Comfort Marker 2.0

K222112 · Medical Precision BV · QRN · Mar 30, 2023 · Radiology

Device Facts

• Record ID: K222112
• Device Name: Comfort Marker 2.0
• Applicant: Medical Precision BV
• Product Code: QRN · Radiology
• Decision Date: Mar 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5785
• Device Class: Class 2

Indications for Use

The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.

Device Story

Comfort Marker 2.0 is an application system for placing reference tattoo markers on patients undergoing radiotherapy. The device comprises a control unit, a pen module, and a safety needle. The pen module uses a driving rod to actuate the safety needle; a measuring coil monitors needle movement to control depth settings. The device is used in clinical radiotherapy departments by radiotherapy professionals. The control unit is rechargeable via a docking station. The device provides accurate, durable reference points, reducing procedural pain and improving cosmesis compared to manual lancets. It enhances clinical workflow by providing a standardized, easier-to-use method for marking patients, with integrated safety features to prevent needle stick injuries.

Clinical Evidence

Clinical trial (n=100) compared Comfort Marker 2.0 to lancets. Primary endpoints: patient comfort (pain) and effectiveness (visibility). Results: 44% of Comfort Marker patients reported painless procedure vs 16% for lancets (p=0.008). Effectiveness: 100% of Comfort Marker markings remained good/excellent throughout treatment vs 67% for lancets (p=0.003). Secondary endpoints: professional satisfaction (98% vs 78% ease of use, p=0.008) and cosmesis (median score 4.5 vs 3.5, p<0.001). No sharps injuries reported.

Technological Characteristics

Battery-powered (3.7V, 2.4Ah Li-ion) handheld device with control unit and pen. Materials: Zylar 960 (housing), AISI 304H stainless steel (needles), UGI S4310-6 (spring), Dymax 1405-M-UR-SC (glue), ABS/PC+ABS plastics. Sensing: Measuring coil for depth control. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 10993 (biocompatibility), IEC 60601-1/1-2/1-6 (electrical safety/EMC), ISO 11135 (sterilization), ISO 14971 (risk management).

Indications for Use

Indicated for applying ink to skin to identify radiation therapy margins in patients with undamaged skin undergoing repeated radiotherapy. Contraindicated for use on damaged or dermatitis skin.

Regulatory Classification

Identification

A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. The Comfort Marker 2.0 is an application system for placing reference marks on or in patient's skin to facilitate set-up for radiation therapy treatment, consisting of a battery-powered control unit with pen, a main-powered docking station, and a sterile, single-use safety needle.

Special Controls

In combination with the general controls of the FD&C Act, the radiation therapy marking device is subject to the following special controls: - (1) Design verification and validation must include: - Documentation of performance data from studies that demonstrate: (i) - (A) The indicated colorant is compatible with the device and its method of delivery: - (B) The device can reproducibly deliver the indicated colorant with the specifications described; and - (C) The length of time that compatible colorants remain visible on the skin following device application. - (ii) Documentation of performance data from studies that demonstrate: - Accuracy and reproducibility of needle penetration depth; (A) - Device protection from cross-contamination, including fluid ingress (B) protection: - Adequacy of the cleaning and disinfection instructions to ensure that the (C) reusable components of the device can be cleaned and disinfected; and - (D) The sterility of all patient-contacting components (e.g., safety needle). - Documentation of performance data from studies that demonstrate electrical (iii) safety and electromagnetic compatibility (EMC) of all electrical components of the device. - Documentation of performance data from studies that demonstrate continued (iv) sterility, package integrity, and device functionality over the intended shelf life. - (v) Documentation of software verification, validation, and hazard analysis. - The labeling required under 21 CFR 801.109(c) must include: (2) - An explanation of the device and the mechanism of operation; (i) - Validated methods and instructions for reprocessing of any reusable components; (ii) - (iii) Disposal instructions: and - A shelf life for all sterile components. (iv)

Predicate Devices

• Comfort Marker 2.0 (DEN200041)

Submission Summary (Full Text)

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March 30, 2023

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medical Precision BV % Cherita Jones Regulatory Consultant M Squared Associates, Inc 127 West 30th St. Floor 9 NEW YORK NY 10001

Re: K222112

Trade/Device Name: Comfort Marker 2.0 Regulation Number: 21 CFR 892.5785 Regulation Name: Radiation therapy marking device Regulatory Class: Class II Product Code: QRN Dated: February 27, 2023 Received: February 27, 2023

Dear Cherita Jones:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 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,

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Lora D. Weidner -S. The date of the signature is 2023.03.30, and the time is 20:36:13 -04'00'.

