(23 days)
Contact Transscleral Cyclophotocoagulation (CYC) for the reduction of intra ocular pressure (IOP) in glaucoma patients. This ocular contact probe to be used with marketed (approved) infrared lasers for this procedure. Ablation of the Ciliary Body in glaucoma patients.
The TSX Probe consists of three basic parts; handgrip, tip and focusing lens and is a presterilized (Ethylene Oxide) disposable contact probe. Its tip is a clear amber medical plastic that is angled to match the curvature of the human eye and therefore allows for the placement of the probe vertically, closest to the limbus. The angle of the contact tip (distal end) conforms to the curvature of the eye. The three-meter 600 um fiber plugs into an HGM SmartScan™ laser or other SMA connection compatible device allows the physician to perform noninvasive contact CYC with marketed (approved) infrared lasers.
The provided text is a 510(k) summary for the TSX Probe, a laser delivery device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document. The 510(k) submission primarily focuses on establishing substantial equivalence to an existing legally marketed device, not on presenting detailed performance study results against specific acceptance criteria.
The submission is essentially a declaration that the TSX Probe is similar enough to the Iris G-Probe that it doesn't require a new, full pre-market approval process. It highlights similarities in fiber size, intended use (reduction of IOP in glaucoma patients via CYC), and compatibility with existing lasers.
The information you're asking for would typically be found in a more comprehensive clinical trial report or a detailed performance validation study, which is not included in this 510(k) summary.
{0}------------------------------------------------
K 992508 510(k) Summary per 21 CFR § 807.92 AUG 19 1999
Instruments for Medicine and Diagnostics, Inc. (a.k.a. I4MD) 3959 West 1820 South Salt Lake City, Utah 84104 (801) 972-0500 (801) 972-4884 (fax) Tracy S. Best, Regulatory Manager Preparation Date: July 19, 1999
Summary of Safety and Effectiveness for:
Trade Name: TSX Probe
Common Name: Laser Delivery Device, Ocular Contact Probe
Classification Name: Laser, Ophthalmic, Accessory
Legally Marketed Predicate Devices for Substantial Equivalence:
- Iris G-Probe, Manufactured by Iriderm Division, Laser Instrument, Surgical, Powered
Rationale for SE:
The Iris G-Probe is a sterile single use delivery device for the reduction of intra ocular pressure (IOP) in glaucoma patients. A three meter, 600 um fiber delivers the light energy from the laser to the focusing lens. The g-probe is furnished as sterile to the customer. The treatment performed using this non-invasive contact probe allows for selective ablation of ciliary processes. The procedure, Transscleral Cyclophotocoagulation (CYC), causes less postoperative pain and inflammation and is an alternative treatment from Cyclocryotherapy. The device is compatible with infrared photocoagulators.
Description of Submitted Device:
The TSX Probe consists of three basic parts; handgrip, tip and focusing lens and is a presterilized (Ethylene Oxide) disposable contact probe. Its tip is a clear amber medical plastic that is angled to match the curvature of the human eye and therefore allows for the placement of the probe vertically, closest to the limbus. The angle of the contact tip (distal end) conforms to the curvature of the eye. The three-meter 600 um fiber plugs into an HGM SmartScan™ laser or other SMA connection compatible device allows the physician to perform noninvasive contact CYC with marketed (approved) infrared lasers.
{1}------------------------------------------------
Intended Uses of the TSX Probe:
See attachment "5" for a complete listing of indicated uses.
Technological Characteristics and Substantial Equivalence:
The TSX Probe is similar to the G-Probe, both have a 600 um fiber which delivers the treatment light to the tip of the contact probe. The TSX Probe is sleeker having a contact tip which is smaller than the G-Probe. Both offer treatment modalities for laser light delivery to ocular tissue, for various types of glaucoma in it's advanced stages. The probes are moved in a circular fashion around the cornea using the limbus as a circular guide. Both probes allow laser energy to be fired at regular intervals into the ciliary body. The two probes are similar in design, intended use, and compatible with lasers widely in use.
Conclusion:
The TSX Probe is substantially equivalent to other existing laser surgical delivery devices already in commercial distribution. The labeling of the TSX Probe as a single-use pre-sterilized delivery device for treatment of (CYC) is an addition to a large field of Ophthalmic treatment methods with medical lasers.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 1999
Mr. Tracy S. Best Regulatory Affairs Instruments for Medicine and Diagnostics, Inc. 3959 West 1820 South Salt Lake City. Utah 84104
Re: K992508 Trade Name: TSX Probe Regulatory Class: II Product Code: GEX Dated: July 19, 1999 Received: July 27, 1999
Dear Mr. Best:
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 (QS) 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.
{3}------------------------------------------------
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,
Russell Sage
he 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
{4}------------------------------------------------
510(k) Number (if known): _ K 992908
Device Name: _ TSX Probe
Indications For Use:
Contact Transscleral Cyclophotocoagulation (CYC) for the reduction of intra
ment of the same was in the saylar contact on the to be Contact Transscieral Cyclopholocoagnation. This ocular contact probe to be
ocular pressure (IOP) in glaucoma patients. This ocular contact probe to be ocular pressure (1017 in glausema partices for this procedure.
Ablation of the Ciliary Body in glaucoma patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PROED IS NEEDED IS NEEDED IS Concurrence of CDRH, Office of Device Evaluation (ODE)
Russell Payne for JPD
Division of General Restorative
Prescription Use . (Per 21 CFR 801.109)
OR
Over-The-Counter Use -
§ 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.