(13 days)
The Royale® AE-9036 LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens will be removed out of the cartridge and delivered to the desired position.
The injectors are autoclavable, reusable titanium hand pieces which are used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens. They are a modification to the previously cleared Injector Royale AE 9045 K023737. The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured.
The provided text describes a 510(k) submission for the "Royale AE 9036 LSP" intraocular lens injector. It includes information about tests performed to demonstrate the device's performance, but it does not provide a table of acceptance criteria with corresponding performance metrics in a defined quantitative format, nor does it detail a study that directly proves the device meets specific quantitative acceptance criteria.
The document primarily focuses on verifying the device's functionality and safety through mechanical, optical, and cleaning tests, largely in comparison to a predicate device and relevant international standards.
However, I can extract the relevant information based on the request, even if it's not presented in the exact requested format:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table. Instead, it describes passing various tests to ensure the integrity of the IOL and the cleanliness and safety of the injector. The "reported device performance" is generally stated as "the instrument has passed all the necessary tests successfully."
| Acceptance Criteria (Inferred from tests performed) | Reported Device Performance |
|---|---|
| IOL Integrity (Mechanical & Optical) | IOLs remained mechanically and optically undamaged after manipulation with the AE-9036LSP injector (in combination with one-piece ACRYSOF® acrylic foldable IOLs (SN60WF) and Alcon III Monarch Cartridges). |
| Compliance with ISO 11979-2 (Optical properties) | Passed |
| Compliance with ISO 11979-3 (Mechanical properties) | Passed |
| Compliance with FDA IOL Guidance Document | Passed |
| Device Cleanliness & Biocompatibility | Passed all tests successfully. |
| Acrinol Test (cleanliness by Acrinol staining and light microscopy) | Passed |
| Bio-Burden Test (cleanliness by microbiological methods and light microscopy) | Passed |
| Intra-ocular Irritation Test | Passed |
| Functionality (Lens Delivery) | Smooth and well-controlled lens delivery ensured due to ball bearing technology. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the precise sample size (number of lenses, number of injectors, or number of tests) used for the performance tests. It refers to "the IOLs" and "the instrument" generally.
Data Provenance: Not explicitly stated, but given the manufacturer (ASICO LLC, USA) and the context of a 510(k) submission to the FDA, it is highly probable the testing was conducted in a controlled laboratory environment, likely in the US or by a recognized testing facility. The data appears to be prospective as it describes tests performed specifically for device qualification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The ground truth in this submission is established through objective laboratory testing (e.g., optical property measurements, mechanical property tests, microbiological analysis, irritation tests) based on recognized international standards (ISO 11979-2, ISO 11979-3) and internal protocols (Acrinol test, Bio-Burden test, Intra-ocular irritation test). It does not involve human interpretation or consensus for establishing the ground truth of a diagnostic outcome.
4. Adjudication Method for the Test Set
Not Applicable. As the tests are objective, laboratory-based evaluations against specified standards or criteria, there is no need for an adjudication method by experts in the typical clinical sense (like 2+1, 3+1). The "adjudication" is inherent in passing or failing the defined test protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The Royale AE 9036 LSP is an intraocular lens injector, a surgical instrument. The evaluation focuses on its mechanical, optical, and biological safety performance, not on human interpretation.
6. Standalone Performance Study (Algorithm Only)
Not Applicable. This device is a manual surgical instrument and does not incorporate an algorithm in the sense of AI or automated analysis. Its "standalone performance" is its functional performance as an injector for IOLs, which was evaluated as described in the "Tests Performed" section.
7. Type of Ground Truth Used
The ground truth used for performance evaluation is based on:
- International Standards: Compliance with ISO 11979-2 (optical properties) and ISO 11979-3 (mechanical properties) for IOLs.
- FDA Guidance Document: Compliance with the FDA IOL Guidance Document.
- Objective Laboratory Test Results: Outcomes of Acrinol staining, microbiological burden assessment, and intraocular irritation tests.
- Visual Inspection/Assessment: For damage to IOLs after manipulation.
8. Sample Size for the Training Set
Not Applicable. This device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms. The tests performed are for device verification and validation.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an algorithm, there is no ground truth to be established for it.
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SECTION 4 イ 510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).
