(139 days)
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
The provided text is a 510(k) summary for the DC 7 Diode Laser Therapy System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the document, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
The DC 7 device is a diode laser therapy system. The acceptance criteria are based on substantial equivalence to predicate devices rather than meeting specific performance metrics in a clinical study. The device meets "acceptance criteria" by demonstrating that its technical and functional characteristics are either identical or sufficiently similar to legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Table of Acceptance Criteria (based on comparison to predicate devices) and Reported Device Performance (DC 7):
| Characteristic | Predicate Device (DenLase 980/7 & Diolase 10S) Performance (Acpt. Criteria Implied by Equivalence) | DC 7 Reported Performance | Comparison Analysis (Acceptance Status) |
|---|---|---|---|
| Regulation | 21CFR878.4810 (Class II, Laser Surgical Instrument) | 21CFR878.4810 | Identical |
| Category of Device | Prescription Device | Prescription Device | Identical |
| Laser Medium | Diode Laser (GaAlAs) | Diode Laser (GaAlAs) | Identical |
| Wavelength | 980 nm (for DenLase 980/7), 940 +/- 15 nm (for Diolase 10S) | 980 nm | The DC 7 matches one predicate and is within a similar therapeutic range to the other. Not considered to affect safety/effectiveness. |
| Power to Tissue | Up to 7 Watts (DenLase 7), Up to 10 Watts (Diolase 10S) | Up to 7 Watts | Meets Acceptance: "The maximum power output of proposed device is between that of the two predicates devices, and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device." |
| Laser Class | Class IV | Class IV | Identical |
| Operating Modes | Continuous, Pulsed | Continuous, Pulsed | Identical |
| Pulse Width | 50us - 30s Up to 100 Hertz | 50us - 30s Up to 100 Hertz | Meets Acceptance: "The comparatively short pulse duration of DC7 will not introduce any problems regarding the safety and effectiveness of the device. In addition, the shorter pulse duration will decrease the injury which the laser beam bring to the normal tissue, at the same time the shorter pulse duration will reduce the smoke caused by treatment, then correspondingly optimize the vision during the treatment also. Considering the pulse duration range of the proposed product include the pulse duration range of the predicated product, the difference will not introduce any problems regarding the safety and effectiveness of the device." |
| Beam Delivery | Fibers, handpieces and tips | Fibers, handpieces and tips | Identical |
| Aiming Beam | 650 nm @ 1.0 mW Max adjustable | 650 nm @ 1.0 mW Max adjustable | Identical |
| Contacting Material | Stainless steel, polypropylene and quartz | Stainless steel, polypropylene and quartz | Identical |
| Contacting Components | Handpieces, tips and fiber | Handpieces, tips and fiber | Identical |
| Control System | Microprocessor | Microprocessor | Identical |
| Laser Operation | Footswitch | Footswitch | Identical |
| Electrical Supply | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz | Identical |
| Cooling | Internal | Internal | Identical |
| Weight | 3 Pounds | 3 Pounds | Identical |
| Accessories | Fiber, disposable tips, handpieces | Fiber, disposable tips, handpieces | Identical |
| Software Validation | Comply with the FDA Guidance for traditional 510(k) | Comply with the FDA Guidance for traditional 510(k) | Identical |
| Electrical Safety | Comply with IEC60601-1 | Comply with IEC60601-1 | Identical |
| Electromagnetic Compatibility | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Identical |
| Labeling | Comply with related standards and refer to Labeling documentation of 510(k) submission | Comply with related standards and refer to Labeling documentation of 510(k) submission | Identical |
Study Details
The provided document (510(k) summary) explicitly states:
- Non clinical Performance Data: None
- Clinical Performance Data: None
This means that a traditional "study" to prove the device meets acceptance criteria in terms of performance was not performed in the context of this 510(k) submission. Instead, the "study" demonstrating that the device meets criteria is a comparative analysis proving substantial equivalence to predicate devices, which is sufficient for 510(k) clearance for this type of device.
Given the absence of clinical/non-clinical performance data, the following points cannot be addressed as no such studies were conducted or presented in this summary:
- Sample size used for the test set and the data provenance: Not applicable, as no test set data from performance studies were provided. The "test set" here would implicitly be the specifications of the predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device performance was not established via expert review in this submission.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical laser, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical laser.
