DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

K051996 · Diomed, Ltd. · GEX · Aug 18, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051996
• Device Name: DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
• Applicant: Diomed, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 18, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Diomed Delta 15 and 30 are Class IV GaAlAs diode lasers (810 nm) with 635-655 nm aiming beams. Delta 15 delivers up to 15W continuous or 119 J/cm² pulsed; Delta 30 delivers up to 30W continuous or 400 J/cm² pulsed. Energy is delivered via fiber optic handpiece or optical fiber coupled to aperture. Used by physicians in surgical settings for soft tissue procedures, including EVLT. Output allows precise tissue interaction (ablation/coagulation) to treat venous insufficiency and various surgical conditions. Replaces previous Diomed 15plus/30plus models.

Clinical Evidence

No clinical data provided. Performance validated via bench testing protocols demonstrating equivalence to predicate devices, which possess established clinical and market evidence.

Technological Characteristics

Class IV GaAlAs diode laser; 810 ± 20 nm treatment wavelength; 635-655 nm aiming beam. Delta 15: 15W max power, 119 J/cm² max fluence. Delta 30: 30W max power, 400 J/cm² max fluence. Delivery via fiber optic handpiece or optical fiber. Standalone surgical laser system.

Indications for Use

Indicated for soft tissue ablation, incision, excision, coagulation, and vaporization in general surgery, ophthalmology/oculoplastic, urology, gastroenterology, gynecology, otorhinolaryngology, pulmonary/thoracic, dermatology/plastic surgery, neurosurgery (coagulation only), and orthopedics. Also indicated for treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein and incompetent refluxing veins in the superficial venous system of the lower limb.

Regulatory Classification

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.

Predicate Devices

• Diomed D15Plus (K013499)
• Diomed D30Plus (K012398)
• Diomed D15Plus/D30Plus (K023543)
• Diomed D15Plus/D30Plus (K041957)

Submission Summary (Full Text)

{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.<br>Building 2000<br>Beach Drive<br>Cambridge Research Park<br>Waterbeach<br>Cambridge<br>CB5 9TE<br>United Kingdom |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Timothy G Phipps<br>Address as above<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | July 15, 2005 |
| 2. Names | |
| Device Name: | Diomed Delta 15 Laser and<br>Diomed Delta 30 Laser |
| Classification Name: | Laser Instrument, Surgical Powered<br>Product Code: GEX<br>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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

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

Page 1 of 1