The Elekta Esarte™ Frame System is part of Leksell Stereotactic System®, which is intended for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.

Device Description

The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) to provide target localization (spatial reference), and the fixation of the patient's head at prescribed geometric coordinates on the Precise table top of the digital accelerator. The Elekta Esarte™ Frame also attaches to the table of the CT scanner that is used to acquire images for the SRT planning.

AI/ML Overview

The provided document is a 510(k) summary for the "Elekta Esarte™ Frame System," a stereotactic instrument. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating the performance of an AI-powered device. Therefore, the information requested in the prompt about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth for an AI device is not available in the provided text.

The document focuses on:

Device Description: The Elekta Esarte™ Frame System is used in stereotactic radiation therapy (SRT) for target localization and patient head fixation.
Intended Use: Localization and diagnosis of intracranial disorders and their surgical treatment, including radiosurgery and stereotactic radiation therapy, as part of the Leksell Stereotactic System®.
Substantial Equivalence: The device is claimed to be substantially equivalent in safety and effectiveness to its predicate device, the Leksell® Stereotactic System with disposable biobsy needle kit (K031980), with similar fundamental technical characteristics.
Regulatory Classification: Class II device, product code HAW (Stereotaxic instrument) and LHN (Medical charged-particle radiation therapy system).

Since this document is a 510(k) summary for a physical medical device and not an AI or software as a medical device, it does not contain the information required to answer the prompt. There are no performance metrics, clinical study details, or AI-specific validation information to report.

Summary

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JUL	25 2005
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ELEKTA INSTRUMENT AB	K051746	Dokumentnamn/Name of document	Special 510(k)	13
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Utfärdare/Issuer	Anders Skoglund
Ref nr/Dok nr/Ref no/Doc no	.	Utgåva /Edition	1
Avser/Regarding	Elekta Esarte™ Frame System		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: (011) 46 8 587 254 00 Fax: (011) 46 8 587 255 00 Contact Person for this submission: Mr Anders Skoglund Official Correspondent: Mr Peter Löwendahl

Trade Name 2.

Elekta Esarte™ Frame System

Device Classification 3.

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

Regulatory History (Unmodified Predicate Device) 4.

Devices	510(k) #
Leksell® Stereotactic System with disposable biobsy needle kit	K031980
Leksell® Stereotactic System with MR Post Kit	K031999
Leksell® Stereotactic System	K972324

ર . Other relevant submissions

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ELEKTA INSTRUMENT AB KOS 1746
Dokumentnamn/Name of document Special 510(k) 14

Utfärdare/Issuer	Ref nr/Dok nr/Ref no/Doc no	Utgåva /Edition
Anders Skoglund	.	1
Avser/Regarding		Directory
Elekta Esarte™ Frame System	.	.

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

Intended Use 7.

Substantial Equivalence 8

The functionality for the Elekta Esarte™ Frame System is equivalent to its predicate device Leksell® Stereotactic System with disposable biobsy needle kit (K031980) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains text around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Löwendahl Ouality and Regulatory Affairs Manager Elekta Instrument AB P.O. Box 7593 SE-103 93 Stockholm SWEDEN

Re: K051746

JUL 2.5 2005

Trade/Device Name: Elekta Esarte™ Frame System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: HAW and LHN Dated: June 27, 2005 Received: June 29, 2005

Dear Mr. Löwendahl:

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, 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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); 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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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K051716

Dokumentnamn/Name of document Special 510lk)

Utfärdare/Issuer	Anders Skoglund
Ref nr/Dok nr/Ref no/Doc no
Utgåva /Edition	1
Avser/Regarding	Elekta Esarte™ Frame System
	Directory

Section 7- Indications for Use Statement

510(k) Number	To be defined
Device Name	Elekta Esarte™ Frame System
Indications for Use	The Elekta Esarte™ Frame System is part of Leksell StereotacticSystem®, which is intended for localization and diagnosis ofintracranial disorders and their surgical treatment includingradiosurgery and stereotactic radiation therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

. .

ANDIOR

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)

Daniel R. Seymour

(Division Sign-Off) (Division of Reproductive, Abdon and Radiological Devices 510(k) Number _

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).