(212 days)
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraccular lens that allow use of this injector in their approved labelling. The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip. There are different Injector sets based on the type of cartridge that is used (AS-9300-16, AS-93001620, AS-9300-24,AS-9300-2420). The product is manufactured according to the ISO 13485:2003 Quality Standards and Quality System Requlations. The Injector body is manufactured from Polycarbonate 144R Blue. The plunger assembly which consists of plunger, shaft and outer and inner cap is made up of, Polycarbonate 144R white and the spring is made of stainless steel (SS304) under validated conditions. The cartridge is made from medical grade lubricated polypropylene and the silicon tip is also from medical grade. The injector system will be delivered sterile.
The provided text describes the acceptance criteria and the study conducted for the ASICO SofTip Injector System but does not contain information about AI or machine learning. Therefore, I cannot address aspects related to AI/ML performance, training datasets, or multi-reader multi-case studies with AI assistance.
Based on the provided text, here's the information about the device's acceptance criteria and the study to demonstrate its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance (Summary) |
|---|---|
| Mechanical Properties | The IOLs remained mechanically and optically undamaged after manipulation with the AS-9300 injection system. |
| Cytotoxicity Test | No evidence of causing cell lysis or toxicity. Met requirements. |
| ISO Systematic Toxicity Test | No mortality or evidence of systemic toxicity. Met requirements. |
| Intracutaneous Test | No erythema and no edema from SC test extract. Very slight erythema and no edema from SO test extract. Met requirements. |
| Maximization Sensitization Test | No evidence of causing delayed dermal contact sensitization. Not considered sensitizers. |
| Aging Study | IOLs remained mechanically and optically undamaged after manipulation with the injector (report included from Lenstec). |
| Sterilization Validity | Sterilization validity study performed and included for review. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the mechanical performance testing (e.g., how many IOLs were tested). It refers to the "IOL's" (plural) remaining undamaged.
For biocompatibility tests:
- Cytotoxicity Test: Not specified.
- ISO Systematic Toxicity Test: Not specified (refers to "extracts" and "test article extracts").
- Intracutaneous Test: Tested on "rabbits." The number of rabbits is not specified.
- Maximization Sensitization Test: Tested on "guinea pig." The number of guinea pigs is not specified.
The data provenance is not explicitly mentioned as retrospective or prospective, nor does it specify the country of origin of the data beyond implying the studies were conducted to FDA and ISO standards. The tests were performed by "ASICO" or supplied by "Lenstec" (a predicate company) for the aging study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The device testing primarily focuses on mechanical and biocompatibility properties, not diagnostic interpretation requiring expert ground truth establishment.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the tests performed are laboratory-based mechanical and biological evaluation, not clinical or image-based evaluations requiring adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is not an AI/ML-driven diagnostic or assistive tool. It is an intraocular lens injector system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an AI/ML algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the mechanical and aging studies, the "ground truth" was established by the physical and optical integrity of the IOLs after manipulation, determined through unspecified measurement methods.
For biocompatibility tests, the "ground truth" was established by the absence of adverse biological reactions (e.g., cell toxicity, systemic toxicity, irritation, sensitization), as measured by the specific ISO standard protocols.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a physical medical instrument, not an AI/ML system requiring a training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for ASICO. The logo is in black and white and features the company name in large, bold letters. There is a horizontal line underneath the company name. The registered trademark symbol is located in the upper right corner of the logo.
SECTION 3 → 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 |
Contact Person: A.N.Gowtham
June 17, 2011 Date:
807.92(a)(2)
ASICO SofTip Injector System, AS-9300 Trade Name:
Common Name: Injector
Intraocular lens guide, Classification Name(s):
CFR 886.4300 Classification Number: Regulatory class : Class I ( Reserve)
807.92(a)(3)
Predicate Device(s)
| Device | |
|---|---|
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 |
| K063802 | LENSTEC LC INJECTION SYSTEM |
807.92 (a)(4)
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are black, and there is a horizontal line underneath the word. There is a registered trademark symbol to the right of the letter "O". There is a black rectangle in the middle of the letter "S".
