(377 days)
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 rm diode tabletop laser is indicated for endoluminal or 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 mm diode tabletop 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.
The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.
The provided text pertains to a 510(k) premarket notification for a medical device called the "Alma Diode Tabletop Laser." It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.
However, the document does not contain information related to acceptance criteria, device performance against those criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as would be expected for a product relying on AI/ML or complex diagnostic capabilities.
The core of this 510(k) submission is for a laser surgical instrument, and the significant change described is the addition of a temperature sensing thermistor to a cannula used during laser lipolysis. The testing for this modification focused on bench testing to verify the performance of the temperature sensor and its accuracy in an ex vivo porcine model, rather than complex AI/ML performance metrics.
Therefore, many of the requested elements of your prompt are not applicable or cannot be extracted from this specific document.
Here's what can be extracted based on the provided text, and where gaps exist:
Acceptance Criteria and Study Details for the Alma Diode Tabletop Laser (K212073)
Summary of Device and Key Change:
The Alma Diode Tabletop Laser is a laser surgical instrument used in dermatologic and general surgical procedures, specifically for saphenous incompetent veins and laser-assisted lipolysis. The K212073 submission describes a modification to a previously cleared device (K160952), primarily the addition of a temperature-sensing thermistor to a cannula used during laser lipolysis procedures. This thermistor is designed to detect tissue temperature in near real-time and alert the user if a preset temperature is exceeded.
Study Type:
The study described is non-clinical bench testing to verify the performance of the modified device, particularly the added temperature sensing functionality.
Missing Information:
- This document does not describe the testing of an AI/ML component. Therefore, acceptance criteria regarding AI diagnostic performance (e.g., sensitivity, specificity, AUC) are not present.
- No human reader studies (MRMC) were conducted as the device's function does not involve diagnostic interpretation by human readers.
- No standalone algorithm performance metrics are provided as it's not an AI-driven diagnostic algorithm.
- Ground truth establishment methods (expert consensus, pathology, outcome data) are not relevant in the context of this device's functional testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria and corresponding reported performance values for properties like sensitivity, specificity, or similar metrics typically associated with AI/ML products. Instead, the performance testing described relates to the functionality of the new temperature sensor.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Demonstrate time required for temperature sensor to register tissue temperature and notify user. | Performed (details not explicitly quantified in this summary) |
| Demonstrate accuracy of temperature detection in an ex vivo porcine model. | Performed (details not explicitly quantified in this summary) |
| Demonstrate relationship between tissue temperature at thermistor and temperature at a specified distance from the thermistor (in ex vivo porcine model). | Performed (details not explicitly quantified in this summary) |
| Meet general safety and performance standards for medical electrical equipment and laser products. | Passed (compliant with IEC 60601-1, -1-2, -2-22; IEC 60825-1; ISO 17665-1; ISO 10993) |
| Software Validation & Verification Test | Passed |
| Biocompatibility evaluation | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "ex vivo porcine model" for performance testing of the temperature sensor.
- Sample Size: Not specified (e.g., number of porcine samples or measurements).
- Data Provenance: Ex vivo porcine model (experimental, not human clinical retrospective or prospective data). The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the performance of a temperature sensor is typically established by calibrated reference instruments, not expert human readers or consensus, especially in an ex vivo setting.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not relevant here.
5. 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
No. An MRMC study was not conducted. This device is a surgical laser, and the testing described is not related to human diagnostic performance or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML algorithm or diagnostic device tested for standalone performance. The testing involved the functional performance of a physical component (temperature sensor) within a laser system.
7. The Type of Ground Truth Used
The ground truth for the temperature sensor's performance would be derived from calibrated temperature measurement devices in the ex vivo porcine model, comparing the thermistor's readings against these reference measurements. This is a type of "bench testing" or "experimental setup" ground truth, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product that undergoes a training phase with a dedicated dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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July 14, 2022
Alma Lasers, Ltd. % Connie Hoy Consultant Hoy & Associates Regulatory Consulting 1830 Bonnie Way Sacramento, California 95825
Re: K212073
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: June 10, 2022 Received: June 13, 2022
Dear Connie Hoy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212073
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 |
| 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 rm diode tabletop laser is indicated for endoluminal or 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 mm diode tabletop 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.
| 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) |
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.
