(85 days)
No
The summary describes a continuous-wave diode laser with various operating modes and a graphic display. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies section focuses on compliance with laser safety standards, not AI/ML performance metrics.
Yes.
The device is used in various medical and surgical specialties for procedures like cutting, vaporization, ablation, and coagulation of soft tissue, indicating its role in treating medical conditions.
No
The document states that the device is "intended for use in cutting, vaporization, ablation and coagulation of soft tissue" and "in the treatment and/or removal of vascular lesions (tumors)". These are therapeutic applications, not diagnostic ones.
No
The device description clearly states it is a continuous-wave diode laser, which is a hardware component. The summary also mentions calibration during manufacturing and service calls, further indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Dornier Medilas D 1064 Laser is a surgical laser used for cutting, vaporization, ablation, and coagulation of soft tissue within the body. It directly interacts with the patient's tissues during surgical procedures.
- Intended Use: The intended use clearly describes surgical applications in various medical specialties, not the analysis of specimens outside the body.
- Device Description: The description focuses on the laser's technical specifications and operating modes for surgical use.
- Lack of IVD Characteristics: There is no mention of specimen collection, analysis of biological samples, or providing diagnostic information based on laboratory tests.
Therefore, based on the provided information, the Dornier Medilas D 1064 Laser is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties:
- Urology
- Plastic Surgery
- . General Surgery
- ◆ Dermatology
- Gynecology
- Pulmonary Surgery
- Neurosurgery ●
- . Gastroenterology
- . ENT
- Radiology .
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is 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/excission, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
Product codes
GEX
Device Description
The Dornier Medilas D 1064 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1064 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 1064 Laser incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D 1064 Laser features several operating modes, including Standard, Fibertom, LITT and LPS. The laser can be used in contact or non-contact open surgery with or without handpieces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 1064 Laser is 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 laser also complies 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN 2-7-2008-
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 and
Address: | Dornier MedTech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theron Gober,
Quality & Regulatory Manager |
| Phone Number: | 770-514-6204 |
| Fax Number: | 770-514-6288 |
| Establishment
Registration Number: | 1037955 |
| Date Prepared: | February 23, 2007 |
| Device Trade Name(s): | Medilas D 30 Laser, model name Medilas D 1064 |
| Device Common Name: | Diode Laser System |
| Classification Name: | GEX - Laser Instrument, Surgical Powered |
| Predicate Device(s): | The Dornier Medilas D 1064 Laser is substantially equivalent
in terms of its technological performance to Dornier Medilas D family lasers, including Medilas D
LiteBeam, Medilas D LiteBeam+, Medilas D UroBeam,
Medilas D MultiBeam, Medilas D FlexiPulse
(K070536) Diomed Delta 15 and Diomed Delta 30 (K051996) The Dornier Medilas D 1064 Laser is substantially equivalent
in terms of its laser wavelength performance to Dornier Medilas Fibertome model 5100 (K964760) Diomed Delta 25 (K063828) Laserscope Lyra Surgical Laser System (K020021) |
| General Device
Description: | The Dornier Medilas D 1064 Laser is a continuous-wave
diode laser emitting laser radiation in the invisible range of
1064 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 1064 Laser
incorporate a graphic display panel, which shows laser
operating parameters, application modes, time functions,
system status and messages for the user. The Medilas D
1064 Laser features several operating modes, including |
1
Standard, Fibertom, LITT and LPS. The laser can be used in contact or non-contact open surgery with or without handpieces.
Intended Use: The Dornier Medilas D 1064 Laser is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology.
The Dornier Medilas D 1064 Laser is 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 coaqulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
Technological From a clinical perspective and comparing design specifications, the Dornier Medilas D 1064 Laser and the Characteristics: 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 laser and the predicate devices.
Dornier MedTech America, Inc. believes the minor differences of the Medilas D 1064 Laser and 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, and Cosmetic Act, the Dornier Medilas D 1064 Laser is 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 laser also complies 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).
Conclusion: Based on the technological characteristics and overall performance of the devices, Dornier MedTech America, Inc. believes that the Medilas D 1064 Laser and the predicate
2
devices selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.
Dornier MedTech America, Inc. Medilas D 1064 Laser 510(k) Submission February 23, 2007
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 7 2008
Dornier Medtech America, Inc. % Mr. Theron Gober Quality and Regulatory Manager 1155 Roberts Boulevard, Suite 100 Kennesaw, Georgia 30144
Re: K080959
Trade/Device Name: Medilas D 1064 Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 9, 2008 Received: June 10, 2008
Dear Mr. 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); labcling (21 CFR Part 801); good manufacturing practice requirements as set
4
Page 2 - Mr. Theron Gober
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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. Mullison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number (if known): | K080954 |
|---|---|
| --------------------------- | --------- |
Device Name: Medilas D 1064 Laser
Indications for Use:
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties:
- Urology �
- Plastic Surgery �
- . General Surgery
- ◆ Dermatology
- Gynecology �
- � Pulmonary Surgery
- Neurosurgery ●
- . Gastroenterology
- . ENT
- Radiology .
The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is 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), and in the treatment and/or removal of vascular lesions (tumors).
(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) | | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) | |
| ------------------------------------------------- | -------------------------------------------------- | -------- | ------------------------------------------------ | -- |
|---|
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 2650982 |
|---|---|
| --------------- | --------- |