Device Description
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision, allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraccular lens that allow use of this injector in their approved labelling
The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip.
There are different Injector sets based on the type of cartridge that is used (AS-9300-16, AS-93001620, AS-9300-24,AS-9300-2420)
The product is manufactured according to the ISO 13485:2003 Quality Standards and Quality System Requlations.
The Injector body is manufactured from Polycarbonate 144R Blue. The plunger assembly which consists of plunger, shaft and outer and inner cap is made up of, Polycarbonate 144R white and the spring is made of stainless steel (SS304) under validated conditions. The cartridge is made from medical grade lubricated polypropylene and the silicon tip is also from medical grade.
The injector system will be delivered sterile.
807.92(a)(5)
Technological Characteristics
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. The plunger's head is covered by a silicone cushion that provide a good contact to the lens to ensure a smooth delivery. The plunger is advanced by direct forward motion applied to the syringe type plunger. This instrument has substantially equivalent technological characteristics to the predicate devices refer to the device matrix comparison chart below. The set consists of a disposable injector, a cartridge and a silicone tip.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the word "ASICO" in a bold, stylized font. The letters are large and black, with a thick, sans-serif typeface. A registered trademark symbol is present to the right of the letter "O".
Device Comparison Matrix
| TRADE NAME | ASICO AS Injector system,AS-9300 | I MULTIJECT INJECTORAND MICROGLIDECARTRIDGEK040837 | NAVIJECT SUB2-1PMODEL: LP604430K092023 | LENSTEC LC INJECTIONSYSTEMK063802 | ADE NAME | ASICO AS Injectorsystem, AS-9300 | MULTIJECT INJECTORAND MICROGLIDECARTRIDGEK040837 | NAVIJECT SUB2-1P,MODEL: LP604430/K092023 | LENSTEC LC INJECTIONSYSTEMK063802 |
|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstec LC | Materials | 1.Outer Body -Polycarbonate 144RBLUE2.Plunger -Polycarbonate144R WHITE3.Cap -Polycarbonate 144RWHITE4. spring is made ofSS304 | Unable to Obtain | Unable to Obtain | 1.Outer Body -Polycarbonate 144RBLUE2.Plunger -Polycarbonate 144RWHITE3.Cap -Polycarbonate 144RWHITE4. spring is made ofSS304 |
| Regulationnumber | 886.4300 | 886.4300 | 886.4300 | 886.4300 | Forward motionprinciple | Plunger/Syringe/screw Type | Plunger/Syringe Type | Plunger/Syringe Type | Plunger/Syringe Type |
| Product Code | MSS | MSS | MSS | MSS | Design | is a sterile, single usedevice | is a sterile, single usedevice | is a sterile, single usedevice | is a sterile, single usedevice |
| DeviceDescription | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular LensGuide | Sterilization | Single use device | Single use device | Single use device | Single use device |
| 510(k)Number | Via this submission | K040837 | K092023 | K063802 | Where used | Hospital/ surgerycentre | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre |
| Operatingprinciple | The cartridge is loadedinto the InjectionSystem and the IOL ispushed through thecartridge into the eye | The cartridge is loadedinto the InjectionSystem and the IOL ispushed through thecartridge into the eye | The cartridge is loadedinto the InjectionSystem and the IOL ispushed through thecartridge into the eye | The cartridge isloaded into theInjection System andthe IOL is pushedthrough the cartridgeinto the eye | compatible | Yes | Yes | Yes | Yes |
| PatientContact | Tip of the Injector toplace the lens | Tip of the Injector toplace the lens | Tip of the Injector toplace the lens | Tip of the Injector toplace the lens | Recommend touse with | FDA approvedviscoelastic | FDA approved viscoelastic | FDA approvedviscoelastic | FDA approved viscoelastic |
