(82 days)
The intended use of the LANTIS TREATSTATION is to allow the radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying, and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures. The intended use is the same as the predicate device.
LANTIS TREATSTATION is a direct replacement for the sequencing/VMI module of the Impac Sequencer Record and Verify Radiation Treatment System. The TREATSTATION coexists with the LANTIS Commander application on the target platform to allow the user access to the information system's other functions and provide the complete spectrum of required functionality.
The provided text describes a 510(k) submission for the "LANTIS TREATSTATION," a Record and Verify Radiation Treatment System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or details about standalone or MRMC studies that would typically be found in a detailed device performance evaluation section.
The document states:
- "Performance tests were conducted and the results indicated that the device consistently performed within the design parameters and equivalently to the predicate device." This is a high-level statement without specific data.
- "The LANTIS TREATSTATION software does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it." This emphasizes equivalence rather than specific, new performance targets.
Given the limitations of the provided text, I can only create a table and response based on the information explicitly stated or implied about equivalence. Most sections below will indicate that the information is "Not provided in the text."
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device (Impac Medical Systems' Sequencer, K913612) and consistent performance within "design parameters."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 1. Substantial equivalence to predicate device (K913612) | Device is substantially equivalent to the predicate device. |
| 2. Consistent performance within design parameters | Device consistently performed within the design parameters. |
| 3. No significant changes in performance characteristics | Performance characteristics are the same as the predicate device. |
| 4. Intended use is same as predicate device | Intended use is the same as the predicate device. |
| 5. Supports auto sequencing | TREATSTATION supports auto sequencing. |
| 6. Supports Intensity Modulation (IM) | LANTIS TREATSTATION supports intensity modulation (IM). |
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the text. The document refers generally to "performance tests."
- Data Provenance: Not provided in the text (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided in the text. The type of "performance tests" conducted doesn't suggest a human-expert-driven ground truth process for a software system that records and verifies radiation treatment.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the text.
-
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 MRMC study was mentioned. The device described (a "Record and Verify Radiation Treatment System") is a software system for treatment delivery and recording, not an AI diagnostic or assistive tool that would typically involve human "readers" in the context of improving diagnostic accuracy.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance tests" described would be considered a form of standalone testing of the software's functionality, as it assesses the device's ability to "consistently perform within the design parameters" and equivalence to the predicate. However, specific methodology and results for such standalone performance beyond the general statement are not detailed.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Given the nature of the device (a record and verify system for radiation treatment delivery), the "ground truth" for performance tests would likely involve comparisons against expected computational outputs, physical measurements of delivered radiation fields (if applicable), and human observation of correct system functionality, rather than medical ground truths like pathology or expert consensus on a diagnosis. Details are not provided.
-
The sample size for the training set:
- Not applicable/Not provided. This device is a software system for recording and verifying treatment delivery, not a machine learning or AI model that requires a "training set" in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable/Not provided, for the same reasons as above.
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SEP - 8 1997
K972a275
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: June 9, 1997 |
|---|---|---|
| Siemens Medical Systems | ||
| Oncology Care Systems Group | ||
| 4040 Nelson Avenue | ||
| Concord, CA 94520 | ||
| Contact Person: | Kathryn B. Dodd | |
| Vice President Regulatory Affairs and Quality Assurance | ||
| 2. | Common or Usual Name: | Record and Verify Radiation Treatment System |
| Proprietary Name: | LANTIS TREATSTATION | |
| Classification Names: | Record and Verify Radiation Treatment System | |
| 21 CFR § 892.5710 |
Class II, Product Code: RA 90 IYE
Impac Medical Systems' Sequencer (K913612) 3. Predicate Device:
- Description of Device: LANTIS TREATSTATION is a direct replacement for the 4. sequencing/VMI module of the Impac Sequencer Record and Verify Radiation Treatment System. The TREATSTATION coexists with the LANTIS Commander application on the target platform to allow the user access to the information system's other functions and provide the complete spectrum of required functionality.
- Statement of intended use: The intended use of the LANTIS TREATSTATION is to allow the પં radiation therapist to deliver treatment to the patient using the MEVATRON and all available accessories. This entails selecting a patient, selecting today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, LANTIS TREATSTATION supports intensity modulation (IM), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures. The intended use is the same as the predicate device.
- Statement of technological characteristics: The LANTIS TREATSTATION software does not 6. have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
- Differences: The minor configuration and specification differences between the LANTIS 7. TREATSTATION and Impac's Sequencer does not alter the intended use or affect the safety and effectiveness of the LANTIS TREATSTATION when used as labeled.
- Performance Evaluation: Performance tests were conducted and the results indicated that the 8. device consistently performed within the design parameters and equivalently to the predicate device.
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Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1997
Kathryn B. Dodd Vice President Regulatory and Affairs and Quality Assurance Siemens Medical Systems, Inc. 4040 Nelson Avenue Concord, CA 94520
Re: K972275 Lantis Treatstation Dated: June 9, 1997 Receivced: June 18, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Dodd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
h.Liau Yu-
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K972275
Device Name: LANTIS TREATSTATION
Indications For Use:
The intended use of the LANTIS TREATSTATION is to allow the radiation the intendta deliver treatment to the patient using the MEVATRON and all This entails selecting a patient, selecting available accessories. today's treatment for that patient, setting up and delivering the treatment fields, and recording the delivered treatment. TREATSTATION supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user In addition, LANTIS TREATSTATION supports intensity intervention. modulation (IM), a process of shaping, modifying, and moving the modulation (11), a t to maximize the dose at the target and minimize the dose to all normal structures.
The intended use is the same as the predicate device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K972275 |
Prescription Use (Per 21 CFR 801 109)
CR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
iOpliena! Format 1-2-36;
§ 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.