(33 days)
Not Found
No
The device description and intended use focus solely on physical positioning and immobilization components for radiotherapy and radio diagnostics. There is no mention of software, image processing, or any terms related to AI or ML.
No
The device is used for positioning and immobilization during radiotherapy, which is a therapeutic process, but the device itself does not deliver therapy or perform a therapeutic function on the patient.
No
The input text explicitly states the devices are for "Positioning and immobilization of the patient during radiotherapy" and "Positioning of the patient during radiotherapy and radio diagnostics". While the latter includes "radio diagnostics," the primary function is positioning and immobilization, not generating diagnostic information or interpreting medical images. The text consistently describes the devices' role in patient setup for treatment or imaging, not in diagnosing conditions.
No
The device description clearly details physical components such as baseplates, cradles, and masks made of thermoplastic, which are used for positioning and immobilization. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "Positioning and immobilization of the patient during radiotherapy and radio diagnostics." This is a physical function related to patient treatment and imaging, not the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device components (baseplate, cradles, masks, handgrips) are all physical items used to hold and stabilize a patient. They do not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is entirely external to the patient's internal biological processes.
The device is a medical device used in a clinical setting for patient positioning and immobilization during medical procedures (radiotherapy and radio diagnostics).
N/A
Intended Use / Indications for Use
All devices apart from Handgrips HNS, set/2 (111730): Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment. Handgrips HNS, set/2 (111730): Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Product codes (comma separated list FDA assigned to the subject device)
IYE, LNH
Device Description
The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available.
The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available.
The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate.
The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
Head, neck and shoulder region; head only.
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)
Clinical and non-clinical testing was performed. Non-clinical performance testing was completed to ensure that the devices fulfilled the defined requirements. Clinical testing was performed to ensure that the use of the devices supports the achievement of submillimeter positional accuracy. In addition, attenuation measurements were taken, and water equivalence measurements were calculated, for the devices. The testing confirmed that the new devices are as safe and effective as the predicate devices.
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.
Not Found
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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March 19, 2025
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 in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
MacroMedics BV Elizabeth Hajos QARA Director Oostbaan 670 Moordrecht Netherlands
Re: K250429
Trade/Device Name: DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set/5 (113910); Mask DSPS®-PROSHL set/5 (113920); Mask DSPS®-PROH. set/5 (113930): Mask DSPS®-PROSHVR set/5 (113940); Mask DSPS®-PROSVRL, set/5 (113950); Mask DSPS®-PROS, set/5 (113960); Mask DSPS®-PROSVR, set/5 (113970); Mask DSPS®-PROSL, set/5 (113980); Mask DSPS®-PRO, set/5 (113990); DSPS-Prominent® SH profile set/2 (113090); DSPS PRO Mask Shim Set HNS (113250); DSPS PRO Mask Shim Set HO (113270); DSPS®-PRO Coil Ref Tool (113710); Handgrips HNS, set/2 (111730) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE, LNH Dated: February 12, 2025 Received: February 14, 2025
Dear Elizabeth Hajos:
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 (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
1
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).
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 (QS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rele"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
2
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Locoa 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
Enclosure
3
Indications for Use
Submission
| Number (if known) | |
|---|---|
K250429 Device Name
DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260): Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set/5 (113910); Mask DSPS®-PROSHL set/5 (113920); Mask DSPS®-PROH, set/5 (113930); Mask DSPS®-PROSHVR set/5 (113940); Mask DSPS®-PROSVRL, set/5 (113950); Mask DSPS®-PROS, set/5 (113960); Mask DSPS®-PROSVR, set/5 (113970); Mask DSPS®-PROSL, set/5 (113980); Mask DSPS®-PRO, set/5 (113990); DSPS-Prominent® SH profile set/2 (113090); DSPS PRO Mask Shim Set HNS (113250); DSPS PRO Mask Shim Set HO (113270); DSPS®-PRO Coil Ref Tool (113710); Handgrips HNS, set/2 (111730) Indications for Use (Describe)
All devices apart from Handgrips HNS, set/2 (111730):
Prescription Use (Part 21 CFR 801 Subpart D)
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment.
Handgrips HNS, set/2 (111730):
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Type of Use (Select one or both, as applicable)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/0 description: The image is a logo for "macromedics SOLUTIONS IN RADIOTHERAPY". The logo features a stylized "m" symbol on the left, followed by the word "macromedics" in a sans-serif font. Below "macromedics" is the text "SOLUTIONS IN RADIOTHERAPY" in a smaller font size. The color scheme is a light blue.
