(143 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 processes indicative of AI/ML.
No.
This device is an IOL delivery system, which is an accessory used for a surgical procedure to insert an intraocular lens. It does not provide any therapeutic effect itself.
No
Explanation: This device is described as an "IOL Delivery System" intended to insert an intraocular lens into the human eye. Its function is to facilitate a surgical procedure, not to diagnose a condition.
No
The device description explicitly states it is a "single-use, sterile device" consisting of a "syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge." This describes physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The pioli™ IOL Delivery System is a surgical tool used to physically insert an intraocular lens (IOL) into the human eye. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for "insert[ing] a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure." This is a surgical intervention, not an in vitro diagnostic test.
The device is a surgical instrument used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I 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 pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-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. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on 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.
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.
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 pioli™ 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 the pioli™ IOL Delivery System, as well as lens opening time after folding. The pioli™ 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 11979-2. 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 damaqes or scratches, and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.
The resulting data from simulated surgical manipulation of pioli™ IOL Delivery System to deliver intraocular lenses (IOLs) showed that pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device as indicated on the IOL approved labeling without affecting the functionality of the lens.
The components of pioli™ IOL Delivery System that have direct and indirect contact with the patient are manufactured of the same materials and same manufacturing processes as the predicate device, lioli™ IOL Delivery System.
Since the same materials and the same manufacturing processes have been used for components that have direct and indirect contact with the patient in both medical devices, we therefore conclude that the biocompatibility testing on particularly the cartridge and the silicone tip of the predicate device are applicable to the subject device.
The resulting data from packaging validation showed that the most suitable parameter to seal the packaging of pioli™ IOL Delivery System was under the condition of 129°C, 3.6 seconds, with all blisters passing the appearance inspection, peeling strength and adhesion tests.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
December 15, 2017
AST Products, Inc. William Lee, Ph.D. R&D and Regulatory Affairs 9 Linnell Circle Billerica. MA 01821
Re: K172228
Trade/Device Name: pioli™ IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 2, 2017 Received: November 6, 2017
Dear William Lee, Ph.D .:
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
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 devicerelated 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
Denise L. Hampton -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172228
Device Name pioli™ IOL Delivery System
Indications for Use (Describe)
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraccular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the Lenstec Softee I 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
Requlatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner. VA 24149 Tel: (800) 321-8567 Email: info@regulatorydoctor.com
4. Product Name
- Trade Name: pioli™ IOL Delivery System
- 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
- K142056: lioli™ IOL Delivery System (Models: LIOLI-18, LIOLI-22, LIOLI-24)
7. Device Description
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation
4
through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated on the IOL approved labeling.
The set consists of a single-use, sterile svringe 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.
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.
8. Intended Use and Indications for Use
The pioli™ IOL Delivery System is a single-use, sterile device intended to insert a single-piece foldable intraocular lens (IOL) into the human eve through a surqical procedure. The system provides a tubular pathway for lens implantation through an incision. The pioli™ IOL Delivery System is only for the insertion of the Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the IOL approved labeling.
The pioli™ 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.
5
| Trade
Name | Manufacturer | Regulation
No. | Product
Code | Regulation
Description | 510(k) No. | Intended Use &
Indications for Use |
|----------------------------------|--------------------|-------------------|-----------------|---------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| pioli™ IOL
Delivery
System | AST Products, Inc. | 886.4300 | MSS | Intraocular
Lens Guide | New device | The pioli™ 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. The
pioli™ IOL Delivery System is only for
the insertion of Lenstec Softec I IOL
and IOL models validated for use with
this device as indicated on the IOL
approved labeling. |
| lioli™ IOL
Delivery
System | AST Products, Inc. | 886.4300 | MSS | Intraocular
Lens Guide | K142056 | 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. |
Table 1. Device Comparisons – Intended Use and Indications for Use
6
9. Technological Characteristics
The pioli™ 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 lubricious coated cartridge structure in preparation for intraocular lens loading and lens folding (2) a single-use injector with a silicone-tipped plunger used to advance the lens into the capsular bag.
The pioli™ IOL Delivery System is intended for use during cataract surgery.
An intraocular lens folded into the cartridge reduces the surgical incision size.
The pioli™ 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. Refer to Tables 2 and 3.
7
Table 2. Device Comparisons – Technological Characteristics
| Trade Name | Design | Operating Principle | Forward Motion Principle | Biocomp. | Sterilization Method | Setting Used | Patient Contact | Recommended for Use With | Human Factors | Performance Criteria Met? |
|---|---|---|---|---|---|---|---|---|---|---|
| Dioli™ IOL | ||||||||||
| Delivery System | A sterile, single use disposable device | The cartridge is back 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 | ||||||
| ioli™ 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 |
Table 3. Device Comparisons – Materials
| Trade Name | Device Materials | Standards Met |
|---|---|---|
| pioli™ IOL | ||
| Delivery System | Injector - Polycarbonate (144R) | |
| Plunger - Polycarbonate (144R) | ||
| Silicone Tip - Silicone (R 401) | ||
| Cartridge - Polypropylene (HD850MO) | ||
| Spring - Stainless Steel (SS304) | ISO 11979-3:2012 | |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 | ||
| 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 |
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10. Performance Data (Nonclinical and/or Clinical)
- Non-clinical Tests:
All lenses were delivered through the pioli™ 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 the pioli™ IOL Delivery System, as well as lens opening time after folding. The pioli™ 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 11979-2. 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 damaqes or scratches, and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.
The resulting data from simulated surgical manipulation of pioli™ IOL Delivery System to deliver intraocular lenses (IOLs) showed that pioli™ IOL Delivery System (Model: PIOLI-D) can successfully deliver Lenstec's hydrophilic Softec 1 IOLs of low to high diopters and IOL models validated for use with this device as indicated on the IOL approved labeling without affecting the functionality of the lens.
The components of pioli™ IOL Delivery System that have direct and indirect contact with the patient are manufactured of the same materials and same manufacturing processes as the predicate device, lioli™ IOL Delivery System.
Since the same materials and the same manufacturing processes have been used for components that have direct and indirect contact with the patient in both medical devices, we therefore conclude that the biocompatibility testing on particularly the cartridge and the silicone tip of the predicate device are applicable to the subject device.
The resulting data from packaging validation showed that the most suitable parameter to seal the packaging of pioli™ IOL Delivery System was under the condition of 129°C, 3.6 seconds, with all blisters passing the appearance inspection, peeling strength and adhesion tests.
Clinical Tests: Not required for this device. |
9
11. Conclusion
The pioli™ 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.
Based on the assessment of these findings, along with the results of Biocompatibility, Sterilization and Shelf-Life testing, the pioli™ IOL Delivery System is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.