(143 days)
Not Found
No
The device description and performance studies focus on mechanical delivery of the IOL and do not mention any computational or data-driven components indicative of AI/ML.
No
The device is an intraocular lens delivery system, which is a tool used during cataract surgery to insert an intraocular lens. It facilitates the procedure but does not directly treat a disease or condition itself. The therapeutic aspect is the replacement of the human crystalline lens, which is performed by the implanted IOL, not by this delivery system.
No
This device is intended to insert an intraocular lens, not to diagnose a condition. Its function is to deliver a medical implant during surgery, which is a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is composed of two physical parts: a cartridge and a single-use injector with a silicone-tipped plunger. This indicates it is a hardware device, not software-only.
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 approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision." This is a surgical procedure performed directly on the human body.
- Device Description: The device is described as an "intraocular lens delivery system" used during "cataract surgery." It is a tool for physically implanting a lens.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures directly on the body itself. This device is a surgical instrument.
N/A
Intended Use / Indications for Use
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.
The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
Product codes (comma separated list FDA assigned to the subject device)
MSS
Device Description
The bioli™ 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 bioli™ IOL Delivery System is intended for use during cataract surgery.
The bioli™ IOL Delivery System is composed of two parts:
- (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and
- (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag
The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity.
The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.
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:
The bioli™ IOL Delivery System contacts the patient's eye directly for a limited (≤24hr) time. The device also has limited contact with the IOL. Based on the contact duration, cytotoxicity, sensitization and ocular irritation tests were performed. In addition, acute systemic toxicity and material-mediated pyrogenicity tests were also performed. The biocompatibility testing was performed in accordance with International Standard Orqanization (ISO) Biocompatibility evaluation of medical devices- parts 5, 10 and 11. The biocompatibility testing was found acceptable.
All lenses were delivered through the bioli™ IOL Delivery System according to the loading and delivery instructions.
The IOLs were evaluated for optical properties, dimensional properties and overall surface and bulk homoqeneity before and after being surgically manipulated using the bioli™ IOL Delivery System, as well as lens opening time after folding. The bioli™ IOL Delivery System was 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 11979-3:2012, Ophthalmic implants – Intraocular lenses - Part 3: Mechanical properties and test methods.
After delivery, lenses were observed for possible damages or scratches using a 10x microscope and showed passing results, and were within dimensional specifications. The bioli™ IOL Delivery System also showed no damage after lens delivery.
The resulting data from simulated surgical manipulation of bioli™ IOL Delivery System (Models: BIOLI-C, BIOLI-IC, BIOLI-D) to deliver intraocular lenses showed that the device can successfully deliver Lenstec's hydrophilic Softec 1 IQLs of low to high diopters and IOL models validated for use with this device as indicated in the IOL approved labeling without affecting the functionality of the lens.
Package stability and performance stability test results met the defined acceptance criteria and requirements for a shelf-life claim of 5 years. Visual inspection, package seal and package integrity of the sterile barrier system of bioli™ IOL Delivery System met the requirements in accordance with ASTM F1980-2007(2011 reapproved). The post aging tests were carried out in accordance with ASTM F88-09, ASTM F1929-12, ISO 11737-2:2009, USP 35 and ASTM F1140/F1140M-2013.
Results from sterilization validation testing conducted in accordance with ISO 11135:2014 demonstrated that bioli™ IOL Delivery System is able to be sterilized using EtO sterilization parameters with residual EO found to be within safe levels post-aeration period.
A transport stability study was conducted according to requirements in ISO 2233:2001, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1929-15. The results demonstrated that bioli™ IOL Delivery System was able to resist the physical damage caused by drop, vibration and short extreme temperature impacts during transportation.
- Clinical Tests: Not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
AST Products, Inc. William Lee VP, R&D and Regulatory Affairs 9 Linnell Circle Billerica, Massachusetts 01821
Re: K200057
Trade/Device Name: bioli IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: April 26, 2020 Received: April 28, 2020
Dear William Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm_identifies_combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200057
Device Name bioli™ IOL Delivery System
Indications for Use (Describe)
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.
The bioli™ IOL Delivery System is for implantation of qualified Lenstec Softec 1 IOL and 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 CFR 801 Subpart C) |
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3
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.
