(15 days)
The Leksell® SurgiPlan with AtlasSpace™ is intended for use in planning invasive intra-cranial stereotactic surgical procedures.
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.
The provided document is limited in the detail required to thoroughly describe acceptance criteria and a study proving device performance as it's a 510(k) summary from 2001. The document is primarily focused on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
However, based on the available information, here's what can be inferred and presented:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Leksell® SurgiPlan with AtlasSpace™ does not explicitly state quantitative acceptance criteria or a specific table-formatted performance report. Instead, it makes a general statement about performance testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs as intended for planning invasive intra-cranial stereotactic procedures, with the added AtlasSpace module functioning correctly. | "All results of testing and software evaluation were found to be acceptable. The Leksell® SurgiPlan with AtlasSpace performed as intended." |
| Functionality and indications for use remain unchanged from the predicate Leksell® SurgiPlan. | Stated that "The SurgiPlan System has not changed in its functionality or its indications for use." and "The functionality and the indications for use have not changed with the proposed modifications." |
| The AtlasSpace software module is equivalent to the brain atlas in the Radionics AtlasPlan™ predicate device. | "The addition of the brain atlas software module is equivalent to the brain atlas found in the Radionics AtlasPlan predicate device." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any test set or the data provenance. It vaguely refers to "performance testing" and "software evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method for the test set
This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The device's clearance predates widespread AI integration in medical devices and the focus here is on adding a digital atlas, not an AI-driven interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the Leksell® SurgiPlan with AtlasSpace™ as a planning tool that overlays atlas contours on patient images. This implies it's an assistive tool intended for human-in-the-loop use, not an algorithm operating in a standalone capacity for diagnosis or intervention. No standalone performance study is mentioned.
7. The type of ground truth used
The document does not explicitly state the type of ground truth used for any testing. Given the nature of a brain atlas and a stereotactic planning system, the "ground truth" for evaluating the AtlasSpace module would likely relate to the accuracy of anatomical mapping and the correspondence of the atlas to patient-specific imaging, potentially validated against known anatomical landmarks or surgical outcomes, but this is speculative as the document is silent on this.
8. The sample size for the training set
No information about a training set is provided. The AtlasSpace module is described as a "second generation computerized brain atlas, based on three orthogonal series of the Schaltenbrand-Wahren atlas," implying it's a pre-computed anatomical reference rather than a machine learning model developed with a training set.
9. How the ground truth for the training set was established
Since no training set is mentioned (see point 8), there is no information on how its ground truth was established. The "ground truth" for the AtlasSpace module itself would be the accuracy and anatomical correctness of the underlying Schaltenbrand-Wahren atlas data, which is a published anatomical reference.
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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 93Stockholm, Sweden |
| c. Company Phone:Company Facsimile: | (011) 46 8 5872 54 00(011) 46 8 5872 55 00 |
| d. Contact Person: | Sverker GlansVice PresidentQuality 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 Instrument21 CFR 882.4560 |
17.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| ElektaInstruments, AB | Leksell® SurgiPlan | K943468 | 01/20/1995 |
| Radionics, Inc. | AtlasPlan | K980584 | 05/18/1998 |
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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
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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
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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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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 usein planning invasive intra-cranial stereotactic surgicalprocedures. |
(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
§ 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).