(71 days)
Not Found
No
The document describes a mechanical accessory for a laser system and does not mention any AI or ML components or functions.
No
The device is used for surgical incision and excision, which are interventional procedures rather than therapeutic ones. It does not treat or cure a disease or condition.
No
Explanation: The device is indicated for incision and/or excision of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is an "accessory hand piece" consisting of a "diamond cutting blade and handle coupled to a flexible fiber guide cable," which are physical hardware components.
Based on the provided information, the Diamond LaserKnife™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "incision and/or excision... of soft tissue" in various surgical procedures. This involves direct interaction with living tissue within the body.
- Device Description: The description details a surgical accessory that uses laser energy to cut tissue. This is a surgical tool, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Diamond LaserKnife™'s function is surgical intervention, not in vitro analysis.
N/A
Intended Use / Indications for Use
The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue. Specific examples mentioned include: oral, dental, skin, neurosurgical sites, periorbital, pulmonary, vocal cords, larynx, foot, external genitalia, urethra, and kidney.
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)
Non-Clinical Tests: The Diamond LaserKnife 1 " performance characteristics have been evaluated through analysis of laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past.
Conclusions Drawn from Tests and Analysis: The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence.
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
MED OPTICS
Dlamond LaserKnife™
Premarket Notification 1510(k)] -- K983463 1c983463
DFC 1 1 1998
FDA Premarket Notification [510(k)] Summary
Preparation Date: 24 November 1998
Contact: Gerald S. Palecki, Director, Quality and Regulatory
Device Name: Proprietary: Diamond LaserKnife™
Common: Laser Scalpel
Predicate Device: Sapphire Laser Scalpel, reference K863086
Device Description:
The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.
Intended Use:
The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.
Technological Characteristics Compared to Predicate Device:
A crystal with sharpened edges is used as a scalpel to cut tissue during surgical procedures and also conducts laser energy to the tissue to cauterize and coagulate.
Non-Clinical Tests:
The Diamond LaserKnife 1 " performance characteristics have been evaluated through analysis of laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past.
Conclusions Drawn from Tests and Analysis:
The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence.
510_CvDLK5
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. Gerald S. Palecki Director, Quality and Regulatory Clinicon Corporation 2752 Loker Avenue West Carlsbad, California 92008
Re: K983463 Trade Name: Diamond LaserKnife™ Regulatory Class: II Product Code: GEX Dated: September 30, 1998 Received: October 1, 1998
Dear Mr. Palecki:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register, Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
3
Page 1 of 2
510(k) Number: K983463
Device Name: ____Diamond Laserknife™
Indications for Use:
The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, and urological procedures.
See Attachment 2 for a listing of medical specialties and typical contact laser procedures.
510_DLK_Ind2
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | C983463 |
Prescription Use (Optional Format 3-10-98)
4
CLINICON CORPORATION
Premarket Notification 1510(k)] -- K983463 Diamond LaserKnife ™
Attachment 2
Listing of medical specialties and typical contact laser procedures.
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- Dentistry/Oral Surgery
Incisional/excisional biopsies, removal of benign and cancerous lesions, frenectomy, gingivectomy, gingivoplasty, operculectomy, coagulation of graft donor sites, removal of vascular lesions, minor flap surgery, leukoplakia, and lymphangioma.
- Dentistry/Oral Surgery
2. Dermatology
Removal of warts, neruofibromas, hemangioma, epidermal nevi, eruptive vellus hair cysts, telangiectasia, basal cell carcinoma, and granuloma.
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- General and Plastic Surgery
Removal of skin tumors, hemorrhoidectory, lipomas, partial splenectomy, and rectal strictures. Blepharoplasty, breast reduction/reconstruction, and hair grafts.
- General and Plastic Surgery
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- Neurosurgery: Incision/excision of tumors, lesions, and cysts,
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- Ophthalmology Incision/excision of periorbital lesions.
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- Oto-rhino-laryngology
Excision of pulmonary lesions, vocal cord dysplasia and carcinoma. bronchoectorny, cordectomy, polyps, larynx leukoplakia, papillomas, lymphangioma, and myringotomy.
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- Podiatry
Excision of Morton's neruoma, porokeratotic lesions, and plantar warts.
- Podiatry
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- Urology
Benign neoplasia and carcinoma of external genitalia, urethral condyloma, phimosis, and renal resection.
- Urology
Prescription Use
(Per 21 CFR 801.109)
Pcolleto
(Division Sign-Off)
I.S. Central Restorative Devices 16003463
ivision Sign-Off)
ivision of General Restorative Devices 10(k) Number .