(64 days)
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome. "dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;" ... etc. Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
The provided text describes a 510(k) premarket notification for a Punctal Occluder device (K972523), comparing it to a previously marketed Odyssey Punctal Occluder. The submission focuses on demonstrating substantial equivalence.
Based on the provided text, the following information regarding acceptance criteria and a study to prove it can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with numerical performance metrics as would be seen in a clinical study for a new device. Instead, the acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to a predicate device.
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of medical grade silicone, titanium dioxide as a colorant, and proprietary surface treatment. | The new device is stated to be "made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices." This matches the description of the previous device implicitly, as the claim is substantial equivalence. |
| Design Equivalence (functional): Small, generally "plug" shaped design for total occlusion of individual punctal openings. | The description states it is a "small, generally 'plug' shaped design." While there are design differences (larger overall diameter, smaller effective nose, shorter length), these are presented as enhancements for ease of insertion, removal, and anchoring, rather than fundamental changes to the core function of occlusion. The claim is that "By material, design and intended use, the Odyssey Punctal Occluder is substantially equivalent to the previous Odyssey Punctal Occluder." |
| Intended Use Equivalence: Treatment of "dry eye" conditions through total occlusion of individual punctal openings. | The new device is intended "for the treatment of 'dry eye' conditions through the total occlusion of individual punctal openings," which is the same intended use as the predicate. |
| Biocompatibility: Surface treatment does not reduce biocompatibility. | "Testing has indicated that the surface treatment does not reduce the biocompatibility of the device." (No specific test results or metrics are provided in this summary.) |
| Safety and Reversibility: Functionally safe and fully reversible, without breaching intact tissue surfaces or risk of damage upon reversal. | "Alternative methods of punctal 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 nor the risk of damaging said surfaces should reversal become desirable." This highlights comparison to alternative methods, reinforcing the safety profile, but doesn't explicitly state new device performance vs. predicate on these specific metrics. |
2. Sample size used for the test set and the data provenance:
The provided text does not include information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on design and material comparisons, and a statement about biocompatibility testing, rather than a clinical performance study using a defined test set of patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document. As there's no mention of a clinical test set with patient outcomes, there's no need for experts to establish ground truth in the context of this 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not present in the provided document. The device is a physical punctal occluder, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided document. The device is a physical medical device and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically applied to diagnostic algorithms or AI models is not directly relevant here. For this 510(k) submission, the "truth" being established is the substantial equivalence of the new device to the predicate device in terms of materials, design, intended use, and safety. This is established through the manufacturer's self-declaration and substantiation, reviewed by the FDA. The biocompatibility statement suggests in vitro or in vivo testing, but the nature of the "ground truth" (e.g., specific assays, observed reactions) is not detailed.
8. The sample size for the training set:
This information is not present in the provided document. As it is a physical device, there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not present in the provided document, for the same reason as point 8.
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Image /page/0/Picture/3 description: The image shows the word "ODYSSEY" followed by "- K 972523". The word "ODYSSEY" is in a sans-serif font, and the numbers are handwritten. To the left of the word "ODYSSEY" is a logo that appears to be a circle with lines inside.
a look SEP
SECTION 5 - 510(K) SUMMARY
Submitted: August 28, 1997
By: Raymond G. Wallace
Trade Name: Punctal Occluder
Common Name: Punctum Plugs
Classification Name: Punctum Plugs (per 21 CFR § 886)
Summary:
This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.
By material, design and intended use, the Odyssey Punctal Occluder is substantially equivalent to the previous Odyssey Punctal Occluder.
Differences between the two devices may be described as follows:
The old Odyssey plug has a larger "solid" diameter nose, whereas the new plug has a larger overall diameter, but a smaller "effective" or "solid" diameter nose to ease required insertion pressure and removal trauma. The new plug is also somewhat shorter to enhance the anchoring of the flange under the fibroelastic punctal ring.
The new plug has been surface enhanced utilizing ion beam technology to reduce the friction and increase the hydrophilicity of the plug for additional ease of insertion and comfort for the wearer. Testing has indicated that the surface treatment does not reduce the biocompatibility of the device.
Alternative methods of punctal 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 nor the risk of damaging said surfaces should reversal become desirable.
ODYSSEY Medical, Inc. / 1710 Shelby Oaks Drive, Suite 21 / Memphis, TN 38134 / 901-383-777 / Fax 901-382-2712
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Raymond A. Wallace Director, Technical Services Odyssey Medical, Inc. 1710 Shelby Oaks Dr., Suite 21 Memphis, TN 38134
9 1997 SEP
Re: K972523 Trade Name: Punctal Occluder Regulatory Class: Unclassified Product Code: 86 LZU Dated: July 1, 1997 Received: July 7, 1997
Dear Mr. Wallace:
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. Raymond A. Wallace
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl lorential
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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STATEMENT OF INDICATIONS FOR USE
Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome. "Dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;" ... etc. Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.
10-0 Dorne
(Division Sign-Off) Division of Ophthalmic Devices 4972523 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
2-1
1 Taber's Cyclopedic Medical Dictionary © 1989
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