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

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# Indications for Use

510(k) Number (if known) K222112

Device Name

Comfort Marker 2.0

Indications for Use (Describe)

The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <div style="display:inline-block;"> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:inline-block;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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## 510(K) Summary

The following information is provided as required by 21 CFR § 807.87 for Traditional 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

| Contact Details | |
|-----------------------------------|----------------------------------|
| Applicant Name | Medical Precision b.v. |
| Applicant Address | Telfordstraat 9 - 30 |
| | NL 8013 RL, ZWOLLE |
| | The Netherlands |
| | |
| Applicant Contact | Blerta Kukaj |
| Applicant Contact E-mail | [e-mail] |
| Correspondent Name | M Squared Associates, Inc |
| Correspondent Address | 901 King Street, Suite 200 |
| | Alexandria, VA 22314 |
| | |
| Correspondent Telephone Number | 347-954-0624 |
| Correspondent Contact | Cherita James |
| Correspondent E-mail | [e-mail] |
| Submission Date | 27 February 2023 |
| Device Name | |
| Device Trade Name | Comfort Marker 2.0 |
| Common Name | Radiation Therapy Marking Device |
| Classification | II |
| Regulation | 21 CRF 892.5785 |
| Product Code | QRN |
| Legally Marketed Predicate Device | |
| Predicate Trade Name | Comfort Marker 2.0 (DEN200041) |
| Product Code | QRN |
| | |

# Device Description Summary

Comfort Marker 2.0 is an application system for placing reference marks on patients eligible for Radiotherapy treatments.

The Comfort Marker 2.0 allows the user to place accurate tattoo markers (reference points) on patients enabling radio therapy. The device consists of a Control and Pen module which drives a Safety Needle.

Different depth settings can be chosen to accommodate for different skin types. When the tattoo marking has been placed the Control Unit can be stored and charged in the Docking station.

## Intended Use/Indications for Use

The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.

## Indications for Use Comparison

No change in intended use

#### Technological Comparison

Both the subject (Comfort Marker 2.0 in this 510k) and the predicate device (Comfort Marker 2.0, De Novo DEN200041) are the same in this case. No technological differences exist. Comfort Marker 2.0 received De novo clearance on 10th of December 2021. This 510(K) is prepared to include clinical

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data on pain experience by patients undergoing radiotherapy treatment. Therefore, the predicate and the legally marketed device are substantially equivalent.