K250429
510(k) Summary
- Statement: Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "510(k) Summarises and 510(k) Statements" (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
1. Submitter Details
Name: MacroMedics BV
Address: Oostbaan 670, 2841ML Moordrecht, The Netherlands
Contact Person: Elizabeth Hajos
Phone Number: +31 (0)182 389777
Date Prepared: 13-MAR-2025
2. Device Details
- DSPS-Prominent® baseplate, MR (113820); Trade Name: DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV ( 113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set/5 (113910); Mask DSPS®-PROSHL set/5 (113920); Mask DSPS®-PROH, set/5 (113930); Mask DSPS®-PROSHVR set/5 (113940); Mask DSPS®-PROSVRL, set/5 (113950);
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Image /page/6/Picture/0 description: The image shows the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized "m" symbol on the left, followed by the company name in a sans-serif font. Below the company name is the tagline "SOLUTIONS IN RADIOTHERAPY" in a smaller font.
| Mask DSPS®-PROS, set/5 (113960); | |
|---|---|
| Mask DSPS®-PROSVR, set/5 (113970); | |
| Mask DSPS®-PROSL, set/5 (113980); | |
| Mask DSPS®-PRO, set/5 (113990); | |
| DSPS-Prominent® SH profile set/2 (113090); | |
| DSPS PRO Mask Shim Set HNS (113250); | |
| DSPS PRO Mask Shim Set HO (113270); | |
| DSPS®-PRO Coil Ref Tool (113710); | |
| Handgrips HNS, set/2 (111730) | |
| Common Name: | Patient Positioning Devices |
| Classification: | Class II |
| Regulation: | 21 CFR 892.5050 |
| Regulation Name: | Medical Charged-Particle Radiation Therapy System |
| Product Code: | IYE, LNH |
| Review Panel: | Radiology |
3. Predicate Device Details
| 510k Number | Predicate Device Name | Manufacturer | Subject Device for
which Substantial
Equivalence is
claimed |
|-------------|---------------------------------|----------------|----------------------------------------------------------------------|
| K222977 | DSPS-Prominent
Baseplate, MR | MacroMedics BV | DSPS-Prominent
Baseplate, MR |
| K222977 | DSPS-Prominent
Baseplate, MR | MacroMedics BV | DSPS-Prominent
Baseplate |
| K222977 | DSPS-Prominent
Baseplate, MR | MacroMedics BV | DSPS-Prominent
Cradle |
| K222977 | DSPS-Prominent Masks | MacroMedics BV | DSPS-Prominent Masks |
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Image /page/7/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a stylized "m" symbol to the left of the word "macromedics", with the tagline "SOLUTIONS IN RADIOTHERAPY" underneath. The logo is in a light blue color and the text is in all caps.
4. Indications For Use of Subject Devices
All devices apart from Handgrips HNS, set/2 (111730):
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment.
Handgrips HNS, set/2 (111730):
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
5. Subject Device Description, Technological Characteristics and Substantial Equivalence
5.1 Device (1) - DSPS-Prominent Baseplate, MR
| Item code | Brand Name | Device Identifier |
|---|---|---|
| 113820 | DSPS-Prominent® baseplate, MR | 08720168162182 |
| 113710 | DSPS®-PRO Coil Ref Tool | 08720168162694 |
Description:
The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available.
Differences in Indications for Use:
The differences between the Indication for Use statements of the predicate device and the new device do not affect the safety and effectiveness of the devices and are not critical to their intended use because they only represent a minor change which does not affect the purpose or use of the devices.
Comparison of technological characteristics:
The technological characteristics of the device have not changed.
Substantial equivalence summary:
MacroMedics claims the proposed devices to be substantially equivalent to the devices previously cleared by the FDA in the 510(k) specified above. These devices are also cleared for use in a radiotherapy environment.
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Image /page/8/Picture/0 description: The image shows the logo for "Macromedics". The logo consists of a stylized letter "m" enclosed in a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The color of the logo is a light teal.
MacroMedics claims this equivalence because the proposed devices are the same: the design, use, technological characteristics and all other aspects are the same. The only difference is the minor difference in indications for use which does not affect either the safety and effectiveness or the substantial equivalence of the devices.
Conclusion:
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
5.2 Device (2) - DSPS-Prominent Baseplate
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 113120 | DSPS-Prominent® baseplate | 08720168160140 |
| 111730 | Handgrips HNS, set/2 | 08720168162908 |
Description:
The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available.
Differences in Indications for Use:
The differences between the Indication for Use statements of the predicate device and the new device do not affect the safety and effectiveness of the devices and are not critical to their intended use because they only represent a minor change which does not affect the purpose or use of the devices.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and predicate device are equivalent in shape, materials, construction and functionality. Both devices are constructed of rigid materials and are baseplates which support the upper anatomy of the patient. Both devices feature a cantilevered frame at the cranial end which facilitates the use of DSPS-Prominent facial and occipital masks. Both devices are fixed to the couch using couch strips. The difference between the predicate device is that the new device is constructed of carbon fibre rather than glass fibre.
