(25 days)
The Diomed 15plus and Diomed 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
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.
This 510(k) summary for the Diomed 15plus and Diomed 30plus Lasers does not contain the specific acceptance criteria or a detailed study report that quantitatively proves the device meets specific performance criteria.
The submission primarily focuses on demonstrating substantial equivalence to predicate devices (Diomed 15 and Diomed 30 Lasers) and describes the modifications made to the new devices.
However, based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended." This is a general statement and does not provide specific numerical acceptance criteria or the reported performance values. The primary "performance" mentioned is the addition of a shorter pulse duration (50 ms), a spot handpiece/software delivery system, and a Fluence Display with a power meter for accuracy. These are functional additions, not quantitative performance metrics with acceptance ranges.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in the document beyond general "function as intended") | * Incorporates a shorter pulse duration (50 ms) |
| * Offers both fiberoptic and spot handpiece modes (predicate only fiberoptic) | |
| * Includes a Fluence Display | |
| * Diomed 15plus laser includes a power meter (previously only in Diomed 30) to improve accuracy of delivered power/fluence. | |
| * Verification and validation testing was successfully performed to confirm that the modified Diomed 15plus and Diomed 30plus Lasers function as intended. |
Missing information: The document does not specify quantitative acceptance criteria for parameters like:
- Accuracy of delivered power/fluence (e.g., ±X% of set value)
- Stability of laser output
- Beam quality parameters
- Safety parameters (e.g., maximum temperature, electrical safety)
- Specific performance metrics for the new pulse duration or spot handpiece.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. This type of submission would typically involve internal laboratory testing rather than clinical data from a specific country or retrospective/prospective studies for these types of modifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This submission is for laser device modifications, not a diagnostic device requiring expert consensus on clinical data for ground truth. The "ground truth" would be engineering specifications and functional performance.
4. Adjudication method for the test set:
- Not applicable/Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or diagnostic device. Performance testing would be for the laser's physical and functional output.
7. The type of ground truth used:
- Ground Truth: Engineering specifications, functional requirements, and safety standards for medical laser devices. The "verification and validation testing" would have assessed compliance against these predefined technical specifications.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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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
Page E-1
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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.
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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
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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
Page v
§ 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.