1. Submitter
AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778
2. Official Correspondence/Contact Person
William Lee, Ph.D. VP, 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
3. 510(k) Preparer
William Lee, Ph.D. VP, R&D and Requlatory Affairs AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778 Email: wlee@astp.com
4. Product Name
- Trade Name: bioli™ IOL Delivery System (Models: BIOLI-C, BIOLI-rC, BIOLI-D)
- Common Name: Folders and Injectors, Intraocular Lens (IOL)
5. Device Classification
- | Classification Name: Class I (21 CFR § 886.4300 Intraocular lens guide)
- Classification Panel: Ophthalmic (86)
- Product Code: MSS
6. Legally Marketed Predicates
- K182965 BL-Cart™ IOL Delivery Cartridge
4
7. Device Description
The bioli™ 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 bioli™ IOL Delivery System is intended for use during cataract surgery.
The bioli™ IOL Delivery System is composed of two parts:
- (1) a cartridge that holds the intraocular lens in position in preparation for loading and folding, and
- (2) a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag
The cartridge incorporates a smooth, internal geometry that progressively folds the lens for delivery through conventional nozzle geometry. A coating is applied to the cartridge including the inner surfaces to increase lubricity.
The cartridge is loaded by positioning the intraocular lens into the cartridge, folding the trailing haptic onto the anterior side of the optic, and finally pushing the optic edge of the lens to position it as far into the cartridge as the forceps will permit. After the cartridge is attached onto the injector, the system is now ready for the advancement of the plunger to deliver the lens.
The bioli™ IOL Delivery System and the referenced legally marketed predicate, BL-Cart™ IOL Delivery Cartridge, share the same principal method to implant an intraocular lens into the eye. Both utilize the same lens folding system design in which IOLs are folded and/or delivered from an injector system and the resulting optical and physical properties of the IOL remain unchanged as a result of folding/delivery.
Note: LubriMATRIX™ is a proprietary treatment composed of a hydrophilic polymer and a lubricious polymer engrafted onto the surface of the cartridge via a chemical polymerization process. Refer to MAF-1963 for further information. LubriMATRIX™ is applied to AST Products' current line of IOL Delivery Systems: lioli™ IOL Delivery System (K142056), pioli™ IOL Delivery System (K172228), and BL-Cart™ IOL Delivery Cartridge (K182965).
8. Intended Use and Indications for Use
The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision.
The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.
The bioli™ IOL Delivery System and the referenced legally marketed predicate device share the same principal folding method to implant an intraocular lens into the eye and similar intended use and indications for use for lens insertion into the eye, and thus does
5
not raise any new questions or concerns regarding safety and effectiveness. Refer to Table 1.
| Trade Name | Manufacturer | Regulation
No. | Product
Code | Regulation
Description | 510(k) No. | Intended Use &
Indications for Use |
|------------------------------------------------------------------------------|-----------------------|-------------------|-----------------|---------------------------|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| bioli™ IOL
Delivery System
(Models: BIOLI-
C, BIOLI-rC,
BIOLI-D) | AST Products,
Inc. | 886.4300 | MSS | Intraocular
Lens Guide | New device | The bioli™ IOL Delivery System is a
single-use, sterile device intended to
insert an approved single-piece foldable
acrylic intraocular lens (IOL) into the
human eye through an incision.
The bioli™ IOL Delivery System is only for
the insertion of Lenstec Softec I IOL and
IOL models validated for use with this
device as indicated in the approved IOL
labeling. |
| BL-Cart™ IOL
Delivery
Cartridge
(Model: Type D) | AST Products,
Inc. | 886.4300 | MSS | Intraocular
Lens Guide | K182965 | The BL-Cart™ IOL Delivery Cartridge is a
single-use, sterile device intended to
insert an approved single-piece foldable
acrylic intraocular lens (IOL) into the
human eye through a surgical procedure.
The cartridge is intended to be used in
conjunction with Alcon Monarch® III IOL
Delivery System injector.
The BL-Cart™ IOL Delivery Cartridge is
only for the insertion of Lenstec Softec I
IOL and IOL models validated for use with
this device as indicated in the approved
IOL labeling. |
Table 1. Device Comparisons – Intended Use and Indications for Use
6
9. Technological Characteristics
The bioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering of an intraocular lens into the eye for replacement of the human crystalline lens during cataract surgery. The device consists of a lubricious coated cartridge and a single-use injector with a silicone-tipped plunger used to advance the lens into the capsular bag.
