(53 days)
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.
Not Found
Here's a breakdown of the acceptance criteria and study information for the VeriSuite device, based on the provided text.
Note: The provided document is a 510(k) premarket notification summary, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, or comprehensive acceptance criteria that would typically be found in a full clinical or performance study report. Therefore, much of the requested information (like specific sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this document. The information provided below is extracted directly from the available text.
Acceptance Criteria and Device Performance (Limited Information)
The document states: "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..." This indicates that the primary acceptance criterion for the 510(k) submission was demonstrating substantial equivalence to existing predicate devices (specifically, EXACTRAC 5.5 / ExacTrac X-RAY 6D K072506).
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Determined to be substantially equivalent to EXACTRAC 5.5 / ExacTrac X-RAY 6D (K072506). The VeriSuite system is used for verification and correction of patient position during radiotherapy, based on stereoscopic X-ray images and DRRs. |
Study Information (Based on Available Text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document primarily focuses on the regulatory review rather than detailed study methodology. It is likely that testing data would have been generated internally by the manufacturer during development and validation, but specific details are absent here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No evidence of an MRMC study related to human readers or AI assistance in this document. The VeriSuite system is described as a "patient position verification system" based on X-ray images, implying an automated or semi-automated system for patient positioning rather than an AI-assisted diagnostic tool that would typically involve human readers and diagnostic accuracy studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The description "patient position verification system... It is based on stereoscopic X-ray images and DRRs calculated from a CT image series..." suggests that the system operates in a standalone capacity to perform its verification function. However, the document does not explicitly present a "standalone performance study" with specific metrics or results. The FDA's determination of substantial equivalence implies they reviewed performance data, but the details are not included in this summary.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the "ground truth" for patient position verification would be the actual patient position or a carefully measured, validated reference position. This would likely be established through precise physical phantoms or highly accurate imaging modalities. However, the exact method for establishing ground truth for any testing is not specified in this regulatory filing summary.
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The sample size for the training set:
- Not specified. The document does not describe a training set as would be relevant for machine learning models. If the system uses algorithms that were "trained," the details are not in this summary.
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How the ground truth for the training set was established:
- Not applicable/Not specified, as no training set is described in the provided text.
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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
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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
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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.
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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
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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
§ 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.