| Intended Use | The ASICO SofTipInjector system is asterile, single usedevice intended to inserta foldable intraocularlens through a surgicalprocedure in a Humaneye. The systemprovides a tubularpathway through anincision, allowing thedelivery of a IOL intothe Human eye. This isindicated for theinsertion only of modelsof intraocular lens thatallow use of this injectorin their approvedlabelling | The Medicel MultiJectinjector for theintraocular lenses isindicated for theinsertion of foldableintraocular lensesCeeon913A and TecnisZ9000 made byPharmacia when used inconjunction with theMicro Glide cartridges | The Navijet Sub2-1P IOLinjector and cartridge setfor the intraocular lens isindicated for the insertiononly of models ofintraocular lens that allowuse of this injector in theirapproved labelling | The Lenstec LCInjection system isintended for use inimplantation of StaarCollamer IntraocularLens modelCC4204BF into thecapsular bagfollowingextracapsularextraction | SterilizationMethod | ETO sterilizationSAL Level 1X10-6 | ETO sterilizationUnable to Obtain SALlevel | ETO sterilizationUnable to Obtain SALlevel | ETO sterilizationSAL Level 1X10-6 |
| Diameter ofBarrel Tip | 5mm | Unable to Obtain | Unable to Obtain | 5mm | |||||
| Human Factors | By Doctors only | By Doctors only | By Doctors only | By Doctors only | |||||
| Standards Met | ISO 11979-3: 2006ISO 10993-5:2009ISO 10993-10:2002ISO 10993-10:2002 | Unable to Obtain | Unable to Obtain | ISO 11979-3: 2006ISO 10993-5:2009ISO 10993-10:2002ISO 10993-10:2002 | |||||
| Performance | Performance criteriamet | Performance criteria met | Performance criteriamet | Performance criteria met |
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "ASICO" in a bold, black font. The letters are large and spaced closely together. There is a registered trademark symbol to the right of the letter "O". A horizontal line is present at the bottom of the word.
Most of the predicate devices use the same principal (plunger/syringe type) to implant the lens into the eye and there for is very similar to each other. Difference can be the composition of the instrument. All the devices including ASICO AS-9000 injection system have been tested to according to Recognized Consensus Standards ISO 11979-3:2006. Ophthalmic implants --Intraocular lenses -- Part 3: Mechanical properties and test methods. (Ophthalmic): and they have passed the tests.
There is nothing in the ASICO AS9000 injection system that negatively affects the safety or performance o
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "ASICO" in a bold, black font. The letters are large and spaced closely together. There is a registered trademark symbol to the right of the letter "O". A horizontal line is present in the middle of the word, obscuring part of the letters.
Tests Performed
The objective of the study was to demonstrate that the IOL's remain mechanically and optically undamaged after manipulation with the AS-9300 injection system. The instrument has passed all the necessary tests.
We have performed various bio compatibility tests. As per FDA guidelines we have the following tests. Cytotoxicity Test, ISO Systematic Toxicity Test, Intracutaneous Test and Maximization Sensitization Test. Test results below.
| Test | ISO Standard | Summary | Test Result |
|---|---|---|---|
| Cytotoxicity Test | ISO 10993-5:2009Biological evaluationof medical devicesPart 5: Tests for invitro cytotoxicity | The Test article extractshowed no evidence ofcausing cell lysis or toxicity.The test article extract metthe requirements of the testsince the grade was less than | Passed |
| ISO SystematicToxicity Test | ISO 10993-11:2006Biological evaluationof medical devicesPart 11: Tests forsystemic toxicity | There was no mortality orevidence of systemic toxicityfrom the extracts. The testarticle extracts met therequirements of the study | Passed |
| IntracutaneousTest | ISO 10993-10:2002/ And 1:2006Biological evaluationof medical devicesPart 10: Tests forirritation anddelayed-typehypersensitivity | There was no Erythema andno edema from the SC testextract injectedintracutaneously into therabbits. There was very slighterythema and no edema fromthe SO test extract injectedIntracutaneously into rabbits.Each test article met therequirements of the testsince the difference betweenthe test extract overall meanscore and correspondingcontrol overall mean scorewas 0.0 | Passed |
| MaximizationSensitization Test | ISO 10993-10:2002/Amd1:2006 Biologicalevaluation ofmedical devices Part10: Tests forirritation anddelayed-typehypersensitivity | The test article showed noevidence of causing delayeddermal contact sensitizationin the guinea pig. The testarticle was not consideredsensitizers in the guinea pigmaximization test. | Passed |
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are black, and the background is white. There is a registered trademark symbol to the right of the letter "O". The letter "S" has a horizontal line through it.
