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510(k) Data Aggregation
K Number
K143211Device Name
myVision Track Model 005
Manufacturer
Date Cleared
2015-03-20
(130 days)
Regulation Number
886.1330Why did this record match?
Applicant Name (Manufacturer) :
VITAL ART AND SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The my VisionTrack® Model 0005 is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® Model 0005 is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
Device Description
The myVisionTrack® Model 0005 is a vision function test provided as a downloadable app on to the user's supplied cell phone or tablet. The myVisionTrack® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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K Number
K121738Device Name
MYVISIONTRACK(TM)
Manufacturer
Date Cleared
2013-02-22
(254 days)
Regulation Number
886.1330Why did this record match?
Applicant Name (Manufacturer) :
VITAL ART AND SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
Device Description
The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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K Number
K020881Device Name
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
Manufacturer
Date Cleared
2002-03-27
(9 days)
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit is intended to provide continuous infusion of physician-prescribed local anesthetic medications directly into the intraoperative site of a patient for management of postoperative pain. Medication is delivered percutaneously, through the infusor's administration line, which is attached to a catheter.
The Personal Infusor is portable and is suitable for use by ambulatory patients.
The Personal Infusor is intended for single use only.
The Personal Infusor is not intended for rapid infusion, intravenous or intra-arterial drug infusion, for the delivery of blood, blood products, lipids, or fat emulsions, or for use by patients with a history of allergic reactions to anesthetics.
Device Description
The Science Incorporated Personal Infusor Local Pain Management Procedural Kit consists of a Personal Infusor provided in a kit with medical device components including a catheter set, catheter introducer, 60 mL syringe, dressings and accessories. Each of the additional medical device components is purchased in finished form and is packaged with the Personal Infusor in the Personal Infusor Local Pain Management Procedural Kit.
The Personal Infusors provided in the Personal Infusor Local Pain Management Procedural Kit will be offered in three volume / flow rate configurations.
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K Number
K010824Device Name
PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT
Manufacturer
Date Cleared
2001-06-05
(78 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K990208Device Name
PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT
Manufacturer
Date Cleared
1999-03-25
(63 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation. The device is, also, designed to allow for the removal of parenteral medication to allow for the proper disposal of both the device and the medication where disposal of both together would be contrary to normal professional health care practice.
The flexibility offered by the PDS Personal Infusor with Drug Disposal Septal Port will enable physicians to choose from a variety of fluid flow rates and drug concentrations. It will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients, as well as allow for proper disposal of device and unused fluid medications.
Device Description
The Science Incorporated PDS Personal Infusor with Drug Disposal Septal Port is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36-inch tubing set that adjoins a preexisting venous access site. The unit has a septal port which allows easy removal of unused medications to allow for proper disposal of both device and medication. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in multiple volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities. It has a drug disposal septal port for proper disposal of the unused drug per normal hospital practice.
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K Number
K971362Device Name
PERSONAL INFUSOR
Manufacturer
Date Cleared
1997-12-04
(237 days)
Product Code
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Science Incorporated Personal Infusor is designed for the ambulatory infusion of physician-prescribed parenteral medications. The device is intended to be filled and prepared for administration by pharmacists, and provided to patients who have been trained in the pump's operation.
The flexibility offered by the Personal Infusor will enable physicians to choose from a variety of fluid flow rates and drug concentrations, and will provide clinicians and patients with a convenient and efficient option for administration of fluid medications to patients.
Device Description
The Science Incorporated Personal Infusor is a self-contained, low-profile, disposable infusion device intended for the ambulatory delivery of physician-prescribed parenteral medications to patients. Its design engages three principle elements: a substrate base with molded ullage, a stored energy elastomeric film, and a preset rate control component with filter. Fluid medicaments are delivered to a patient via an attached 36 inch tubing set that adjoins a preexisting venous access site. The unit is disposable following a single use and features a novel visual flow status indicator that facilitates patient monitoring. The pump will be available in seven volume/flow rate configurations, and prototype models have demonstrated unsurpassed accuracy and consistency of fluid flow over a broad gamut of operating temperatures and with solutions of widely varying viscosities.
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