Delta4 Insight

K223234 · Scandidos AB · IYE · Jan 16, 2024 · Radiology

Device Facts

• Record ID: K223234
• Device Name: Delta4 Insight
• Applicant: Scandidos AB
• Product Code: IYE · Radiology
• Decision Date: Jan 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment plans by an independent dose calculation. Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.

Device Story

Delta4 Insight is a software module for radiotherapy quality assurance (QA). It performs independent secondary dose calculations to verify treatment plans generated by a primary treatment planning system (TPS). Inputs include DICOM patient treatment plans, CT images, structure sets, and beam model data. The device utilizes a Monte-Carlo based dose calculation engine to compute dose distributions independently of the TPS. It is used in hospital radiotherapy departments by trained oncology personnel (physicists/dosimetrists). The software compares the calculated dose against the TPS dose using gamma analysis metrics. Results are viewed on a networked PC. The device does not influence radiation delivery directly; it serves as a secondary check to ensure plan accuracy, potentially improving patient safety by identifying calculation errors.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated using anonymized DICOM patient treatment plans across various tumor sites, field sizes, and tissue depths. Verification and validation testing confirmed functionality, accuracy, and safety. Gamma comparison analysis was used to compare Insight dose results against reference TPS doses, demonstrating performance comparable to the predicate device.

Technological Characteristics

Software-only device; no physical materials. Operates via Monte-Carlo dose calculation engine. Connectivity via TCP/IP and DICOM protocols within hospital networks. Complies with IEC 62304:2006/A1:2016. Supports MV photon radiation therapy. Standalone software module within the broader Delta4 software suite.

Indications for Use

Indicated for quality assurance of radiotherapy treatment plans for patients undergoing curative or palliative radiotherapy treatments using MV photons.

Regulatory Classification

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.

Predicate Devices

• SciMoCa (K180595)

Submission Summary (Full Text)

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January 16, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

ScandiDos AB % Daniel Pederson QA & RA Manager Dag Hammarskjölds väg 52A Uppsala, Uppland 752 37 SWEDEN

Re: K223234

Trade/Device Name: Delta4 Insight Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: December 1, 2023 Received: December 12, 2023

Dear Daniel Pederson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Locon Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K223234

Device Name Delta4 Insight

### Indications for Use (Describe)

Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment dose calculation.

Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used radiation oncology personnel for quality assurance purposes.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

#### 1 APPLICANT

| 510(k) owner's Name | ScandiDos AB |
|-----------------------------------------------|---------------------------|
| Street address | Dag Hammarskjölds väg 52A |
| Postal Code, City | SE-75237 Uppsala |
| Country | Sweden |
| Phone Number (mobile) | [phone] |
| Fax Number | [phone] |
| Name of official correspondent | Daniel Pederson |
| Date the summary<br>was prepared (yyyy-mm-dd) | 2023-12-01 |

#### ମ DEVICE

| Trade Name | Delta4 Insight |
|----------------------------|------------------------------------------------------------------|
| Common/Usual Name | Secondary Check QA Software |
| Device Classification Name | Medical charged-particle radiation therapy system<br>(§892.5050) |
| Product code | IYE |

#### 3 PREDICATE DEVICES/

| Predicate Devices | Registered<br>Establishment Number | 510(k) Premarket submission<br>number |
|-------------------|------------------------------------|---------------------------------------|
| SciMoCa | 3009140718 | K180595 |

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#### 4 DESCRIPTION OF THE DEVICE

Delta4 Insight is software specifically design for quality assurance of radiotherapy treatment plans generated by a treatment planning system. The device calculates a secondary dose calculation via an independent Monte-Carlo based dose calculation software and compares this to the treatment planning system dose. The device is used as a secondary check for the results of a TPS and not for comparison with a measurement.

Delta4 Insight is a software module within the General Delta4 software. The software module is independent of all other software modules within the Delta4 software. The device is NOT a treatment planning system or a radiation therapy delivery device. It is only used by trained radiation therapy oncology personnel for the purposes of quality assurance in a hospital setting.

Insight supports treatments with MV photons. No other radiation type is supported.

#### 5 INTENDED USE OF THE DEVICE

Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment plans by an independent dose calculation.

Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes.

The intended use of the new device is contained within the intended use of the predicate device.

#### 6 SAFETY AND ESSENTIAL PERFORMANCE

The following standards apply to the device (general use): IEC 62304:2006/A1:2016

#### 7 PERFORMANCE DATA

The following performance data were provided in support of substantial equivalence:

### Software verification and validation testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Validation testing involved testing of clinical treatment plans and simulated clinical workflows and environment. Verification tests were performed to verify the product performed to specification and functions as it was designed. These tests include tests to verify requirements for functionality, accuracy,

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compatibility, tests to ensure risk mitigations function as intended, and regression tests to ensure the safety and effectiveness of functionality.

## Test plans

Non-clinical testing was conducted in accordance with the FDA guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]." The dose from anonymized DICOM patient treatment plans from chosen reference algorithms were re-calculated with Insight and the dose compared. Test plans were chosen to span the space of test parameters for the types of treatment types/modalities/energies/TPS/machines that are supported. The variety of plans tested are reflective of common clinical treatments and turnor sites and span many field sizes and tissue depths. The results were analyzed using a gamma comparison between Insight dose results and the original reference TPS dose.

## Summary

The device passed verification and validation testing and was deemed safe and effective for its intended use. All test plans passed using a similar criteria to that of the predicate. Based on results of this testing the device was found to have a safety and effectiveness profile similar to the predicate device, supporting the claim of substantial equivalence.

