(155 days)
No
The device description and performance studies focus on the mechanical delivery of an IOL and biocompatibility, with no mention of AI or ML capabilities.
No.
The device is an IOL delivery cartridge, which is an instrument used to insert a therapeutic device (the IOL) into the eye, rather than being a therapeutic device itself.
No
Explanation: The device is a cartridge used to deliver an intraocular lens during cataract surgery. Its function is to assist in the surgical insertion of a lens, not to diagnose a condition or illness.
No
The device description clearly states it is a physical cartridge used to deliver an intraocular lens, and it undergoes sterilization and biocompatibility testing, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically insert an intraocular lens into the human eye during surgery. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is a cartridge used to deliver a lens. It doesn't analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties of the cartridge and the lens after delivery, as well as biocompatibility. They do not involve evaluating the device's ability to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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 Cartidge 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.
Product codes
MSS
Device Description
BL-Cart™ IOL Delivery Cartridge (Model: Type D) is an intraocular lens (IOL) delivery cartridge solution capable of supplying the ophthalmologist surgeon with a cartridge precoated with lubricious coating for use during a typical cataract surgery. The BL-Cart™ cartridge is used to deliver an approved IOL lens.
The BL-Cart™ IOL Delivery Cartridge and referenced predicate device. Monarch® III D cartridge, 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.
The BL-Cart™ IOL Delivery Cartridge comes with one pre-coated cartridge, packaged in a Tyvek pouch, placed in a 10 unit box as intended for marketing, and sterilized by ethylene oxide (EtO).
The BL-Cart™ IOL Delivery Cartridge and the referenced legally marketed predicate device share the same principal method to implant an intraocular lens into the eve.
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) and pioli™ IOL Delivery System (K172228).
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
Non-clinical Tests:
The BL-Cart™ IOL Delivery Cartridge 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 were also performed. The biocompatibility testing was performed in accordance with International Standard Organization (ISO) Biocompatibility evaluation of medical devices-parts 5. 10 and 11. The biocompatibility testing was found acceptable.
All lenses were delivered through the BL-Cart™ IOL Delivery Cartridge according to the loading and delivery instructions.
The IOLs were evaluated for optical properties, dimensional properties and overall surface and bulk homogeneity before and after being surgically manipulated using the BL-Cart™ IOL Delivery Cartridge, as well as lens opening time after folding. The BL-Cart™ 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 microscope and showed passing results, and were within dimensional specifications. BL-Cart™ also showed no damage after lens delivery.
The resulting data from simulated surgical manipulation of BL-Cart™ IOL Delivery Cartridge (Model: Type D) to deliver intraocular lenses showed that the device 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 in the IOL approved labeling without affecting the functionality of the lens.
Clinical Tests: Not required for this device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 29, 2019
AST Products, Inc. % Dr. David Lim VP. R&D and Regulatory Affairs 9 Linnell Circle Billerica. MA 01821
Re: K182965
Trade/Device Name: BL-Cart™ IOL Delivery Cartridge Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: February 14, 2019 Received: February 19, 2019
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. 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.
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 of medical devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Jennifer N. Brown -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
2
Indications for Use
510(k) Number (if known) K182965
Device Name BL-Cart™ IOL Delivery Cartridge
Indications for Use (Describe)
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 Cartidge 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.
| 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
Regulatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner, VA 24149 Tel: (800) 321-8567 Email: info@regulatorydoctor.com
4. Product Name
- Trade Name: BL-Cart™ IOL Delivery Cartridge (Model: Type 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
- K063155: Monarch® III IOL Delivery System (D Cartridge)
7. Device Description
BL-Cart™ IOL Delivery Cartridge (Model: Type D) is an intraocular lens (IOL) delivery
4
cartridge solution capable of supplying the ophthalmologist surgeon with a cartridge precoated with lubricious coating for use during a typical cataract surgery. The BL-Cart™ cartridge is used to deliver an approved IOL lens.
The BL-Cart™ IOL Delivery Cartridge and referenced predicate device. Monarch® III D cartridge, 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.
