(141 days)
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IQL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
Here's a breakdown of the acceptance criteria and study information for the Easy-Load Lens Delivery System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | New materials found to be biocompatible (Implicit: no adverse biological reactions) | New materials for the Easy-Load Lens Delivery System were found to be biocompatible. |
| Bench Testing | Met acceptance criteria (Implicit: no damage to IOLs, successful delivery, proper visual appearance of injector) | All nonclinical tests met the acceptance criteria. |
| Surface Homogeneity of Delivered IOLs | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Bulk Homogeneity of Delivered IOLs | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Delivery Outcome | (Not explicitly stated, but implied as successful and effective) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Injector Visual Inspection | (Not explicitly stated, but implied as satisfactory) | (Covered under "All nonclinical tests met the acceptance criteria.") |
| Sterility Assurance Level | 10^-6 | 10^-6 |
| Shelf Life | 12 months | 12 months |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for each bench test or biocompatibility test. It generally refers to "the new Easy-Load Lens Delivery System materials" and "Easy-Load Lens Delivery Systems with the new materials."
The data provenance is retrospective, as the testing was performed on the device prior to submission and regulatory review. The country of origin for the data is not mentioned, but given the submission to the FDA, it is likely that the studies were either performed in the US or in a manner compliant with US regulatory requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document describes bench and biocompatibility testing, which are typically performed in laboratories according to established protocols, rather than relying on expert consensus for "ground truth" in the same way clinical imaging studies might.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are making subjective assessments, such as interpreting medical images. Bench and biocompatibility testing rely on objective measurements and predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is more relevant for diagnostic devices where human interpretation interacts with AI, and this device is a surgical delivery system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable). This device is a manual intraocular lens delivery system, not an algorithm or AI-powered system. Therefore, the concept of "standalone algorithm performance" does not apply. The device's performance is inherently "human-in-the-loop" as it is operated by a surgeon.
7. The Type of Ground Truth Used
The ground truth for the performance of the Easy-Load Lens Delivery System was established through objective laboratory testing and measurements.
- For biocompatibility, the ground truth is the absence of biological reactivity or toxicity, verified through standardized assays and tests.
- For bench testing (surface and bulk homogeneity of delivered IOLs, delivery outcome, and injector visual inspection), the ground truth is established by design specifications and performance requirements (e.g., IOL delivered undamaged, correct placement, injector integrity), verified by direct observation, measurement, and functional testing.
8. The Sample Size for the Training Set
N/A (Not Applicable). As this is a mechanical medical device, there is no "training set" in the context of an algorithm or AI system. The device design and manufacturing processes are likely informed by engineering principles, material science, and previous product iterations, but not a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
N/A (Not Applicable). Since there is no training set for an algorithm, there is no ground truth established for it in this context.
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DEC 2 7 2013
510(K) SUMMARY
This summary document has been prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Jason Smith Global Regulatory Affairs Manager Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 Phone: 800-393-6642 Fax: 949-398-5764
Date Summary Prepared: December 23, 2013
Subject Device: 1.
Trade Name: Easy-Load Lens Delivery System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300
2. Predicate Device:
K970727, MPORT Foldable Lens Placement System
3. Device Description:
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IQL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.
4. Indications for Use:
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
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5. Brief Summary of Nonclinical Tests and Results:
The Easy-Load Lens Delivery System was evaluated via biocompatibility and bench testing. Biocompatibility testing was performed on the new Easy-Load Lens Delivery System materials and they were found to be biocompatible. Bench testing (surface and bulk homogeneity of delivered IOLs, delivery outcome, and injector visual inspection) was performed on Easy-Load Lens Delivery Systems with the new materials. All the nonclinical tests met the acceptance criteria.
Comparative Analysis 6.
A table comparing the proposed device to the predicate devices is provided below.
| Table 6-1: Comparison of Predicate Device to the Proposed Easy-Load | ||||
|---|---|---|---|---|
| Lens Delivery System | ||||
| AL --------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Characteristic | Predicate K970727MPORT Foldable Lens PlacementSystem | Easy-Load Lens Delivery System(Proposed Device) |
|---|---|---|
| Indications for use | The MPORT Foldable Lens PlacementSystem is a Class I device indicated forcompressing and inserting a Soflex(formerly Chiroflex II) series multi-pieceintraocular lens into the eye duringsmall incision cataract surgery. | The Easy-Load Lens Delivery Systemis indicated for the folding and injectionof Bausch + Lomb intraocular lensesidentifying the Easy-Load Lens DeliverySystem in their approved labeling. |
| Contraindications | None | None |
| Materials | Body, drawer, haptic puller, plunger:polypropyleneSpring: stainless steel | Body, drawer, haptic puller, plunger:polypropyleneSpring: stainless steel |
| Is the product singleuse? | Single use | Single use |
| Is the product sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurancelevel | 10-6 | 10-6 |
| Shelf life | 12 months | 12 months |
7. Conclusion
The Easy Load Lens Delivery System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2013
Bausch + Lomb % Mr. Jason Smith Manager, Global Regulatory Affairs 50 Technology Drive Irvine, CA 92618
Re: KI32481
Trade/Device Name: Easy-Load Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I (reserve) Product Code: MSS Dated: November 19, 2013 Received: November 20, 2013
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Jason Smith
"You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Deborah L. Falls -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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5 Indications for Use Statement
510(k) Number (if known): 132481
Device Name: Easy-Load Lens Delivery System
Indications for Use:
The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.
Prescription Use _ X __ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susanna W. Jones -S 2013.12.23 13:26:27 -05'00'
Page 1 of 1
CONFIDENTIAL
0138
§ 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.