(255 days)
Not Found
No
The description focuses on the mechanical and user-controlled aspects of applying ink, with no mention of AI/ML terms or functions.
No.
The device is used to apply ink to the skin for identifying margins for radiation therapy. While it aids in therapy by marking the treatment area, it does not directly treat a disease or condition. Its purpose is for preparation and guidance, not therapeutic intervention.
No
The device is used to apply ink to the skin for identifying margins for radiation therapy. Its purpose is to mark the skin, not to diagnose a condition or disease.
No
The device description explicitly states it consists of a "Control and Pen module which drives a Safety Needle" and a "Docking station," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Comfort Marker 2.0 is used to apply ink to the skin of a patient. It does not analyze or test any biological samples.
- The intended use is for applying ink for radiation therapy marking. This is a physical procedure performed on the patient, not a diagnostic test performed on a sample.
- The device description focuses on the mechanical application of ink. It describes a control unit, pen module, safety needle, and depth settings, all related to the physical act of tattooing.
- The performance studies evaluate the comfort, effectiveness, satisfaction, and cosmesis of the marking process. These are outcomes related to the physical application and appearance of the marks on the patient, not diagnostic results from a biological sample.
The Comfort Marker 2.0 is a device used in a clinical setting for a therapeutic procedure (radiation therapy preparation), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
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.
Product codes
QRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Radiotherapy professionals / clinical settings (Radiotherapy department of a hospital)
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
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%).
Photographic assessment: 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).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Randomized, multi-arm, double-blind clinical study with concurrent ("active") control.
Sample Size: 100 patients (50 in investigational device arm, 50 in control arm).
Key Results:
- 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).
- Effectiveness endpoint: No fading of the reference points for both lancet and Comfort Marker 2.0 arms was recorded. 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 2.0 had significantly higher radiotherapy professionals reported tattooing processes evaluated as easy (78.0% vs. 98.0%, respectively; p=0.008).
- Cosmesis endpoint: Patients receiving Comfort Marker 2.0 had a significantly higher score on the photographic assessment, with a median score of 3.5 and 4.5 for the lancets and the Comfort Marker 2.0 group, respectively (p
N/A
0
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
1
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 (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 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 | kukaj@medicalprecision.nl |
| 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 | cjames@msquaredassociated.com |
| 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
4
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
DEN200041 | Similarities/Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Product Code | QRN | QRN | No difference in
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
used in clinical setting by
Radiotherapy professionals | The device is intended to be
used in clinical setting by
Radiotherapy professionals | No difference |
| Indications for
use | The device is indicated for
use for applying ink to the
skin to identify the margins
of radiation therapy. | The device is indicated for
use for applying ink to the
skin to identify the margins
of radiation therapy. | No difference |
| Target
population | Patients with undamaged
skin undergoing repeated
radiotherapy. | Patients with undamaged
skin undergoing repeated
radiotherapy. | No difference: |
| Contra
indications | Do not use the device on
damaged or dermatitis skin. | Do not use the device on
damaged or dermatitis skin. | No difference |
| Where used | In a Radiotherapy
department of a hospital | In a Radiotherapy
department of a hospital | No difference |
| Energy used /
delivered | Battery: Rechargeable
battery, 3.7 V, 2.4 Ah,
Lithium Ion
AC/DC power supply:
18W, 12V, 1.5A | Battery: Rechargeable
battery, 3.7 V, 2.4 Ah,
Lithium Ion
AC/DC power supply:
18W, 12V, 1.5A | No difference |
| Design /
operating
principle | Longitudinal movement of
the driving rod in the pen
actuates the safety needle.
The movement of the safety
needle is measured by a
measuring coil and to
control desired depth
setting. | Longitudinal movement of
the driving rod in the pen
actuates the safety needle.
