LEKSELL GAMMAPLAN

K103093 · Elekta Instrument AB · MUJ · Dec 21, 2010 · Radiology

Device Facts

• Record ID: K103093
• Device Name: LEKSELL GAMMAPLAN
• Applicant: Elekta Instrument AB
• Product Code: MUJ · Radiology
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

Device Story

Leksell GammaPlan® is a computer-based dose planning system for stereotactic radiosurgery and radiotherapy. It is designed for use with the Leksell Gamma Knife®. The system enables clinicians to perform dosimetry planning for patient treatments. It processes clinical data to calculate radiation dose distributions, assisting healthcare providers in planning precise treatment delivery. The system is intended for professional use in clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Computer-based dose planning system; software-based; designed for integration with Leksell Gamma Knife® hardware.

Indications for Use

Indicated for use as a computer-based dose planning system for stereotactic radiosurgery and stereotactic radiotherapy treatments using the Leksell Gamma Knife®.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Leksell GammaPlan® (K090972)
• XiO RTP (K092132)

Submission Summary (Full Text)

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# DEC 2 1 2010

## ELEKTA INSTRUMENT AB

| Dokumentnamn/Name of document |
|-------------------------------|
| Special 510(k) |

| Utfärdare/Issuer | Viveka Wretman |
|-----------------------------|--------------------|
| Avser/Regarding | Leksell GammaPlan® |
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| 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: Mrs Viveka Wretman Official Correspondent: Mr Anders Skoglund

#### Trade Name 2.

Leksell GammaPlan®

#### 3. Device Classification

| Common Name<br>Comments of the programments of the All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All All Al | Product Code Class | Regulation Number |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------|
| Radionuclide radiation therapy system | | 892.5750 |

#### Predicate Device Identification 4.

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Leksell GammaPlan® | K090972 |
| XiO RTP | K092132 |

#### 5. Other relevant submissions

| ----------<br>1<br>Carrely of Canadian Career of<br>10111000<br>1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>And Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of<br>----------------- | Property of Children<br>No. of Cattle<br>PAGI |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Amore of the property of | Michael Address Marcel<br>And Antiques of Concession of Concession of Children Andrew And | -<br>Character of Children of Children Company of Children Company Company Comments of Children |

### COMPANY CONFIDENTIAL

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

K103093

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### ELEKTA INSTRUMENT AB

| Utfärdare/Issuer | Ref nr/Dok nr/Ref no/Doc no | Utgåva /Edition | Special 510(k) |
|--------------------|-----------------------------|-----------------|----------------|
| Viveka Wretman | - | - | |
| Avser/Regarding | | Directory | |
| Leksell GammaPlan® | - | - | |

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

Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with the Leksell Gamma Knife®. Leksell Gamma Plan® is intended to be used for planning the dosimetry of treatments, in stereotactic radiosurgery and stereotactic radiotherapy.

#### 7. Intended Use

Leksell GammaPlan® is a computer-based dose planning system specifically designed for use with Leksell Gamma Knife®.

#### 8 Substantial Equivalence

The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K090972) and XiO RTP System (K092132) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices. .

# COMPANY CONFIDENTIAL

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

14

Dokumentnamn/Name of document

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Bo Nilsson Director Quality & Regulatory Affairs Elekta Instrument AB, Box 7593 SE-103 93 Stockholm SWEDEN

Re: K103093

BEE 2 1 2019

Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 30, 2010 Received: December 2, 2010

Dear Mr. Nilsson:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 000). This recei notification. The FDA finding of substantial equivalence of your device to a legally ronalteted 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 fre number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dan

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure.

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Dokumentnamn/Name of docume

## ELEKTA INSTRUMENT AB

| Utfärdare/Issuer | Viveka Wretman |
|-----------------------------|--------------------|
| Ref nr/Dok nr/Ref no/Doc no | - |
| Utgåva /Edition | - |
| Special 510(k) | |
| Avser/Regarding | Leksell GammaPlan® |
| Directory | |

# Section 7- Indications for Use Statement

| 510(k) Number | To be defined |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|
| Device Name | Leksell GammaPlan® |
| Indications for Use | Leksell GammaPlan® is a computer-based dose planning system<br>specifically designed for use with Leksell Gamma Knife®. |

Prescription Use X (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)

0 (Division Sign-Off)

Concurrence of CDRH, Office

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103093

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