DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE

K990671 · Hurricane Medical · HOZ · May 10, 1999 · Ophthalmic

Device Facts

• Record ID: K990671
• Device Name: DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE
• Applicant: Hurricane Medical
• Product Code: HOZ · Ophthalmic
• Decision Date: May 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4790
• Device Class: Class 2

Intended Use

These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.

Device Story

Hurricane Medical ophthalmic devices include corneal light shields, surgical spears, sponges, instrument wipes, and fluid wicks. Corneal light shields protect the retina from operating microscope light and maintain corneal moisture. Surgical spears and sponges absorb blood, tissue debris, and vitreous during anterior segment surgery. Instrument wipes clean surgical instruments and blades. Fluid wicks drain excess saline from the surgical site via capillary action. All devices are manufactured from hydrophilic polyvinyl alcohol (PVA) sponge (pore size ~100 microns) or other absorbent materials like hydrocellulose, viscose, or cotton. Devices are used by ophthalmic surgeons and surgical staff in clinical settings. They are sterile, single-use, and intended to improve surgical site visibility and patient safety by preventing infection and light-induced retinal damage.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on established material safety and historical use of similar ophthalmic sponges, wicks, and shields in surgical practice.

Technological Characteristics

Materials: Hydrophilic polyvinyl alcohol (PVA) sponge (approx. 100 micron pore size), hydrocellulose, viscose, cotton. Sterilization: Gamma radiation per ISO 11137, 10^-6 SAL. Form factor: Spears, sponges, wicks, and corneal shields. Non-linting.

Indications for Use

Indicated for use during ophthalmic surgery to remove excess fluid and debris from the surgical site or instruments, and to protect the cornea and retina from light exposure and desiccation.

Regulatory Classification

Identification

An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

Submission Summary (Full Text)

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MAY 1 0 1999

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Summary of Safety and Effectiveness Corneal Light Shield

In 1968, Kuwabara et al. demonstrated that light exposure from an ophthalmoscope would cause varying degrees of damage ranging from total degeneration of the whole retina to minimal changes in the photoreceptors. Archives in Ophthalmology, 1968; 79:69-77.

In 1979, Hochheimer et al. first described retinal changes that are caused by exposure to the light from an operating microscope and a slit lamp. American Journal of Ophthalmology, 1979; 88:1039-1044.

Ophthalmic surgeons have been protecting the cornea since about 1979. At that time, they began using paper punch discs of opaque trash bags. In 1984, Schwartz et al introduced an opaque silicone corneal shield. The shield could be used in cataract and lens implantation and may have application for vitrectomy, pterygium, and lid procedures. It was reported that the device was non-toxic to the corneal epithelium. Ophthalmology Times, September 15, 1994, p. 9.

Olander et al. described a variety of corneal occluder materials that include hydrated HEMA, sponge, PMMA, and silicone. Use of the corneal occluder is a simple way to reduce the light exposure delivered to the retina by the operating microscope. The ideal occluder should have a light transmittance close to zero and should be made of a hydrating material. The author reported that he had used corneal occluders for years during routine cases and found them safe and effective. Ophthalmic Surgery, 1991; 22:356-357.

Hurricane Medical corneal light shields are manufactured from non-linting hydrophilic polyvinyl alcohol sponge with a pore size of approximately 100 micron.

Hurricane Medical utilizes Gamma radiation for product sterilization. Processing is in accordance with ISO 11137. The sterilization process is validated periodically and provides a 10° sterility assurance level (SAL).

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#### Summary of Safety and Effectiveness Instrument Wipes

Wipes are commonly used to clean surgical instruments and gem blades. The nonlinting types of wipes don't leave debris on the instrument and will not drag on blades or serrated tips.

Hurricane Medical wipes are made from medical grade nonlinting hydrophilic polyvinyl alcohol (PVA) sponge.

Hurricane Medical utilizes Gamma radiation for product sterilization. Processing is in accordance with ISO 11137 and European Standard EN552 for medical device sterilization process is validated periodically and provides a 10t6 sterility assurance level (SAL).

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## Summary of Safety and Effectiveness for Surgical Spears and Sponges

Surgical spears and sponges were developed by surgical staff to keep the surgical site clean and free from blood and tissue debris. Also, they are used to remove lost vitreous during anterior segment surgery. Ophthalmic Surgery, 1975 Summer; 6(2):58-66.

Later, the nonlinting material polyvinyl alcohol was introduced as a neurosurgical pattie and then incorporated as an ophthalmic microsponge. Journal of Neurosurgery, 54, Feb. 1981.

Hurricane Medical Eye Sponges and Spears are highly absorbent materials designed for absorption of fluids during eye surgery.

Absorbent materials will include hydrocellulose, polyvinyl alcohol, viscose and US-origin cotton.

Hurricane Medical utilizes Gamma radiation for product sterilization. Processing is in accordance with ISO 11137. The sterilization process is validated periodically and provides a 10 sterility assurance level (SAL).

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#### Summary of Safety and Effectiveness Fluid Wicks

During eve surgery, it is important to keep the comea surface moist continuously. This is commonly achieved by dripping saline on the eye at regular intervals. The excess flows and forms a pond in the nasal or temporal canthal triangle. Blanksma et al., Ophthalmic Surgery, 14:501.

Absorption or mechanical removal, which includes aspiration, must handle the fluid runoff, by a catheter connected to a suction pump. Freeman et al., Atlas of Vitreoretinal Surgery, 1990, p. 42-45.

The conjunctiva is contaminated with microorganisms even after washing with antibiotic solution. This creates a danger of the dripping solution back flowing into the surgically opened area which may result in an intraocular infection.

In 1983, Blanksma et al. devised a simple drain constructed from a woven cotton strip that is laid down in the lower fornix and stretched along the side of the face. The device works on capillary action and is adequate for draining fluid away from the surgical site. Ophthalmic Surgery, 14:501.

Hurricane Medical fluid wicks are made from non-linting polyvinyl alcohol (PVA) sponge with a pore size of approximately 100 microns.

Hurricane Medical utilizes Gamma radiation for product sterilization. Processing is in accordance with ISO 11137. The sterilization process is validated periodically and provides a 10 sterility assurance level (SAL).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 1999

Mr. David A. Clapp Regulatory Affairs Head Official Correspondent Hurricane Medical 2331K 63td Avenue East Bradenton, FL 34203

Re: K990671

Trade Name: Drainage Wick; Surgical Spears and Sponges, Corneal Light Regulatory Class: II Product Code: 86 HOZ Dated: April 13, 1999 Received: April 19, 1999

Dear Mr. Clapp:

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. David A. Clapp

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 [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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph 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 : K990671

Device Name: Drainage Wick, Sugical Spears and Sponges, Corneal Light Shield

Indications For Use:

These devices are used to remove excess fluid and debris from the surgical area or instrument. Also, placed on the cornea to moisten the cornea and protect the retina from the intense operating light during ophthalmic surgery.

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Concurrence of CDRH, office of Device Evaluation (ODE)

A Prescription Use

or

Over-the -counter use ________________________________________________________________________________________________________________________________________________________

Janice W.L. Brown, Ph.D.

Division of Ophthalmic Devices

510(k) Number K990671