(408 days)
Not Found
No
The summary explicitly states "There are no modifications to the INTRABEAM® System hardware or software" and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is used to administer radiation to tissue for the treatment of tumors, which is a therapeutic intervention.
No
The device is described as an applicator set used in combination with a radiation system to administer radiation to tissue, specifically for intraoperative irradiation of intracranial tumors. This is a therapeutic, not a diagnostic, function.
No
The device description explicitly lists physical components like a polycarbonate case, stainless steel shaft, polyetherimide tip, and stainless steel guide shafts, indicating it is a hardware device. While it is used with a system that includes software, the submitted device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "intraoperatively administer radiation to tissue including irradiation of intracranial tumors." This describes a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an accessory to a radiation therapy system (INTRABEAM® System) and is used to deliver radiation directly to the tumor site. This is a treatment delivery device.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) to deliver therapy.
N/A
Intended Use / Indications for Use
The Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
Product codes
IAD, JAD
Device Description
The proposed device is a modification of the INTRABEAM® System with Balloon Applicator, K090584, incorporating a Needle Applicator and guide shafts that are used to open a tract for the positioning of the applicator for irradiation of tumors.
The INTRABEAM® System that will be used with the new Needle Applicator accessory was most recently described in K090584. There are no modifications to the INTRABEAM® System hardware or software. The INTRABEAM® Core System consists of the following components:
- . PRS500 Control Console
- . XRS4 X-ray source
- . User terminal
Components of the Needle Applicator set are as follows:
-
- Inner Sterile Packaging
-
- 5 cm guide shaft
-
- 6 cm guide shaft
-
- Needle Applicator
The XRS 4 X-ray source generates X-rays according to the parameters set for the required treatment on the PRS500 Control Console. The Needle Applicator allows radiation treatment to be delivered directly to the target (e.g. an intracranial tumor).
The physical design of the Needle Applicator consists of a polycarbonate case which fits over the probe of the XRS 4 X-ray source, a stainless steel shaft, and a polyetherimide tip for the Applicator. The guide shafts are stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Tissue including intracranial tumors
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization Validation:
Performed in compliance with AAMI/ANSI/ISO 11137-1:2006, AAMI/ANSI/ISO 11137-2:2006, and AAMI/ANSI/ISO 11137-3:2006. Sterilization assurance level is 10.
Performance Testing:
- Dosimetry and Aging: Five samples of INTRABEAM® Needle Applicators were visually inspected before and after sterilization and accelerated aging (equivalent to five years). The functionality was tested, and all applicators passed tests, were fully functional, and met engineering specifications.
- Dosimetry Equivalence: Dosimetry testing (isotropy and transfer functions using a water phantom) of the PRS400 with the XRS probe (with sheath) compared to the INTRABEAM® System with Needle Applicator demonstrated equivalence. Dose depth curves matched those of the bare probe with sheath, and isotropy met acceptance criteria.
Biocompatibility Testing:
| Material | Test | Comments | Result |
|---|---|---|---|
| Needle Applicator | Cytotoxicity EN ISO 10993-5 | L 929 cell cultures, quantitative determination of cell proliferation | No relevant effects observed in comparison to controls |
| Guide shaft | Cytotoxicity EN ISO 10993-5 | L 929 cell cultures, quantitative determination of cell proliferation | No relevant effects observed in comparison to controls |
| Needle Applicator | Chemical Analysis EN ISO 10993-18 | GC-FID, quantification of organic and inorganic leachables | No relevant effects observed in comparison to controls |
Clinical Testing:
No clinical testing was conducted to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KI10580
510(k) Summary for
APR 1 3 2012
Carl Zeiss Meditec AG INTRABEAM® System Needle Applicator per 21 CFR 807.92
1. SUBMITTER/510(K) HOLDER
Manufacturer: Carl Zeiss Meditec AG Carl-Zeiss-Strasse 22 D-73447 Oberkochen Germany
Contact Person: Judith A. Brimacombe, MA Director, Regulatory/Clinical Affairs Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, CA 94568 Phone: (925) 557-4616 FAX: (925) 557-4259
2. DEVICE NAME
Proprietary Name: Carl Zeiss INTRABEAM® System with Needle Applicator Common/Usual Name: X-ray radiation therapy system Classification Name: System, Therapeutic, X-ray, (21 CFR 892.5900) Product Code: IAD
3. PREDICATE DEVICES
- . Photon Radiosurgery System PRS 400 System, K980526
- INTRABEAM® System with Balloon Applicator, most recently cleared in K090584 .
4. DEVICE DESCRIPTION
Physical Description
The proposed device is a modification of the INTRABEAM® System with Balloon Applicator, K090584, incorporating a Needle Applicator and guide shafts that are used to open a tract for the positioning of the applicator for irradiation of turnors.
