LEKSELL GAMMAPLAN

K090972 · Elekta Instrument AB · MUJ · Jul 20, 2009 · Radiology

Device Facts

• Record ID: K090972
• Device Name: LEKSELL GAMMAPLAN
• Applicant: Elekta Instrument AB
• Product Code: MUJ · Radiology
• Decision Date: Jul 20, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 used in clinical settings for stereotactic radiosurgery and stereotactic radiotherapy. It is designed specifically for use with the Leksell Gamma Knife®. The system assists clinicians in planning the dosimetry of treatments. By processing patient-specific data, it enables the calculation and visualization of radiation dose distributions, allowing healthcare providers to optimize treatment plans. The output is used by physicians to guide the delivery of radiation therapy, potentially benefiting patients by providing precise, targeted treatment for intracranial and other lesions.

Clinical Evidence

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

Technological Characteristics

Computer-based dose planning software system. Designed for integration with Leksell Gamma Knife® hardware. Operates as a specialized planning workstation for stereotactic radiosurgery and radiotherapy dosimetry.

Indications for Use

Indicated for use as a computer-based dose planning system for stereotactic radiosurgery and stereotactic radiotherapy in conjunction with 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® (K061540)
• Leksell GammaPlan® (K051022)
• Leksell GammaPlan® 4C with Multiview (K042269)
• Leksell Gamma Plan® (K973441)
• Leksell GammaPlan® (K914808)

Submission Summary (Full Text)

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K090972

## 510(k) Summary

## JUL 2 0 2009

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

#### 1. Subscribers Name & Address

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

#### 2. Trade Name

Leksell GammaPlan®

#### 3. . Device Classification

| Common Name | Product Code | Class | Regulation Number |
|---------------------------------------|--------------|-------|-------------------|
| Radionuclide radiation therapy system | IWB | II | 892.5750 |

#### Predicate Device Identification 4.

| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|----------------------------------------------------------------|----------|
| Leksell GammaPlan® | K061540 |
| Leksell GammaPlan® | K051022 |
| Leksell GammaPlan® 4C with Multiview | K042269 |
| Leksell Gamma Plan® | K973441 |
| Leksell GammaPlan® | K914808 |

#### 5. Other relevant submissions

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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.

#### Intended Use 7.

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

#### Substantial Equivalence 8

The functionality for Leksell GammaPlan® is equivalent to its predicate devices Leksell GammaPlan® (K061540) and Leksell GammaPlan® (K051022) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 2009

Mr. Anders Skoglund Director Regulatory Affairs Elekta Instrument AB Kungstensgatan 18. P.O. Box 7593 SE-103 93 Stockholm SWEDEN

Re: K090972

Trade/Device Name: Leksell GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 2, 2009 Received: June 4, 2009

Dear Mr. Skoglund:

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 (PMA), it may be subject to 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); medical device reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number | K0909072 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|
| 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 X Over-The-Counter Use Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Heidi Reimer
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 09/972 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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