(87 days)
The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.
The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.
The provided text describes a 510(k) submission for the "Eye-Deal Eye Irrigator" and a preliminary study conducted to support its substantial equivalence. However, it does not explicitly define acceptance criteria in a quantitative manner or present a rigorous study designed to prove the device meets such criteria. Instead, the study aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define explicit, quantitative acceptance criteria in the way you might expect for a typical performance study (e.g., "device must achieve 90% sensitivity"). Instead, the 'acceptance' is based on demonstrating substantial equivalence to the predicate device, the Morgan Lens. The reported performance is qualitative for the most part.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Efficacy of Irrigation (compared to predicate) | "The Eye Irrigator was efficient in clearance of fluorescein, an indicator dye commonly used as an indicating dye." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Patient Tolerance (compared to predicate) | "The Eye Irrigator was well tolerated by the patient." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Ease of Insertion/Use by Emergency Care Provider (compared to predicate) | "easy to use by the technician." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Material Biocompatibility | "materials passed the required assays" for surface devices/mucosal membrane/short-term ocular membrane contact, in accordance with ISO 10993-1. Materials were pre-qualified as medical or food grade. |
| Sterilization Efficacy | "Validation of the sterilization process... showed that the ethylene oxide gas cycle will reproducibly provide a sterility assurance level of 10-6 for processes meeting the specified cycle parameters." (according to ANSVAAMI/ISO 11135-1994). Note: This is a process validation, not direct device performance in a clinical setting but crucial for safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Six patients and 12 total eyes" were compared.
- Data Provenance: Not explicitly stated, but clinical studies are generally conducted in the country of origin of the submitter unless otherwise specified. Given the company is based in Wisconsin, USA, and the correspondent in Minnesota, USA, it is highly probable the data is from the USA. The study was prospective as it involved actual comparison in patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The study does not describe establishing a "ground truth" using experts in the clinical sense (e.g., diagnosis verification). Instead, it compares the physical performace of two devices in terms of fluorescein clearance, patient tolerance, and ease of use. The "technicians" or "emergency care providers" who inserted the device would be the evaluators of "ease of insertion," and the patients provided feedback on "tolerance."
4. Adjudication Method for the Test Set
Not applicable in the typical sense. The study was a direct comparison of device performance parameters (fluorescein clearance, tolerance, ease of use) between the Eye Irrigator and the Morgan Lens, rather than a diagnostic performance study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (physical irrigator), not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
For the clinical comparison, the "ground truth" was the direct observation of fluorescein clearance by an observer (likely a clinician), patient self-reported tolerance, and clinician assessment of ease of use. This is essentially an observational outcome comparison.
For the material and sterilization aspects:
- Materials: Laboratory testing against ISO 10993-1 standards (biocompatibility assays).
- Sterilization: Process validation based on physical/biological indicators to achieve a Sterility Assurance Level (SAL) of 10-6.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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SUBMITTER:
Submitted on behalf of:
| Company Name: | Eye-Deal Ocular Safety, Inc. | |
|---|---|---|
| Address: | 3620 Lake Mendota DriveMadison, WI 53705 | |
| Telephone: | 608-238-9004 | |
| by: | Elaine DuncanPaladin Medical®, Inc.PO Box 560Stillwater, MN 55082715-549-6035 | Official Correspondent |
| CONTACT PERSON: | Elaine Duncan | |
| DATE SUMMARY PREPARED: | February 13, 1998: Revised 5-11-98 |
Eye Irrigator, Ocular Irrigator TRADE NAME: Eye irrigator COMMON NAME:
SUBSTANTIALLY EQUIVALENT TO: The Eye Irrigator is substantially equivalent to the Morgan Lens, by Mortan, Inc., K821897
DESCRIPTION of the DEVICE: The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.
INDICATIONS FOR USE: The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eye irrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.
CLINICAL INFORMATION and SAFETY and EFFECTIVENESS: A preliminary study was conducted to compare the efficacy of the irrigation of the Morgan lens, to evaluate the tolerance of the patient to the device and the ease of insertion of the emergency care provider. Six patients and 12 total eyes were compared, and although the study size was too small for statistically significant results, the trend was clear that the Eye Irrigator was well tolerated by the patient and easy to use by the technician. The Eye Irrigator was efficient in clearance of thorescein, an indicator dye commonly used as an indicating dye. A complete summary of the study is provided in the submission. In addition to the clinical testing, the materials used in the Eye Irrigator were pre-qualified by selecting materials with medical or food grade toxicity testing. In addition, the complete assembly (after sterilization) was tested for biocompatibility as indicated for surface devices/mucosal membrane/short-term ocular membrane contact by the Blue Book Memorandum for adoption of the ISO 10993-1 Part 1. Testing results indicated that the materials passed the required assays. Validation of the sterilization process that was conducted according to the procedures of ANSVAAMI/ISO 11135-1994 showed that the ethylene oxide gas cycle will reproducibly provide a sterility assurance level of 10-6 for processes meeting the specified cycle parameters.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a series of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | 5 1998
Eye-Deal Ocular Safety Products, Inc. c/o Ms. Elaine Duncan Paladin Medical Inc. P.O. Box 560 Stillwater, MN 55082-0560
Re: K980647 Trade Name: Eye-Deal Eye Irrigator Regulatory Class: I Product Code: 86 KYG Dated: February 13, 1998 Received: February 13, 1998
Dear Ms. Duncan:
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 (OS) 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 - Ms. Elaine Duncan
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 Roerl 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 (if known) _ K 980647
Eye-Deal EYE IRRIGATOR, Ocular Irrigator Device Name
Indications for Use:
The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over -The-Counter Use
(Optional Format 1-2-96)
Musa Smith
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980647
§ 886.4360 Ocular surgery irrigation device.
(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(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.