(13 days)
K 023737, K 003768, K 011392
Not Found
No
The description focuses on mechanical components and manual operation, with no mention of AI/ML terms or functionalities.
Yes
The device is used to implant intraocular lenses during cataract surgery, which is a medical procedure to treat a health condition (cataracts). This aligns with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No.
The device is described as a reusable instrument used to implant intraocular lenses during cataract surgery. Its function is to deliver lenses, not to diagnose medical conditions.
No
The device description clearly states it is a reusable titanium handpiece and describes mechanical components like a piston and plunger, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Royale® AE-9036 LSP Injectors are surgical instruments used to physically implant an intraocular lens into the eye. They are used during a surgical procedure, not for analyzing samples taken from the body.
The description clearly states its purpose is to "assist in implanting Alcon ACRYSOF® foldable intraocular lenses during a normal small incision cataract surgery." This is a surgical delivery device, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
MSS
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
K 023737, K 003768, K 011392
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
.
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
$\leftarrow$ $\searrow$
1
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
2
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.
3
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.
4
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
5
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