(258 days)
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, and Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
The Dornier Medilas D Family Lasers are continuous-wave diode laser emitting laser radiation in the invisible range of 940 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D Family Lasers incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D Family Lasers feature several operating modes, including Standard, Fibertom, LITT and LPS. The lasers can be used in contact or non-contact open surgery with or without handpieces.
The provided text describes a 510(k) premarket notification for the Dornier Medilas D Family Lasers. However, it does not contain information about acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria.
The document primarily focuses on:
- Intended Use and Indications for Use: Delineating the medical specialties and specific procedures for which the lasers are intended.
- Technological Characteristics: Stating that the device is substantially equivalent to predicate devices.
- Regulatory Compliance: Listing the performance standards and voluntary standards with which the device complies (e.g., 21 C.F.R. §1040.10 and §1040.11, IEC 60601-1, etc.). These are regulatory compliance standards, not performance acceptance criteria from a clinical study.
- Administrative Information: Submitter details, device trade names, common names, classification, and predicate devices.
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices based on the information provided.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.
The document does not include any details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance studies.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The "Performance Data" section explicitly states: "While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE)."
This indicates compliance with electrical safety and laser product performance standards, which are different from acceptance criteria for clinical efficacy or diagnostic accuracy that would be proven in a clinical study.
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Dornier MedTech America, Inc. AUG 2 0 2008
11073427
Medilas D Family Lasers
510(k) PREMARKET NOTIFICATION
SECTION 6
510(K) Summary of Safety and Effectiveness
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Intended Use: The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam. Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology. Pulmonary Surgery, Gastroenterology, ENT, and Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting. vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes. and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.
Technological From a clinical perspective and comparing design Characteristics: specifications, the Dornier Medilas D Family Lasers and the predicate devices are substantially equivalent. Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that no significant differences exist between the proposed diode lasers and the predicate devices. Dornier MedTech America, Inc. believes the minor differences of the Medilas D Family Lasers ant its predicates lasers should not raise any concerns regarding the overall safety or effectiveness.
Performance Data: While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug,
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and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968. See 21 C.F.R. §1040.10 and §1040.11. The lasers also comply with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE).
Based on the technological characteristics and overall inclusion: performance of the devices, Dornier MedTech America, Inc. believes that the Medilas D Family Lasers and the predicate devices selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.
ം: MedTech America, Inc. ilas D Family Lasers 510(k) Submission
Der 1, 2007
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Name andAddress: | Dornier MedTech America, Inc.1155 Roberts Blvd.Kennesaw, GA 30144 |
|---|---|
| Contact Person: | Theron GoberQuality and Regulatory Manager |
| Phone Number: | 770-514-6204 |
| Fax Number: | 770-514-6288 |
| EstablishmentRegistration Number: | 1037955 |
| Date Prepared: | October 1, 2007 |
| Device Trade Name(s): | Medilas D Family Lasers, including:■ Medilas D Litebeam■ Medilas D Litebeam +■ Medilas D Urobeam■ Medilas D Multibeam■ Medilas D FlexiPulse■ Medilas D MagnaPulse |
| Device Common Name: | Diode Laser System |
| Classification Name: | GEX - Laser Instrument, Surgical Powered |
| Predicate Device(s): | Medilas D Compact (K982629, K003993)Medilas D fibertom (K982629, K003993)Medilas D SkinPulse (K000072, K020339)Medilas D SkinPulse S / D940 (K003993, K020339) |
| General DeviceDescription: | The Dornier Medilas D Family Lasers are continuous-wavediode laser emitting laser radiation in the invisible range of940 nm. Each is calibrated during the manufacturing processand during service calls. The end-user does not calibratefibers for this system. The Medilas D Family Lasersincorporate a graphic display panel, which shows laseroperating parameters, application modes, time functions,system status and messages for the user. The Medilas DFamily Lasers feature several operating modes, includingStandard, Fibertom, LITT and LPS. The lasers can be usedin contact or non-contact open surgery with or withouthandpieces. |
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Image /page/4/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare organizations. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dornier Medtech America, Inc. % Theron Gober Quality and Regulatory Manager 1155 Roberts Boulevard Kennesaw, Georgia 30144
Re: K073427 Trade/Device Name: Medilas D Family Lasers Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II Product Code: GEX Dated: August 14, 2008 Received: August 15, 2008
AUG 2 0 2008
Dear Theron Gober:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Theron Gober
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Medilas D Family Lasers
Indications for Use
October 1, 2007
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are indicated for use in medicine and surgery, in the following medical Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, specialties: Pulmonary Surgery, Gastroenterology, ENT, and Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D Litebeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysterenscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excipion, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, for endovascular coagulation of the goreater saphenous vein of the thigh in patients with superficial vein reflux.
The Dornier Medilas D Family Lasers, specifically the Medilas D UroBeam, Medilas D MultiBeam, Medilas D FlexiPulse and Medilas D MagnaPulse, are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to bening brostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral blobs ranging in total volume from 28-85 cc.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (Part 21 CFR 801 Subpart C) |
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | L093427 |
|---|---|
| --------------- | --------- |
§ 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.