(27 days)
No
The document describes a radiation therapy system and its components, focusing on hardware, software control, and safety functions. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is intended for radiation therapy treatment to deliver a prescribed dose of radiation, which is a therapeutic intervention.
No.
The device is intended for radiation therapy treatment, not for diagnosing conditions. It delivers radiation and manages treatment parameters.
No
The device description explicitly states that the system consists of hardware components like the PRS500 Control Console, XRS 4, User Terminal, and various accessories, in addition to the Workstation Software. The performance studies also include testing of hardware, firmware, and accessories.
Based on the provided information, the INTRABEAM® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states "radiation therapy treatment." This is a therapeutic application, not a diagnostic one performed on samples taken from the body.
- Device Description: The description details a system for delivering radiation, including a control console, X-ray source, software, and accessories used in the treatment process. This aligns with a therapeutic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro analysis.
Therefore, the INTRABEAM® System is a therapeutic medical device used for delivering radiation therapy.
N/A
Intended Use / Indications for Use
The INTRABEAM® System is intended to be used for radiation therapy treatment.
The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.
Product codes
JAD
Device Description
The INTRABEAM® System described in this Special 510(k) is a modification and enhancement of the PRS400 System cleared under K980526 and K992577. The INTRABEAM® System consists of the PRS500 Control Console, the XRS 4, the Workstation Software, the User Terminal, the verification accessories, and the treatment accessories. The PRS500 Control Console provides all low-level operational control and safety functions of this System. The User Terminal with Workstation Software is the primary interface between the System and the user. The Software provides the high level control and display functions of the System. With the INTRABEAM® System, the radiologist, physicist, or technologist uses the Workstation Software on the User Terminal to set up the PRS500 Control Console (perform the pre-treatment verification and treatment planning), perform the treatment to completion, log all procedure variables and events, and after completion of the treatment, save and/or print treatment and performance data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologist, physicist, or technologist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The INTRABEAM® System was systematically tested to demonstrate that the modifications did not adversely affect safety and effectiveness. Testing described in this premarket notification included functionality (integration testing of hardware, firmware, and accessories), safety, electrical safety, electromagnetic compatibility, environmental testing, mechanical stress testing, and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.(b)
Classification. Class II.
0
KOSIOSI
510(k) Summary Carl Zeiss Surgical GmbH INTRABEAM® System
MAY 2 3 2005
1. SPONSOR
Carl Zeiss Surgical GmbH Carl Zeiss Strasse 4-54 D-73446 Oberkochen Germany
| Contact Person: | Michael Haisch, Director, Quality Management |
|---|---|
| Telephone: | +49-7364-20-2555 |
April 20, 2005 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | INTRABEAM® System |
|---|---|
| Common/Usual Name: | X-Ray Radiation Therapy Control Unit |
| Classification Name: | X-ray Radiation Therapy Systems and Accessories |
3. PREDICATE DEVICES
PRS400 System (K980526 and K992577)
4. DEVICE DESCRIPTION
The INTRABEAM® System described in this Special 510(k) is a modification and enhancement of the PRS400 System cleared under K980526 and K992577. The INTRABEAM® System consists of the PRS500 Control Console, the XRS 4, the Workstation Software, the User Terminal, the verification accessories, and the treatment accessories. The PRS500 Control Console provides all low-level operational control and safety functions of this System. The User Terminal with Workstation Software is the primary interface between the System and the user. The Software provides the high level control and display functions of the System. With the INTRABEAM® System, the radiologist, physicist, or technologist uses the Workstation Software on the User Terminal to set up the PRS500 Control Console (perform the pre-treatment verification and treatment planning), perform the treatment to completion, log all procedure variables and events, and after completion of the treatment, save and/or print treatment and performance data.
1
5. INTENDED USE
The INTRABEAM® System is intended to be used for radiation therapy treatment.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
تم ﻬﺎ ﺗ
Equivalence of the INTRABEAM® System with the PRS 400 System is based on intended use, indications for use, technological characteristics, system specifications, and operational characteristics.
7. TESTING
The INTRABEAM® System was systematically tested to demonstrate that the modifications did not adversely affect safety and effectiveness. Testing described in this premarket notification included functionality (integration testing of hardware, firmware, and accessories), safety, electrical safety, electromagnetic compatibility, environmental testing, mechanical stress testing, and validation testing.
2
Image /page/2/Picture/1 description: The image shows a circular logo with a stylized bird in the center. The bird is facing left and has three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, following the curve of the logo. The text is in a sans-serif font and is relatively small compared to the size of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Carl Zeiss Surgical GmbH c/o Rosina Robinson, RN, MEd, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
MAY 2 3 2005
Re: K051055
R031055
Trade/Device Name: Carl Zeiss Surgical GmbH INTRABEAM® System Regulation Number: 21 CFR §892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: April 25, 2005 Received: April 26, 2005
Dear Ms. Robinson:
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 lave 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 do not require apperal 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 Aporaval), it may be subject to such additional controls. Existing major regulations affecting your Apple rary, it ifaly 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 I reaso or arrison 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 I cacial states and regaring, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, modialing practice requirements as set forth in the quality systems (QS) (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 5 10(k)
The status and the first of the success of your device to Ilegal This letter will allow you to begin harketing your aver equivalence of your device to a legally premarket notification. The FDA Inding of saosantal equil and this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased on the regulation rumber If you desire spectic advice for your device on our laboring agains of (
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 Also, please note the regulation entitled, "virsonants of your responsibilities under the Act from the 807.97). You may obtain other general information on your of 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. 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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510(k) Number (if known): K051055
Device Name: Carl Zeiss Surgical GmbH INTRABEAM® System
Indications for Use:
The INTRABEAM® System is indicated for radiation therapy treatments. The INTRABEAM® Spherical Applicators are indicated for use with the INTRABEAM® System to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity or intraoperative radiotherapy treatments.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Lyon
(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal in a mical Devices