(310 days)
The Oculase MD is indicated for use in general ophthalmic soft tissue surgical indications such as: incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.
The Oculase MD Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) tissue cutting system is a unique device with diverse ophthalmic tissue applications. A flexible fiber optic with handpiece delivers the laser wavelength to the target tissue. A red light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output may be adjusted to specific user requirements for tissue applications. Laser radiation is delivered from the laser unit to the handpiece through the optical fiber. A sterile water spray is emitted at the same time laser radiation is delivered to the tissue site. The handpiece is rotatable and detachable from the optical shaft. The tip is detachable from the handpiece and serves as the optical power conduit to the target tissue.
The provided document is a 510(k) Summary of Safety and Effectiveness for the Oculase MD, dated July 5, 2006. It describes the device, its indications for use, and its substantial equivalence to predicate devices. Crucially, the document explicitly states under the section "6. Performance Data": "None presented."
Therefore, based on the provided text, there is no information regarding acceptance criteria or a study proving the device meets acceptance criteria. The device's clearance was based on substantial equivalence to predicate devices, not on performance data from a specific study.
As such, I cannot provide the requested table or detailed information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as this information is not present in the given text.
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JUL - 5 2006
510(k) Summary of Safety and Effectiveness for the Oculase MD
KOS2354
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:
BIOLASE Technology, Inc. 4 Cromwell Irvine, CA 92618.
Contact Person:
Maureen O'Connell 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-207-1246
Summary Preparation Date:
June 30, 2006 .
Oculase MD
- Names
Device Name:
Classification Name:
Ophthalmic Laser Product Code: HQF
3. Predicate Devices
The Oculase MD® is substantially equivalent to a combination of the following devices: BIOLASE's WaterLase® (K031140, K030523, K012511, K011041), and DermaLase™ (K971459), MSq (M2) Ltd. MSq Family of Lovely Light/Laser Systems (K042000), Laserscope's Erbium:YAG Laser System and Accessories (K971843), Aesculap-Meditec's MCL 29 Dermablate Erbium Laser System (K964128), Pfizer Laser Systems' Centauri (K905141), and the Friendly Light ER:YAG Pulsed Laser (K000023).
4. Device Description
The Oculase MD Er,Cr:YSGG (Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet) tissue cutting system is a unique device with diverse ophthalmic tissue applications. A flexible fiber optic with handpiece delivers the laser wavelength to the target tissue. A red light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output may be adjusted to specific user requirements for tissue applications. Laser radiation is delivered
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from the laser unit to the handpiece through the optical fiber. A sterile water spray is emitted at the same time laser radiation is delivered to the tissue site. The handpiece is rotatable and detachable from the optical shaft. The tip is detachable from the handpiece and serves as the optical power conduit to the target tissue.
5. Indications for Use
The Oculase MD is indicated for use in general ophthalmic soft tissue surgical indications such as: incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.
6. Performance Data
None presented.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, wave-like design at the bottom. Encircling the central image is text that reads 'DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
BIOLASE Technology, Inc. % Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Re: K052354 Trade/Device Name: Oculase MD 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: June 7, 2006 Received: June 8, 2006
Dear Ms. O'Connell:
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 i'ddications for use stated in the enclosure) to legally marketed prodicate 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 evay 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 quality systems (QS) regulation (21 CFR Part 820); and if applicable. the accornit product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 – Ms. Maureen O'Connell
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 logally marketed predicate device results in a classification for your device and thus, permitts varueday ce 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 mon ohtain 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 yours,
Hubert Humphrey
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
510(k) Number (if known): _ _ K052354
Device Name: _ Oculase MD
Indications for Use:
The Oculase MD may be indicated for general ophthalmic soft tissue surgical indications such as:
Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulur Lisan
(Division Sign-Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K052354
§ 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.