ELEKTA ESARTE FRAME SYSTEM

K051746 · Elekta Instrument AB · HAW · Jul 25, 2005 · Neurology

Device Facts

• Record ID: K051746
• Device Name: ELEKTA ESARTE FRAME SYSTEM
• Applicant: Elekta Instrument AB
• Product Code: HAW · Neurology
• Decision Date: Jul 25, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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 Story

Elekta Esarte™ Frame System serves as a stereotaxic instrument for intracranial procedures. It provides spatial reference (target localization) and patient head fixation at specific geometric coordinates. The device attaches to the table of a CT scanner for image acquisition and to the Precise table top of a digital accelerator for stereotactic radiation therapy (SRT). Used in clinical settings by medical professionals, the frame ensures precise patient positioning relative to imaging and treatment equipment. By maintaining stable, accurate coordinates, it facilitates targeted surgical or radiation treatment of intracranial disorders, potentially improving therapeutic accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technical characteristics and intended use.

Technological Characteristics

Stereotaxic instrument for head fixation and spatial localization. Mechanical frame system designed for integration with CT scanners and digital accelerators. No software, energy source, or electronic sensing components described.

Indications for Use

Indicated for patients requiring localization, diagnosis, and surgical treatment of intracranial disorders, including radiosurgery and stereotactic radiation therapy.

Regulatory Classification

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.

Predicate Devices

• Leksell® Stereotactic System with disposable biobsy needle kit (K031980)
• Leksell® Stereotactic System with MR Post Kit (K031999)
• Leksell® Stereotactic System (K972324)

Submission Summary (Full Text)

{0}------------------------------------------------

| JUL | 25 2005 |
|-----|---------|
|-----|---------|

| ELEKTA INSTRUMENT AB | K051746 | Dokumentnamn/Name of document | Special 510(k) | 13 |
|----------------------|---------|-------------------------------|----------------|----|
|----------------------|---------|-------------------------------|----------------|----|

| 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: [phone] Fax: [phone] 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.

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.

### Intended Use 7.

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.

### 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.

{3}------------------------------------------------

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 [phone] or [phone] 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)

20

| 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 Stereotactic<br>System®, which is intended for localization and diagnosis of<br>intracranial disorders and their surgical treatment including<br>radiosurgery and stereotactic radiation therapy. |

Prescription Use X (Part 21 CFR 801 Subpart D)

. .

ANDIOR

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

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(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 _