(84 days)
Not Found
No
The summary describes a laser device with various operating modes and a graphic display, but there is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
Yes
The device is indicated for medical and surgical procedures such as cutting, vaporization, ablation, and coagulation of soft tissue, treatment of vascular lesions, removal of unwanted hair, and treatment of BPH, all of which are considered therapeutic interventions.
No
Explanation: The device is described as a laser system intended for surgical procedures such as cutting, vaporization, ablation, and coagulation of soft tissue, as well as treatment of BPH and removal of unwanted hair. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is a continuous-wave diode laser emitting laser radiation, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Dornier Medilas D Family Lasers are used for surgical procedures involving cutting, vaporization, ablation, and coagulation of soft tissue. This is an in vivo (within the living body) application, not an in vitro (outside the living body) test.
- Intended Use: The intended uses listed are all surgical or therapeutic procedures performed directly on the patient.
Therefore, the Dornier Medilas D Family Lasers are medical devices used for surgical and therapeutic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and 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, and Medilas D FlexiPulse, 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 last volume information is cut off in the provided text, but inferred from the similar statement in the earlier section).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, vascular lesions (tumors), the greater saphenous vein of the thigh, benign prostatic hyperplasia (BPH) in men with prostates.
Indicated Patient Age Range
Men over the age of 50 (for BPH treatment). No specific age range for other indications.
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medilas D Compact (K982629, K003993), Medilas D fibertom (K982629, K003993, K021724), Medilas D SkinPulse (K000072, K020339, K021724), Medilas D SkinPulse S / D940 (K003993, K020339, K021724)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Proprietary to Dornier MedTech America, Inc.
070536
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: | Tim Thomas, Vice President
Regulatory/ Quality/ Clinical |
| Phone Number: | 770-514-6163 |
| Fax Number: | 770-514-6288 |
| Establishment
Registration Number: | 1037955 |
| Date Prepared: | February 23, 2007
MAY 21 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 |
| 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, K021724)
Medilas D SkinPulse (K000072, K020339, K021724)
Medilas D SkinPulse S / D940 (K003993, K020339, K021724) |
| General Device
Description: | 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. |
1
Intended Use:
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology.
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and 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, and Medilas D FlexiPulse, 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, and Cosmetic Act, the Dornier Medilas D Family Lasers are in compliance with class IV performance standards for light
2
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).
Conclusion:
Based on the technological characteristics and overall 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dornier MedTech America, Inc. % Mr. Tim Thomas VP, Regulatory, Quality & Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144
MAY 2 1 2007
Re: K070536 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: February 23, 2007 Received: February 27, 2007
Dear Mr. Thomas:
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
4
Page 2 -- Mr. Tim Thomas
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.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 you
Mark N. Melker 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): ____________________________________________________________________________________________________________________________________________________
Device Name: Medilas D Family Lasers
Indications for Use:
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse are indicated for use in medicine and surgery, in the following medical specialties:
- . Urology
- Plastic Surgerv .
- . General Surgery
- . Dermatology
- . Gynecology
- . Pulmonary Surgery
- . Gastroenterology
- ENT .
- Radiology .
The Dornier Medilas D Family Lasers, specifically the Medilas D LiteBeam, Medilas D LiteBeam +, Medilas D UroBeam, Medilas D MultiBeam, and Medilas D FlexiPulse, 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, and 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, and Medilas D FlexiPulse, 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
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 510(k) Number | L603531 |
|---|---|
| --------------- | --------- |
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) |
|---|---|---|
| ---------------------------------------------- | -------- | --------------------------------------------- |