(254 days)
Not Found
No
The device description and performance studies focus on the mechanical delivery of an IOL and do not mention any computational or data-driven components.
No.
This device is an IOL delivery system, which is a surgical tool used to insert an intraocular lens. It delivers a therapeutic device (the IOL), but it is not therapeutic itself.
No
This device is an IOL delivery system used for inserting an intraocular lens during surgery, not for diagnosing a condition.
No
The device description explicitly details physical components like a syringe injector, silicone tip, and cartridge, indicating it is a hardware device for surgical delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to insert an intraocular lens into the human eye during a surgical procedure. This is a surgical tool used in vivo (within the body).
- Device Description: The description details a mechanical system for delivering a lens, not a device that analyzes biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological specimens.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.
Product codes
MSS
Device Description
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.
The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.
The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.
The lioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The device consists of:
(1) a cartridge that holds the intraocular lens in position in preparation for loading
(2) and a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag.
An intraocular lens folded into the cartridge reduces the surgical incision size. Injector tip outer diameter measurements vary in size (1.67mm, 2.00mm and 2.25mm, respectively).
- Model LIOLI-18 is with an injector tip outer diameter of 1.67mm
- Model LIOLI-22 is with an injector tip outer diameter of 2.00mm
- Model LIOLI-24 is with an injector tip outer diameter of 2.25mm
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
Hospital/Surgery center
For use by doctors only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Tests:
All lenses were delivered through the lioli™ according to the loading and delivery procedure in the Indications for Use (IFU).
The IOLs were evaluated for the optical properties, sagitta, and overall surface and bulk homogeneity before and after being surgically manipulated using each of the 3 models of lioli™ IOL Delivery System, as well as lens opening time after folding. Each lioli™ IOL Delivery System were also evaluated for its cartridge performance, such as overall cartridge surface and bulk homogeneity.
IOL optical properties and overall surface and bulk homogeneity inspection were conducted in accordance with ISO 11979-2. Ophthalmic implants -Intraocular lenses – Part 2: Optical properties and test methods and ISO 11979-3, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods.
After delivery, all lenses were observed for possible damages or scratches using a microscope. All delivered lenses showed no damages or scratches. and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.
The resulting data from simulated surgical manipulation of lioli™ IOL Delivery System to deliver hydrophilic intraocular lenses (IOL) showed that lioli™ IOL Delivery System models LIOLI-18, LIOLI-22 and LIOLI-24, can successfully deliver Lenstec's Softec 1 IOL of low to high diopters without affecting the functionality of the lens.
To evaluate the safety of the proposed new device, performance testing for all contact materials has been tested for biocompatibility and was found to be safe.
Clinical Tests: Not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
AST Products, Inc. % David Lim, Ph.D. Regulatory Consultant 3955 Riner Road, Box 148 Riner, VA 24149
Re: K142056
Trade/Device Name: lioli™ IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: March 4, 2015 Received: March 6, 2015
Dear Dr. Lim:
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.
1
Page 2 - David Lim, Ph.D.
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Y. Alexander -A
for 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142056
Device Name lioli™ IOL Delivery System
Indications for Use (Describe)
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
CFR 801 Subpart C)
3
1. 510(k) Summary
As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, 510(k) summary is provided.
2. Submitter
AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778
3. Official Correspondence/Contact Person
William Lee, Ph.D. Director, R&D and Regulatory Affairs AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778 Email: wlee@astp.com
4. 510(k) Preparer
Regulatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner. VA 24149 Tel: (800) 321-8567 Email: info@regulatorydoctor.com
5. Product Name
Trade Name: lioli™ IOL Delivery System Common Name: Folders and Injectors, Intraocular Lens (IOL)
6. Device Classification
Classification Name: Class I (21 CFR § 886.4300 Intraocular lens quide) Classification Panel: Ophthalmic (86) Product Code: MSS
7. Leqally Marketed Predicate
K103495: ASICO SofTip Injector System, AS-9300
8. Device Description
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through
4
an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.
The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.
The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.
9. Intended Use and Indications for Use
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.
The lioli™ IOL Delivery System shares the same intended use and indications for use for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application. Refer to Table 1.
Note: One of the statutory requirements for demonstrating substantial equivalence (SE) is to show that a new device has the same intended use, which is broader than indications.
5
| Trade
Name | Manufacturer | Regulation
No. | Product
Code | Regulation
Description | 510(k) No. | Intended Use &
Indications for Use |
|---------------------------------------------------|--------------------|-------------------|-----------------|---------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| lioliTM IOL
Delivery
System | AST Products, Inc. | 886.4300 | MSS | Intraocular
Lens Guide | New device | The lioliTM IOL Delivery System is a
single-use, sterile device intended to
insert a one-piece foldable intraocular
lens (IOL) into the human eye through
a surgical procedure. The system
provides a tubular pathway for lens
implantation through an incision. Only
for the insertion of IOL models
validated for use with this device as
indicated in the IOL approved labeling. |
| ASICO
SofTip
Injector
System,
AS-9300 | ASICO LLC | 886.4300 | MSS | Intraocular
Lens Guide | K103495 | 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 an IOL into the
human eye. This is indicated for the
insertion only of models of IOL that
allow use of this injector in their
approved labeling. |
Table 1. Device Comparisons – Intended Use and Indications for Use
6
10. Technological Characteristics
The lioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The device consists of:
(1) a cartridge that holds the intraocular lens in position in preparation for loading
(2) and a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag.
