(133 days)
Not Found
No
The description focuses on the laser technology and procedure kit components, with no mention of AI or ML capabilities.
Yes
The device is intended for the "treatment of superficial vein reflux of the greater saphenous vein associated with varicosities," which is a therapeutic purpose.
No
The device is a therapeutic laser system used for treating superficial vein reflux associated with varicosities, not for diagnosing conditions.
No
The device description clearly details hardware components including diode lasers, fiber optic handpieces, optical fibers, and an EVLT procedure kit containing various physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of superficial vein reflux" and "treatment of incompetence and reflux of superficial veins in the lower extremity." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system and procedure kit designed to deliver energy to tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to treat a condition, not to diagnose it.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture. An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater saphenous vein, superficial veins in the lower extremity.
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)
Clinical data was presented on 213 subjects treated with endovenous laser treatment with the Diomed D15Plus Laser System and EVLT Kit.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC - 1 2004
510(k) Summary of Safety and Effectiveness for the × 04195 Diomed, Inc. EVLT Kit and D15Plus and D30Plus 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, Inc.
One Dundee Park, Suites 5 and 6
P.O. Box 97
Andover, MA 01810 |
|---------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | November 16, 2004 |
| 2. Names. | |
| Device Name: | EVLT Kit and D15Plus and D30Plus Lasers |
| Classification Name: | Laser Instrument, Surgical Powered
Product Code: GEX
Panel: Dermatology and Plastic Surgery |
3. Predicate Devices
The EVLT Kit and the D15Plus and D30Plus Lasers are substantially equivalent to the Diomed EVLT Kit and D15Plus and D30Plus Diode Lasers (K023543), the Diomed 810 nm Surgical Lasers and EVLT Procedure Kit (K012398) and the Diomed 15Plus and Diomed 30Plus Lasers (K013499).
4. Device Description
The DIOMED 15 Plus is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The DIOMED 30 Plus is a diode laser capable of delivering up to 400 J/cm² of pulsed radiation via a fiber optic handpiece or 0.5-30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.
1
An EVLT procedure kit is available which may contains a 400 -1000 micron corc, 2.5 meter long bare tip fiber with location markers, a 25-100 cm long, 4- 5 Fr graduated introducer sheath with dilator, a 19 Gauge, 7 cm percutaneous entry needle, and a 0.035" J guide wire.
5. Indications for Use
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
6. Performance Data
Clinical data was presented on 213 subjects treated with endovenous laser treatment with the Diomed D15Plus Laser System and EVLT Kit.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized eagle with three wavy lines representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2004
Diomed Inc. C/o Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864
Re: K041957
K041937
Trade/Device Name: EVLT Kit and D15 Plus and D30 Plus Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFR 076.1010
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 15, 2004 Received: October 18, 2004
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your bection 910(t) premained is substantially equivalent (for the indications felerenced above and nave determined and and and and and one of the marketed in interstate for use stated in the clerosule) to regally manat date of the Medical Device Ameradments, or to commerce prior to May 28, 1976, the enaeminen with the provisions of the Federal Food. Drug, devices mat have been recalismou in accerative approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval alle Costine Act (Tec) that do not requent of the general controls provisions of the Act. The f ou may, therefore, market the dorres, becject of the ments for annual registration, listing of general controls provisions of the rist 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 If your device is classified (600 above) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be devilsed that I Drissan that your device complies with other requirements of the Act that I DA has made a as a regulations administered by other Federal agencies. You must or any I cuttar statures und regaranents, including, but not limited to: registration and listing (21 Compry with an the Her Stequirements, and manufacturing practice requirements as set CFR Part 607), adoning (21 OF R Part 820); and if applicable, the electronic form in the quarty bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Maureen O'Connell
This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter war a my way tinding of substantial equivalence of your device to a legally premainst notification "The 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 If you attire 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,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of The 8 runn Diomed Laser and Ever 1 roceans the are nother with varicosities. The Diomed D15 superilicial vein reliux of the greater suphonous for treatment of incompetence and reflux of superficial veins in the lower extremity.
AND/OR X Prescription Use (Part 21 CFR 801 Subpart D)
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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number K041957