LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS

• K Number: K080355
• Device Name: LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS
• Manufacturer: ELEKTA INSTRUMENT AB
• Date Cleared: 2009-05-01 ( 445 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K031999
• Predicate For: K171123 , K190887

Intended Use

The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

Device Description

The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.

AI/ML Overview

The provided documents seem to be segments of a 510(k) submission for a medical device called "Leksell Stereotactic System® with Reusable Fixation Screws." This submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data for a new, standalone device or AI algorithm.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given text.

Here's an explanation of why and what information can be extracted:

Information NOT available in the provided text:

• Acceptance Criteria Table and Reported Device Performance: This type of document is a 510(k) summary, which typically focuses on demonstrating equivalence to an existing device rather than presenting raw performance data against specific, quantifiable acceptance criteria. There are no tables outlining performance metrics like accuracy, sensitivity, specificity, resolution, etc., or corresponding acceptance thresholds.
• Sample sizes (test set), data provenance: There is no mention of a specific test set, its size, or the origin of the data.
• Number and qualifications of experts for ground truth: No information is provided about experts used to establish a ground truth.
• Adjudication method for the test set: No adjudication method is mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned. The submission aims for substantial equivalence, not necessarily a comparison of reader performance with and without an AI.
• Standalone (algorithm only) performance: This device is a physical stereotactic system, not an AI algorithm, so standalone algorithm performance is not applicable or discussed.
• Type of ground truth used: Since no specific performance study is detailed, the type of ground truth used is not described.
• Sample size for the training set: Not applicable as it's a physical device, not a machine learning algorithm.
• How ground truth for the training set was established: Not applicable.

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However, some relevant information can be extracted regarding the device and its regulatory context:

Device Description and Intended Use:

• Device Name: Leksell Stereotactic System® with Reusable Fixation Screws
• Intended Use: The system is intended for "localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiation therapy."
• Device Classification:
  • Common Name: Stereotaxic instrument
  • Product Code: HAW
  • Class: II
  • Regulation Number: 21 CFR 882.4560

Substantial Equivalence Claim:

• Predicate Device: Leksell Stereotactic System® (K031999)
• Claim: The functionality of the Leksell Stereotactic System® with Reusable Fixation Screws is "equivalent to its predicate device... in safety and effectiveness." The fundamental technical characteristics are stated to be "the same to those of the predicate device."

Regulatory Outcome:

• The FDA reviewed the 510(k) application (K080355) and determined the device is substantially equivalent to legally marketed predicate devices. This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not require premarket approval (PMA).

In summary: The provided documents detail a 510(k) submission for a stereotactic system, focusing on its equivalence to a previously cleared device. It does not contain the specific performance study data and acceptance criteria typically associated with testing a new device or an AI algorithm against defined performance metrics.

Summary

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ELEKTA INSTRUMENT AB

Dokumentnamn/Nama of document Traditional 510/k)

Utfärdare//ssuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva ¡Edition
Anders Skoglund	--	--
Avser/RegardingLeksell Stereotactic System® with Reusable Fixation Screws		Directory

Section 4- 510(k) Summary

As Required by 21 CFR 807.87(k)510 (k) Summary

Subscribers Name & Address 1.

Elekta Instrument AB Kungstensgatan 18, P.O. Box 7593 SE-103 93 Stockholm, Sweden Tel: [phone] Fax: [phone] Contact Person for this submission: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl

Trade Name 2.

Leksell Stereotactic System® with Reusable Fixation Screws

3. Device Classification

Common Name	Product Code	Class	Regulation Number
Stereotaxic instrument	HAW	II	21 CFR 882.4560

Predicate Device Identification 4.

Legally marketed devices to which equivalence is being claimed	510(k) #
Leksell Stereotactic System ®	K031999

5. Other relevant submissions

10.0.000 0010.000 0AVICAS.	1
SUSTEM9000	VA21000
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Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel [phone] Fax [phone]

MAY - 1 2009

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K040 355

S

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document

F-Utl-1 (5.12.1)

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	--	--
Avser/Regarding	Directory
Leksell Stereotactic System® with Reusable Fixation Screws

6. Device Description (for detailed description see Section "Device Description")

The Reusable Fixation Screws are a part of the Leksell Stereotactic System® and are used to affix the Leksell® Coordinate Frame G firmly to the patient's skull with minimal inconvenience to the patient.

7. Intended Use

The Leksell Stereotactic System® with Reusable Fixation Screws is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy.

Substantial Equivalence 8

The functionality for the Leksell Stereotactic System® with Reusable Fixation Screws is equivalent to its predicate device the Leksell Stereotactic System® (K031999) in safety and effectiveness. The fundamental technical characteristics are the same to those of the predicate device and are listed on the comparison charts provided in this 510 k submission.

· Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tel [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elekta Instrument AB % Mr. Anders Skoglung Director Regulatory Affairs P.O. Box 7593. SE-103 93 Stockholm Sweden

MAY - 1 2009

Re: K080355

Trade/Device Name: Leksell Stereotactic System® with Reusable fixation Screws Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 27, 2009 Received: April 29, 2009

Dear Mr. Skoglung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Anders Skoglung

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A Millman

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K.050355

ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510/k)

Utfärdare/Issuer	Rel. nr/Dok. nr/Ref. no/Doc. no	Utgåva /Edition
Anders Skoglund	--	--
Avser/Regarding	Directory
Leksell Stereotactic System® with Reusable Fixation Screws

Section 7- Indications for Use Statement

510(k) Number	To be defined
Device Name	Leksell Stereotactic System® with Reusable Fixation Screws
Indications for Use	The Leksell Stereotactic System® with Reusable Fixation Screws isa system intended for localization and diagnosis of intracranialdisorders and their surgical treatment, including radiotherapyand stereotactic radiaton therapy

Prescription X Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oslen forman

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K040355

Elekta Instrument AB, P.O. Box 7593, SE-103 93 Stockholm, Sweden Tei [phone] Fax [phone]

Regulation Number and Section

§ 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).