The assigned 510(k) Number: K212073
- Date of Preparation 1. 07/14/2022
| 2. Applicant | |
|---|---|
| Name: | Alma Lasers, Ltd. |
| Address: | Alma Lasers, Ltd., 18 Haharsah Street, North Industrial Park Caesarea, Israel 3079895. |
| Contact Person: | Avi Farbstein, Chief Technology and Strategy Officer |
| Telephone: | +972-54-3303402 |
| Email: | avi.farbstein@almalasers.co.il |
3. Identification of the Proposed Device
| Trade/Device Name: | Alma Diode Tabletop Laser |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Powered Laser Surgical Instrument |
| 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 |
-
- Identification of Predicate Device
| 510(k) Number: | K160952 |
|---|---|
| Product Name: | Alma Diode Tabletop Laser |
| Manufacturer: | Alma Lasers, Ltd. |
-
- Device Description
The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.
- Device Description
-
Indications for Use 6. 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 rm 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
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saphenous vein in patients with superficial vein reflux. The Alma 980 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The indcations for use for the 1470 nm 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.
-
- Substantially Equivalent (SE) Comparison
Comparison of the Indications for Use: Indications for use statement of the subject and predicate devices are identical.
- Substantially Equivalent (SE) Comparison
| Device & Predicate Device(s): | K212073 | K160952 |
|---|---|---|
| Alma Diode Tabletop Laser | Alma Diode Tabletop Laser | |
| General Device Characteristics | ||
| Product Code | GEX | GEX |
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Laser wavelengths | 810 nm980 nm1470 nm | 810 nm980 nm1470 nm |
| Maximum power | 30 W @ 810nm30 W @ 980 nm15 W @ 1470 nm | 30 W @ 810nm30 W @ 980 nm15 W @ 1470 nm |
| Light source | Diode | Diode |
| Operation mode | Continuous wave, single pulse,pulsed | Continuous wave, single pulse,pulsed |
| Pulse duration | 10-990 ms | 10-990 ms |
| Laser delivery | Optical fiber | Optical fiber |
| Bare fiber size (µm) | 200, 300, 320, 400, 600, 800, 1000 | 200, 300, 320, 400, 600, 800, 1000 |
| User interface | LCD touch screen | LCD touch screen |
| Aiming beam | 635 nm | 635 nm |
| Temperature sensing forlipolysis | Yes, via LipoSense cannula | No |
Comparison of Technology:
The technological features of the subject device are comparable to the corresponding technological features of the predicate device. Any difference in the technological features do not raise different questions of safety and effectiveness.
The modified Alma Diode Tabletop laser, subject of this submission, is a modification of the previously cleared device. The modification is to add a temperature sensing thermistor to the cannula to be use during laser lipolysis procedures. The temperature sensor will detect the tissue temperature in near real time and notify the user via an audible beep if the preset temperature has been exceeded. Performance testing was conducted to demonstrate the time required for the temperature sensor to register the tissue temperature and notify the user. Additional performance testing was conducted in an ex vivo porcine model to demonstrate the accuracy of the temperature detection and the relationship between the tissue temperature located at the thermistor as opposed to the temperature a specified distance from the thermistor. Based on the overall performance characteristics, Alma Lasers Ltd believe that there is no significant difference in the subject device and the predicate device.
-
- Non-Clinical Testing
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:
- Non-Clinical Testing
-
A IEC 60601-1:2005/A1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance;
-
IEC 60601-1-2:2014 Test for Medical Equipment for General Requirements for basic safety
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and essential performance: electromagnetic compatibility;
-
IEC 60601-2-22:2012, Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment;
- A IEC 60825-1: 2014, Safety of laser products - Part 1: Equipment classification and requirements;
- ▲ ISO 17665-1:2006/(R)2013 Sterilization of health care products - Moist Heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices;
-
Biocompatibility evaluation per ISO 10993 and FDA guidance;
-
Software Validation & Verification Test;
-
Bench Testing to verify the performance.
-
- Clinical Testing
No clinical study is included in this submission.
-
- Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.
- Conclusion
§ 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.