807.92(a)(1)
Submitter Information
ASICO LLC 26 Plaza Drive Westmont, IL 60559
| Phone: | 630 986 8032 |
|---|---|
| Facsimile: | 630 986 0065 |
| NOV 07 2007 |
| Contact Person: | A.N.Gowtham |
|---|---|
| Date: | Oktober 16, 2007 |
807.92(a)(2)
| Trade Name: | Royale AE 9036 LSP |
|---|---|
| Common Name: | Injector |
| Classification Name(s): | Intraocular lens guide, |
| Classification Number: | CFR 886.4300 |
807.92(a)(3)
FDA CDRH DMC
OCT 2 5 2007
Received## Predicate Device(s)
| 510(k) Number | Device |
|---|---|
| K 023737 | Injector Royale® AE 9045 |
| K 003768 | MONARCH® II IOL Delivery System |
| K 011392 | Micra Instument Ltd. Lens Insertion System |
807.92 (a)(4)
Device Description
The injectors are autoclavable, reusable titanium hand pieces which are used to deliver folded intraocular lenses into the eye for replacement of the human crystalline lens. They are a modification to the previously cleared Injector Royale AE 9045 K023737. The injector reusable hand piece accepts the cartridges with a sterile single use cartridge which incorporates the folded lens and delivers the lens by using a plunger to express
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the lens. The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured
807.92(a)(5)
Intended Use(s)
The Royale® 9036LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges Type D and Monarch II type C cartridge for foldable intraocular lenses
807.92(a)(6)
Technological Characteristics
The plunger's head is contoured to provide a good contact to the lens as well as an adequate clearance for the trailing haptic. The plunger is advanced by direct forward motion applied to the syringe type plunger. Due to the ball bearing technology a smooth and well controlled lens delivery is ensured. This product has a plunger style mechanises which is similar to the predicate device AE-9045 and the Micra Instument Ltd. Lens Insertion System and is different from that of the Monarch II IOL delivery system as this is a screw type mechanism. Some of the dimensions of the AE-9036LSP and that of the AE-9045 are the same. The Overall body diameter is 10 mm and the length is 99.60mm for both the injectors. The Thumb ring diameter is 28mm for both of the injectors. Both the AE-9045 and the AE-9045LSP have similar plunger style mechanism and the plungers are similar except for dimensional difference in the tips. Both the AE-9045 and the AE-9036LSP the injectors are made of Titanium Grade 5 (ASTM 136) and/or medical grade stainless steel (DIN ISO 5832-1).
Tests Performed
The objective of the study was to demonstrate that the IOLs remain mechanically and optically undamaged after manipulation with the AE-9036LSP injector in combination with one-piece ACRYSOF® acrylic foldable IOLs (SN60WF) for posterior chamber application and Alcon III Monarch Cartridges as manufactured by ALCON Laboratories Inc. This test report is in Tab E. The instrument has passed all the necessary tests and has been qualified for the DFU.
In Tab F, G and H we have performed various cleaning test to validate our Direction for use document which will be supplied with injector. In Tab F we have performed the
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Acrinol test where we have evaluated the cleanliness by Acrinol staining and light microscopy methods. In Tab G we have done the Bio-Burden test to evaluate cleanliness by microbiological methods and light microscopy. In Tab H we have performed the Intra-ocular irritation test. The instrument has passed all three tests successfully.
In conclusion we have performed all the tests that were required to qualify the lens accordance with the provisions of ISO 11979-2 in regards to their optical properties, ISO 1 1979-3 [2] in regard to their mechanical properties, and the FDA IOL Guidance Document. We have perfomed more extensive cleaning tests then what we have done for our predicate device AE-9045. We have perofrmed the Acrinol test, the Bioburden test and the Intrsaoccular irritation test. Ths instrument has passed all the tests succsefully.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Asico LLC c/o Ms. Silvia Ankova Underwriters Laboratories, Inc. 333 Pfingsten Rd. Northbrook, IL 60062
NOV 0 7 2007
Re: K073010
Trade/Device Name: Royale AE 9036 LSP Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 1, 2007 Received: November 2, 2007
Dear Ms. Ankova:
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Eglinton, mrd
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 3 -> Indications for Use Statement
510(k) Number (if known): _ Ko7 301D _
Device Name: Injector Royale® AE-9036 LSP
Indications for Use:
The Royale® AE-9036 LSP Injectors are reusable instruments to assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery. They are designed to incorporate Monarch III cartridges D and Monarch II cartridge C for foldable intraocular lenses. The cartridges are loaded into the injector body. By pushing the piston, the lens will be removed out of the cartridge and delivered to the desired position.
Prescription Use ﺍﻟ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ph.D.
(Division Sign Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number_K073010
510(k) Injector Royale® AE 9036LSP. ASICO LLC. Page 2-1
§ 886.4300 Intraocular lens guide.
(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.