AMOILS EPITHELIAL SCRUBBER

K962989 · S. Percy Amoils · HOG · Jan 9, 1997 · Ophthalmic

Device Facts

• Record ID: K962989
• Device Name: AMOILS EPITHELIAL SCRUBBER
• Applicant: S. Percy Amoils
• Product Code: HOG · Ophthalmic
• Decision Date: Jan 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4070
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Device Story

Amoils Epithelial Scrubber is a powered, hand-held device used by surgeons to remove corneal epithelium. The device features a rotating brush tip (6.3mm diameter) composed of Tynex microfilaments, which rotates at approximately 1500 RPM. The device neck is angled at 90 degrees to improve visualization under a microscope during surgery. The surgeon applies the rotating brush to the cornea for 3-5 seconds to remove the epithelium while preserving Bowman's layer and the peripheral epithelial rim. This mechanical removal avoids the use of alcohol, preventing stromal dehydration. The device is intended for use in a clinical or surgical setting to prepare the cornea for subsequent procedures, such as laser surgery, facilitating rapid epithelial regrowth and healing.

Clinical Evidence

Clinical evidence includes bench testing on eye bank eyes using SEM and TEM imaging to confirm epithelial removal without damage to Bowman's layer, including 'worst-case' testing (double duration and excessive pressure). A clinical study of 500 human eyes demonstrated a procedure time of 3-5 seconds, consistent with the predicate, and observed rapid central epithelial regrowth due to preservation of the peripheral epithelial rim.

Technological Characteristics

Powered hand-held corneal burr. Tip: Tynex microfilament brush, 6.3mm diameter. Rotation: ~1500 RPM. Geometry: 90° angled neck. Usage: Single-use brush tip. Energy source: Powered (motorized).

Indications for Use

Indicated for patients undergoing corneal surgery requiring deepithelialization of the central cornea. No specific age or gender contraindications provided.

Regulatory Classification

Identification

A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

Predicate Devices

• Pallikaris Automated Epithelial Removal Brush (K960261)

Submission Summary (Full Text)

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BURDITT & RADZIUS, CHARTERED
JAN - 9 1997
333 WEST WACKER DRIVE, SUITE 2600
CHICAGO, ILLINOIS 60606-1218
FAX: [phone]
TELEPHONE: [phone]
510(K) SUMMARY¹ K962989

## 1. Name and Address

The U.S. Contact is

Dr. S. Percy Amoils,
134 Grayston Drive, Suite 1K,
Sandown, Sandton 2010,
South Africa.
(27) 11 884 5624/5.

Mr. Richard O. Wood
Burditt & Radzius, Chtd.
333 W. Wacker Dr.
Suite 2600
Chicago, IL 60606-1218
[phone]
[phone] fax

Date Summary Prepared: December 23, 1996

## 2. Name of the Device

Tradename: Amoils Epithelial Scrubber
Common name: Corneal Epithelial Removal Device
Classification: Powered corneal burr, Class I, 21 CFR §886.4070
Panel: 86 Ophthalmic
Procode: HOG (Burr, Corneal)

## 3. Identification of Predicate Device(s)

The Pallikaris Automated Epithelial Removal Brush, K960261

## 4. Description of the Device

The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered hand-held device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.

## 5. Intended Use of the Device

The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.

¹ The FDA Checklist for summaries is attached.

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6. Comparison of Technological Characteristics

| Item to be Compared | Amoils Epithelial Scrubber | Pallikaris Epithelial Removal Brush, K960261 |
| --- | --- | --- |
| Intended Use | deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea. | removal of the corneal epithelium prior to T-PRK® or PRK surgery |
| Tips, material | Tynex microfilament | soft plastic "pins" derived from a surgical hand brush |
| Tips, size | 6.3mm | 7mm |
| Tips, usage | single use | single use |
| Angle of Device Neck | 90° | 0° |
| Removal Time | 3-5 seconds | 2-5 seconds |

The differences between the epithelial scrubber and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way. The difference in tip size does not affect safety and effectiveness, because the treatment zones can be increased with both devices by moving the device sideways to create a larger diameter. The 90° angle in the neck of the Amoils scrubber permits easier visualization of the epithelial removal by the surgeon, and the Tynex microfilaments of the Amoils device and the soft plastic "pins" of the Pallikaris brush are comparable.

7. Performance Data

The Amoils epithelial scrubber was used according to the instructions for use on eyes drawn from an eye bank. The eyes were then subjected to SEM and TEM photos, which confirmed that the epithelium was removed and the surface of the cornea was extremely smooth, with no damage to Bowman's layer. In addition, certain of the eye bank eyes were exposed to "worst case" treatments with the device, i.e., at twice the time and with excessive pressure. The photos from that part of the study again confirmed that the epithelium was removed and the surface of the cornea was extremely smooth, with no damage to Bowman's layer

The device was evaluated on 500 human eyes in a study conducted in South Africa. The procedure took from 3 to 5 seconds, confirming its equivalence to the reported speed of the Pallikaris brush (2 to 5 seconds). It was also found to promote quick healing, because the procedure does not remove the healthy epithelial rim from the 7 mm. zone to the limbus. This facilitates rapid central epithelium regrowth.

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8. Safety and Effectiveness

Based on the data presented in this PMN, the Amoils epithelial scrubber is safe and effective:

- It permits rapid removal of the central 7 mm. corneal epithelium without damage to the harder Bowman's layer lying underneath.

- The Bowman's layer is not dried out by alcohol used in certain procedures and uneven dehydration of the stroma after mechanical scraping is eliminated.

- It is easy to visualize and manipulate through the microscope in the laser apparatus.

- No epithelial "tags" remain after the scrub.

- It promotes quick healing since it leaves intact healthy epithelial rim from the 7 mm. zone to the limbus, which facilitates rapid central epithelium regrowth.

In addition, a manual search in the Product SOS™² book found that no MDRs were reported.

9. Conclusions

The similarity in technological characteristics, coupled with the results of the work on both eye bank and human eyes, demonstrate the safety and efficacy of the Amoils Epithelial Scrubber and support the finding of substantial equivalence to the Pallikaris Epithelial Removal Brush, K960261.

² Product SOS™, Medical Economics Data Production Company, Montvale, NJ 07645-1742.