(53 days)
No
The summary describes a system based on stereoscopic X-ray images and DRRs for patient position verification, without mentioning any AI or ML components.
No
The device is used for verification and correction of patient position during radiotherapy, which is a therapeutic treatment, but the device itself is a system for ensuring the accuracy of the treatment delivery, not the treatment itself.
No
The device is used for "verification and correction of the patient's position during a radiotherapy treatment," which speaks to treatment guidance rather than diagnosis of a disease or condition.
No
The device description is not available, but the intended use clearly states it is a "patient position verification system" based on "stereoscopic X-ray images and DRRs calculated from a CT image series". This implies the system includes hardware components for acquiring and processing these images, such as X-ray detectors and potentially a processing unit beyond just software. The predicate device also appears to be a hardware/software system.
Based on the provided information, the VeriSuite patient position verification system 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.
- VeriSuite's Function: The VeriSuite system is used for patient positioning during radiotherapy. It utilizes imaging modalities (X-ray and CT) to verify and correct the patient's physical position relative to the treatment beam. This is an in vivo process, meaning it is performed on the living patient, not on samples taken from the patient.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples or the detection of diseases or conditions through laboratory testing.
Therefore, the VeriSuite system falls under the category of a medical device used for treatment delivery and verification, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VeriSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
Product codes (comma separated list FDA assigned to the subject device)
LHN, IYE
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
stereoscopic X-ray images, CT image series
Anatomical Site
treatment region of the patient
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)
Not Found
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.
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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MAY - 9 2008
Page 4 of 26
III. Summary of Safety and Effectiveness
A. Applicant
Name: Address: MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE 64283 Germany
VeriSulte 1.6 and VeriSuite-Particle and VeriSuite-Particle 1.6
B. Device Trade name: Common name Classification name:
Classification Number: Classification: Product code:
VeriSuite Patient position verification system System, Radiation Therapy, Charged-Particle, Medical 892.5050 Class II LHN
C. Device Trade Name VeriSuite also marketed as
D. Predicate device
Device trade name: 510(k) number: Company name: Classification Number: Classification: Product code:
EXACTRAC 5.5 / ExacTrac X-RAY 6D K072506 BRAINLAB AG 892.5050 Class II LHN
X-Ray Generator, Sedecal SHF 835
| Device trade name: | |
|---|---|
| Classification name: | Generator, High Voltage Xray, |
| Diagnostic | |
| Classification Number: | 892.1700 |
| Classification: | Class I Exempt |
| Product Code: | IZO |
| Manufacturer: | |
| Registration Number: | 9617251 |
X-Ray Tubes, Varian A277 / A272
Classification name: Assembly, Tube, Housing X-ray, Diagnostic Classification Number: 892.1700 Classification: Class I Exempt Product Code: IZO Manufacturer Registration Number: 1717855
1
Flat Panel Digital Imager, Varian PaxScan 4030R
Classification name: Solid State X-ray Imager Classification Number: 892.1630 Classification: Class II Product Code: MQB 510(k) Number: K024147
Collimator, Ralco 302
Classification name:
Classification Number: Classification: Product Code: 510(k) Number:
Device, Beam Limiting, X-ray Solid State X-ray Imager 892.1610 Class II KPW K946320
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stefan Walter Quality Manager MedCom GmbH 12 Rundeturmstrasse Darmstadt, HE 64283 GERMANY
Re: K080742
Trade/Device Name: VeriSuite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 14, 2008 Received: March 17, 2008
Dear Mr. Walter:
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 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.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy Burgdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
구, 대학
일본
代表示范
ිනු ක්රියා ක්රියා ලෙස හැකියා විශ්වය විය. මෙම ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධාන බව ප්රධ
VIII. Indications for Use Statement
510(k) Number (if known): K080742
Device Name: VeriSuite
The VeriSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
| Document : | MC.5024.MSC.2100.0002.A |
|---|---|
| File : | mc.5024.msc.2100.0002.fda_completeadmission.doc |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080742 |
|---|---|
| --------------- | --------- |
© MedCom GmbH 2008
Printed 05.06.2008, 13:24