(260 days)
The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in coniunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
The INTERmedic Diode Laser Family is designed to deliver laser power at wavelengths of 810nm and 980nm, depending on model, that can be used for the procedures indicated in the section "Indication for Use" in this summary. The ContrÂge model can be used with or without the RF unit. The different models can be identified by their different names, output frequency and maximum power. Each system is comprised with the following main components: Operating software controlled by a microprocessor, A footswitch (detachable), A laser cabinet/console with fiber port, A safety Interlock.
The provided document is a 510(k) summary for the INTERmedic Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria in a clinical setting.
Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable and not present in this type of regulatory submission.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices.
However, I can extract information related to the device's technical specifications and intended uses, which serve as the basis for the FDA's determination of substantial equivalence.
Here's the partial information that can be extracted, framed within the context of the device's substantial equivalence claim:
1. A table of acceptance criteria and the reported device performance
In the context of a 510(k) submission, "acceptance criteria" for the new device largely revolve around demonstrating that its performance specifications and indications for use are substantially equivalent to those of the predicate devices. The "reported device performance" is a comparison of these technical specifications and intended uses.
The tables in the document compare the INTERmedic Diode Laser Family models with various predicate devices. Below is a synthesized table based on these comparisons, highlighting key characteristics that are compared for substantial equivalence.
| Feature / Model | INTERmedic ENDO Laser (980nm) | INTERmedic SURGICAL Laser (980nm) | INTERmedic PL3D (980nm) | INTERmedic ContrÂge (980nm + RF) | INTERmedic SLP (810nm) | INTERmedic VARIUS / VARIUS 1000 (980nm) | INTERmedic ODONT (800-980nm) |
|---|---|---|---|---|---|---|---|
| Acceptance Criteria (Predicate Device Specification) | Dornier K020339 Medilas: Wavelength 940nm, Peak Power 120W, Pulse Mode 10-100ms, Same Indications for use. | BioLitec K050824 Medilas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use. | BioLitec K050824 Ceralas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use. | Syneron K052324/K050452/K0507796 Polaris/Aurora: Wavelength 900-980nm, Peak Power Up to 100W, Same Indications for use. | Dornier K050824/K021724/K020339 Medilas D Skin Pulse: Wavelength 940nm, Peak Power 120W, Same Indications for use. | Dornier K050824/K021724/K020339 Medilas D Skin Pulse: Wavelength 940nm, Peak Power 120W, Same Indications for use. | BioLitec K050824 Ceralas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use. |
| Reported Device Performance (INTERmedic Device) | INTERmedic ENDO Laser: Wavelength 980nm, Peak Power 50W, Pulse Mode 5ms to 10s, Same Indications for use (Minimally invasive endovenous treatment). | INTERmedic SURGICAL Laser: Wavelength 980nm, Peak Power Up to 120W, Exp. Time 5ms to 10s, Same Indications for use (broad surgical applications). | INTERmedic PL3D: Wavelength 980nm, Peak Power Up to 25W, Exp. Time 50ms to cw, Same Indications for use (Neurosurgery). | INTERmedic ContrÂge: Wavelength 980nm, Peak Power Up to 40W, RF Freq 0.45MHz, RF Energy 50-150 J/cm², Same Indications for use (Aesthetics, Dermatology, wrinkle reduction). | INTERmedic SLP: Wavelength 810nm, Peak Power Up to 90W, Exp. Time 5-500ms (vascular), 50-1200ms (hair removal), Same Indications for use (Dermatology, vascular/hair removal). | INTERmedic VARIUS/VARIUS 1000: Wavelength 980nm, Peak Power Up to 50W, Pulse interval 50-900ms, Same Indications for use (Dermatology, vascular, skin treatments, cutaneous surgery). | INTERmedic ODONT: Wavelength 800-980nm, Peak Power Up to 50W, Pulse interval 50-900ms, Same Indications for use (Oral Surgery). |
| Comparison Rationale | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." Wavelength and power are within acceptable range or variations explained (e.g., higher power doesn't affect safety). | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." (Increase of power to 120W does not affect safety and security characteristics and provides shorter treatment time). | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." | "Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document is a 510(k) summary, which does not typically include data from clinical test sets in the manner of a clinical trial. The "test" for substantial equivalence relies on comparing the device's design, specifications, and intended uses against legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. There is no "test set" or ground truth established by experts in this type of regulatory submission. The FDA reviews the provided technical and descriptive information for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication process as described in clinical studies is reported.
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
- Not Applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices as legally marketed, and the demonstration that the new device shares similar technological characteristics and intended uses.
8. The sample size for the training set
- Not Applicable. This document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
- Not Applicable. This document does not describe a machine learning model or a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The "study" described in the 510(k) summary is a comparative analysis demonstrating substantial equivalence to predicate devices already cleared by the FDA.
- Rationale for Substantial Equivalence: The INTERmedic Diode Laser Family, including its accessories, is claimed to have:
- The same intended uses and indications for use as the listed predicate devices.
- Similar technological characteristics to the predicate devices, specifically mentioning "treatment wavelengths, laser media, mode of operation, power output, exposure duration, treatment intervals, laser energy delivery control."
- Methodology: The submission provides detailed specification tables comparing each INTERmedic model (ENDO, SURGICAL, PL3D, ContrÂge, SLP, VARIUS/VARIUS 1000, ODONT) against specific predicate devices (e.g., PhotoMedex Laser Pro, Syneron Lasers, Ceralas D, Dornier's Diode Laser Family). The comparison highlights parameters such as:
- Wavelength (nm)
- Peak Power (W)
- Pulse Mode/Exposure time
- Laser Medium
- Aiming Beam characteristics
- Power Requirements
- Operation Mode (Continuous or Pulsed)
- Physical Dimensions and Weight
- Indications for use (emphasized as being the same or functionally equivalent).
- Conclusion of the Comparison: INTERmedic Arfran S.A. believes that "no significant differences exist between the INTERmedic Diode Laser Family and the predicate devices" based on overall performance and technological characteristics, and that "They all work in the same range of wavelength and have the same indications for use." The document explicitly states that the device's introduction provides "no new clinical indications, which have previously demonstrated clinical effectiveness."
This type of submission relies on the established safety and efficacy of the predicate devices. The "proof" is the detailed comparison showing that the new device does not raise new questions of safety or effectiveness.
§ 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.