We also have done a 5 year ageing study on the cartridge. The cartridges and silicone are being supplied to us by Lenstec which is one of our predicate companies. The plastic injector is supplied to Lenstec by us. We have included their report as it shows the IOL's remain mechanically and optically undamaged after manipulation. The Sterilization Validity study has been performed. .
Substantial Equivalence Discussion
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surgical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eve. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling
The plunger's head is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunced by direct forward motion applied to the syringe type plunger. The set consists of a disposable injector, a cartridge and a silicone tip.
This instrument has substantially equivalent technological characteristics to the predicate devices the Navijet and the multi-jet system from Medicel as well Lenstec LC Injection system. They use the same principal and have a similar silicon tip, injector and cartridge.
ASICO cartridges are equivalent to Lenstec cartridges LC16, LC1620, LC24, LC2420. Lenstec supplies to ASICO the same cartridges and silicon tips they combine their cartridges with Injectors that ASICO supplies and sterilizes them similar to their LC injection system which is our predicate device and supplies to ASCIO under the ASICO SofTip Injector System, AS-9300 brand name. A brief device comparison is below. A detailed comparison matrix is listed below.
| TRADE NAME | ASICO AS Injectorsystem, AS-9300 | MULTIJECTINJECTORANDMICROGLIDECARTRIDGEK040837 | NAVIJECTSUB2-1PMODELLP604430K092023 | LENSTEC LC INJECTIONSYSTEMK063802 |
|---|---|---|---|---|
| Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstech LC |
| TargetPopulation | Different Lenscompanies | DifferentLenscompanies | Different Lenscompanies | Use for their own lens |
| SterilizationMethod | ETO sterilization | ETOsterilization | ETO sterilization | ETO sterilization |
| DeviceDescription | Intraocular LensGuide | IntraocularLens Guide | Intraocular LensGuide | Intraocular Lens Guide |
| Operatingprinciple | The cartridge isloaded into the | The cartridgeis loaded into | The cartridge isloaded into the | The cartridge is loaded intothe Injection System and the |
Device Comparison Matrix
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are large and black, and there is a registered trademark symbol to the right of the letter "O". There is a horizontal line below the word.
| Injection Systemand the IOL ispushed through thecartridge into theeye | the InjectionSystem andthe IOL ispushedthrough thecartridge intothe eye | Injection Systemand the IOL ispushed throughthe cartridge intothe eye | IOL is pushed through thecartridge into the eye | |
|---|---|---|---|---|
| Patient Contact | Tip of the Injectorto place the lens | Tip of theInjector toplace thelens | Tip of the Injectorto place the lens | Tip of the Injector to place thelens |
| Intended Use | The ASICO SofTipInjector system isa sterile, singleuse deviceintended to insert afoldable intraocularlens through asurgical procedurein a Human eye.The systemprovides a tubularpathway through aincision , allowingthe delivery of aIOL into theHuman eye. Thisis indicated for theinsertion only ofmodels ofintraocular lensthat allow use ofthis injector in theirapproved labelling | The MedicelMultiJectinjector fortheintraocularlenses isindicated forthe insertionof foldableintraocularlensesCeeon913Aand TecnisZ9000 madebyPharmaciawhen used inconjunctionwith theMicroGlidecartridges | The Navijet Sub2-1P IOL injectorand cartridge setfor the intraocularlens is indicatedfor the insertiononly of models ofintraocular lensthat allow use ofthis injector intheir approvedlabelling | The Lenstec LC Injectionsystem is intended for use inimplantation of Staar CollamerIntraocular Lens modelCC4204BF into the capsularbag following extracapsularextraction |
Image /page/6/Picture/3 description: The image shows a table with different trade names and their corresponding models or systems. The trade names listed are ASICO AS, MULTIJECT, NAVIJECT, and LENSTEC LC INJECTION. The ASICO AS is an injector system AS-9300, MULTIJECT is an injector and microglide cartridge, NAVIJECT is SUB2-1P model LP604430 K092023, and LENSTEC LC INJECTION is a system K063802.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "ASICO" in a bold, sans-serif font. The letters are large and black, and there is a registered trademark symbol to the right of the letter "O". A horizontal line is present at the bottom of the image.