The bioli™ IOL Delivery System shares similar technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application. Refer to Tables 2 and 3.
7
| Trade Name | Design | Operating Principle | Advancement
Mechanism | Biocomp. | Sterilization
Method | Setting Used | Patient
Contact | Recommended
for Use With | Human
Factors | Performance
Criteria Met |
|--------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|----------|---------------------------------------|--------------------------------|-------------------------------------------------------|------------------------------|----------------------------------|-----------------------------|
| bioli™ IOL
Delivery System
(Models: BIOLI-C,
BIOLI-rC, BIOLI-D) | 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 |
| BL-Cart™ IOL
Delivery Cartridge
(Model: Type D) | A sterile,
single-use
disposable
coated
cartridge | The one-piece
disposable cartridge is
loaded into a reusable
handpiece injection
system and the IOL is
pushed through the
cartridge into the eye | Plunger-like,
non-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 |
|---|---|---|
| bioli™ IOL Delivery System | ||
| (Models: BIOLI-C, BIOLI-rC, BIOLI-D) | Injector Barrel - Polycarbonate (144R) | |
| Plunger - ABS (PA-758) | ||
| Silicone Tip - Silicone (R 401) | ||
| Cartridge - Polypropylene (RJ880MO-12) | ||
| Spring - Stainless Steel (SS304) | ISO 11979-3:2012 | |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 | ||
| BL-Cart™ IOL Delivery Cartridge (Model: Type D) | Cartridge - Polypropylene (RJ880MO-12) | ISO 11979-3:2012 |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 |
8
10. Performance Data (Nonclinical and/or Clinical)
- Non-clinical Tests:
The bioli™ IOL Delivery System contacts the patient's eye directly for a limited (≤24hr) time. The device also has limited contact with the IOL. Based on the contact duration, cytotoxicity, sensitization and ocular irritation tests were performed. In addition, acute systemic toxicity and material-mediated pyrogenicity tests were also performed. The biocompatibility testing was performed in accordance with International Standard Orqanization (ISO) Biocompatibility evaluation of medical devices- parts 5, 10 and 11. The biocompatibility testing was found acceptable.
All lenses were delivered through the bioli™ IOL Delivery System according to the loading and delivery instructions.
The IOLs were evaluated for optical properties, dimensional properties and overall surface and bulk homoqeneity before and after being surgically manipulated using the bioli™ IOL Delivery System, as well as lens opening time after folding. The bioli™ IOL Delivery System was 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 11979-3:2012, Ophthalmic implants – Intraocular lenses - Part 3: Mechanical properties and test methods.
After delivery, lenses were observed for possible damages or scratches using a 10x microscope and showed passing results, and were within dimensional specifications. The bioli™ IOL Delivery System also showed no damage after lens delivery.
The resulting data from simulated surgical manipulation of bioli™ IOL Delivery System (Models: BIOLI-C, BIOLI-IC, BIOLI-D) to deliver intraocular lenses showed that the device can successfully deliver Lenstec's hydrophilic Softec 1 IQLs of low to high diopters and IOL models validated for use with this device as indicated in the IOL approved labeling without affecting the functionality of the lens.
Package stability and performance stability test results met the defined acceptance criteria and requirements for a shelf-life claim of 5 years. Visual inspection, package seal and package integrity of the sterile barrier system of bioli™ IOL Delivery System met the requirements in accordance with ASTM F1980-2007(2011 reapproved). The post aging tests were carried out in accordance with ASTM F88-09, ASTM F1929-12, ISO 11737-2:2009, USP 35 and ASTM F1140/F1140M-2013.
Results from sterilization validation testing conducted in accordance with ISO 11135:2014 demonstrated that bioli™ IOL Delivery System is able to be sterilized using EtO sterilization parameters with residual EO found to be within safe levels post-aeration period.
A transport stability study was conducted according to requirements in ISO 2233:2001, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, and ASTM F1929-15. The results demonstrated that bioli™ IOL Delivery System was able to
9
resist the physical damage caused by drop, vibration and short extreme temperature impacts during transportation.
- Clinical Tests: Not required for this device.
11. Conclusion
The resulting data from simulated surgical manipulation of bioli™ IOL Delivery System to deliver intraocular lenses showed that bioli™ (Models: BIOLI-C, BIOLI-rC, BIOLI-D) can successfully deliver Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling 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, we conclude that the bioli™ IOL Delivery System is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.