The BL-Cart™ IOL Delivery Cartridge comes with one pre-coated cartridge, packaged in a Tyvek pouch, placed in a 10 unit box as intended for marketing, and sterilized by ethylene oxide (EtO).
The BL-Cart™ IOL Delivery Cartridge and the referenced legally marketed predicate device share the same principal method to implant an intraocular lens into the eve.
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) and pioli™ IOL Delivery System (K172228).
8. Intended Use and Indications for Use
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 IOL approved labeling.
The BL-Cart™ IOL Delivery Cartridge 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 not raise any new questions or concerns regarding safety and effectiveness. Refer to Table 1.
5
| Trade
Name | Manufacturer | Regulation
No. | Product
Code | Regulation
Description | 510(k) No. | Intended Use &
Indications for Use |
|-------------------------------------------------------------|-------------------------|-------------------|-----------------|---------------------------|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BL-Cart™
IOL Delivery
Cartridge
(Model:
Type D) | AST Products,
Inc. | 886.4300 | MSS | Intraocular
Lens Guide | New device | 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 IOL approved labeling. |
| Monarch® III
IOL Delivery
System (D
Cartridge) | Alcon Research,
Ltd. | 886.4300 | MSS | Intraocular
Lens Guide | K063155 | The MONARCH® III IOL Delivery
System is used for implantation of
ALCON® qualified ACRYSOF®
intraocular lenses into the eye
following cataract removal. |
Table 1. Device Comparisons – Intended Use and Indications for Use
6
9. Technological Characteristics
The BL-Cart™ IOL Delivery Cartridge is an intraocular lens delivery cartridge used for progressive folding in combination with a reusable handpiece to deliver an intraocular lens into the eye for replacement of the human crystalline lens during cataract surgery. The device consists of a lubricious coated cartridge in preparation for intraocular lens loading and lens folding.
The BL-Cart™ IOL Delivery Cartridge 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 | Biocomp. | Sterilization
Method | Setting
Used | Patient
Contact | Recommended
for Use With | Human
Factors | Performance
Criteria Met? |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|---------------------------------------|--------------------------------|-------------------------------------------------------|------------------------------|-------------------------------|------------------------------|
| 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 | 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 |
| Monarch®
III IOL
Delivery
System (D
Cartridge) | Monarch® III
reusable
handpiece and
single-use,
sterile 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 | Yes | ETO sterilization | 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 |
|---|---|---|
| BL-Cart™ IOL Delivery Cartridge (Model: Type D) | Cartridge - Polypropylene (RJ880MO-12) | ISO 11979-3:2012 |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 | ||
| Monarch® III IOL Delivery System (D Cartridge) | Cartridge- Polypropylene with a polyvinylpyrrolidone (PVP) coating on the inner lumen | ISO 11979-3:2012 |
| ISO10993-5: 2009 | ||
| ISO 10993-10: 2010 |
8
10. Performance Data (Nonclinical and/or Clinical)
- Non-clinical Tests:
The BL-Cart™ IOL Delivery Cartridge 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 were also performed. The biocompatibility testing was performed in accordance with International Standard Organization (ISO) Biocompatibility evaluation of medical devices-parts 5. 10 and 11. The biocompatibility testing was found acceptable.
All lenses were delivered through the BL-Cart™ IOL Delivery Cartridge according to the loading and delivery instructions.
The IOLs were evaluated for optical properties, dimensional properties and overall surface and bulk homogeneity before and after being surgically manipulated using the BL-Cart™ IOL Delivery Cartridge, as well as lens opening time after folding. The BL-Cart™ 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 microscope and showed passing results, and were within dimensional specifications. BL-Cart™ also showed no damage after lens delivery.
The resulting data from simulated surgical manipulation of BL-Cart™ IOL Delivery Cartridge (Model: Type D) to deliver intraocular lenses showed that the device 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 in the IOL approved labeling without affecting the functionality of the lens.
- Clinical Tests: Not required for this device.
11. Conclusion
The resulting data from simulated surgical manipulation of BL-Cart™ IOL Delivery Cartridge to deliver intraocular lenses showed that BL-Cart™ (Model: Type 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 BL-Cart™ IOL Delivery Cartridge is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.