KEELER PULSAIR 3000 NON CONTACT TONOMETER

K990257 · Keeler Instruments, Inc. · HKX · Mar 25, 1999 · Ophthalmic

Device Facts

• Record ID: K990257
• Device Name: KEELER PULSAIR 3000 NON CONTACT TONOMETER
• Applicant: Keeler Instruments, Inc.
• Product Code: HKX · Ophthalmic
• Decision Date: Mar 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

Measurement of the Intraocular Pressure

Device Story

Keeler Pulsair 3000 is a non-contact tonometer used to measure intraocular pressure (IOP). Device operates by directing a puff of air at the cornea; measuring the corneal deformation response to determine pressure. Used in clinical settings by eye care professionals to assist in glaucoma screening and management. Output provides IOP measurement to the clinician, facilitating clinical decision-making regarding ocular health and potential treatment. Non-contact nature eliminates need for topical anesthesia, improving patient comfort and reducing risk of cross-contamination.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Non-contact tonometer; utilizes air-puff technology for corneal applanation/deformation measurement. Class II device, product code 86 HKX.

Indications for Use

Indicated for the measurement of intraocular pressure in patients requiring such assessment.

Regulatory Classification

Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 1999

Mr. Eugene R. Van Arsdale Marketing Manager Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008

Re: K990257

Trade Name: Keeler Pulsair 3000 Non Contact Tonometer Regulatory Class: II Product Code: 86 HKX Dated: January 25, 1999 Received: January 27, 1999

Dear Mr. Van Arsdale:

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 requirements, 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 .

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Page 2 - Mr. Eugene R. Van Arsdale

· 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health ..............

Enclosure

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510(k) Number (if Known) 《鳥羽のここ「フ

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Device Name: Keeler Pulsair 3000 Non Contact Tonometer

Indications For Use: Measurement of the Intraocular Pressure

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ×

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Over-The-Counter USE

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Denis L. McCarthy