#### 8 TECHNOLOGICAL COMPARISON WITH THE PREDICATE DEVICES

The primary technological components of the device and its predicate device are an independent dose calculation algorithm and functionality that allows comparison between an independentlycalculated dose and a dose generated by a treatment planning system, all for quality assurance purposes. The technological characteristics are believed to be substantially equivalent to the predicate device. This is summarized in the table below:

| Area | SciMoCa (primary predicate Device) | Delta4 Insight |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SciMoCa is a software product intended to provide quality assurance of a radiotherapy dose calculated by a treatment planning system by allowing a clinician to re-calculate the dose with an independent dose calculation algorithm and compare the two doses. SciMoCa is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance | Delta4 Insight is a software intended to provide quality assurance of the radiotherapy treatment process by an independent dose calculation. Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to modify or influence radiation treatments. Delta4 Insight is to be used only by trained radiation oncology personnel for quality assurance purposes. |
| | purposes. | |
| Intended User | The intended user is a<br>health care professional in<br>the field of radiotherapy<br>like a medical physicist or<br>a dosimetrist who have<br>been educated in the safe<br>use of the device. | Same as predicate device |
| Spatial use context | The device is a software<br>program used on a<br>computer in a radiotherapy<br>department | Same as predicate device |
| Social use context | Only health care<br>professionals have access<br>to the software. See<br>"Intended user" | Same as predicate device |
| Hygienic use context | N/A- Software program | Same as predicate device |
| Physical use context | The device is a software<br>program installed on a<br>computer in a radiotherapy<br>department. Radiotherapy<br>departments have highly<br>controlled environmental<br>conditions to allow for<br>patient comfort. The<br>temperature is typically very<br>stable at about 22 C°. Also,<br>the humidity is typically<br>controlled (non condensing,<br>30-70%), | Same as predicate device |
| Activity use context | Independent calculation of<br>radiotherapy dose is set up<br>to calculate automatically.<br>User can access and<br>analyze results using the<br>program just like any<br>other PC program- often<br>by sitting in front of the<br>screen and interacting with<br>a mouse and short phrases<br>of text. No further<br>physical interaction is<br>required. | Same as predicate device |
| Biocompatibility | N/A- Software program | Same as predicate device |
| Communication | TCP/IP protocol between<br>server and clients through<br>hospital network. Input<br>files sent to server via<br>DICOM protocol. | Same as predicate device |
| Energy delivered | No energy is delivered. | Same as predicate device |
| | Device is a software | |
| Intended medical indication | See “Intended Use” | See “Intended Use” |
| Intended patient population | Verification of treatment plans of patients undergoing radiotherapy treatments-typically curative or palliative treatments | Same as predicate device |
| Intended part of the body or type of tissue applied to or interacted with | The device is never applied to a body part. No patients ever interact with the device. No patients are ever intended to touch the PC. | Same as predicate device |
| Intended user profile | The device is a software.<br>See “Intended user” | See “Intended user” |
| Intended condition of use (environment, including hygienic requirement, frequency of use, location, mobility) | See “IntendedUse environment” | See “Intended Use environment” |
| Sterile or non sterile | N/A the device is a software. PC (not part of the device) is non-sterile | Same as predicate device |
| Single or re-usable | N/A device is a software | Same as predicate device |
| Hospital or home use | The device is used in a radiotherapy device in a hospital | Same as predicate device |
| Measured quantity | Software uses input from the treatment planning system for an independent dose calculation. | Same as predicate device |
| Operating Principle | The software is independent of any measuring device or treatment planning system. The software receives data from the treatment planning system and independently calculates dose. The user can then analyze the dose calculated with the software and compare with the dose from the treatment planning system. | Same as predicate device |
| | Various metrics are<br>available for analysis. | |
| Software analysis | Comparing TPS dose with<br>dose calculated from PC<br>program | Same as predicate device |
| Dose calculation engine<br>type | Monte Carlo | Same as predicate device |
| Dose calculation engine<br>& viewing station<br>arrangement | Dose calculated on a<br>server inside hospital.<br>User can access results<br>from multiple devices<br>which are on the same<br>network. | Same as predicate device |
| Main inputs | TPS dose, plan, CT, and<br>structures. Beam model<br>information and CT to<br>density table. | Same as predicate device |
| Commissioning data<br>collection | Machine specific beam<br>information (proprietary<br>beam modeling) | Same as predicate device |
| Dose reporting type | Dose to water or dose to<br>medium | Same as predicate device |
| Accuracy/Performance<br>of calculation | When comparing the dose<br>calculation results of<br>patient plans to a reference<br>algorithm (Acuros), 97%<br>of the dose voxels with<br>more than 5% of the<br>maximum dose pass a<br>gamma criteria of<br>2%/2mm [Hoffman et al,<br>Validation of the Acuros XB<br>dose algorithm versus Monte<br>Carlo for clinical treatment<br>plans. MedPhys 2018 June 16]. | Calculation results of<br>patient plans to a reference<br>algorithm (Monaco,<br>Acuros) have a similar<br>gamma pass rate to that of<br>the predicate. |

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Although proprietary details of the calculation algorithms differ, the technological characteristics of the device are the same as the predicate. The intended use of the new device is contained within the intended use of the predicate device. Performance test plans using the device passed with a similar gamma criteria to that of the predicate.

#### CONCLUSIONS 9

The non-clinical performance data support the safety of the device and the software verification and validation demonstrate that the device performs as intended in the specified use conditions.

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Performance test plans using the device passed with a similar gamma criteria to the predicate, demonstrating that the device performs comparably to the predicate device that is currently marketed for a comparable intended use. It is the opinion of Scandidos AB that the device, Delta4 Insight, is as safe, is as effective, and performs as well as the predicate device.