtlasSpace module is a second generation computerized brain atlas, ased on three orthogonal series of the Schaltenbrand-Wahren atlas. The SurgiPlan System has not changed in its functionality or its indications for use. As a result of the addition of the AtlasSpace, the SurgiPlan software and instruction manuals have been updated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-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)
Performance testing was conducted on the Leksell SurgiPlan with AtlasSpace based on product specifications and hazard effects determined from the risk analysis. All results of testingand software evaluation were found to be acceptable. The Leksell® SurgiPlan with AtlasSpace performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 0 6 2001 SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 17:
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 17.1
| 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: | November 19, 2001 |
DEVICE IDENTIFICATION 17.2.
| a. Trade/Proprietary Name: | Leksell® SurgiPlan with AtlasSpace™ |
|---|---|
| b. Classification Name: | Stereotaxic Instrument |
| 21 CFR 882.4560 |
17.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Elekta | |||
| Instruments, AB | Leksell® SurgiPlan | K943468 | 01/20/1995 |
| Radionics, Inc. | AtlasPlan | K980584 | 05/18/1998 |
1
17.4 DEVICE DESCRIPTION
The Leksell® SurgiPlan with AtlasSpace is intended for use in planning invasive intra-cranial stereotactic procedures. The Leksell SurgiPlan was cleared for commercial distribution under K943468 on January 20, 1995. The purpose of this special premarket 510(k) notification is to describe the addition of the AtlasSpace software module. The AtlasSpace module is a second generation computerized brain atlas, ased on three orthogonal series of the Schaltenbrand-Wahren atlas. The SurgiPlan System has not changed in its functionality or its indications for use. As a result of the addition of the AtlasSpace, the SurgiPlan software and instruction manuals have been updated.
17.5 SUBSTANTIAL EQUIVALENCE
The Leksell® SurgiPlan with AtlasSpace™ is substantially equivalent to the current version of the Leksell® SurgiPlan and the Radionics AtlasPlan™
The fundamental technical characteristics of the Leksell SurgiPlan with AtlasSpace are similar to those of the predicate devices. The functionality and the indications for use have not changed with the proposed modifications. The addition of the brain atlas software module is equivalent to the brain atlas found in the Radionics AtlasPlan predicate device.
17.6 INDICATIONS FOR USE
The Leksell® SurgiPlan with AtlasSpace is intended for use in planning invasive intra-cranial stereotactic surgical procedures.
17.7 TECHNOLOGICAL CHARACTERISTICS
Modifications have been made to the Leksell® SurgiPlan to add the AtlasSpace software module. The SurgiPlan software program has been enhanced to include a brain atlas that relates the precise anatomy of a patient to a functional or
2
anatomical map of the brain. AtlasSpace overlays the atlas contours directly on the patient's anatomical images and matches the data in three dimensions using the 3-D Talairach proportional grid. Comparison of the technological characteristics to those of the predicate devices has been provided in this submission.
PERFORMANCE DATA 17.8
Performance testing was conducted on the Leksell SurgiPlan with AtlasSpace based on product specifications and hazard effects determined from the risk analysis. All results of testingand software evaluation were found to be acceptable. The Leksell® SurgiPlan with AtlasSpace performed as intended.
510(K) CHECKLIST 17.9
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are arranged in a way that resembles a bird in flight, symbolizing hope and progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 6 2001
Elekta Instrument AB Ms. Carol Patterson c/o Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630
Re: K013861
Trade Name: Leksell Surgiplan with Atlasspace™ Accessory Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: November 19, 2001 Received: November 21, 2001
Dear Ms. Patterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Scotton 310(i) prohip prohesis substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to indications for use stated in the cholosal Device Amendments, or to device that have May 28, 1970, the enactinent date of the Federal Food, Drug, and Cosmetic Act been reclassified in accordance with alo proval application (PMA). You may, (Act) that do not require approval of a provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions of the Act mende requirentisitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (soc above) this Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controllations, Title 21, Parts 800 to 898. In addition, FDA may oe found in the Code of I ouchar single in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issuation of a backers of a bases in the requirements of the Act that FDA has inade a decemination administered by other Federal agencies. You must or any Federal statutes and regulations and instituting, but not limited to: registration and listing (21 comply with an the Act 3 requirements, news 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 800); good manage (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GFR 1000 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carol Patterson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organization of substantial equivalence of your device to a legally premaired predicated. The PDF miaing of casion 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 If you desire specific advice for your dovitro diagnostic devices), please contact the Office of additionally 21 CFR Fall 807.10 for m. March 1.6g r. car on the promotion and advertising of Compliance at (301) 597-1637. Tiber of Compliance at (301) 594-4639. Also, please note the your device, piease ochiaso and a by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outler general information on your respectional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
$\beta$
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
5
INDICATION FOR USE
| 510(k) Number: | To Be Assigned By FDA K013861 |
|---|---|
| Device Name: | Leksell® SurgiPlan with AtlasSpace™ |
| Indications for Use: | The Leksell® SurgiPlan with AtlasSpace™ is intended for use |
| in planning invasive intra-cranial stereotactic surgical | |
| procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Walker
(Division Sign-Division of Ger Restorative and Neurologic ... .. vices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use