(24 days)
No
The summary describes a diode laser system for surgical procedures and does not mention any AI or ML components or functionalities.
Yes.
The device is used for ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures, as well as treatment of varicose veins, all of which are considered therapeutic interventions.
No
Explanation: The provided text explicitly states that the device is a laser for surgical procedures like "ablation, incision, excision, coagulation and vaporisation of soft tissues." These are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description explicitly states that the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs diode laser and a visible light diode laser, which are hardware components. The device delivers radiation via a fiber optic handpiece or optical fiber, further indicating a hardware-based system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser for the ablation, incision, excision, coagulation, and vaporization of soft tissues. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a laser system designed to deliver energy to tissue via optical fibers or handpieces. This aligns with surgical laser technology, not IVD technology which typically involves analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device is a surgical laser used for treating conditions, not for diagnosing them.
N/A
Intended Use / Indications for Use
The Diomed Delta 15 and Diomed Delta 30 Lasers are intended for use in delivering up to 15 or up to 30 Watts, respectively, of continuous wave or pulsed radiation to a flexible optical fiber or spot handpiece for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures, including EndoVenous Laser Treatment (EVLT).
- General Surgery .
- Ophthalmology/Oculoplastic .
- Urology .
- Gastroenterology .
- Gynecology .
- Otorhinolaryngology .
- Pulmonary/Thoracic .
- Dermatology/Plastic Surgery .
- Neurosurgery (coagulation only) .
- Orthopedic .
- Treatment of varicose veins and varicosities with superficial reflux of the Greater ● Saphenous Vein.
- Treatment of incompetent refluxing veins in the superficial venous system in the lower limb
Product codes
GEX
Device Description
The purpose of this Special 510(k) is to notify FDA of the proposed new Diomed Delta 15 and Diomed Delta 30 Lasers, which are equivalent replacements for the Diomed 15plus and 30plus. Like their predecessors, the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs (Gallium Aluminium Arsenide) diode laser with a wavelength of 810 ± 20 nm and a visible light (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.
The Diomed Delta 15 and Diomed Delta 30 Lasers are made up of a treatment laser and aiming beam. The Diomed Delta 15 is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic hand piece or 15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The Diomed Delta 30 is a diode laser capable of delivering up to 400 J/cm2 of pulsed radiation via a fiber optic hand piece or 30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, Greater Saphenous Vein, incompetent refluxing veins in the superficial venous system in the lower limb
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)
The Diomed Delta 15 and Diomed Delta 30 lasers have undergone a comprehensive series of test protocols in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The Diomed Delta 15 and Diomed Delta 30 are therefore validated for use on this basis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K013499, K012398, K023543, K041957
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.
0
Image /page/0/Picture/1 description: The image shows the word "DIOMED" in all capital letters, with a simple sans-serif font. To the left of the word is a circular logo. The logo is black with white markings that appear to be abstract.
KOS 1996
(Special 510(k) Section 5. Page 6 of 9)
510(k) Summary of Safety and Effectiveness for the Diomed Delta 15 and Delta 30 Lasers
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Diomed, Ltd.
Building 2000
Beach Drive
Cambridge Research Park
Waterbeach
Cambridge
CB5 9TE
United Kingdom |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Timothy G Phipps
Address as above
Telephone: +44 1223 729314
Fax: +44 1223 729329 |
| Summary Preparation Date: | July 15, 2005 |
| 2. Names | |
| Device Name: | Diomed Delta 15 Laser and
Diomed Delta 30 Laser |
| Classification Name: | Laser Instrument, Surgical Powered
Product Code: GEX
Panel: Dermatology and Plastic Surgery |
3. Predicate Devices
The Diomed Delta 15and Diomed Delta 30 Lasers are substantially equivalent to the Diomed D15Plus and D30Plus Diode Lasers (K013499, K012398, K023543, K041957).
4. Device Description
The purpose of this Special 510(k) is to notify FDA of the proposed new Diòmed Delta 15 and Diomed Delta 30 Lasers, which are equivalent replacements for the Diomed 15plus and 30plus. Like their predecessors, the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs (Gallium Aluminium Arsenide) diode laser with a wavelength of 810 ± 20 nm and a visible light
1
Image /page/1/Picture/0 description: The image shows the word "DIOMED" in a simple, sans-serif font. To the left of the word is a circular graphic. The graphic is mostly black, with some white shapes inside the circle.
(Special 510(k) Section 5. Page 7 of 9)
(aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.
The Diomed Delta 15 and Diomed Delta 30 Lasers are made up of a treatment laser and aiming beam. The Diomed Delta 15 is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic hand piece or 15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The Diomed Delta 30 is a diode laser capable of delivering up to 400 J/cm2 of pulsed radiation via a fiber optic hand piece or 30 W of continuous wave radiation via an optical fiber coupled to the laser aperture. Drawings and photographs of the Diomed Delta 15 and Diomed Delta 30 Lasers are included in the operator manual found in Appendix K
5. Indications for Use
The Diomed Delta 15 and Diomed Delta 30 Lasers are intended for use in delivering up to 15 or up to 30 Watts, respectively, of continuous wave or pulsed radiation to a flexible optical fiber or spot handpiece for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures, including EndoVenous Laser Treatment (EVLT).
6. Performance Data
The Diomed Delta 15 and Diomed Delta 30 lasers have undergone a comprehensive series of test protocols in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The Diomed Delta 15 and Diomed Delta 30 are therefore validated for use on this basis.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." written around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2005
Mr. Timothy G. Phipps Quality Assurance & Regulatory Affairs Director Diomed, Ltd. Building 2000, Beach Drive Cambridge Research Park, Waterbeach Cambridge, United Kingdom CB5 9TE
Re: K051996
Trade/Device Name: Diomed Delta 15 and Diomed Delta 30 Laser Regulation Number: 21 CFR 807.92 Regulation Name: Content and format of a 510(k) summary Regulatory Class: II Product Code: GEX Dated: July 15, 2005 Received: July 25, 2005
Dear Mr. Phipps:
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 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.
3
Page 2- Mr. Timothy G. Phipps
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchhus
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for DIOMED. The logo consists of a circular graphic to the left of the word "DIOMED". The graphic appears to be a stylized representation of a person in motion, possibly running or jumping, set against a dark background within the circle. The word "DIOMED" is in a simple, sans-serif font.
(Special 510(k) Section 5. Page 5 of 9)
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Diomed Delta 15 and Diomed Delta 30 Laser Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
- General Surgery .
- Ophthalmology/Oculoplastic .
- Urology .
- Gastroenterology .
- Gynecology .
- Otorhinolaryngology .
- Pulmonary/Thoracic .
- Dermatology/Plastic Surgery .
- Neurosurgery (coagulation only) .
- Orthopedic .
- Treatment of varicose veins and varicosities with superficial reflux of the Greater ● Saphenous Vein.
- Treatment of incompetent refluxing veins in the superficial venous system in the � lower limb
AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)
11/1-) Nirmha
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
arbare Buch for Melkerson
vision sign-Off)
ision of General, Restorative,
d Neurological Devices
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