PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000

{0}------------------------------------------------ K093298 # eele ### Ophthalmic Instruments DEC 1 0 2010 ### 510(k) Summary Keeler Non Contact Tonometer Product Family 7th October 2010 ## 1. Submitter Contact Information: | Company Name/Address: | Keeler Instruments Inc<br>456, Parkway,<br>Broomall,<br>PA 19008 | |--------------------------------------|------------------------------------------------------------------------------------------| | Company Phone No:<br>Company Fax No: | (610) 353 4350<br>(610) 353 7814 | | Contact Person: | Mr. Eugene VanArsdale (Marketing Director). | | Manufacturing Location: | Keeler Ltd<br>Clewer Hill Road,<br>Windsor,<br>Berkshire.<br>SL4 4AA.<br>United Kingdom. | | Company Phone No:<br>Company Fax No: | (44) 1753 857177<br>(44) 1753 830247 | | Contact Person: | Mr. Neil Atkins (QA and Production Engineering<br>Manager). | ### 2. Subject Device Information | Device Trade Name: | Keeler Pulsair IntelliPuff Tonometer<br>Keeler Pulsair Desktop Tonometer | |-----------------------|--------------------------------------------------------------------------| | Common Name: | Tonometer | | Class: | II | | Classification Panel: | 86 | | Product Code: | HKX | | Regulation Number: | 886.1930 | ## 3. Predicate Device Description | Predicate Device:<br>Tonometer | Keeler | Pulsair | 3000 | Non | Contact | |------------------------------------------------|---------|-----------------|------|-----|---------| | 510(k) Reference:<br>Submission Approval Date: | K990257 | 25th March 1999 | | | | {1}------------------------------------------------ ### 4. Device Description The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor. The Pulsair Intellipuff non-contact Tonometer was faunched into the European market in April 2007. The Pulsair Desktop non-contact Tonometer was launched into the European market in April 2009. ### 5. Indications for Use The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. ## 6. Statement of Intended Use The Pulsair Intellipuff and Pulsair Desktop tonometers are instruments that are intended to be used by trained healthcare professionals such as Ophthalmologists and Optometrists to aid with the screening of glaucoma. In isolation, the devices can not determine the presence of glaucoma but as part of a suite of screening instruments including Field screeners can help with screening and diagnosis. The instruments can be used on all age groups but variation in corneal properties such as corneal thickness, corneal scaring and 'Dry Eye' could affect the performance of the instruments. It is recommended that all trained Healthcare professionals take these sources of variation into consideration when taking tonometric measurements of the eve. There are no differences in Intended Use of the Pulsair Intellipuff and Pulsair Desktop Tonometer compared to the predicate device referenced in K990257. {2}------------------------------------------------ | | Comparison of Non Contact Tonometer Technological Characteristics | | | |-----------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Criteria | Predicate Device<br>Keeler Pulsair 3000<br>Non-contact Tonometer<br>(Re:510(k) K990257) | Subject Device 1:<br>Keeler Pulsair<br>IntelliPuff Tonometer | Subject Device 2:<br>Keeler Pulsair<br>Desktop Tonometer | | Type | Air Puff Non-Contact<br>Tonometer | Air Puff Non-Contact<br>Tonometer | Air Puff Non-Contact<br>Tonometer | | Illumination | 6V, 6 Watt Halogen<br>Filament Bulb | 720nm, 1 Watt LED | 720nm, 1 Watt LED | | Measurement Range | 7-50mmHg | 5 to 50mmHg | 5 to 50mmHg | | Displayed scale | Direct in mmHg | Direct in mmHg | Direct in mmHg | | Air Puff Generation | Vacuum Diaphragm<br>Pump<br>(Type:KNF 16961-86) | Vacuum Diaphragm<br>Pump (Type:NPK 04) | Vacuum Diaphragm<br>Pump (Type:NPK 04) | | Pressure of Air<br>Expelled from<br>Tonometer | 70mmHg | 30mmHg & 70mmHg | 30mmHg & 70mmHg | | Power Source | Built into instrument-<br>Mains powered | Keeler Power Supply<br>(EP29-32777) 12V<br>2.5A | Keeler Power Supply<br>(EP29-32777) 12V<br>2.5A | | Input Voltage | 100, 110, 120, 220, 240-<br>Note ±10% | 100 -240V (±10%) | 100 -240V (±10%) | | Input Frequency | 50/60 Hz | 50/60 Hz | 50/60 Hz | | Measurement<br>Method | Opto-Electronic | Opto-Electronic | Opto-Electronic | | Device Features | N/A | Forehead rest | Chin rest & Forehead<br>rest | | User Interface | Factory set | Factory set/User<br>changeable | Factory set/User<br>changeable | | Printer | External | Built in | Built in | | Data Display | LCD | Dot Matrix LED<br>Display | Single line 16<br>character<br>alphanumeric LCD<br>display | | Mounting Options | Wall and Desk<br>Mountable | Wall and Desk<br>Mountable | Desk mountable | | Hand Unit<br>Dimension | (H)265mm x (D)115mm x<br>(W)40mm | (H)315mm x<br>(D)150mm x<br>(W)46mm | No hand Unit | | Console Dimensions | (H)355mm x (D)305mm x<br>(W)205mm | (H)260mm x<br>(D)215mm x<br>(W)220mm | (H)450mm x<br>(D)435mm x<br>(W)245mm | | Hand Unit weight | 0.887Kg | 0.89kg | No Hand Unit | | Console weight | 7.280kg | 2.465kg | 16Kg | | Length of umbilical<br>cord | 2.0m | 2.0m | No umbilical cord | | Software Level of<br>Concern | Moderate | Moderate | Moderate | | Reliance on<br>Standards | Full clinical trial<br>conducted in 1997 to ISO<br>8612:1997 | Full Clinical trial<br>conducted in 2007 to<br>ISO 8612:2001 | Clinical Equivalence of<br>the Pulsair Desktop<br>Tonometer to the<br>Pulsair Intellipuff<br>Tonometer<br>demonstrated by a 28<br>eye three way<br>comparison study with<br>the Goldmann<br>tonometer | : : ### 7. Technology Characteristics and Equivalence to Predicate Device . . {3}------------------------------------------------ A description of the main changes introduced in the Pulsair IntelliPuff and Pulsair desktop in relation to the FDA approved predicate device Keeler Pulsair 3000 Non-Contact Tonometer are as follows:- - > A sub-miniature Halogen bulb (note: visible light filtered out. Wave length of 680nm and above used) is replaced by a 720nm LED. - > Air puff control introduced i.e. softer puff used to obtain measurements on patients with IOP less than 23mmHg. This improves patient comfort. - > Photo sensors changed due to obsolescence of previously specified components. - > Smaller and quieter pump used to reduce environmental noise. - > Introduction of a user menu that allows the practitioner (user) to set the instrument to individual requirements. - > The instrument continuously compares measurements and when enough measurements have been taken, the instrument indicates this fact to the user via audible sound. This ensures that the patient does not receive more measurements than is absolutely necessary. ## 9. Technological Equivalence between Pulsair IntelliPuff and Pulsair Desktop Keeler Pulsair IntelliPuff and Pulsair Desktop have similar technological features with regards to the optical system, optoelectronic devices, electronics, pneumatic system, contained software, measurement technique, calibration technique, safety, effectiveness and intended use. Minor differences between Pulsair Desktop and Pulsair IntelliPuff are listed in the table below: | Pulsair IntelliPuff | Pulsair Desktop | |------------------------------------------------------------------------------|----------------------------------------------------| | Hand Held | Desk mounted & Joystick driven | | Operator view through an eye<br>piece | Operator view through a Camera and<br>TFT Screen | | One measurement displayed at<br>a time | Can display up to four readings plus an<br>average | | Instrument goes to sleep mode<br>on returning the hand unit to its<br>cradle | Instrument sleeps after 5 minutes of<br>inactivity | | Left/right eye selection is<br>manual | Left/Right eye selection is automatic | #### 10. Calibration The Pulsair Tonometer is an eye pressure measuring device. For this purpose, the system is equipped with an internal pressure transducer which is calibrated against an external pressure transducer, which in turn is calibrated against a known standard. The calibration process involves calibrating the optical and pneumatic systems of the instrument in various stages. The Keeler Pulsair IntelliPuff and Desktop are calibrated in the same manner as the predicate device Pulsair 3000 non-contact Tonometer. {4}------------------------------------------------ #### 11. Performance testing Device performance: Risk management completed as per BS EN ISO 14971:2001(IntelliPuff) and BS EN ISO 14971:2007 (Desktop), which analyses and evaluates risks associated to the product and preventive actions to mitigate each risk. The Pulsair IntelliPuff and the Pulsair Desktop have been tested in accordance with BS EN ISO 15004 -2:2007 and are within the limits specified for Optical radiation Hazard. The Pulsair IntelliPuff and Desktop uses a medically approved Power supply (Keeler Ref: EP29-3277) which is compliant with BS EN 60601-1 and 60601-1-2. Pulsair Desktop and IntelliPuff have been tested for electrical safety to BS EN 60601-1 and Electromagnetic compatibility to BS EN 60601-1-2. Software Development & Performance: Pulsair IntelliPuff and Pulsair Desktop software are derivatives of Pulsair 3000 non-contact Tonometer which was granted FDA approval in 1999. The algorithm for IQP calculation remains the same. Keeler sub-contracted the further development of this software for the Pulsair Intellipuff to an external development organisation. The organisation were employed to develop the functionality and usability of the existing software based on an initial Product Design Requirements Specification developed by Keeler for the Pulsair Intellipuff non contact Tonometer. They generated the subsequent