- The type of ground truth used: For the purpose of this 510(k), the "ground truth" for proving substantial equivalence comes from the established safety and effectiveness of the legally marketed predicate devices, against which the DC 7's technical specifications are compared.
- The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary, the clearance for the DC 7 is based on a demonstration of substantial equivalence to predicate devices through a detailed comparison of technical specifications, rather than new performance studies with specific acceptance criteria that would typically involve test sets, expert ground truth, or statistical analysis of clinical outcomes.
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510(k) SUMMARY
Title:
DC 7
-
Submitter: DC International, LLC David Boëgler 317-730-4601 DC International, LLC 624 Cypress Green Cir. Wellington, FL 33414
NOV 0 7 2013 -
David Boëgler Contact: 317-730-4601 DC International, LLC 624 Cypress Green Cir. Wellington, FL 33414
-
Date Prepared: June 2, 2013
Device Trade Name: DC 7
Common Name: Diode Laser Therapy System
- Classification Name: Instrument, surgical, powered laser GEX 21 CFR 878.4810
- China Daheng Group Inc DenLase (K102669), Biolase Technology Predicate Devices: Inc Diolase (K121327)
Device Description:
The DC International, LLC DC 7 is a medical grade, solidstate, infrared diode lasers (AlGaAs). The lasers are designed to deliver continuous or pulsed laser energy with a wavelength at 980 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch.
{1}------------------------------------------------
THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel.
THE MAIN CONSOLE: Contains the major electrical components
r
DELIVERY SYSTEM: The DC 7 is delivered with fibers, handpieces and tips Safety glasses/goggles and a safety sign are also provided with the systems.
{2}------------------------------------------------
| DC International, LLCDC.7 | ||
|---|---|---|
| Regulation: | 21CFR878.4810 | |
| Category of Device: | Prescription Device | |
| Laser Medium: | Diode Laser (GaAIAs) | |
| Wavelength: | 980 nm | |
| Power to Tissue: | DC 7: Up to 7 Watts | |
| Laser Class | Class IV | |
| Operating Modes: | Continuous, Pulsed | |
| Pulse Width: | 50us - 30s Up to 100 Hertz | |
| Beam Delivery: | Fibers, handpieces and tips | |
| Aiming Beam: | 650 nm @ 1.0 mW Max adjustable | |
| Contacting Material | Stainless steel, polypropylene and quartz | |
| Contacting Components | Hanpieces, tips and fiber | |
| Control System | Microprocessor | |
| Laser Operation: | Footswitch | |
| Electrical Supply: | 100-230 VAC, 50-60 Hz | |
| Cooling: | Internal | |
| Weight: | 3 Pounds | |
| Accessories: | Fiber, disposable tips, handpieces | |
| Software Validation: | Comply with the FDA Guidance for traditional 510(k) | |
| Electrical Safety: | Comply with IEC60601-1 | |
| ElectromagneticCompatibility: | Comply with IEC60601-1-2 | |
| Labeling: | Comply with the related standards and refer to Labelingdocumentation of 510(k) submission |
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.
:
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Intended Use:
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of Keloids
Excision of cutaneous lesions
Photocoagulation of telangiectasia, venulectasia of the legs and face
Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
Comparison: The DC 7 has the exact technological characteristics, design, material, components, energy source as the China Daheng Group DenLase 980/7 (K102669) and it is similar to the Biolase Technology Diolase 10S, the safety and effectiveness of the DC 7 (K121327) is based upon a determination of the substantial equivalence as well as the safety and effectiveness of the medical devices.