The movement of the safety
needle is measured by a
measuring coil and to
control desired depth
setting. | No difference |
| Clinical
Performance | Clinical trial was performed
on 100 patients. Pain and
user experience was
recorded. | N/A | Clinical data on pain
experience, user
experience and
clinical effectiveness
was recorded in this
study. |
| Bench
Performance | • Needle depth
• Needle sharpness test
• Drop test
• Ink migration test
• Needle pattern test
• Glue strength test
• Needle protrusion test | • Needle depth
• Needle sharpness test
• Drop test
• Ink migration test
• Needle pattern test
• Glue strength test
• Needle protrusion test | No difference |
| | Durability of reference
•
points on human
volunteers | Durability of reference
•
points on human
volunteers | |
| Standards met | Biological evaluation:
• ISO 10993-1, 2018
• ISO 10993-10,
2009,
• ISO 10993-5, 2009
Sterilization:
• ISO
11135,2014/Amd
1:2018
Packaging:
• ISO 11607-1, 2019
• ISO 11607-2, 2019
Risk Management:
• ISO 14971:2012
Electrical safety:
• IEC 60601-1,
2005/A1:2012
• IEC 60601-1-2,
2014
• IEC 60601-1-6,
2010
Clean rooms:
• ISO 14644-1, 2015
• ISO 14644-2, 2015
| Biological evaluation:
• ISO 10993-1, 2018
• ISO 10993-10, 2009,
• ISO 10993-5, 2009
Sterilization:
• ISO 11135,2014/Amd
1:2018
Packaging:
• ISO 11607-1, 2019
• ISO 11607-2, 2019
Risk Management:
• ISO 14971:2012
Electrical safety:
• IEC 60601-1,
2005/A1:2012
• IEC 60601-1-2, 2014
• IEC 60601-1-6, 2010
Clean rooms:
• ISO 14644-1, 2015
• ISO 14644-2, 2015
| No difference |
| Device
materials | Safety Needle:
• Needle housing:
Zylar 960 (Methyl
Methacrylate
Butadiene Styrene)
• Needles: Stainless
Steel AISI 304H
• Spring: Stainless
steel UGI S4310-6
• Glue: Dymax
1405-M-UR-SC
Pen :
• Pen shield : Ferro
Magnetic steel
1018
• Pen ring: Ferro
Magnetic iron-
ETG100
• Pen actuator: ABS
PA
757_CHIMET_Pol
ylacR
• Pen coilformer:
ABS PA
757_CHIMET_Pol
ylacR | Safety Needle:
• Needle housing:
Zylar 960 (Methyl
Methacrylate
Butadiene Styrene)
• Needles: Stainless
Steel AISI 304H
• Spring: Stainless
steel UGI S4310-6
• Glue: Dymax
1405-M-UR-SC
Pen :
• Pen shield : Ferro
Magnetic steel
1018
• Pen ring: Ferro
Magnetic iron-
ETG100
• Pen actuator: ABS
PA
757_CHIMET_Pol
ylacR
• Pen coilformer:
ABS PA
757_CHIMET_Pol
ylacR | No difference |
| | | | |
| | Control Unit:
PC+ABS PC510 CHIMEI WONDERLOY Silicone rubber Docking station:
PC+ABS PC510 CHIMEI WONDERLOY | Control Unit:
PC+ABS PC510 CHIMEI WONDERLOY Silicone rubber Docking station:
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
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
safety needle | SAL: 10-6
Ethylene oxide sterilization
Single use component of the device system | SAL: 10-6
Ethylene oxide sterilization
Single use component of the device system | No difference |
| Mechanical
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
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 |
5
6
7
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:
8
| Stage | Investigational
device arm
(Comfort
Marker 2.0) | Control
arm
(lancets) | Total |
|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------------|-------|
| Enrollment | 50 | 50 | 100 |
| Treatment (reference points tattooing) | 50 | 50 | 100 |
| Primary outcome endpoint analysis: Patient's comfort
(experienced pain during tattooing process) | 50 | 50 | 100 |
| Primary outcome endpoint analysis: effectiveness
(reference points visibility for radiotherapy professionals) | 50 | 48 | 98 |
| Secondary outcome endpoint analysis: Radiotherapy
professional satisfaction | 50 | 50 | 100 |
| Secondary outcome endpoint analysis: Cosmesis
(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.
-
- 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)
-
- 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).
-
- 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