(68 days)
The Surgidev Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex learing, itching or foreign body sensations which can be relieved by blockage of the punctum.
The Surgidev Sillcone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as comeal ulcers, conjunctivitis, pterygium, blepharitis, keratils, red lid margins, recurrent chalazions, recurrent comeal eroston, filamentry keratitis and other external eye diseases.
When indicated the Surgidev Silicone Puncture Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing ocular dryness secondary to contact lens use may also be alded by Slicone Puncturn Plugs.
A flexible silicone ophthalmic device designed to fit and be retained in the punctum.
Here's an analysis of the provided text regarding the Surgidev Silicone Punctum Plug:
Acceptance Criteria and Device Performance
Based on the provided documents, there are no explicit acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) submission process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct performance against formal acceptance criteria through clinical studies.
The document states: "Clinical Tests: None" and "Adverse S&E Information: None". This strongly indicates that no specific performance metrics with acceptance criteria were defined or tested in a clinical setting for this device. The basis for clearance was comparison to predicate devices, which means that the device is considered substantially equivalent if its indications for use, technological characteristics, and safety and effectiveness are similar to those of a pre-existing device.
Therefore, the table below reflects that there are no specified acceptance criteria or reported performance data from a clinical study within these documents.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| No specific acceptance criteria are described in the provided document. | No specific device performance metrics from a clinical study are reported in the provided document. |
Detailed breakdown of why specific sections are unanswered based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No clinical tests or test sets are mentioned. The clearance is based on comparison to predicate devices and general controls.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is mentioned.
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
- Not applicable. This device is a physical medical device (punctum plug), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm. Standalone performance studies are not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No clinical studies or ground truth establishment are mentioned. The basis for clearance relies on substantial equivalence to predicate devices, which implies that the safety and effectiveness of the device type are already established.
8. The sample size for the training set
- Not applicable. No "training set" in the context of an algorithm or clinical study is mentioned.
9. How the ground truth for the training set was established
- Not applicable. No "training set" or ground truth establishment for it is mentioned.
Summary of what was done for this device's clearance:
The device (Surgidev Silicone Punctum Plug) received 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (Soft Plug™, Punctum Plug (FCI Ophthalmics), and Tapered-Shaft Punctum Plug). This equivalence was established by comparing:
- Indications Claimed: The indications for the Surgidev device (Treatment of dry eye, enhance efficacy of medications, treatment of contact lens problems, adjunctive treatment aid) are similar to those of the predicate Soft Plug™ and Tapered-Shaft Punctum Plug.
- Function: All devices cause occlusion of the punctum to retain tears.
- Design (Length/Diameter): The Surgidev device's typical length (2.0 mm) and diameter (0.8 mm) are identical to the Soft Plug™ and FCI Punctum Plug, and very similar to the Tapered-Shaft Punctum Plug.
- Material: All compared devices are made from Medical Grade Silicone.
The FDA's review concluded that, based on these comparisons and subject to general controls, the device is substantially equivalent to legally marketed predicate devices, and therefore can be marketed. No new clinical safety or effectiveness data were required or submitted for this specific 510(k) clearance.
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MAY | | 1998
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510(k) Notification Summary
| Device Name: | Surgidev Silicone Punctum Plug |
|---|---|
| Device Common Name: | Punctum Plug |
| Classification Name: | Punctum Plug (86LZU) |
| Predicate Devices: | • Soft Plug™ (marketed by Oasis) |
| • Punctum Plug (marketed by FCI Ophthalmics) | |
| • Tapered-Shaft Punctum Plug (marketed by Eagle Vision andCiba Vision) | |
| Device Description: | A flexible silicone ophthalmic device designed to fit and beretained in the punctum. |
| Device Use: | Used to enhance retention of eye fluids by occlusion of one ormore punctum, reducing lacrimal flow. Useful for treatment of dryeye and other conditions where enhancement of tear retention isindicated. |
Comparison To Predicate Devices:
| Device NameFeatures | Surgidev SiliconePunctum Plug(Surgidev) | Soft Plug™(Oasis) | Punctum Plug(FCI) | Tapered-Shaft PunctumPlug(Eagle Vision & Ciba) |
|---|---|---|---|---|
| 1. Indicationsclaimed | Treatment of dry eyeafter surgeryEnhance efficacy ofmedicationsTreatment of contactlens problemsAdjunctive treatmentaid | Treatment of dry eyeafter surgeryEnhance efficacy ofmedicationsTreatment of contactlens problemsAdjunctive treatmentaid | (Not available) | Treatment of dry eye |
| 2. Function | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater tear retention | Causes occlusion ofpunctum, resulting ingreater tear retention |
| 3. Design - LengthDiameter (typical) | 2.0 mm0.8 mm | 2.0 mm0.8 mm | 2.0 mm0.8 mm | 1.8 mm0.7 mm |
| 4. Material | Medical Grade Silicone | Medical Grade Silicone | Medical Grade Silicone | Medical Grade Silicone |
Clinical Tests:
None
Adverse S&E Information: None
i Dennis V. Dunlahl
Dennis T. Grendahl Presdient & CEO
2/27/98
Date
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 1 1998
Khalid Mentak, Ph.D. Surgidev Corporation 5743 Thornwood Drive Goleta, CA 93117
Re: K980844 Trade Name: Surgidev Silicone Punctum Plug Regulatory Class: Unclassified Product Code: LZU Dated: February 27, 1998 Received: March 4, 1998 Amended: May 6, 1998
Dear Mr. Grendahl:
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. Dennis T. Grendahl
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. Ralph L. Rosenthal
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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510(k) Number (If known);
Device Name: Silicone Puncturn Plugs
Indications For Use:
The Surgidey Silicone Punctum Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex learing, itching or foreign body sensations which can be relieved by blockage of the punctum.
The Surgidey Sillcone Punctum Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases such as comeal ulcers, conjunctivitis, pterygium, blepharitis, keratils, red lid margins, recurrent chalazions, recurrent comeal eroston, filamentry keratitis and other external eye diseases.
When indicated the Surgidev Silicone Puncture Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing ocular dryness secondary to contact lens use may also be alded by Slicone Puncturn Plugs.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| FOR DRL | ||
| (Division Sign-Off) | ||
| Division of Ophthalmic Devices | ||
| 510(k) Number: 980844 | ||
| Prescription Use | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |
N/A