26 Plaza Drive, Westmont, IL 60559 U.S.A. Phone: 630-986-8032 • Fax: 630-986-0065 E--mail:info@asico.com • http://www.asico.com
| K040837 | ||||
|---|---|---|---|---|
| Forward motionprinciple | Plunger/SyringeType | Plunger/SyringeType | Plunger/SyringeType | Plunger/Syringe Type |
| Biocompatible | Yes | Yes | Yes | Yes |
| Design | is a sterile,single usedevice | is a sterile,single usedevice | is a sterile, singleuse device | is a sterile, single use device |
| Sterilization | Single usedevice | Single usedevice | Single use device | Single use device |
| Where used | Hospital/surgery centre | Hospital/surgery centre | Hospital/ surgerycentre | Hospital/ surgery centre |
| Materials | 1.Outer BodyPolycarbonate144R BLUE2.PlungerPolycarbonate144R WHITE3.CapPolycarbonate144R WHITE4. spring ismade of SS304 | Unable toObtain | Unable to Obtain | 1.Outer BodyPolycarbonate 144R BLUE2. PlungerPolycarbonate 144R WHITE3.CapPolycarbonate 144R WHITE4. spring is made of SS304 |
Summary
The test have been done according to Recognized Consensus Standards ISO 11979-3:2006, Ophthalmic implants - Intraocular lenses -- Part 3: Mechanical properties and test methods. (Ophthalmic): The cartridges are being supplied to us by Lenstec which is one of our predicate companies. We have included their report as it shows the IOL's remain mechanically and optically undamaged after manipulation. We also have included a 5 year ageing study on the cartridge and injector. The Sterilization Validity study and summary are also included for review
We have performed various bio compatibility tests. As per FDA guidelines we have done the following tests. Cytotoxicity Test, ISO Systematic Toxicity Test, Intracutaneous Test and Maximization Sensitization Test
We thereby conclude that ASICO AS-9300 SofTip Injecotion system is has substantially equivalent technological characteristics to the predicate devices the Navijet and the multi-jet system from Medicel as well Lenstec LC Injection system
{8}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and healing. The caduceus is depicted as a bird-like figure with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ASICO LLC c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville, NY 11747
JUN 2 9 2011
Re: K103495
Trade/Device Name: ASICO SofTip Injector System, AS-9300 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: June 17, 2011 Received: June 21, 2011
Dear Mr. Conry:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{9}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/9/Picture/5 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with a loop extending downwards and to the left, forming the main body of the signature. There is a smaller loop or curve at the top right, possibly representing the end of the name or initials. The signature is simple and elegant, with clean lines and a flowing design.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{10}------------------------------------------------
Indications for Use
510(k) Number (if known): K103495
Device Name: __ ASICO SofTip Injection System
Indications for Use:
The ASICO SofTip Injector system is a sterile, single use device intended to insert a foldable intraocular lens through a surqical procedure in a Human eye. The system provides a tubular pathway through a incision , allowing the delivery of a IOL into the Human eye. This is indicated for the insertion only of models of intraocular lens that allow use of this injector in their approved labelling
Prescription Use X (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)
.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number K103495
§ 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.