(62 days)
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings.
This 510(k) summary (K090938) describes a Micro Flow Punctal Occluder, a medical device intended for the treatment of "dry eye" conditions. The submission makes a case for substantial equivalence to a predicate device (Odyssey Punctal Occluder, K970631) rather than directly presenting a study to prove new acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them is not explicitly available in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device.
Here's an explanation based on the provided text:
- Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the form of measurable acceptance criteria or performance metrics derived from a study. The submission asserts substantial equivalence based on material, design, and intended use.
- Study Details: There is no description of a study conducted to demonstrate the device's performance against specific acceptance criteria.
Key points from the 510(k) summary regarding the device and its comparison to the predicate:
- Device Description: The Micro Flow Punctal Occluder is made of medical grade silicone with titanium dioxide as a colorant and a proprietary surface treatment. It's a small, "plug" shaped design.
- Intended Use: Treatment of "dry eye" conditions through partial occlusion of individual punctal openings.
- Predicate Device: Odyssey Punctal Occluder (K970631).
- Differences from Predicate (Micro-Flow vs. Original Odyssey Plug):
- Original: Larger angle nose, no through hole, shorter length.
- Micro-Flow (New):
- Has a through hole for partial occlusion.
- A 0.002 ridge on the nose to support the through hole.
- Smaller angle on the nose (tip).
- Safety and Reversibility: The document highlights that the submitted method is functionally safe and fully reversible, unlike some alternative methods that are permanent or difficult to reverse, or risk damaging intact tissue.
In summary, the provided document does not contain the details of a study with acceptance criteria, sample sizes, expert qualifications, or adjudication methods as requested. It is a 510(k) submission relying on substantial equivalence to a predicate device.
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Image /page/0/Picture/1 description: The image shows the word "ODYSSEY" in a stylized font. To the left of the word is a graphic of an arrow piercing through three concentric circles. The arrow is pointing towards the right, and the circles are arranged around the arrow's shaft. The word "ODYSSEY" is written in all capital letters, with each letter outlined in black.
Odyssey Medical, Ir 2975 Brother Blvd. Bartlett, TN 38133 Ph 901-383-777 Fax 901-382-2712
JUN - 4 2009
510K Summary
Submitted: 03/12/2009 By: Terry Green Registration Number: 1060840 Trade Name: Punctal Occluder Common Name: Plug, Punctum Product Name: Micro Flow Classification Name: LZU Classification Panel: Ophthalmic Device Class: Unclassified Performance Standards: None Established
Summary:
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings. By material, design and intended use, Micro Flow is substantially equivalent to the previous Odyssey Punctal Occluder (K970631).
Differences between the two devices may be described as follows:
The original Odyssey plug under 510 K970631 has a larger angle nose, no through hole and shorter in length.
The new design "Micro-Flow" is similar to the original plug with the exceptions of the following:
- A through hole which allows for partial occlusion of individual punctual openings. .
- A .002 ridge on nose to help support the designed through hole. .
- Angle on nose (tip) is smaller. ●
Alternative methods of punctual occlusion are either permanent or difficult to reverse. In contrast, the submitted method is both functionally safe and fully reversible. Unlike some other methods, this device does not require the breach of intact tissue surfaces or the risk of damaging said surface should reversal become desirable.
Kim Finch for Jerry Green Kim Finch
(Signature) (Typed Name)
6/2/09
(Date)
(Premarket Notification [510(k)] Number)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oddyssey Medical. Inc. c/o Terry R. Green 2975 Brother Blvd. Bartlett, Tennessee 38133
Re: K090938
Trade/Device Name: Micro Flow Punctal Occluder Regulatory Class: Unclassified Product Code: LZU Dated: March 26, 2009 Received: April 3, 2009
Dear Mr. Green:
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 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 (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.
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Malvina B. Eplehnus, m.d.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) K090938 Number:
Name: Micro Flow Device
Indications for Use:
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.
Prescription Use
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
AND/OR
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number_109
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Division of Ophthalmic and Ear, Nose and Throat Devices
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