documentation and conducted the various development activities associated with software and hardware development. All change control was managed by them until transfer into the Keeler QMS in 2007. All subsequent changes have been controlled under the Keeler Change Control Process. The software for the Pulsair Desktop non contact Tonometer was designed under Keeler design and development processes. The products have had numerous validation and verification activities conducted including bench and clinical testing. The results are included in this 510(k) submission. The software for both the Pulsair Intellipuff and Pulsair Desktop are considered 'Moderate' level of concern. Clinical Trial: A new independent clinical study was conducted on the Keeler Pulsair IntelliPuff Tonometer to show the design compliance of the Pulsair Tonometer against a reference Tonometer (Goldmann Tonometer). The study requirement for design compliance as specified in the ANSI Z80.10-2003 and ISO 8612:2001 stipulates that no more than 5% of the paired differences between the reference Tonometer and the Pulsair Tonometer should be outside the ±5mmHg tolerance in the three IOP ranges. The study showed that the readings obtained using the Pulsair Intellipuff were not significantly biased relative to those obtained using the Goldmann Tonometer, and the paired differences between the Intellipuff and Goldmann were within ±5mmHg for over 95% of the eyes tested. The Pulsair Intellipuff readings tended to fall slightly below the Goldmann readings at IOP's exceeding 30mmHg, but the difference was not clinically significant. To demonstrate equivalence between the Pulsair Intellipuff Tonometer and the Pulsair Desktop Tonometer an additional small scale trial was conducted within a clinical environment on 28 eyes. The trial compared readings between the Pulsair Intellipuff, Pulsair Desktop and the Goldmann Tonometer. The results obtained from the trial demonstrate that the readings obtained using the Pulsair Desktop Tonometer were not significantly biased relative to those obtained using the Goldmann Tonometer, and the paired differences between the Desktop and Goldmann were within ±5mmHg for over 95% of the eyes tested. Further the results obtained from the trial demonstrate that the readings obtained using the Pulsair Desktop Tonometer were not significantly biased relative to those obtained using Pulsair Intellipuff, and the paired differences between the Desktop and Intellipuff were within ±5mmHg for over 95% of the eyes tested. We therefore conclude that the Pulsair Intellipuff and Pulsair Desktop tonometers are clinically equivalent. {5}------------------------------------------------ Bench Testing: The performance of the Pulsair Desktop and Pulsair IntelliPutf Tonometer were tested under laboratory test conditions using and industry approved test set-up. The results of bench testing show that Keeler Pulsair Intellif and Keeler Pulsair Desktop do produce repeatable and comparable measurements. ### 12. Conclusions Based on the product verification and product validation activities we conclude that the Pulsair Intellipuff and Desktop Tonometers are substantially equivalent to the predicate device described in 510(k) K990257. The clinical trials conducted demonstrate the measurements obtained by the product are not significantly biased relative to those obtained by the established, gold standard Goldmann Tonometer and with no adverse customer feedback from sales of units throughout the EU demonstrate that both products are safe and effective. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human form, with three flowing lines representing the human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Keeler, LTD. c/o Mr. Eugene R. VanArsdale Marketing Director Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008 DEC 1 0 20. Re: 510(k) K093298 Trade/Device Name: Keeler Pulsair Intellipuff Tonometer and Keeler Pulsair Desktop Tonometer Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometers and Accessories Regulatory Class: Class II Product Code: HKX Dated: October 12, 2010 Received: October 14, 2010 Dear Mr. VanArsdale: 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 I ou may, aterest of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. {7}------------------------------------------------ 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Kesia Alexander for N I I C Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if know): K093298 DEC 1 0 2010 Device Name: Puslair Intellipuff and Pulsair Desktop non-contact Tonometer. Indications for Use: The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of qlaucoma. The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter USE AND/OR (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Az. L. Kaufman, M.A. (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K093298