(182 days)
K 862386, K 884414, K 902306, K 921615
Not Found
No
The device description focuses on ultrasonic technology and standard electronics, with no mention of AI, ML, or related concepts. The performance studies describe a standard cleaning effectiveness evaluation protocol.
No.
The device is used for cleaning contact lenses, which does not directly treat or diagnose a disease. It functions as an accessory for cleaning, not for therapeutic purposes.
No
The device is intended for cleaning contact lenses, not for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a piezo-electric crystal, reservoir, electronics, transducer, housing, lens baskets, and a power cord with a transformer.
Based on the provided text, the Lena Comfort Contact Lens Care Accessory is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as an "accessory in the cleaning of contact lenses." This is a physical cleaning process for a medical device (contact lenses), not a diagnostic test performed on biological samples.
- Device Description: The description details the mechanism of action as using ultrasonic waves to create cavitation for physical cleaning. It does not mention any analysis of biological samples or diagnostic measurements.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a cleaning accessory for contact lenses, which are themselves medical devices. Its function is to maintain the cleanliness and usability of the contact lenses, not to provide diagnostic information about a patient's health.
N/A
Intended Use / Indications for Use
The Lena Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses.
Lens Comfort is Indicated as aid for cleaning as on accossory for soft hydrophilic lanses and gas permeable lenses when used with the appropriate Barnea-i hind® Soft Mate solutions such as the Consept Cleaning and Disintection System which is comprised of the Bernes-Hinde Soft Mare Consept . 1 Cleaning and Disinfecting solution and Barnes-Hinde Soft Mate® Consepte-2 Neutralizing and Pinaing Solution or Spray. The Lans Comfort Contact Lons Care Accessory Is indicalad for use for gas permeable solutions auch as Barnes. Hind® Gas Permeable Daily Cleaner and Barnes-Hind® ComfortCare GP Welting and Solution. The Lens Comfort Contact Lens Care Accessory may be used for a receptacie for chamical disinfection.
Product codes
86LYL
Device Description
The Lens Comfort Ultrasonic Contact Lens Care Accessory uses a plezo-electric crystal to generate a wave form. In a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of tomperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The Lans Comfort device uses standerd power (110 v/120 v). There is a four (4) foul cord and a UL approved wall transformer.
The Lens Comfort device consists of the housing, lens beskets, a reasivoir, electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally merkated predicate devices in the United States. The housing is injection molded of polycarbonate. The baskets and supporting structure are injection molded from polyethylene. The reservoir is deep drawn stallnioss steel, is passivated and pollshed. The electronic circultry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A protocol was obtained from the Office of Device Eveluation (ODE) that has been used by the industry to assess the affactiveness of devices and cleaning anutions and their impact, if any, on the contact lenses. Lenses were selected from Group 1, Group 3, Group 4 and the Gas Permeable class. They were soaked in an artificial tear solution. Physical and optical parameters were measured before the lenses were treated with the artificial tear solution and then after each cycle. Thirty (30) cyclas were performed on all lenses.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the Lens Comfort Device, based on a protocol used by the Industry to assess the effectiveness of systems and solutions designed to clean contact lenaes. Was conducted by an optometriat who is director of optometric bervices In a large ophthalmology practice.
No ahanges were noted in color, olority, power, diameter or base curve. The lenses all appeared clear and no deposits or residue or damage were noted on any of the lenses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P 810017, P 840068, K 862386, K 884414, K 902306, K 921615
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
ID :
NOV 29 1996
510(k) SUMMARY K962112
(807.92(g))
[807.92(a)(1)]
Prepared:
- May 24, 1996
- 810(k) Summary Reference:
- James Demestiches Submission by:
Lons Comfort, Inc. Entity: 912 Broad Street Ellzabeth, New Jersey 07280 908-268-0699 201-693-0428 Fax
(807.92(a)(2))
Classification
Not Classified Nama and Code: Accessory to Contact Lens Solutions Product Code (86LYL)
Common or Usual
- Ultrasonic Contact Lons Care Accessory Name:
Trade pr
Proprietary Name:
Lens Comfort Contact Lens Care Accessory
(807.92(a)(3))
The Sola/Barnes-Hind® Hydra-Mat® (PMA Nos. P 810017 and Equivalence: P 840068); the Sola/Barnes-Hind Soft Marce Automotic Cleaning Unit (K 862386); the Clensatron® 700 CL (K 884414); the Visonic Dome* (K 902306); and the Lensonic (K 921615) all have been given market clearance to be used as an accessory for contact lens care.
