(205 days)
Not Found
No
The summary describes a radiation therapy system and its applicators, focusing on their physical characteristics and clinical trial results. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality.
Yes
Explanation: The device is indicated for radiation therapy treatments for cancer, which is a therapeutic intervention.
No
The device is indicated for radiation therapy treatments to deliver a prescribed dose of radiation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a miniature, high-dose rate, low energy X-ray source, which is a physical hardware component. The applicators are also described as accessories to this system.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The INTRABEAM System and its applicators are used to deliver radiation therapy directly to a tumor or tumor bed within the body during surgery. This is a therapeutic treatment, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "radiation therapy treatments" and "deliver a prescribed dose of radiation." This aligns with a therapeutic device, not a diagnostic one.
- Device Description: The description details an X-ray source used for "treatment of cancer at the tumor cavity." This further reinforces its therapeutic nature.
Therefore, the INTRABEAM System and Spherical Applicators are therapeutic devices used for radiation treatment, not in vitro diagnostics.
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 and intraoperative radiotherapy treatments.
The INTRABEAM® Spherical Applicators used with the INTRABEAM System are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
Product codes
JAD
Device Description
The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the tumor cavity. The INTRABEAM Spherical applicators are accessories to the INTRABEAM System. The INTRABEAM Spherical Applicators received 510(k) clearance in K992577. There are eight sizes of applicators in a set ranging from 1.5 cm to 5.0 cm in diameter. The INTRABEAM Spherical Applicators have not changed in design or technological characteristics as described in K992577.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments. / breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / intracavity and intraoperative radiotherapy treatments
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: Randomized, non-inferiority phase 3 trial.
Sample Size: N=2,232.
Key Results: The results of the trial demonstrate a non-significant rate of recurrence between the INTRABEAM Spherical Applicators versus whole breast radiation (1.2% versus 0.95%. p=0.41). The study concluded that IORT treatment using INTRABEAM Spherical Applicators can be used in conjunction with whole breast radiotherapy.
Key Metrics
Recurrence rates (1.2% vs 0.95%, p=0.41)
Predicate Device(s)
K992577, K051055, K011690, K091378
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.
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Carl Zeiss Meditec Premarket Notification 510(k)
SECTION 2: 510(K) SUMMARY 1
DEC 2 7 2012
510(k) SUMMARY (per 21 CFR §807.92)
INTRABEAM® System with INTRABEAM® Spherical Applicators
General Information
Manufacturer:
Carl Zeiss Meditec AG Carl-Zeiss-Strasse 22 D-73447 Oberkochen Germany Est. Reg. No. 9615010
Contact Person:
Sarah Harrington, MS, MBA Staff Regulatory Specialist Carl Zeiss Meditec Inc. 5160 Hacienda Drive Dublin, California 94568 Phone: (925) 560-5134 FAX: (925) 557-4259 Email: s.harrington@meditec.zeiss.com
Device Name/Classification
| Trade/Proprietary name: | INTRABEAM® System with INTRABEAM® Spherical
Applicators |
|-------------------------|------------------------------------------------------------|
| Common/Usual Name: | X-ray radiation therapy system |
| Classification name: | System, Therapeutic, X-ray |
| Classification: | Class II (21 CFR 892.5900) |
| Product Code: | JAD |
Predicate Devices
Company: Device:
Carl Zeiss Meditec AG INTRABEAM® System with INTRABEAM® Spherical Applicators, K992577, K051055
Company: Device:
Hologic, Inc. MammoSite Radiation Therapy System, K011690, K091378
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- Intended Use
The INTRABEAM® System is intended to be used for radiation therapy treatment.
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 and intraoperative radiotherapy treatments.
The INTRABEAM® Spherical Applicators used with the INTRABEAM System are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
Device Description
The INTRABEAM System is a miniature, high-dose rate, low energy X-ray source that emits Xray radiation intraoperatively for the treatment of cancer at the tumor cavity. The INTRABEAM Spherical applicators are accessories to the INTRABEAM System. The INTRABEAM Spherical Applicators received 510(k) clearance in K992577. There are eight sizes of applicators in a set ranging from 1.5 cm to 5.0 cm in diameter. The INTRABEAM Spherical Applicators have not changed in design or technological characteristics as described in K992577.
TARGIT-A Trial
The modifications to the indications for use are supported by the publication, "Targeted intraoperative radiotherapy versus whole breast radiotherapy for breast cancer (TARGIT-A trial): an international, prospective, randomized, non-inferiority phase 3 trial", published by Vaidya, Joseph, Tobias et al. The study was published in The Lancet (Lancet 2010; 376: 71-72). The TARGIT-A trial was designed to test the hypothesis that in selected patients, substituting whole breast radiotherapy after breast-conserving surgery with targeted intraoperative radiotherapy (IORT) to the tumor bed would not lead to inferior local control of breast cancer. The randomly controlled study (N=2,232) was conducted by physicians around the world using the INTRABEAM System with Spherical Applicators as the only abbreviated partial breast irradiation (ABPI) device. The results of the trial demonstrate a non-significant rate of recurrence between the INTRABEAM Spherical Applicators versus whole breast radiation (1.2% versus 0.95%. p=0.41).
The study concluded that IORT treatment using INTRABEAM Spherical Applicators can be used in conjunction with whole breast radiotherapy.
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2
3
·Substantial Equivalence
Similar to the INTRABEAM System, the MammoSite Radiation Therapy System (RTS) provides a means of delivering radiation therapy in a tumor cavity. Both the MammoSite RTS and the INTRABEAM System with INTRABEAM Spherical Applicators are APBI technology and are comparable in target site and clinical usage.
The INTRABEAM Spherical Applicators that are the subject device for this 510(k) are equivalent to the currently marketed INTRABEAM Spherical Applicators in design, material, radiation doses and principles of operation. Based on the predicate devices and on the findings presented in the TARGIT-A trial publication, the INTRABEAM System with INTRABEAM Spherical Applicators is safe and effective with regards to the proposed indications for use.
Summary
As described in this 510(k) summary and based on the findings presented in the TARGIT-A trial publication, the INTRABEAM Spherical Applicators are safe and effective for their indications for use.
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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The background is plain white.
Public Health Service
December 27, 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ms. Sarah Harrington Staff Regulatory Specialist Carl Zeiss Meditech, Inc. 5160 Hacienda Drive DUBLIN, CA 94568
Re: K121653 Trade/Device Name: INTRABEAM® System with INTRABEAM® Spherical Applicators Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 17, 2012 Received: December 18, 2012
Dear Ms. Harrington:
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 (reporting of medical
4
Page 2 - Ms. Sarah Harrington
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 out labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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,
Michael D. O'Hara
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K121653
Device Name: INTRABEAM® System with INTRABEAM® Spherical Applicators
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 turnor bed during intracavity and intraoperative radiotherapy treatments.
The INTRABEAM® Spherical Applicators used with the INTRABEAM System are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.
Prescription Use (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 In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)
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