| Item | Subject Device | Predicate Device<br>DEN200041 | Similarities/Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Product Code | QRN | QRN | No difference in<br>FDA product code |
| Trade Name | Comfort Marker 2.0 | Comfort Marker 2.0 | No difference |
| 510 (K) number | Not assigned | De Novo: DEN200041 | N/A |
| Intended use | The device is intended to be<br>used in clinical setting by<br>Radiotherapy professionals | The device is intended to be<br>used in clinical setting by<br>Radiotherapy professionals | No difference |
| Indications for<br>use | The device is indicated for<br>use for applying ink to the<br>skin to identify the margins<br>of radiation therapy. | The device is indicated for<br>use for applying ink to the<br>skin to identify the margins<br>of radiation therapy. | No difference |
| Target<br>population | Patients with undamaged<br>skin undergoing repeated<br>radiotherapy. | Patients with undamaged<br>skin undergoing repeated<br>radiotherapy. | No difference: |
| Contra<br>indications | Do not use the device on<br>damaged or dermatitis skin. | Do not use the device on<br>damaged or dermatitis skin. | No difference |
| Where used | In a Radiotherapy<br>department of a hospital | In a Radiotherapy<br>department of a hospital | No difference |
| Energy used /<br>delivered | Battery: Rechargeable<br>battery, 3.7 V, 2.4 Ah,<br>Lithium Ion<br><br>AC/DC power supply:<br>18W, 12V, 1.5A | Battery: Rechargeable<br>battery, 3.7 V, 2.4 Ah,<br>Lithium Ion<br><br>AC/DC power supply:<br>18W, 12V, 1.5A | No difference |
| Design /<br>operating<br>principle | Longitudinal movement of<br>the driving rod in the pen<br>actuates the safety needle.<br>The movement of the safety<br>needle is measured by a<br>measuring coil and to<br>control desired depth<br>setting. | Longitudinal movement of<br>the driving rod in the pen<br>actuates the safety needle.<br>The movement of the safety<br>needle is measured by a<br>measuring coil and to<br>control desired depth<br>setting. | No difference |
| Clinical<br>Performance | Clinical trial was performed<br>on 100 patients. Pain and<br>user experience was<br>recorded. | N/A | Clinical data on pain<br>experience, user<br>experience and<br>clinical effectiveness<br>was recorded in this<br>study. |
| Bench<br>Performance | • Needle depth<br>• Needle sharpness test<br>• Drop test<br>• Ink migration test<br>• Needle pattern test<br>• Glue strength test<br>• Needle protrusion test | • Needle depth<br>• Needle sharpness test<br>• Drop test<br>• Ink migration test<br>• Needle pattern test<br>• Glue strength test<br>• Needle protrusion test | No difference |
| | Durability of reference<br>•<br>points on human<br>volunteers | Durability of reference<br>•<br>points on human<br>volunteers | |
| Standards met | Biological evaluation:<br>• ISO 10993-1, 2018<br>• ISO 10993-10,<br>2009,<br>• ISO 10993-5, 2009<br>Sterilization:<br>• ISO<br>11135,2014/Amd<br>1:2018<br>Packaging:<br>• ISO 11607-1, 2019<br>• ISO 11607-2, 2019<br>Risk Management:<br>• ISO 14971:2012<br>Electrical safety:<br>• IEC 60601-1,<br>2005/A1:2012<br>• IEC 60601-1-2,<br>2014<br>• IEC 60601-1-6,<br>2010<br>Clean rooms:<br>• ISO 14644-1, 2015<br>• ISO 14644-2, 2015<br> | Biological evaluation:<br>• ISO 10993-1, 2018<br>• ISO 10993-10, 2009,<br>• ISO 10993-5, 2009<br>Sterilization:<br>• ISO 11135,2014/Amd<br>1:2018<br>Packaging:<br>• ISO 11607-1, 2019<br>• ISO 11607-2, 2019<br>Risk Management:<br>• ISO 14971:2012<br>Electrical safety:<br>• IEC 60601-1,<br>2005/A1:2012<br>• IEC 60601-1-2, 2014<br>• IEC 60601-1-6, 2010<br>Clean rooms:<br>• ISO 14644-1, 2015<br>• ISO 14644-2, 2015<br> | No difference |
| Device<br>materials | Safety Needle:<br>• Needle housing:<br>Zylar 960 (Methyl<br>Methacrylate<br>Butadiene Styrene)<br>• Needles: Stainless<br>Steel AISI 304H<br>• Spring: Stainless<br>steel UGI S4310-6<br>• Glue: Dymax<br>1405-M-UR-SC<br>Pen :<br>• Pen shield : Ferro<br>Magnetic steel<br>1018<br>• Pen ring: Ferro<br>Magnetic iron-<br>ETG100<br>• Pen actuator: ABS<br>PA<br>757_CHIMET_Pol<br>ylacR<br>• Pen coilformer:<br>ABS PA<br>757_CHIMET_Pol<br>ylacR | Safety Needle:<br>• Needle housing:<br>Zylar 960 (Methyl<br>Methacrylate<br>Butadiene Styrene)<br>• Needles: Stainless<br>Steel AISI 304H<br>• Spring: Stainless<br>steel UGI S4310-6<br>• Glue: Dymax<br>1405-M-UR-SC<br>Pen :<br>• Pen shield : Ferro<br>Magnetic steel<br>1018<br>• Pen ring: Ferro<br>Magnetic iron-<br>ETG100<br>• Pen actuator: ABS<br>PA<br>757_CHIMET_Pol<br>ylacR<br>• Pen coilformer:<br>ABS PA<br>757_CHIMET_Pol<br>ylacR | No difference |
| | | | |
| | Control Unit:<br>PC+ABS PC510 CHIMEI WONDERLOY Silicone rubber Docking station:<br>PC+ABS PC510 CHIMEI WONDERLOY | Control Unit:<br>PC+ABS PC510 CHIMEI WONDERLOY Silicone rubber Docking station:<br>PC+ABS PC510 CHIMEI WONDERLOY | |
| Biocompatibility | Complies with ISO 10993 series of standards for Cytotoxicity Skin Irritation Skin Sensitization Material Mediated pyrogenicity Acute Systemic Toxicity | Complies with ISO 10993 series of standards for Cytotoxicity Skin Irritation Skin Sensitization Material Mediated Pyrogenicity Acute Systemic Toxicity | No difference |
| Electrical safety<br>and EMC | Complies with IEC 60601 series of standards: IEC 60601-1 ,2005/A1:2012 IEC 60601-1-2, 2014 IEC 60601-1-6, 2010 | Complies with IEC 60601 series of standards: IEC 60601-1 ,2005/A1:2012 IEC 60601-1-2, 2014 IEC 60601-1-6, 2010 | No difference |
| Sterility of<br>safety needle | SAL: 10-6<br>Ethylene oxide sterilization<br>Single use component of the device system | SAL: 10-6<br>Ethylene oxide sterilization<br>Single use component of the device system | No difference |
| Mechanical<br>safety | The safety Needle extends max up to 1 mm during operation (mechanical stop) The safety needle is covered by housing to prevent needle stick injuries while not in operation | The safety Needle extends max up to 1 mm during operation (mechanical stop) The safety needle is covered by housing to prevent needle stick injuries while not in operation | No difference |
| Software and<br>Cybersecurity | The software does not impact any risk related solutions and no injury or damage to health is possible due to software. The software is therefore classified as class A Complies with IEC 62304:2006-05 and IEC62304:2015-06 | The software does not impact any risk related solutions and no injury or damage to health is possible due to software. The software is therefore classified as class A Complies with IEC 62304:2006-05 and IEC62304:2015-06 | No difference |
| MRI safety | MRI unsafe | MRI unsafe | No difference |

