(161 days)
Not Found
No
The device description and performance studies focus on a mechanical process (rotating brush) for epithelial removal. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation.
No.
A therapeutic device is typically one that treats a disease or condition, whereas this device is used for deepithelialization in preparation for subsequent surgical procedures, not as a standalone treatment for a specific condition.
No
The device is described as an "epithelial scrubber" intended for "deepithelialization of the cornea in preparation for subsequent surgical procedures." Its purpose is to physically remove a layer of tissue, which is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "small, powered handheld device" with a physical brush component, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Amoils Epithelial Scrubber is a surgical device used to physically remove the epithelium from the cornea on the patient's eye. It is a direct surgical tool, not a device that analyzes samples taken from the body.
- Intended Use: The intended use clearly states "deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea." This describes a surgical procedure performed directly on the patient.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.
Product codes
HOG
Device Description
The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 eves in a study conducted in South Africa.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 eves 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Removal Time: 3-5 seconds
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4070 Powered corneal burr.
(a)
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.(b)
Classification. Class I (general 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.
0
BURDITT & RADZIUS, CHARTERED
JAN - 9 1997
333 WEST WACKER DRIVE, SUITE 2600 CHICAGO, ILLINOIS 60606-1218 FAX: (312) 781-6630 TELEPHONE: (312) 781-
510(K) SUMMARY
1. Name and Address
Dr. S. Percy Amoils, 134 Grayston Drive, Suite 1K, Sandown, Sandton 2010, South Africa.
The U.S. Contact is
Mr. Richard O. Wood Burditt & Radzius, Chtd. 333 W. Wacker Dr. Suite 2600 Chicago, IL 60606-1218 (312) 781-6611 (312) 781-6630 fax
(27) 11 884 5624/5.
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 handheld 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.
1
| 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 |
6. Comparison of Technological Characteristics
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 eves 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.
2
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 eve bank and human eves, 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.