GAMMAPLAN

K051022 · Elekta Instrument AB · IWB · Jun 1, 2005 · Radiology

Device Facts

• Record ID: K051022
• Device Name: GAMMAPLAN
• Applicant: Elekta Instrument AB
• Product Code: IWB · Radiology
• Decision Date: Jun 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2

Intended Use

GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.

Device Story

GammaPlan® is a computer-based dose planning system for Gamma Knife® stereotactic radiosurgery and radiotherapy. It processes clinical data to assist clinicians in planning radiation dosimetry. Used in clinical settings by medical professionals, the system enables precise treatment planning, which informs clinical decision-making for patient radiation therapy. The device facilitates the delivery of targeted radiation, potentially benefiting patients by optimizing treatment accuracy.

Clinical Evidence

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

Technological Characteristics

Computer-based software system for radiation therapy dosimetry planning. Operates as a standalone planning workstation for Gamma Knife® systems. Technical details regarding specific algorithms or hardware specifications are not provided in the summary.

Indications for Use

Indicated for use as a computer-based system for Gamma Knife® treatment planning in stereotactic radiosurgery and stereotactic radiotherapy.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• Leksell GammaPlan® (K973441)
• Leksell GammaPlan® 4C with MultiView (K042269)

Reference Devices

• Leksell Gamma Knife® Target System, Model 24001 (K984328)

Submission Summary (Full Text)

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ELEKTA INSTRUMENT AB

JUN 1 - 2005

Dokumentnamn/Name of document Traditional 510(k)

| Utfärdare/Issuer | Louise Lindblad |
|-----------------------------|-----------------|
| Avser/Regarding | GammaPlan® |
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| | Directory |

Section 4- 510(k) Summary

Kosiolzz

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: Ms Louise Lindblad Official Correspondent: Mr Peter Löwendahl

### Trade Name 2.

GammaPlan®

### Device Classification 3.

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

## Regulatory History (Unmodificd Predicate Device) 4.

| Devices | 510(k) # |
|--------------------------------------|----------|
| Leksell GammaPlan® | K973441 |
| Leksell GammaPlan® 4C with MultiView | K042269 |

### 5. Other relevant submissions

| Devices | 510(k) # |
|-------------------------------------------------|----------|
| Leksell Gamma Knife® Target System, Model 24001 | K984328 |

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## ELEKTA INSTRUMENT AB

# Kos 1022

Dokumentnamn/Name of document Traditional 510(k)

| Utfärdare/Issuer | Louise Lindblad |
|-----------------------------|-----------------|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | GammaPlan® |
| | Directory |

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

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

### Intended Use 7.

GammaPlan® is a computer-based system designed for Gamma Knife® treatment planning.

#### Substantial Equivalence 8

The functionality for the GammaPlan® is equivalent to its predicate device Leksell GammaPlan® (K973441) and Leksell GammaPlan® 4C with MultiView (K042269) in safety and effectiveness. The fundamental technical characteristics are similar to those of the predicate device.

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JUN 1 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter Löwendahl Manager Quality & Regulatory Affairs Elekta Instrument AB Kunsgstensgatan 18, P.O. Box 7593 Stockholm, SE-10393 SWEDEN

Re: K051022 Trade/Device Name: GammaPlan® Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide radiation therapy system Regulatory Class: II Product Code: IWB and MUJ Dated: April 13, 2005 Received: April 22, 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) I mis letter with and w Jourse organ inding of substantial equivalence of your device to a legally prematice notification: - The PDF maces
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 If you done sportive at no af 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 Also, prease note the regulation on your responsibilities under the Act from the 601:57). I ou may orders, 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. Hodgdon

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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## ELEKTA INSTRUMENT AB

Dokumentnamn/Name of document Traditional 510(k)

| Utfärdare/Issuer | Louise Lindblad |
|-----------------------------|-----------------|
| Ref nr/Dok nr/Ref no/Doc no | |
| Utgåva /Edition | 1 |
| Avser/Regarding | GammaPlan® |
| Directory | |

# Section 7- Indications for Use Statement

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

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ra-E. Phillips

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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