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## Non-Clinical and/or Clinical test Summary and Conclusions

Non-Clinical and Clinical Summary

Product functionality: The Control unit, the pen and the safety needle all meet the requirements presented in bench testing.

Biocompatibility: The Safety Needle meets cytotoxicity requirements of ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity.

Biocompatibility: The Safety Needle meets sensitization requirements of ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization.

Biocompatibility: The safety Needle meets the Material Mediated pyrogenicity requirements of ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity.

Biocompatibility: The safety Needle meets the Acute Systemic Toxicity requirements of ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity.

Sterilization: A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.

Electrical Safety and EMC: The device meets safety and EMC standards requirements of IEC 60601-1 ,2005/A1:2012, IEC 60601-1-2, 2014 and IEC 60601-1-6, 2010

Software and Cybersecurity: The software is compliant with Complies with IEC 62304:2006-05 and IEC62304:2015-06 Medical device software life cycle processes.

Clinical simulated use testing: The performance of Comfort Marker 2.0 and durability of reference points (at 3 different depth settings) were tested on 6 healthy volunteers. The reference points were tracked for 12 weeks for visibility, migration and clearance. The healthy volunteer study showed that Comfort Marker 2.0 can place well defined reference points at all three depth settings using three inks. The reference points did not show any migration on the skin. All reference points from three inks were clearly visible during week 2 until 8, a period in which radiotherapy treatment is provided.

Clinical testing: The aim of the randomized, multi-arm, double-blind study with concurrent ("active") control was to establish whether the use of Comfort Marker 2.0 translates into a benefit in terms of comfort, satisfaction, effectiveness, and cosmesis compared to the use of lancets (standard, control). The clinical study was performed in Portugal between October 2021 and January 2022. Target one hundred patients (18 years or older) were enrolled (50 assigned to lancet arm and 50 assigned to Comfort Marker 2.0 arm.