The INTRABEAM® System that will be used with the new Needle Applicator accessory was most recently described in K090584. There are no modifications to the INTRABEAM® System hardware or software. The INTRABEAM® Core System
1
consists of the following components:
- . PRS500 Control Console
- . XRS4 X-ray source
- . User terminal
Components of the Needle Applicator set are as follows:
-
- Inner Sterile Packaging
-
- 5 cm guide shaft
-
- 6 cm guide shaft
-
- Needle Applicator
How the Device Functions
The XRS 4 X-ray source generates X-rays according to the parameters set for the required treatment on the PRS500 Control Console. The Needle Applicator allows radiation treatment to be delivered directly to the target (e.g. an intracranial turnor).
Scientific Concepts that form the Basis for the Device
X-ray irradiation of tumors is a widely used treatment option in a variety of applications. The INTRABEAM® System delivers a controlled X-ray dose.
Significant Physical and Performance Characteristics of the Device, such as Device Design, Material Used, and Physical Properties
The physical design of the Needle Applicator consists of a polycarbonate case which fits over the probe of the XRS 4 X-ray source, a stainless steel shaft, and a polyetherimide tip for the Applicator. The guide shafts are stainless steel.
5. INTENDED USE
The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
6. Summary of Technological Characteristics Compared to the\Predicate DEVICE
Carl Zeiss Meditec AG claims substantial equivalence of the INTRABEAM® System with Needle Applicator to the cited predicate device based on the intended use, design, fundamental technology, and operation characteristics.
2
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The testing summarized below supports the claim of substantial equivalence to the cited predicate by indicating that the Needle Applicator is a sterile device which performs as designed after sterilization and is safe for its intended use as is the predicate device.
Sterilization Validation
Sterilization validation of the Needle Applicator was performed in compliance with AAMI/ANSI/ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Dose setting is performed in accordance with AAMI / ANSI/ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, VDmax 25 method. Dosimetric release complies with AAMI/ANSI/ISO 11137-3:2006. Sterilization of health care products - Radiation - Part 3: Guidance on Dosimetric Aspects. The sterilization assurance level is 10 .
Performance Testing
The testing of the dosimetry of sterilized and aged INTRABEAM® Needle Applicator was performed to demonstrate that sterilization and accelerated aging exert no adverse effect on the INTRABEAM® Needle Applicator. Five samples were inspected visually before and after sterilization and accelerated aging. The functionality of Needle Applicators subjected to sterilization and accelerated aging equivalent to five years was tested by Carl Zeiss Meditec AG. All applicators passed the tests, were fully functional, and met the requirements of the engineering specifications.
Dosimetry testing of the PRS400 with the XRS probe (with sheath) compared to the INTRABEAM® System with Needle Applicator was conducted to demonstrate equivalence. The testing consists primarily of isotropy (radiation characteristics) and transfer functions (using a water phantom) using the same protocol used for past aging studies. The dose depth curves of the Needle Applicators tested matched those of the bare probe with sheath. The isotropy of the tested units met the criteria for passing the test.
3
Biocompatibility Testing Table 5-2. Biocompatibility Testing Performed on the
| Material | Test | Comments | Result |
|---|---|---|---|
| Needle | |||
| Applicator | Cytotoxicity EN | ||
| ISO 10993-5 | L 929 cell cultures, quantitative | ||
| determination of cell proliferation | No relevant effects observed | ||
| in comparison to controls | |||
| Guide shaft | Cytotoxicity EN | ||
| ISO 10993-5 | L 929 cell cultures, quantitative | ||
| determination of cell proliferation | No relevant effects observed | ||
| in comparison to controls | |||
| Needle | |||
| Applicator | Chemical Analysis | ||
| EN ISO 10993-18 | GC-FID, quantification of organic | ||
| and inorganic leachables | No relevant effects observed | ||
| in comparison to controls |
Final Device Components
Based on the information and supporting documentation provided in the premarket notification, the Carl Zeiss INTRABEAM® Needle Applicator is substantially equivalent to the cited predicate devices. Testing demonstrates that the Carl Zeiss INTRABEAM® Needle Applicator fulfills prospectively defined design and performance specifications.
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
No clinical testing was conducted to support this submission.
9. SUMMARY OF OTHER INFORMATION
No other information is provided.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
Based on the information and supporting documentation provided in the premarket notification, the Carl Zeiss INTRABEAM® System with Needle Applicator is substantially equivalent to the cited predicate device. Testing demonstrates that the Carl Zeiss INTRABEAM® with Needle Applicator fulfills prospectively defined design and performance specifications.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that form the body and wings of the bird.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Carl Zeiss Meditec AG Ms. Judith A. Brimacombe. MA Director, Clinical/Regulatory Affairs Carl Zeiss Meditec, Inc. 5160 Hacienda Drive DUBLIN CA 94568
APR 1 3 2012
Re: K110590
Trade/Device Name: Carl Zeiss INTRABEAM® System with Needle Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: March 2, 2012 Received: March 5, 2012
Dear Ms. Brimacombe:
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
5
Page 2
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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): ヒル0590
Carl Zeiss INTRABEAM® System with Needle Applicator Device Name:
Indications for Use:
The Needle Applicator set (comprising the Needle Applicator and guide shaft) is indicated for use in combination with the INTRABEAM® System to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Carl Zeiss Surgical GmbH, Traditional 510(k) INTRABEAM® System with Needle Applicator
510K
CONFIDENTIAL Page 4-1