(25 days)
Not Found
No
The summary describes a laser device with modifications to pulse duration, delivery systems, and displays. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures across various medical specialties, which are therapeutic actions.
No
The device is described as a surgical laser intended for ablation, incision, excision, coagulation, and vaporization of soft tissues, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly mentions "Lasers" and "spot handpiece/software delivery system," indicating the presence of hardware components (lasers and handpieces) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Diomed 15plus and Diomed 30plus Lasers are for surgical procedures on soft tissues within the human body (in vivo).
- Device Description: The description details a laser system used for delivering energy to tissue, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to be used in vitro (outside the living organism) to examine specimens.
Therefore, the Diomed 15plus and Diomed 30plus Lasers are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Diomed 15plus and 30plus Lasers are intended for use in delivering 15 or The Diomed reports wave radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures.
The Diomed 15plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue applications:
- General Surgery
- Ophthamology/Oculoplastic
- Urology
- Gastroenterology
- Gynecology
- Otorhinolaryngology
- Pulmonary/Thoracic
- Dermatology/Plastic Surgery
- Neurosurgery (coagulation only)
- Orthopedic
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A shorter pulse duration (50 ms) has been added to both the 15plus and 30plus lasers. The modified devices include a spot handpiece/software delivery system in addition to a fiber delivery system.
A Fluence Display has been added to enhance the efficiency of existing clinical indications when using the spot hand piece. A power meter (currently used in the Diomed 30 laser) has been added to the Diomed 15plus laser to improve the accuracy of delivered powcr/fluence to the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended.
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.
Diomed 15 and Diomed 30 Lasers -K962354
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
510(k) Summary KO13499 for NOV 1 6 2001 Diomed 15plus and Diomed 30plus Lasers
SPONSOR 1.
| Diomed Inc. |
|---|
| 1 Dundee Park |
| Suite 5/6 |
| Andover |
| MA 01810 |
| USA |
| Contact Person: | Angie Glover |
|---|---|
| Telephone: | 011 44 1223 729 337 |
October 19, 2001 Date Prepared:
DEVICE NAME 2.
| Proprietary Name: | Diomed 15plus and Diomed 30plus Lasers |
|---|---|
| Common/Usual Name: | Surgical Lasers |
| Classification Name: | Laser Surgical Instruments |
PREDICATE DEVICES 3.
Diomed 15 and Diomed 30 Lasers -K962354
DEVICE DESCRIPTION 4.
The Diomed 15plus and Diomed 30plus Lasers are modified versions of the Diomed 15 and Diomed 30 lasers. A shorter pulse duration (50 ms) has been added to both the 15plus and 30plus lasers. The modified devices include a spot handpiece/software delivery system in addition to a fiber delivery system.
A Fluence Display has been added to enhance the efficiency of existing clinical indications when using the spot hand piece. A power meter (currently used in the
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1
Diomed 30 laser) has been added to the Diomed 15plus laser to improve the accuracy of delivered powcr/fluence to the treatment site.
INTENDED USE న.
The Diomed 15plus and 30plus Lasers are intended for use in delivering 15 or The Diomed reports wave radiation to a flexible optical fiber or spot hand piece for use in ablation, incision, excision, coagulation, and vaporization of soft tissues in open and endoscopic surgical procedures.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Diomed 15plus and Diomed 30plus Lasers and the original Diomed 15 and The Diomed 30 Lasers all consist of a Class IV Gallium Aluminum Arsenide diode Diomed 30 Laster ming beam. The original Diomed 15 and Diomed 30 lasers offer a fiberoptic mode while the modified Diomed 15plus and Diomed 30plus offers both a fiberoptic and spot handpiece mode.
The Diomed 15plus and Diomed 30plus Lasers and the Diomed 15 and Diomed The Diomes all have essentially identical performance characteristics except for Both the Diomed 15plus and Diomed slight changes to the pulse duration. signe changes to the predicate devices offer a fiberoptic mode. Additionally, the proposed device offers a spot mode.
PERFORMANCE TESTING 7.
Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with three winding lines, representing health and medicine.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diomed, Inc. c/o Ms. Mary McNamara-Cullinane Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
NOV 1 6 2001
Re: K013499
Trade/Device Name: Diomed 15plus and Diomed 30plus Lasers Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Regulatory Class: II Product Code: GEX
Dated: October 19, 2001 Received: October 22, 2001
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premainer nevinstantially equivalent (for the indications for use stated in the enclosure) the avential the aveces and the second of the states and managements for use stated in the encrosule) to regally manative provice Amendments, or to commerce prof to May 20, 1976, the enational with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that to not require approvise to the general controls provisions of the Act. The You may, therefore, market the abtires, octorements for annual registration, listing of general controls provisions of the free merado required on against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it IT your device is classified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controller L. Ranger Provents 800 to 898. In addition, FDA may be found in the Oouveements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r reast be advised that I Dri brissame at your device complies with other requirements of the Act that IDA has made a colorimiations administered by other Federal agencies. You must of any I cacal statutes and regairements, including, but not limited to: registration and listing (21 Comply with an the Free 5 requirements, as and manufacturing practice requirements as set CFN Fall 807), labeling (21 OFR Part 820), government
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by telems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Mary McNamara-Cullinane
This letter will allow you to begin marketing your device as described in your Section 510(k)
The Children Carling of Clines of a local started assivelence of your device to This letter will allow you to begin harksmig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivaliae and this p premarket notification. The PDA Inding of substantial equivalier and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do vito diagnostic devices), please contact the Office of
additionally 21 CFR Part 809.10 for in vites diagnostic devices the momotion additionally 21 CFR Part 809.10 to minio unances an the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertisi Compliance at (301) 394-4639. Additionally, to: quest.is or state of any 16 the Part the your device, piease contact the Chrysler of remarket notification" (21CFR Part 807.97).
regulation entitled, "Misbranding by reference to the Anney has obtained from the regulation entitled, "Misoranding by reference to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number Division of Binan Mon) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
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
510(k) Number (if known):
Device Name: Diomed 15plus and Diomed 30plus Lasers
NOV 1 6 2001
Indications For Use:
The Diomed 15plus and Diomed 30plus lasers are indicated for contact and non-contact use for the following soft tissue applications:
- General Surgery .
- Ophthamology/Oculoplastic .
- Urology
- Gastroenterology
- Gynecology
- Otorhinolaryngology
- Pulmonary/Thoracic
- Dermatology/Plastic Surgery
- Neurosurgery (coagulation only)
- Orthopedic
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lisa Wall
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013499
Prescription Use
(Per 21 CFR 801.109)
OR
Over- The-Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Diomed Inc. Special 510(k) Diomed 15plus and Diomed 30plus Lasers October 19, 2001
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