[807.82(a)(4)]
Device
The Lens Comfort Ultrasonic Contact Lens Care Accessory Description: uses a plezo-electric crystal to generate a wave form. In a reservoir containing a specific volume of fluid. Cavitation in fluid results in the generation of microscopic bubbles that implode upon the lens surface. The matrix of frequency, duration of ultrasound, and the control of tomperature rise in the fluid medium leads to cleaning when a specific contact lens solution is present. The Lans Comfort device uses standerd power (110 v/120 v). There is a four (4) foul cord and a UL approved wall transformer .
The Lens Comfort device consists of the housing, lens beskets, a reasivoir,
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
Lens Comfort, Inc.
electronics and a transducer. All components that come in contact with contact lenses or solutions are of medical grade composition and have been used in legally merkated predicate devices in the United States. The housing is injection molded of polycarbonate. The baskets and supporting structure are injection molded from polyethylene. The reservoir is deep drawn stallnioss steel, is passivated and pollshed. The electronic circultry has been used in other cleaning applications in other industries for years. The single crystal is affixed directly to the bottom of the reservoir with an epoxy generally used in cleaning applications in the ultrasound industry.
[807.92(a)(5)]
The Lena Comfort Contact Lens Care Accessory is intended for Intended Use: use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses,
Lens Comfort is Indicated as ald for cleaning as on accossory for soft hydrophilic lanses and gas permeable lenses when used with the appropriate Barnea-i lind® Soft Mate solutions auch as the Consept Cleaning and Disintection System which is comprised of the Bernes-Hinde Soft Mare Consept . 1 Cleaning and Disinfecting solution and Barnes-Hinde Soft Mate® Consepte-2 Neutralizing and Pinaing Solution or Spray. The Lans Comfort Contact Lons Care Accessory Is indicalad for use for gas permeable solutions auch as Barnes. Hind® Gas Permeable Daily Cleaner and Barnes-Hind® ComfortCare GP Welting and Solution. The Lens Comfort Contact Lens Care Accessory may be used for a receptacie for chamical disinfection.
[807,92(a)(6)] Comparison of Technological The predicate devices are: Characteristics:
| 1. | Sola/Barnes-Hind® Hydra-Mat® | P 810017 |
|---|---|---|
| P 840066 | ||
| 2. | Sola/Barnes-Hind® Suft Mule® | |
| Automatic Cleaning Unit | K 852386 | |
| 3. | Clensatron® 700 CL | K 884414 |
| 4. | Visonic Dome™ | K 902306 |
| 5. | Lonsonio | K 921615 |
Similarities:
All predicate devices have referenced Sole/Barnes-Hind® Solutions in their aubmissions and specifically the Soft Mate® Concepte-1 and 2 Cleaning and Disinfection Bystem for use with saft lensea. Lons Comfort roforances the seme solutions and data.
Section 7-2
2
Lans Comfort, Inc.
The prodicate devices use medical grade materials that are in contact with the contact lonens or the solutions and have been previously used in ophthalmic modical devices legelly marketed in the United States. Materials in Lens Comfort are the same or similar as predicate devices.
All prodicate devices have a fituid reservoir in which lenses are aubmerged. The Lens Comfort device has a strillar reservoir and submerges lenses for clouning.
All prodiopte devices have plastic lens baskets into which lenses are encased for submersion while cleaning is in process. Lens Comfort has plastic lans baskets.
All predicate devices operate on standard power from a wall recaptacle. Lens Comfort has a cord with a UL approved transformar that plugs into a wall accket.
