(30 days)
Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: General Surgery, Ophthalmology/Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary/Thoracic, Dermatology/Plastic Surgery, Neurosurgery (coagulation only), Orthopedic
The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture.
The provided document is a 510(k) summary for the Diomed Delta 25 Laser, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with acceptance criteria and device performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not explicitly available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The Diomed Delta 25 laser has undergone a comprehensive series of test protocols in order to qualify and validate the performance of the device." It then concludes, "The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance."
It does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. This type of 510(k) summary typically relies on demonstrating that the new device performs as well as or similarly to existing legally marketed devices, rather than establishing new performance benchmarks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative thresholds for the Diomed Delta 25. The general criterion is "equivalent performance to the predicate devices." | Equivalent performance to the Diomed Delta 15 and Diomed Delta 30 (K051996) for technological performance, and to Adept 1064 Laser (K032218), Sciton Inc. Profile 1064 Laser System (K023881), Laserscope Lyra Surgical laser System (K020021), and Spectrum Veinlase (K981952) for laser wavelength performance. The document implies that this equivalence was demonstrated through "comprehensive series of test protocols." This suggests that the device met the performance characteristics (e.g., power output, wavelength stability, safety features) expected for this type of laser system, mirroring those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set in the context of a clinical study or a dataset for AI. This is a medical device approval based on substantial equivalence, which primarily involves comparing technical specifications and safety aspects to existing cleared devices. The "test protocols" mentioned likely refer to engineering and functional testing of the laser itself, not a clinical trial with human subjects or a dataset for AI.
Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable here as no such data is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document describes a physical medical device (laser instrument) and its technical equivalence, not an AI device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices to assess human reader performance with and without the device. The Diomed Delta 25 Laser is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone evaluation was not done. This concept is only relevant for AI algorithms. The Diomed Delta 25 is a physical laser device.
7. The Type of Ground Truth Used:
This information is not applicable as the clearance is for a physical laser surgical instrument, not an AI device. The "ground truth" for this device would be its ability to safely and effectively produce laser energy within specified parameters, as demonstrated through engineering and safety testing.
8. The Sample Size for the Training Set:
This information is not applicable as the Diomed Delta 25 Laser is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as above.
In summary, the provided document is a 510(k) summary for a traditional medical device (a surgical laser) seeking clearance based on substantial equivalence. It does not contain the detailed information about acceptance criteria, study design, and ground truth establishment that would be present for an AI/ML-based device. The "study" mentioned refers to the "comprehensive series of test protocols" to ensure the device's performance is equivalent to predicate devices, focusing on technical specifications and safety rather than clinical endpoints established through a patient study.
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14N 2 5 2007
510(k) Summary of Safety and Effectiveness for the Diomed Delta 25 Laser
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 2000Beach DriveCambridge Research ParkWaterbeachCambridgeCB5 9TEUnited Kingdom |
|---|---|
| Contact Person: | Timothy G PhippsAddress as aboveTelephone: +44 1223 729314Fax: +44 1223 729329 |
| Summary Preparation Date: | December 20th, 2006 |
| 2. Names | |
| Device Name: | Diomed Delta 25 Laser |
| Classification Name: | Laser Instrument, Surgical Powered |
3. Predicate Devices
The Diomed Delta 25 Laser is substantially equivalent in terms of its technological performance to:
- Diomed Delta 15 and Diomed Delta 30 (K051996) .
The Diomed Delta 25 Laser is substantially equivalent in terms of its laser wavelength performance to:
Product Code: GEX
Panel: Dermatology and Plastic Surgery
- . Adept 1064 Laser (K032218)
- Sciton Inc. Profile 1064 Laser System (K023881) .
- Laserscope Lyra Surgical laser System (K020021) .
- Spectrum Veinlase (K981952) .
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4. Device Description
The purpose of this Special 510(k) is to notify FDA of the proposed inclusion of the Diomed Delta 25 Laser into Diomed's range of laser platforms. The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.
The Diomed Delta 25 Laser is made up of a treatment laser and aiming beam. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture. Drawings and photographs of the Diomed Delta 25 Laser are included in the operator manual found in Appendix G.
5. Indications for Use
The Diomed Delta 25 Laser is intended for use in delivering up to 25 Watts of continuous wave or pulsed radiation to a flexible optical fiber for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures.
6. Performance Data
The Diomed Delta 25 laser has undergone a comprehensive series of test protocols in order to qualify and validate the performance of the device. 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 25 is therefore validated for use on this basis.
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Diomed Ltd. % Mr. Tim Phipps OA/RA Director Building 2000, Beach Drive Cambridge Research Park Waterbeach Cambridge, United Kingdom CB5 9TE
JAN 2 5 2007
Re: K063828 Trade/Device Name: Diomed Delta 25 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 20, 2006 Received: December 26, 2006
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
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Page 2 -- Mr. Tim Phipps
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vo
for
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K 063828 510(k) Number (if known): _______________
Diomed Delta 25 Device Name: __________
Indications For Use:
Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures:
- . General Surgery
- Ophthalmology/Oculoplastic .
- Urology .
- Gastroenterology .
- Gynecology .
- Otorhinolaryngology .
- Pulmonary/Thoracic .
- Dermatology/Plastic Surgery .
- Neurosurgery (coagulation only) .
- . Orthopedic
Prescription Use AND/OR X (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)
| Concurrences of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | 2063828 |
| Page 1 of 1 |
§ 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.