Patient demographic and clinical characteristics: The median age of all patients included in the trial was 61 (25-85 years). The majority of patients within the clinical trial were women (73%) with men making up 27% of the patient population. The number of set-up markings was also well balanced: 64.0% of the patients in the lancets group and 68.0% of those in the CM group had received >4 set-up markings, with a median of 9 in both groups. Most of the patients included were referred to irradiate breast or chest wall (61.0%), followed by pelvis (22.0%) and thorax (11.0%).

Patient accountability for the four endpoints defined for the trial is presented in the table below:

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| Stage | Investigational<br>device arm<br>(Comfort<br>Marker 2.0) | Control<br>arm<br>(lancets) | Total |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------|-------|
| Enrollment | 50 | 50 | 100 |
| Treatment (reference points tattooing) | 50 | 50 | 100 |
| Primary outcome endpoint analysis: Patient's comfort<br>(experienced pain during tattooing process) | 50 | 50 | 100 |
| Primary outcome endpoint analysis: effectiveness<br>(reference points visibility for radiotherapy professionals) | 50 | 48 | 98 |
| Secondary outcome endpoint analysis: Radiotherapy<br>professional satisfaction | 50 | 50 | 100 |
| Secondary outcome endpoint analysis: Cosmesis<br>(aesthetic appearance of reference points) | 50 | 48 | 98 |

The Comforttatto trial met all endpoints (outcome measures) set at the start of the trial. No adverse events were reported during the trial.

- 1. Patients comfort endpoint: The percentage of patients that graded the tattooing process as painless was significantly higher for patients receiving Comfort Marker 2.0 compared to lancets (44.0% vs. 16.0%, respectively; p = 0.008). (Table 2 and Figure S1)
- 2. Effectiveness endpoint: No fading of the reference points for both lancet and Comfort Marker 2.0 arms was recorded. During tattoo quality assessment by radiotherapy professionals on 4point scale (bad, reasonable, good and excellent), patient's receiving Comfort Marker 2.0 had a significantly higher proportion of radiotherapy professionals reported good and excellent quality markings compared to those receiving lancets. The median score of set-up markings graded as good/excellent on the last evaluation compared to the first evaluation was significantly worse in patients receiving lancets (67% v 89% respectively; p =0.003). The same effect wasn't found on patients receiving CM (100.0% for both evaluations; p=0.173).
- Satisfaction endpoint: Compared to those receiving lancets, patients receiving Comfort Marker 3. 2.0 had significantly higher radiotherapy professionals reported tattooing processes evaluated as easy (78.0% vs. 98.0%, respectively; p=0.008).
- 4. Cosmesis endpoint: The photographic assessment (reference points photos were taken on one of the last three days of treatment and grading radiotherapy professionals were blind to patient identify and trial arm) of the reference points in both trial arms was performed by 20 observers (both physicians and radiotherapy professionals) on 4-point scale (bad, reasonable, good and excellent). Patients receiving Comfort Marker 2.0 had a significantly higher score on the photographic assessment (Table 5), with a median score of 3.5 and 4.5 for the lancets and the Comfort Marker 2.0 group, respectively (p < 0.001).While 84.0% of the patients in the Comfort Marker 2.0 group had a mean score of at least 4, in the lancets group that number is five times lower (16.7%; p < 0.001).

Additionally, data on sharps injuries was collected. Sharp injuries were considered any incident which causes the needle of the lancet or the CM to inadvertently penetrate the skin of the radiotherapy professionals performing the tattooing during any of the tattooing process (material assembly, tattooing, or sharps disposal). Outcome: no sharp injuries were registered during the Comforttattoo trial.

Conclusion: Based on the two device comparison characteristics presented in this 510K, the subject device is substantially equivalent to the legally marketed predicate device DEN200041. Clinical data

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provided supports the Comfort Marker 2.0 claims as: a) Patients marked with Comfort Marker 2.0 reported less procedural pain than patients marked with lancets, b) Physicians and radiation therapist doing photographic assessment of cosmesis rated Comfort Marker 2.0 better than lancets. - Limitation/ additional claim information: study performed in Europe where majority of the population is Caucasian race, specific to Portugal where the study was performed the majority is from a Mediterranean ethnicity,

c) Radiation therapists rated placing tattoos with Comfort Marker 2.0 easier compared to the use of lancets.