← Product Code LZU · K980844 # SURGIDEV SILICONE PUNCTUM PLUG (K980844) _Advanced Vision Science · LZU · May 11, 1998 · OP · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K980844 ## Device Facts - **Applicant:** Advanced Vision Science - **Product Code:** LZU - **Decision Date:** May 11, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** OP - **Attributes:** Therapeutic ## Intended 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. ## Device Story Flexible medical-grade silicone plug; inserted into punctum by clinician; functions via mechanical occlusion of lacrimal duct; reduces lacrimal flow to increase tear retention; treats dry eye symptoms and ocular surface diseases; enhances efficacy of topical medications; aids patients with contact lens-related dryness; no electronic or software components. ## Clinical Evidence No clinical data. ## Technological Characteristics Material: Medical grade silicone. Form factor: Flexible plug, 2.0 mm length, 0.8 mm diameter. Principle: Mechanical occlusion of the punctum. No energy source, connectivity, or software. ## Predicate Devices - Soft Plug™ (marketed by Oasis) - Punctum Plug (marketed by FCI Ophthalmics) - Tapered-Shaft Punctum Plug (marketed by Eagle Vision and Ciba Vision) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ MAY | | 1998 Image /page/0/Picture/1 description: The image shows the logo for Surgidev Corporation. The logo consists of a circular symbol to the left of the word "SURGIDEV", with the word "CORPORATION" underneath. The logo is black and white and has a registered trademark symbol. Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '8', '0', '8', '4', and '4'. The digits are written in a cursive style, with some of the digits connected to each other. The overall appearance of the sequence is somewhat messy and uneven. ## 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 and
Ciba Vision) | | Device Description: | A flexible silicone ophthalmic device designed to fit and be
retained in the punctum. | | Device Use: | Used to enhance retention of eye fluids by occlusion of one or
more punctum, reducing lacrimal flow. Useful for treatment of dry
eye and other conditions where enhancement of tear retention is
indicated. | ## Comparison To Predicate Devices: | Device Name
Features | Surgidev Silicone
Punctum Plug
(Surgidev) | Soft Plug™
(Oasis) | Punctum Plug
(FCI) | Tapered-Shaft Punctum
Plug
(Eagle Vision & Ciba) | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------| | 1. Indications
claimed | Treatment of dry eye
after surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment
aid | Treatment of dry eye
after surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment
aid | (Not available) | Treatment of dry eye | | 2. Function | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | | 3. Design - Length
Diameter (typical) | 2.0 mm
0.8 mm | 2.0 mm
0.8 mm | 2.0 mm
0.8 mm | 1.8 mm
0.7 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ ## 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 {3}------------------------------------------------ 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |------------------|--------------------------------------------------------|--------------------------| | | Signature | 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) | --- **Source:** [https://fda.innolitics.com/device/K980844](https://fda.innolitics.com/device/K980844) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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