(142 days)
Not Found
No
The device description and intended use focus solely on physical positioning and immobilization components for radiotherapy and imaging, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for positioning and immobilization during radiotherapy, which is a treatment, but the device itself does not deliver or perform the therapeutic action. It is an accessory for the treatment.
No
The device is used for positioning and immobilization of patients during radiotherapy and radio diagnostics, as well as during image acquisition for treatment support. It does not perform any diagnostic function itself.
No
The device description explicitly details physical components such as thermoplastic masks, a baseplate, and couch strips, which are hardware used for patient positioning and immobilization.
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 diagnosis, monitoring, or compatibility.
- Device Description: The device components (masks, baseplate, couch strips) are described as physical items used for positioning and immobilization. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory tests.
The device is a medical device used in a clinical setting for patient positioning during procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
CouchStrip:
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
DSPS-Prominent™ Masks: The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used as part of the DSPS-Prominent system to facilitate accurate positioning and immobilization of the head, neck and shoulder region of the patient.
DSPS-Prominent™ Baseplate, MR: 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. The device is fixed to the couch using couch strips.
CouchStrip: CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. The DSPS-Prominent CouchStrip is MR Safe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems
Anatomical Site
Head, neck and shoulder region
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 enables submillimetre positional accuracy to be achieved. 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional, and they are easily recognizable.
February 17, 2023
MacroMedics BV % Elizabeth Hajos QA/RA Director Oostbaan 670 Moordrecht, South Holland 2841 ML NETHERLANDS
Re: K222977
Trade/Device Name: DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE, LNH Dated: September 26, 2022 Received: September 28, 2022
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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is February 17, 2023, and the time is 10:29:17 -05'00'.
Lora D. Weidner, Ph.D Assistant Director 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
2
Indications for Use
510(k) Number (if known) K222977
Device Name
DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR, CouchStrip
Indications for Use (Describe)
DSPS-Prominent Masks, DSPS-Prominent Baseplate, MR:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
CouchStrip:
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized, circular graphic to the left, followed by the company name "macromedics" in a bold, sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller, lighter font.
K222977
Product Name – Patient Positioning Devices
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.
Submitter Details 1.
| Name: | MacroMedics BV | |
|---|---|---|
| Address: | Oostbaan 670, 2841ML Moordrecht, The Netherlands | |
| Contact Person: | Elizabeth Hajos | |
| Phone Number: | +31 (0)182 389777 | |
| Date Prepared: | 16-FEB-2023 |
2. Device Details
| Trade Name: | DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR, CouchStrip |
|---|---|
| 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 |
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Image /page/4/Picture/0 description: The image contains the logo for "macromedics SOLUTIONS IN RADIOTHERAPY". 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 "macromedics" is the text "SOLUTIONS IN RADIOTHERAPY" in a smaller font size. The color scheme is a light blue.
3. Predicate Device Details
| 510k
Number | Device Name | Manufacturer | New Device for
which Substantial
Equivalence is
claimed |
|----------------|-----------------------------------------------------|----------------|------------------------------------------------------------------|
| K142420 | DSPS & SSPS
thermoplastic masks | MacroMedics BV | DSPS-Prominent™
Masks |
| K142420 | DSPS & SSPS cradles,
ExaFix-IMRT
baseplate MR | MacroMedics BV | DSPS-Prominent™
baseplate, MR |
| K212909 | CouchStrips | MacroMedics BV | CouchStrip |
4. Subject Device Description, Intended Use, Technological Characteristics, Substantial Equivalence and Conclusion
Device (1) - DSPS-Prominent™ Masks 4.1
| Item code | Brand Name | Device Identifier |
|---|---|---|
| 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 |
Intended Use/ Indications for Use:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment, such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
Description:
The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used as part of the DSPS-Prominent system to facilitate accurate positioning and immobilization of the head, neck and shoulder region of the patient.
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
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Image /page/5/Picture/0 description: The image shows the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized "m" inside a circle on the left, followed by the company name "macromedics" in a sans-serif font. Below the company name is the tagline "SOLUTIONS IN RADIOTHERAPY" in smaller letters. The logo is in a light blue color.
intended use because they only represent minor changes which serve to improve the completeness and clarity of the Indications for Use statement and do not alter the purpose or use of the devices.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and the predicate device are equivalent in materials, construction, use and functionality. Both the MacroMedics DSPS & SSPS thermoplastic masks and the new MacroMedics DSPS-Prominent masks are thermoplastic masks made of the same thermoplastic materials which become pliable when heated and rigid when cooled, thus being able to be moulded to the contours of the patient to form a personalised mask. In both cases, occipital and facial masks are available. In both cases, the thermoplastic material is attached to a plastic frame (part of the mask), and this plastic frame is designed to be fixed to the frame of another device to facilitate patient positioning within a double shell' (facial and occipital) mask system. In both cases, the masks are MR Safe. In both cases, the positioning of the head and neck is supported, with the predicate device also offering facial head, neck and shoulder' masks. The DSPS-Prominent masks additionally allow the shoulder region of the patient to be positioned and immobilized within occipital masks.
Substantial equivalence summary:
MacroMedics claims the proposed DSPS-Prominent™ 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 and MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses. These products have very similar positioning and immobilization characteristics.
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.
4.2 Device (2) - DSPS-Prominent™ Baseplate, MR
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 113820 | DSPS-ProminentTM baseplate, MR | 08720168162182 |
| 113710 | MLDRM tool | 08720168162250 |
Intended Use/ Indications for Use:
Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment, such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems.
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Image /page/6/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 company name "macromedics" in a sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller font.
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. The device is fixed to the couch using couch strips.
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 minor changes which serve to improve the completeness and clarity of the Indications for Use statement and do not alter the purpose or use of the devices.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and predicate devices are equivalent in shape. construction, materials and functionality. The new device combines the features of the predicate devices in a glass fiber, MR Safe baseplate which facilitates the positioning of the patient within a double-shell' (facial and occipital mask) system. The predicate devices are also MR Safe, composed of glass fiber and facilitate the positioning of the patient within a double-shell' system. The predicate devices enable the patient to be positioned within head only' occipital masks and either head only' or `head, neck and shoulder' facial masks, whilst the new device enables the patient to be positioned within both facial and occipital 'head, neck and shoulder' thermoplastic masks.
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 and MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses. These products have very similar positioning and immobilization characteristics.
4.3 Device (3) - CouchStrip
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 147410 | CouchStripCS53FGF-PRO | 08720168162199 |
Intended Use/ Indications for Use:
Positioning of the patient during radiotherapy and radio diagnostics, includinq MR where indicated.
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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 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 entire logo is in a light blue color.
Description:
CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. The DSPS-Prominent CouchStrip is MR Safe.
Comparison of technological characteristics:
The designs of the MacroMedics subject device and predicate device are equivalent in shape. design, construction, materials and functionality. Both devices are MR Safe, glass fiber strips which feature three plastic `positioning pins'. Both devices serve to enable a baseplate to be fixed to the treatment table.
Substantial equivalence summary:
MacroMedics claims the proposed device 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 and MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses.
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 enables submillimetre positional accuracy to be achieved. 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.