(212 days)
Not Found
No
The device description and performance studies focus on the mechanical function and biocompatibility of a manual intraocular lens injector system. There is no mention of any computational or data-driven components that would suggest the use of AI or ML.
No
This device is an injector system designed for inserting intraocular lenses, not for treating a disease or condition itself.
No
The device is an injector system designed to deliver an intraocular lens during surgery, not to diagnose a condition.
No
The device description clearly details physical components made of materials like polycarbonate, stainless steel, and polypropylene, indicating it is a hardware device, not software-only.
Based on the provided information, the ASICO SofTip Injector system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to insert a foldable intraocular lens through a surgical procedure in a Human eye. This is a surgical tool used in vivo (within a living organism), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a mechanical system for delivering an intraocular lens during surgery. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's purpose is purely for the physical delivery of a medical implant during a surgical procedure. It does not perform any tests, measurements, or analyses that would lead to a diagnosis or provide information about a patient's health status.
IVD devices are specifically designed to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ASICO SofTip Injector system does not fit this definition.
N/A
Intended Use / 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
Product codes
MSS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
By Doctors only (Hospital/ surgery centre)
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 IOL's remain mechanically and optically undamaged after manipulation with the AS-9300 injection system. The instrument has passed all the necessary tests. Various biocompatibility tests were performed as per FDA guidelines: Cytotoxicity Test, ISO Systematic Toxicity Test, Intracutaneous Test, and Maximization Sensitization Test. All tests passed, indicating no evidence of cell lysis, systemic toxicity, irritation, or delayed-type hypersensitivity. A 5-year aging study on the cartridge and injector was also included to show that IOLs remain mechanically and optically undamaged after manipulation. The Sterilization Validity study was also performed.
Key Metrics
Not Found
Predicate Device(s)
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
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.
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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 INJECTOR
AND MICROGLIDE
CARTRIDGE
K040837 | NAVIJECT SUB2-1P
MODEL: LP604430
K092023 | LENSTEC LC INJECTION
SYSTEM
K063802 | ADE NAME | ASICO AS Injector
system, AS-9300 | MULTIJECT INJECTOR
AND MICROGLIDE
CARTRIDGE
K040837 | NAVIJECT SUB2-1P,
MODEL: LP604430/
K092023 | LENSTEC LC INJECTION
SYSTEM
K063802 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstec LC | Materials | 1.Outer Body -
Polycarbonate 144R
BLUE
2.Plunger -
Polycarbonate
144R WHITE
3.Cap -
Polycarbonate 144R
WHITE
4. spring is made of
SS304 | Unable to Obtain | Unable to Obtain | 1.Outer Body -
Polycarbonate 144R
BLUE
2.Plunger -
Polycarbonate 144R
WHITE
3.Cap -
Polycarbonate 144R
WHITE
4. spring is made of
SS304 |
| Regulation
number | 886.4300 | 886.4300 | 886.4300 | 886.4300 | Forward motion
principle | Plunger/Syringe/scre
w Type | Plunger/Syringe Type | Plunger/Syringe Type | Plunger/Syringe Type |
| Product Code | MSS | MSS | MSS | MSS | Design | is a sterile, single use
device | is a sterile, single use
device | is a sterile, single use
device | is a sterile, single use
device |
| Device
Description | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens Guide | Intraocular Lens
Guide | 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/ surgery
centre | Hospital/ surgery centre | Hospital/ surgery centre | Hospital/ surgery centre |
| Operating
principle | The cartridge is loaded
into the Injection
System and the IOL is
pushed through the
cartridge into the eye | The cartridge is loaded
into the Injection
System and the IOL is
pushed through the
cartridge into the eye | The cartridge is loaded
into the Injection
System and the IOL is
pushed through the
cartridge into the eye | The cartridge is
loaded into the
Injection System and
the IOL is pushed
through the cartridge
into the eye | compatible | Yes | Yes | Yes | Yes |
| Patient
Contact | Tip of the Injector to
place the lens | Tip of the Injector to
place the lens | Tip of the Injector to
place the lens | Tip of the Injector to
place the lens | Recommend to
use with | FDA approved
viscoelastic | FDA approved viscoelastic | FDA approved
viscoelastic | FDA approved viscoelastic |
| Intended Use | 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 an
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 Medicel MultiJect
injector for the
intraocular lenses is
indicated for the
insertion of foldable
intraocular lenses
Ceeon913A and Tecnis
Z9000 made by
Pharmacia when used in
conjunction with the
Micro Glide cartridges | The Navijet Sub2-1P IOL
injector and cartridge set
for the intraocular lens is
indicated for the insertion
only of models of
intraocular lens that allow
use of this injector in their
approved labelling | The Lenstec LC
Injection system is
intended for use in
implantation of Staar
Collamer Intraocular
Lens model
CC4204BF into the
capsular bag
following
extracapsular
extraction | Sterilization
Method | ETO sterilization
SAL Level 1X10-6 | ETO sterilization
Unable to Obtain SAL
level | ETO sterilization
Unable to Obtain SAL
level | ETO sterilization
