(85 days)
Not Found
Not Found
No
The description focuses on the laser technology, power output modifications, and intended surgical applications. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures, for a wide range of medical specialties, which are therapeutic applications.
No
The device is a surgical laser intended for ablation, incision, excision, coagulation, and vaporization of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details hardware components such as diode lasers, power supply, and cooling designs, indicating it is a physical medical device, not software-only.
Based on the provided information, the Diomed Surgical Diode Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures." This describes a device used directly on the patient's body for surgical intervention.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed to deliver energy to tissue, not to analyze biological samples.
- Anatomical Site: The anatomical site is "soft tissue," indicating direct application to the patient.
The information provided consistently points to a surgical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.
Product codes
Not Found
Device Description
The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of 805nm and a visible (aiming beam) 5 milliwatt Class Illa diode laser with a wavelength of 650nm.
The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas:
Labeling: The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser's power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device.
Power Output: Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged.
Indication For Use: The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications:
- General Surgery
- Ophthalmology/Oculoplastic
- Urology
- Gastroenterology
- Gynecology
- Otorhinolaryngology
- Pulmonary/Thoracic
- Dermatology/Plastic Surgery
- Neurosurgery (coagulation only)
- Orthopedic
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)
Nonclinical Tests Used in Determination of Substantial Equivalence: The design of the Diomed surgical Diode Lasers has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied.
Canine tissue studies demonstrate equivalent performance between the Diomed Surgical Diode Laser and predicate laser systems, and concludes that tissue damage effects of the Diomed Surgical Diode Laser do not exceed those of existing Nd: YAG lasers.
Conclusions From Nonclinical Testing: The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate device prior to the modifications.
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.
Not Found
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
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
510(k) Summary for Modifications to the Diomed Surgical Diode Laser
P || 100
:
-
Date Summary Prepared 1.
June 17, 1996 -
- Submitter's Name and Address
Surgimedics/ESP 2828 N. Crescent Ridge Drive The Woodlands, TX 77381
- Submitter's Name and Address
| Contact Person: | Mr. Donald F. Hults |
|---|---|
| Phone Number: | (713) 363-4949 |
| Fax Number: | (713) 298-7930 |
-
- Device Name
| Trade/Proprietary Name: | Diomed 15 Surgical Diode Laser
Diomed 30 Surgical Diode Laser
Diomed 60 Surgical Diode Laser |
|-------------------------|----------------------------------------------------------------------------------------------------|
| Common Name: | Laser, GaAlAs - Diode |
-
- Predicate Device
The legally marketed device to which equivalence is being claimed is:
- Predicate Device
Diomed 25 Surgical Diode Laser
6/17/96
1
Device Description 5.
The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of 805nm and a visible (aiming beam) 5 milliwatt Class Illa diode laser with a wavelength of 650nm.
The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas:
Labeling: The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser's power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device.
Power Output: Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged.
Indication For Use: The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications:
- · General Surgery
- · Ophthalmology/Oculoplastic
- · Urology
- · Gastroenterology
- · Gynecology
- · Otorhinolaryngology
- · Pulmonary/Thoracic
- · Dermatology/Plastic Surgery
- · Neurosurgery (coagulation only)
- · Orthopedic
6/17/96
2
Intended Use 6.
The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.
7. Comparison of Technological Characteristics
The modification replaces the Diomed 25 Surgical Diode Laser with three new models, the Diomed 15, 30, and 60 Surgical Diode Lasers. Modifications are to offer models with different maximum output powers (15, 30, and 60 Watts at the output port), in order to provide sufficient power when it is required, and to provide a more cost effective device for applications that do not require the higher power capabilities. The Diomed 25 Surgical Diode Laser currently operates with a maximum output power of 30 Watts at the output port. In addition indications for use have been expanded to include both contact and non-contact treatment of soft tissues applications for which legally marketed lasers are currently available.
8. Nonclinical Tests Used in Determination of Substantial Equivalence
The design of the Diomed surgical Diode Lasers has been thoroughly validated at the unit and system level. The tests showed that all system specifications are satisfied.
Canine tissue studies demonstrate equivalent performance between the Diomed Surgical Diode Laser and predicate laser systems, and concludes that tissue damage effects of the Diomed Surgical Diode Laser do not exceed those of existing Nd: YAG lasers.
-
- Conclusions From Nonclinical Testing
The testing of the modified devices demonstrates that the performance is substantially equivalent to the predicate device prior to the modifications.
- Conclusions From Nonclinical Testing