(26 days)
Not Found
No
The summary describes a mechanical frame system for stereotactic procedures and does not mention any AI/ML components or image processing capabilities that would typically involve such technology.
No
The device is used for localization and fixation during radiosurgery and stereotactic radiation therapy, which are treatments but the device itself is an accessory for precise positioning rather than directly administering therapy or having a therapeutic effect on its own.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for localization and diagnosis of intracranial disorders."
No
The device description explicitly states it is a "Frame System" used for patient head fixation and attachment to hardware like CT scanners and digital accelerators, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Elekta Esarte™ Frame System is a physical device used for localization, fixation, and spatial referencing of the patient's head during medical procedures (diagnosis, surgery, and radiation therapy). It interacts with imaging equipment (CT scanner) and treatment equipment (digital accelerator), but it does not analyze biological samples.
- Intended Use: The intended use clearly states "localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy." This describes a process involving imaging and treatment, not the analysis of biological samples.
Therefore, the Elekta Esarte™ Frame System falls under the category of a medical device used for patient positioning and guidance during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
HAW, LHN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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: (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
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
THE THE THE T BE T BE THE FORM THE FORD THE FORD THE
Auche
ﻣﺪ ﻣﺎ ﺳﺎ ﺎ
1 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The Claim Couple Call College of Canadian Come of Canadian Come of Concession
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
ı
Acres of a career of
ﻟﻠﻘﻀﺎﺀ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
| t |
|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| "A Status Commend Concession Commend Concessor Concession Concession Concession Concession Concession Concession Concession Concession Concession Concession Concession Conces |
| The proper contract of the research of the research of the contract and the comments of the comments of |
| i |
| . |
1
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.
2
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 (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
4
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 |
| System®, which is intended for localization and diagnosis of | |
| intracranial disorders and their surgical treatment including | |
| radiosurgery 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 _