An intraocular lens folded into the cartridge reduces the surgical incision size. Injector tip outer diameter measurements vary in size (1.67mm, 2.00mm and 2.25mm, respectively).
- Model LIOLI-18 is with an injector tip outer diameter of 1.67mm
- Model LIOLI-22 is with an injector tip outer diameter of 2.00mm
- Model LIOLI-24 is with an injector tip outer diameter of 2.25mm
The lioli™ IOL Delivery System shares many similar technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application.
Differences in design/materials between lioli™ IOL Delivery System and the predicate device are not critical and do not affect its safety and effectiveness when used as labeled as patient contact during lens placement for the listed device is only intended to occur between the human eye and materials in which the both devices share - a single-use, sterile polypropylene cartridge and silicone tip. Refer to Tables 2 and 3.
7
| Trade
Name | Design | Operating Principle | Forward
Motion
Principle | Biocomp. | Sterilization
Method | Setting
Used | Patient
Contact | Recommended
for Use With | Human
Factors | Performance
Criteria Met? |
|---------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------|---------------------------------------|--------------------------------|-------------------------------------------------------|------------------------------|-------------------------------|------------------------------|
| lioli™ IOL
Delivery
System | A sterile, single
use disposable
device | The cartridge is
loaded into the
injection system and
the IOL is pushed
through the cartridge
into the eye | Plunger/
Syringe
type | Yes | ETO sterilization
SAL level 1x10-6 | Hospital/
Surgery
center | Distal end
of cartridge
to place
lens in eye | FDA-approved
viscoelastic | For use by
doctors
only | Yes |
| ASICO
SofTip
Injector
System,
AS-9300 | A sterile, single
use disposable
device | The cartridge is
loaded into the
injection system and
the IOL is pushed
through the cartridge
into the eye | Plunger/
Syringe/
Screw
type | Yes | ETO sterilization
SAL level 1x10-6 | Hospital/
Surgery
center | Distal end
of cartridge
to place
lens in eye | FDA-approved
viscoelastic | For use by
doctors
only | Yes |
Table 2. Device Comparisons – Technological Characteristics
Table 3. Device Comparisons – Materials
| Trade Name | Device Materials | Standards Met |
|---|---|---|
| lioli™ IOL | ||
| Delivery System | Injector - Polycarbonate (144R) | |
| Plunger - ABS | ||
| Silicone Tip - Silicone (R 401) | ||
| Cartridge - Polypropylene (HD850MO) | ||
| Spring - Stainless Steel (SS304) | ISO 11979-3:2012 | |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 | ||
| ASICO SofTip | ||
| Injector System, | ||
| AS-9300 | Injector - Polycarbonate (144R Blue) | |
| Plunger - Polycarbonate (144R White) | ||
| Silicone Tip - Silicone | ||
| Cartridge - Polypropylene | ||
| Spring - Stainless Steel (SS304) | ISO 11979-3:2006 | |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2002 |
8
Performance Data (Nonclinical and/or Clinical) 11.
- Non-clinical Tests:
All lenses were delivered through the lioli™ according to the loading and delivery procedure in the Indications for Use (IFU).
The IOLs were evaluated for the optical properties, sagitta, and overall surface and bulk homogeneity before and after being surgically manipulated using each of the 3 models of lioli™ IOL Delivery System, as well as lens opening time after folding. Each lioli™ IOL Delivery System were also evaluated for its cartridge performance, such as overall cartridge surface and bulk homogeneity.
IOL optical properties and overall surface and bulk homogeneity inspection were conducted in accordance with ISO 11979-2. Ophthalmic implants -Intraocular lenses – Part 2: Optical properties and test methods and ISO 11979-3, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods.
After delivery, all lenses were observed for possible damages or scratches using a microscope. All delivered lenses showed no damages or scratches. and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.
The resulting data from simulated surgical manipulation of lioli™ IOL Delivery System to deliver hydrophilic intraocular lenses ((OL) showed that lioli™ IOL Delivery System models LIOLI-18, LIOLI-22 and LIOLI-24, can successfully deliver Lenstec's Softec 1 IOL of low to high diopters without affecting the functionality of the lens.
To evaluate the safety of the proposed new device, performance testing for all contact materials has been tested for biocompatibility and was found to be safe.
Clinical Tests: Not required for this device. I
Conclusion 12.
The lioli™ IOL Delivery System shares the same intended use and indications for use, and technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application.
Differences in design/materials between lioli™ IOL Delivery System and the predicate device are not critical and do not affect its safety and effectiveness when used as labeled as patient contact during lens placement for the listed device is only intended to occur between the human eye and materials in which both devices share - a single-use, sterile polypropylene cartridge and silicone tip.
9
The resulting data from simulated surgical manipulation of lioli™ IOL Delivery System to deliver intraocular lenses (IOL) showed that lioli™ IOL Delivery System models LIOLI-18, LIOLI-22 and LIOLI-24 can successfully deliver hydrophilic IOLs of low to high diopters without affecting the functionality of the lens.
Based on the assessment of these findings, along with the results of Biocompatibility, Sterilization and Shelf-Life testing, the lioli™ IOL Delivery System is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.