Two predicate devices Lensonic and Visanic Dome™ as well as Lons Comfort use Diezo-electric crystals in the generation of cavitation.
Differences:
Lens Comfort operates at a frequency of approximately 65 Khz and yelds approximately 60.000 vibrations per second. The Hydra-Mat® is hand operated. The SoftMate® Automatic Cleaning Unit vibrates a small frection of the of any of the prodicate davices. The Clansation® 700CL is helt driven and vields 300 cycles a minute. The Visonic Dome™ is ultrasonic and generates approximately 40,000 vibrations a second. The Lensonic device is ultrasonic and generalas approximately 60,000 vibrations per second.
Lens Comfort operates in a specific and controlled range of end temperatures. The predicate devices have and temperatures running from ambient to above 55° C. The Lens Comfort device and temperature is in the middle temperature range of the prodicate devices.
Lens Comfort uses 5 watts of power and the predicate devices range from 1 watt to 8 watts.
Lens Comfort, Clensatron® and Lensonice all transformers while the Visonic Dome™ has no cord and plugs directly into an electrical outlet.
Lens Comfort, Leneonic® and Clenestron® all hovo a start button. Long Comfort and Lensonial have an (LED) that glows and then automotically shuts of after the end of the 10 minute cycle. The Hydra-Mare has no time indicators. The Sott Mate® Automatic Cleuning unit has a timor but it correlates to the vibration cycle and there is no light indication has a timer to stop the revoluliaria of the besket in the reservolr, but It has no light/timo indicator to dafing for the user the ond of a cycle. The Visonic Dome™ has a light that shuts off when the
Santion 7-3
3
ID :
Lons Comfort, Inc.
ultrasound stops, which colncides with the end of a 10 minute cycle. Lensonic has a light that shuts off at the end of 10 minutes.
To create cavitation, the Visonic Dome" uses a piezo-electric crystal. affixed to the battom of the stainless steel reservoir. Lansonic uses a plezo-electric crystal combined with a multi-part transducer affixed to a palycarbonate tank. Lens Comfort uses a plezo-electric crystal affixed to the bottom of a stainless steel reservoir.
The Visonic Dome" runs ultrasound for 10 minutes. Lensonic® runs ultrasound for 3 plus minutes. Lons Comfort rune ultrasound for approximately 3 minutos.
[807.92]b)(1)})
Evaluation of the Lens Comfort Device, based on a protocol used by the Industry to assess the effectiveness of systems and solutions designed to clean contact lenaes. Was conducted by an optometriat who is director of optometric bervices In a large ophthalmology practice.
A protocol was obtained from the Office of Device Eveluation (ODE) that has been used by the industry to assess the affactiveness of devices and cleaning anutions and their impact, if any, on the contact lenses. Lenses were selected from Group 1, Group 3, Group 4 and the Gas Permeable class. They were soaked in an artificial tear solution. Physical and optical parameters were measured before the lenses were treated with the artificial tear solution and then after each cycle. Thirty (30) cyclas were performed on all lenses.
No ahanges were noted in color, olority, power, diameter or base curve. The lenses all appeared clear and no deposits or residue or damage were noted on any of the lenses.
The Company did hot have access to comparative data from the predicate devices, but believe that the test results recorded by the investigator were sufficient to oupport the promise that the Company's dovice porforms to the atandards insonded by the protocol.
[807.92(b)(2))
Clinical deto la not needed and has not been submitted with this 610(k),
[807.92(b)(3))
The data gethered from the cycling tests, strongly supports subscantlal equivalnor, between the Lens Comfort Device and predicato davices classified as contact lans care socassorias. Cyoling tests produced no physical or option! persmeter charges
Section 7-4
4
Lans Comfort, Ino.
19 :
after 30 cycles. There was no reported deposits or residual film observed on test lenses after the tests were concluded. There was its damage to lenses observod. The Lens Comfort device reference the same solutions es the predicate devices.
Section 7-5
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