SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG

K020882 · Surgical Specialties Corp · LZU · Jul 26, 2002 · OP

Device Facts

• Record ID: K020882
• Device Name: SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG
• Applicant: Surgical Specialties Corp
• Product Code: LZU · OP
• Decision Date: Jul 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Sharpoint® UltraPlug™ Extended Wear Plug may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases. When indicated, UltraPlug™ Extended Wear Plugs may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of ocular medications. Patients experiencing dry eye related contact lens problems also may be aided by UltraPlug™ Extended Wear Plugs.

Device Story

Sharpoint UltraPlug Extended Wear Plug is a synthetic, absorbable punctum plug designed for temporary lacrimal occlusion to treat dry eye symptoms. The device is inserted into the canaliculus to reduce tear drainage. It is manufactured from ε-Caprolactone-L-Lactide copolymer (PCL), an absorbable suture material that dissolves in approximately 180 days. Available in multiple diameters (0.2mm, 0.3mm, 0.4mm) and lengths (1.6mm, 2.0mm). The device is intended for use by clinicians to provide longer-term occlusion compared to collagen inserts (7-10 days) while remaining temporary, unlike permanent silicone plugs. By blocking the canaliculus, the plug increases tear film volume, potentially relieving symptoms like redness, burning, itching, and foreign body sensation, and enhancing the efficacy of topical ocular medications.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by material characterization, biocompatibility studies, and absorption data referenced from K003015.

Technological Characteristics

Material: ε-Caprolactone-L-Lactide Copolymer (PCL) synthetic absorbable suture. Dimensions: 1.6mm or 2.0mm length; 0.2mm, 0.3mm, or 0.4mm diameter. Mechanism: Passive mechanical lacrimal occlusion. Absorption profile: ~180 days.

Indications for Use

Indicated for patients with dry eye syndrome, dry eye components of ocular surface diseases (e.g., corneal ulcers, conjunctivitis, pterygium, blepharitis, keratitis, red lid erosion, filamentary keratitis), post-ocular surgery patients requiring dry eye complication prevention or medication retention, and patients with dry eye-related contact lens issues.

Predicate Devices

• Surgidev Silicone Punctum Plug
• US IOL Inc, Occu-Flo Punctum Plug
• Eagle Vision Temporary Intracanalicular Collagen Insert
• Surgical Specialties Corporations Temporary Intracanalicular Collagen Implant

Submission Summary (Full Text)

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# JUL 2 6 2002

#### 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS 5. SUBSTANTIAL EQUIVALENCY

| Submitter<br>Address: | Surgical Specialties Corporation<br>100 Dennis Drive<br>Reading, PA 19606 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Contact Person: | 610 404 1000, ext. 2231<br>Elizabeth Lazaro<br>Regulatory Affairs Specialist |
| Date Prepared: | March 15, 2002 |
| Name of Device: | Sharpoint® UltraPlug™ Extended Wear Plug |
| Common / Usual<br>Classification Name: | Punctum Plug |
| Predicate Devices: | Indications for use Predicate Devices:<br>Surgidev Silicone Punctum Plug,<br>US IOL Inc, Occu-Flo Punctum Plug,<br>Eagle Vision Temporary Intracanalicular Collagen<br>Insert<br>Surgical Specialties Corporations (formerly Look, Inc.) Temporary<br>Intracanalicular Collagen Implant.<br>Material Predicate Device:<br>Surgical Specialties Corporation's PCL Monofilament Synthetic<br>Absorbable Suture Material. |
| Device Description | UltraPlug Extended Wear Punctum Plug are intended for<br>temporary use with patients experiencing dry eye symptoms such<br>as redness, burning, reflex tearing, itching or foreign body<br>sensations which can be relieved by blockage of the canaliculus.<br>The Sharpoint UltraPlug Extended Wear Plug is made from<br>absorbable suture material. The plugs are available in two lengths<br>1.6mm and 2.0mm, and in three diameters: 0.2mm, 0.3mm and<br>0.4mm |
| Indications of Use: | UltraPlug™ Extended Wear Punctum Plugs<br>may be used in the treatment of dry<br>eye syndrome and the dry eye components of various<br>ocular surface diseases such as corneal ulcers,<br>conjunctivitis, pterygium, blepharitis, keratitis, red lid<br>erosion, filamentary keratitis and other external eye<br>diseases. When indicated, UltraPlug Extended Wear<br>Punctum Plug may be used after ocular surgery to<br>prevent complications due to dry eye and to enhance the<br>retention of ocular medications. Patients experiencing<br>dry eye related contact lens problems also may be aided<br>by UltraPlug Extended Wear Punctum Plugs. |
| Technological<br>Characteristics | UltraPlug™ Extended Wear Punctum Plug<br>is made of PCL Absorbable Synthetic Suture material, ε-<br>Caprolactone-L-Lactide Copolymer. This material has<br>been approved for ophthalmic usage in SSC's 510(k)<br>K003015. The material has been well characterized<br>through absorption studies and biocompatibility studies.<br>The product is similar to the predicate device, Eagle<br>Vision Temporary Intracanalicular Collagen insert, in<br>that they are both made from absorbable materials. |
| Punctum Plugs: | PCL' Plugs are a synthetic absorbable suture material,<br>which will dissolve in 180 days (reference 510(k)<br>K003015 data).<br><br>Collagen Plugs provide temporary lacrimal occlusion by<br>reducing tears drainage through Partial blockage of the<br>horizontal canaliculus. Collagen Plugs dissolve in 7 to<br>10 days.<br><br>Silicone Plugs are permanent in that they do not<br>dissolve. |

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Specialties Corporation c/o Ms. Elizabeth Lazaro Regulatory Affairs Specialist 100 Dennis Drive Reading, PA 19606 3776

JUL 2 6 2002

K020882 Re:

> Trade Name: Sharpoint® UltraPlug™ Extended Wear [Punctal] Plug Regulatory Class: Unclassified Product Code: LZU Dated: June 25, 2002 Received: June 26, 2002

Dear Ms. Lazaro:

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 such 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); 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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..

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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### 4. FDA INDICATIONS FOR USE FORM

510(k) Number (if known): _ KO20882

Sharpoint® UltraPlug™ Extended Wear Plug Device Name:

Indications for Use:

Sharpoint® UltraPlug™ Extended Wear Plug may be used in the treatment of dry eve syndrome and the dry eye components of various ocular surface diseases. When indicated, UltraPlug™ Extended Wear Plugs may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of ocular medications. Patients experiencing dry eye related contact lens problems also may be aided by UltraPlug™ Extended Wear Plugs.

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CONCURRENCE OF CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109)

+

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Duna R. Kirchner

(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devises

510(k) Number KO