SAL Level 1X10-6 |
| Diameter of
Barrel 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: 2006
ISO 10993-5:2009
ISO 10993-10:2002
ISO 10993-10:2002 | Unable to Obtain | Unable to Obtain | ISO 11979-3: 2006
ISO 10993-5:2009
ISO 10993-10:2002
ISO 10993-10:2002 | | | | | |
| Performance | Performance criteria
met | Performance criteria met | Performance criteria
met | 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 10993-5:2009 | ||
| Biological evaluation | |||
| of medical devices | |||
| Part 5: Tests for in | |||
| vitro cytotoxicity | The Test article extract | ||
| showed no evidence of | |||
| causing cell lysis or toxicity. | |||
| The test article extract met | |||
| the requirements of the test | |||
| since the grade was less than | Passed | ||
| ISO Systematic | |||
| Toxicity Test | ISO 10993-11:2006 | ||
| Biological evaluation | |||
| of medical devices | |||
| Part 11: Tests for | |||
| systemic toxicity | There was no mortality or | ||
| evidence of systemic toxicity | |||
| from the extracts. The test | |||
| article extracts met the | |||
| requirements of the study | Passed | ||
| Intracutaneous | |||
| Test | ISO 10993-10:2002 | ||
| / And 1:2006 | |||
| Biological evaluation | |||
| of medical devices | |||
| Part 10: Tests for | |||
| irritation and | |||
| delayed-type | |||
| hypersensitivity | There was no Erythema and | ||
| no edema from the SC test | |||
| extract injected | |||
| intracutaneously into the | |||
| rabbits. There was very slight | |||
| erythema and no edema from | |||
| the SO test extract injected | |||
| Intracutaneously into rabbits. | |||
| Each test article met the | |||
| requirements of the test | |||
| since the difference between | |||
| the test extract overall mean | |||
| score and corresponding | |||
| control overall mean score | |||
| was 0.0 | Passed | ||
| Maximization | |||
| Sensitization Test | ISO 10993- | ||
| 10:2002/Amd | |||
| 1:2006 Biological | |||
| evaluation of | |||
| medical devices Part | |||
| 10: Tests for | |||
| irritation and | |||
| delayed-type | |||
| hypersensitivity | The test article showed no | ||
| evidence of causing delayed | |||
| dermal contact sensitization | |||
| in the guinea pig. The test | |||
| article was not considered | |||
| sensitizers in the guinea pig | |||
| maximization 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 Injector
system, AS-9300 | MULTIJECT
INJECTOR
AND
MICROGLIDE
CARTRIDGE
K040837 | NAVIJECT
SUB2-1P
MODEL
LP604430
K092023 | LENSTEC LC INJECTION
SYSTEM
K063802 |
|-------------------------|--------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------|
| Manufacturer | ASICO LLC | MEDICEL AG | MEDICEL AG | Lenstech LC |
| Target
Population | Different Lens
companies | Different
Lens
companies | Different Lens
companies | Use for their own lens |
| Sterilization
Method | ETO sterilization | ETO
sterilization | ETO sterilization | ETO sterilization |
| Device
Description | Intraocular Lens
Guide | Intraocular
Lens Guide | Intraocular Lens
Guide | Intraocular Lens Guide |
| Operating
principle | The cartridge is
loaded into the | The cartridge
is loaded into | The cartridge is
loaded into the | The cartridge is loaded into
the 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 System
and the IOL is
pushed through the
cartridge into the
eye | the Injection
System and
the IOL is
pushed
through the
cartridge into
the eye | Injection System
and the IOL is
pushed through
the cartridge into
the eye | IOL is pushed through the
cartridge into the eye |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Contact | Tip of the Injector
to place the lens | Tip of the
Injector to
place the
lens | Tip of the Injector
to place the lens | Tip of the Injector to place the
lens |
| Intended Use | 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. This
is indicated for the
insertion only of
models of
intraocular lens
that allow use of
this injector in their
approved labelling | The Medicel
MultiJect
injector for
the
intraocular
lenses is
indicated for
the insertion
of foldable
intraocular
lenses
Ceeon913A
and Tecnis
Z9000 made
by
Pharmacia
when used in
conjunction
with the
MicroGlide
cartridges | The Navijet Sub2-
1P IOL injector
and cartridge set
for the intraocular
lens is indicated
for the insertion
only of models of
intraocular lens
that allow use of
this injector in
their approved
labelling | The Lenstec LC Injection
system is intended for use in
implantation of Staar Collamer
Intraocular Lens model
CC4204BF into the capsular
bag following extracapsular
extraction |
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 motion | ||||
| principle | Plunger/Syringe | |||
| Type | Plunger/Syringe | |||
| Type | Plunger/Syringe | |||
| Type | Plunger/Syringe Type | |||
| Biocompatible | Yes | Yes | Yes | Yes |
| Design | is a sterile, | |||
| single use | ||||
| device | is a sterile, | |||
| single use | ||||
| device | is a sterile, single | |||
| use device | is a sterile, single use device | |||
| Sterilization | Single use | |||
| device | Single use | |||
| device | Single use device | Single use device | ||
| Where used | Hospital/ | |||
| surgery centre | Hospital/ | |||
| surgery centre | Hospital/ surgery | |||
| centre | Hospital/ surgery centre | |||
| Materials | 1.Outer Body | |||
| Polycarbonate | ||||
| 144R BLUE | ||||
| 2.Plunger | ||||
| Polycarbonate | ||||
| 144R WHITE | ||||
| 3.Cap | ||||
| Polycarbonate | ||||
| 144R WHITE |
- spring is
made of SS304 | Unable to
Obtain | Unable to Obtain | 1.Outer Body
Polycarbonate 144R BLUE - Plunger
Polycarbonate 144R WHITE
3.Cap
Polycarbonate 144R WHITE - 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
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510(k) Number K103495