Substantial equivalence summary:
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
MacroMedics claims this equivalence because the proposed devices are the same in every way apart from the material, which is equivalent: the devices have the same design, positioning features, and general technological characteristics. The minor difference in indications for use does not affect either the safety
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Image /page/9/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a stylized letter "m" enclosed in a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The color of the logo and text is a light blue.
and effectiveness or the substantial equivalence of the devices. The difference in material also does not raise any questions of safety and effectiveness when the device is used in accordance with its labelling.
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 113140 | DSPS-Prominent® Cradle-l | 08720168162557 |
| 113150 | DSPS-Prominent® Cradle-II | 08720168162564 |
| 113160 | DSPS-Prominent® Cradle-III | 08720168162779 |
| 113170 | DSPS-Prominent® Cradle-IV | 08720168162786 |
| 113180 | DSPS-Prominent® Cradle-VI | 08720168162793 |
| 113260 | DSPS-Prominent® Cradle-VII | 08720168163325 |
5.3 Device (3) - DSPS-Prominent Cradle
Description:
The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and predicate device are equivalent in shape, materials, construction and functionality. Both devices are constructed of rigid materials and feature a cantilevered frame which facilitates the use of DSPS-Prominent facial and occipital masks. Both devices are fixed to an underlying device. The difference between the predicate device and the new devices is that the predicate device was a glass fibre baseplate featuring a (glass fibre) cantilevered frame, whilst the new devices are carbon fibre cradles featuring the same cantilevered frame reproduced in carbon fibre; the new devices are shorter devices and are required to be attached to an underlying baseplate rather than to the treatment table directly (as is the case with the baseplate devices).
Substantial equivalence summary:
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
MacroMedics claims this equivalence because the proposed devices are significantly similar. Specifically, they are governed by the same design principles and feature the same characteristics for patient positioning. Moreover, their technological characteristics and use are significantly similar. The differences, including the minor difference in indications for use, do not affect either the safety and effectiveness or the substantial equivalence of the devices.
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| Selling code | Brand name | Device Identifier |
|---|---|---|
| 113760 | Mask DSPS®-PROSCVRL set/5 | 08720168162854 |
| 113770 | Mask DSPS®-PROSC set/5 | 08720168162861 |
| 113780 | Mask DSPS®-PROSCVR set/5 | 08720168162878 |
| 113790 | Mask DSPS®-PROSCL set/5 | 08720168162885 |
| 113890 | Mask DSPS®-PROSHVRL set/5 | 08720168162571 |
| 113910 | Mask DSPS®-PROSH set/5 | 08720168162595 |
| 113920 | Mask DSPS®-PROSHL set/5 | 08720168162618 |
| 113930 | Mask DSPS®-PROH, set/5 | 08720168162748 |
| 113940 | Mask DSPS®-PROSHVR set/5 | 08720168162649 |
| 113950 | Mask DSPS®-PROSVRL, set/5 | 08720168162250 |
| 113960 | Mask DSPS®-PROS, set/5 | 08720168162205 |
| 113970 | Mask DSPS®-PROSVR, set/5 | 08720168162236 |
| 113980 | Mask DSPS®-PROSL, set/5 | 08720168162267 |
| 113990 | Mask DSPS®-PRO, set/5 | 08720168162755 |
| 113090 | DSPS-Prominent® SH profile set/2 | 08720168163356 |
| 113250 | DSPS PRO Mask Shim Set HNS | 08720168163387 |
| 113270 | DSPS PRO Mask Shim Set HO | 08720168163394 |
5.4 Device (4) - DSPS-Prominent Masks
Description:
The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and predicate device are equivalent in shape, materials, construction and functionality. The predicate and new devices are thermoplastic masks which are constructed of the same materials and are intended to be secured to the frame of another device (cradles/ baseplates). The thermoplastic materials become pliable when cooled, thus being able to be molded to the contours of the patient to form a personalized mask. The technological characteristics have not changed. The only difference is that 'head only' mask models are now also included. The 'head only' masks are shorter masks which do not extend to the shoulder region.
Substantial equivalence summary:
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
MacroMedics claims this equivalence because the proposed devices are significantly similar. Specifically, they are governed by the same design principles, they are composed of the same materials, their general
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Image /page/11/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a circular icon with a stylized "m" inside, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font size.
technological characteristics are the same, and their use is significantly similar. The minor differences, including the minor difference in indications for use, do not affect either the safety and effectiveness or the substantial equivalence of the devices.
6. General
Testing Performed:
Clinical and non-clinical testing was performed. Non-clinical performance testing was completed to ensure that the devices fulfilled the defined requirements. Clinical testing was performed to ensure that the use of the devices supports the achievement of submillimeter positional accuracy. In addition, attenuation measurements were taken, and water equivalence measurements were calculated, for the devices. The testing confirmed that the new devices are as safe and effective as the predicate devices.
Conclusion:
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.