(141 days)
Not Found
No
The device description and performance studies focus on mechanical delivery of an intraocular lens, with no mention of AI/ML terms or data processing.
No.
This device is used for delivering an intraocular lens into the eye, which is a surgical delivery tool, not a therapeutic device.
No
The device is described as a "Lens Delivery System" used for folding and injecting intraocular lenses into the eye. Its function is to facilitate the surgical implantation of a lens, not to diagnose a condition or disease.
No
The device description clearly outlines a physical system with components like a loading area, drawer, plunger, distal end, and haptic puller, indicating it is a hardware device used for surgical delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Easy-Load Lens Delivery System is a surgical tool used to physically implant an intraocular lens (IOL) into the eye. It is used during a surgical procedure on a patient, not for testing samples outside the body.
- Intended Use: The intended use clearly states "folding and injection of Bausch + Lomb intraocular lenses." This is a surgical delivery function, not a diagnostic test.
- Device Description: The description details the mechanical process of loading, compressing, and delivering the IOL into the eye. This is a physical manipulation of a medical device for implantation.
Therefore, the Easy-Load Lens Delivery System is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MSS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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
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.
1
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 K970727
MPORT Foldable Lens Placement
System | Easy-Load Lens Delivery System
(Proposed Device) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The MPORT Foldable Lens Placement
System is a Class I device indicated for
compressing and inserting a Soflex
(formerly Chiroflex II) series multi-piece
intraocular lens into the eye during
small incision cataract surgery. | 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. |
| Contraindications | None | None |
| Materials | Body, drawer, haptic puller, plunger:
polypropylene
Spring: stainless steel | Body, drawer, haptic puller, plunger:
polypropylene
Spring: stainless steel |
| Is the product single
use? | Single use | Single use |
| Is the product sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance
level | 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.
2
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.
3
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
4
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'
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CONFIDENTIAL
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