(30 days)
Not Found
No
The document describes a laser device for surgical procedures and does not mention any AI or ML capabilities. The performance studies focus on mechanical and software verification, not AI/ML model performance.
Yes
The device is indicated for various medical procedures such as endovenous laser surgery for incompetent veins and laser-assisted lipolysis, which are therapeutic interventions aimed at treating medical conditions or performing surgical procedures for patient benefit.
No
Explanation: The provided text describes the Alma Diode Tabletop Laser as being intended for surgical procedures such as laser-assisted lipolysis and endovenous laser surgery. These are therapeutic interventions, not diagnostic procedures. There is no mention of the device being used to identify or determine the nature of a disease or condition.
No
The device description explicitly lists hardware components such as a main console unit, pull-back, footswitch, and accessories. The performance studies also mention mechanical tests and software verification/validation for a device with a pull-back accessory, indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications for use clearly describe the device's application in surgical procedures (dermatologic, general surgical, laser assisted lipolysis, endovenous laser surgery, endovenous occlusion). These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The components listed (main console unit, pull-back, footswitch, accessories) are consistent with a surgical laser system, not an IVD device which would typically involve components for handling and analyzing biological samples.
- Lack of IVD-related terms: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or any other activities typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver laser energy for therapeutic and surgical interventions directly on the patient.
N/A
Intended Use / Indications for Use
The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The Alma Diode Tabletop Laser is comprised of the following major components:
- The main console unit 1.
-
- Pull-back
-
- Footswitch
- Accessories 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Saphenous incompetent veins, greater saphenous vein, 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)
Design verification testing was performed for the Alma 1470mm diode tabletop laser with the pullback accessory. The testing consisted of performing mechanical tests to verify the actual pull back speeds matched the requested speeds.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized graphic of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Alma Ltd % Ms. Kathy Maynor Regulatory Consultant 26 Rebecca Ct Homosassa, Florida 34446
Re: K160952
Trade/Device Name: Alma Diode Tabletop Laser 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: April 1, 2016 Received: April 5, 2016
Dear Ms. Maynor:
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 device
1
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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160952 "
Device Name Alma Diode Tabletop Laser
Indications for Use (Describe)
Intended Use The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
laser assisted lipolysis.
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order. Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include: -The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include: -The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
Section 8 – 510(k) Summary or 510(k) Statement
I. General Information
| Submitter: | Alma Lasers, Ltd,
Halamish St. POB 30
Industrial Park
Caesarea Israel 38900 |
|---------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor
Consultant
352-586-3113 (cell) |
| Summary Preparation Date: | May 4, 2016 |
II. Names
| Device Names: | Alma Diode Tabletop Laser |
|---|---|
| Primary Classification Names: | Surgical Powered Light Instrument |
III. Predicate Devices
| K # | Predicate Device |
|---|---|
| K140005 | ALMA DIODE TABLETOP LASER |
| K133774 | DIOTECH CO LTD - ATOVEN |
IV. Product Description
The Alma Diode Tabletop Laser is comprised of the following major components:
- The main console unit 1.
-
- Pull-back
-
- Footswitch
- Accessories 4.
4
V. Indications for Use
Intended Use
The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include: - The Alma 810 nm diode tabletop laser is indicated for endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indications for use for the 147 0nm Alma Diode Tabletop Laser include:
-The Alma 1470 mm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.