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| Company/Specifications | DC International, LLCDC 7 | China Daheng Group IncDenlase 980/7 | Biolase, IncDiolase 10S |
|---|---|---|---|
| Concurrence:510(k) Number: | K131839 | K102669 | K121327 |
| Regulation: | 21CFR878.4810 | 21CFR878.4810 | 21CFR878.4810 |
| Category of Device: | Prescription Device | Prescription Device | Prescription Device |
| Laser Medium: | Diode Laser (GaAIAs) | Diode Laser (GaAIAs) | Diode Laser (GaAIAs) |
| Wavelength: | 980 nm | 980 nm | 940 +/- 15 nm |
| Power to Tissue: | DC 7: Up to 7 Watts | DenLase 7: Up to 7 Watts | Diolase 10S: Up to 10 Watts |
| Laser Class | Class IV | Class IV | Class IV |
| ComparisonAnalysis: | The maximum power output of proposed device is between that of the two predicates devices,and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will notaffect the safety and effectiveness of the proposed device. | ||
| Operating Modes: | Continuous, Pulsed | Continuous, Pulsed | Continuous, Pulsed |
| Pulse Width: | 50us - 30s Up to 100 Hertz | 50us - 30s Up to 100 Hertz | |
| The pulse duration of laser should be shorter than thermal relax time of target tissues so that the thermal diffusion willnot act on the surrounding tissues during the heating process of the target tissues, in this way the surrounding tissuescan be protected. The comparatively short pulse duration of DC7 will not introduce any problems regarding the safetyand effectiveness of the device. In addition, the shorter pulse duration will decrease the injury which the laser beambring to the normal tissue, at the same time the shorter pulse duration will reduce the smoke caused by treatment, thencorrespondingly optimize the vision during the treatment also. Considering the pulse duration range of the proposedproduct include the pulse duration range of the predicated product, the difference will not introduce any problemsregarding the safety and effectiveness of the device. | |||
| Beam Delivery: | Fibers, handpieces and tips | Fibers, handpieces and tips | Fibers, handpieces and tips |
| Aiming Beam: | 650 nm @ 1.0 mW Maxadjustable | 650 nm @ 1.0 mW Maxadjustable | 650 nm @ 1.0 mW Maxadjustable |
| Contacting Material | Stainless steel,polypropylene and quartz | Stainless steel, polypropyleneand quartz | Stainless steel, polypropyleneand quartz |
| ContactingComponents | Hanpieces, tips and fiber | Hanpieces, tips and fiber | Hanpieces, tips and fiber |
| Control System | Microprocessor | Microprocessor | Microprocessor |
| Laser Operation: | Footswitch | Footswitch | Footswitch |
| Electrical Supply: | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz | 100-230 VAC, 50-60 Hz |
| Cooling: | Internal | Internal | Internal |
| Weight: | 3 Pounds | 3 Pounds | 3 Pounds |
| Accessories: | Fiber, disposable tips,handpieces | Fiber, disposable tips,handpieces | Fiber, disposable tips,handpieces |
| SoftwareValidation: | Comply with the FDAGuidance for traditional510(k) | Comply with the FDAGuidance for traditional510(k) | Comply with the FDAGuidance for traditional510(k) |
| Electrical Safety: | Comply with IEC60601-1 | Comply with IEC60601-1 | Comply with IEC60601-1 |
| ElectromagneticCompatibility: | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 |
| Regulation: | 21CFR878.4810 | 21CFR878.4810 | 21CFR878.4810 |
| ComparisonAnalysis: | The maximum power output of proposed device is between that of the two predicates devices,and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will notaffect the safety and effectiveness of the proposed device. | ||
| Labeling: | Comply with the relatedstandards and refer toLabeling documentation of510(k) submission | Comply with the relatedstandards and refer toLabeling documentation of510(k) submission | Comply with the relatedstandards and refer toLabeling documentation of510(k) submission |
| Based on comparison above, the DC7 Dental Laser Therapy System shares the similar design features andfunctional features with the predicate devices. |
」·
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- From a design and clinical perspective, the predicate and candidate laser Summary: device, are the same technology and have the same intended use. Based upon the fact that the devices are exactly the same or extremely similar, the DC 7 should not raise any concerns regarding its overall safety and/or effectiveness.
Non clinical Performance Data: None
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2013
DC International LLC Mr. David Boegler Vice President 624 Cypress Green Circle Wellington, Florida 33414
Re: K131839
Trade/Device Name: DC7 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 27, 2013 Received: October 7, 2013
Dear Mr. Boegler:
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. 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 (reporting of medical
{7}------------------------------------------------
Page 2 - Mr. David Boegler
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nijelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices . Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
Indications for Use
510(k) Number: K131839
Device Name: DC 7
Indications For Use:
The DC 7 laser and accessories are indicated for General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis; incision, excision, vaporization, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:
Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Photocoagulation of telangiectasia, venulectasia of the legs and face Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Neil R Ogden -2013.11.08 11:01:26 -05'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K131839
Page 1 of _ 1
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.