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VI. Summary of Technical Characteristics
Table 1: Salient Characteristics of the 1470nm module and the Predicate Devices
| | K13
Alma diode tabletop laser | K100558
Quanta Diode Laser Family |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | | |
| Product
Code &
Regulation
No. | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Laser
Wavelength
[nm] | 1470 | 1470 |
| Max power | 15W | 15W |
| Light/Laser
Source | Diode | Diode |
| Laser
Delivery | Optical Fiber | Optical Fiber |
| Operation
Mode | Continuous wave, single
pulse, pulsed | Continuous wave, single pulse,
pulsed |
| Pulse
Duration | 10-990ms | 3ms - 2.5s |
| Bare fiber
size | 200, 300, 320, 400, 600,
800, 1000 | 200, 300, 320, 400, 600, 800,
1000 |
| User
Interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635nm | 650nm |
| Electrical
Requirements | 100-240, V AC 50-60 Hz,
6.3 A, | 100-240, V AC 50-60 Hz, 6.3
A, single phase, |
| Indications
for Use | The Alma 1470nm diode
tabletop laser is indicated
for use in endovenous
occlusion of the greater
saphenous vein in
patients with superficial
vein reflux. The Alma
1470nm diode tabletop
laser is further indicated
for laser assisted
lipolysis, | The QUANTA Diode Laser
System is intended for delivery
of laser light to soft tissue in the
contact and non contact mode
during surgical procedures
including
via endoscopes. The QUANTA
Diode Laser System is generally
indicated for use in endovenous
occlusion of the greater
saphenous vein in Patients with
Superficial Vein Reflux. The
QUANTA1470 Diode
Laser is further indicated for
laser assisted lipolysis |
6
| Manufacturer | Alma Lasers LTD | Alma Lasers LTD | DIOTECH CO LTD |
|---|---|---|---|
| Cleared Device | KXXXXXX | K140005 | K133774 |
| System Platform | Alma Diode Tabletop Laser | Alma Diode Tabletop Laser | ATOVEN |
| Accessory Description | Alma Lasers Pull-Back | ||
| Device | Automatic fiber pull- | ||
| back driver ATOVEN | |||
| Wavelength | |||
| Supported | 1470nm | 810nm, 980nm, and | |
| 1470nm | 1470nm | ||
| Intended Use / | |||
| Indications For Use | The Alma Lasers Pull-Back | ||
| Device is an accessory | |||
| intended for use in | |||
| conjunction with the | |||
| previously cleared Alma | |||
| Diode Tabletop Laser | |||
| 1470nm (K140005). | |||
| The Alma Diode Tabletop | |||
| Laser 1470 nm (K140005) is | |||
| intended for use in | |||
| dermatologic and general | |||
| surgical procedures: | |||
| endovenous occlusion of | |||
| the greater saphenous vein | |||
| in patients with superficial | |||
| vein reflux, and for laser | |||
| assisted lipolysis. | The Alma Diode Tabletop | ||
| Laser 1470 nm is intended | |||
| for use in dermatologic and | |||
| general surgical | |||
| procedures: endovenous | |||
| occlusion of the greater | |||
| saphenous vein in patients | |||
| with superficial vein reflux, | |||
| and for laser assisted | |||
| lipolysis. | ATOVEN is a diode | ||
| laser system | |||
| designed to delivery | |||
| of laser light to soft | |||
| tissue during general | |||
| surgery procedures. | |||
| This device intended | |||
| for treatment of reflux | |||
| of the saphenous | |||
| veins of thigh | |||
| associated with | |||
| varicose veins and | |||
| varicosities. | |||
| Pullback Accessory | |||
| Dimensions (cm) | |||
| (H x W x D) | 5x20x8 | NA | Unk. |
| Weight (kg) | ~0.5 | NA | Unk. |
| Pullback Speed | |||
| (mm/sec) | 4 Steps: | ||
| 1, 2, and 4 mm/sec | NA | 6 Steps: | |
| 0.5, 0.7, 1.0, 1.2, 1.5, | |||
| and 2.0 mm/sec | |||
| Pullback mode | Automatic | NA | Automatic |
| Acceptable fiber sizes | 400µm fiber | ||
| 600µm fiber | NA | 400µm fiber | |
| 600µm fiber | |||
| Mode of Action | Controls the rate of fiber | ||
| movement along the vein | |||
| wall providing consistent | |||
| exposure and minimizing | |||
| treatment time. | NA | Controls the rate of | |
| fiber movement along | |||
| the vein wall | |||
| providing consistent | |||
| exposure and | |||
| minimizing treatment | |||
| time. |
Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics provided demonstrates that the Alma diode tabletop laser is substantially equivalent to the predicate devices. Additional product electrical safety testing and EMC testing was successfully completed in accordance with the following standards:
7
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety ●
- . IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests
VIII. D Design Verification Testing
Design verification testing was performed for the Alma 1470mm diode tabletop laser with the pullback accessory. The testing consisted of performing mechanical tests to verify the actual pull back speeds matched the requested speeds.
Additionally, the software controlling the Alma 1470nm diode tabletop laser with the pull-back accessory was fully verified and validated in accordance with IEC 62304 and the FDA guidance document entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
IX. Conclusion
The Alma diode tabletop laser with the pull-back accessory was found to be substantially equivalent to the predicate device.
The Alma diode tabletop laser with the pull-back accessory shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.