(86 days)
Not Found
No
The description focuses on mechanical actions (folding, injecting, compressing, advancing a plunger) and does not mention any computational or data-driven processes characteristic of AI/ML. The performance studies are nonclinical and evaluate mechanical and material properties, not algorithmic performance.
No
This device is used for the delivery of intraocular lenses, not for a therapeutic effect itself. Its function is mechanical (folding and injecting), not related to treating a disease or condition.
No.
The device is used for folding and injecting intraocular lenses, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines a physical system with components like a loading area, drawer, plunger, distal end, and haptic puller, all used for the mechanical folding and injection of an intraocular lens. The performance studies also focus on physical characteristics and functionality of the device hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The Easy-Load Lens Delivery System is used to physically fold and inject an intraocular lens into the eye. This is a surgical procedure performed inside the body (in vivo).
- Intended Use: The intended use clearly states "folding and injection of Bausch + Lomb intraocular lenses". This describes a surgical delivery mechanism, not a diagnostic test.
- Device Description: The description details the mechanical process of loading, compressing, and delivering the lens into the eye. There is no mention of analyzing biological samples or performing diagnostic tests.
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
MSS
Device Description
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL 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
Nonclinical tests were completed on the proposed Easy-Load Lens Delivery System (Model EZ-24).
Function Performance Tests included:
- IOL surface & bulk homogeneity: Pass (Free from surface and bulk defects and all edges should appear smooth when viewed at 10X magnification).
- IOL lens power: Pass (The diopter power of the lenses shall be within the allowed tolerance).
- IOL image quality: Pass (The image quality of the lenses shall meet or exceed the minimum resolution group element of the Air Force target specified in the protocol).
- IOL dimensions: Pass (The lenses must meet the dimensional requirements specified in the protocol).
- IOL delivery outcome: Pass (The IOLs do not flip over upon delivery; The IOL must exit inserter upon completion of delivery; No cosmetic defects to the IOL's haptic from folding and/or delivery).
- Damage to insertion device: Pass (No damage to the insertion device due to lens delivery).
- Lubricant transfer study: Pass (No detectable transfer).
- Particle study: Pass (Comparable to or lower than control).
Sterilization Verification Tests included:
- Comparative Resistance Performance Determination: Pass (For a given exposure time the average recovery of viable test organisms from biological indicators placed within the barrel of either the EZ-24 or the EZ-28 shall differ by no more than one logarithm of the average of the values determined for both inserters. Alternatively, the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-24 may be less than the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-28 inserters).
- EO transfer test: Pass (
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2016
Bausch and Lomb, Inc. Dr. Joyce Zhong Regulatory Affairs Specialist 50 Technology Drive Irvine, CA92618
Re: K161012
Trade/Device Name: Easy-load Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: June 3, 2016 Received: June 6, 2016
Dear Dr. Zhong:
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. 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
1
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 Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Kesia Alexander
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
5 Indications for Use Statement
510(k) Number (if known):
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 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)
Page 19
CONFIDENTIAL
3
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:
Joyce Zhong, PhD Regulatory Affairs Specialist Bausch + Lomb 50 Technology Drive, Irvine, CA 92618 Phone: 949-398-5594 Fax: 949-398-5764
Date Summary Prepared: April 7, 2016
1. Subject Device:
| Trade name: | Easy-Load Lens Delivery System |
|---|---|
| Common Name: | Intraocular lens Guide |
| Classification Name: | 21 CFR 886.4300 |
Predicate Device: 2.
| Primary Predicate Device | K132481 | Easy-Load Lens Delivery System | EZ-28 |
|---|---|---|---|
| Secondary Predicate Device | K131958 | Bausch + Lomb Injector System | BLIS-X1 |
3. Device Description:
The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL 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.
The indications for use of the proposed device are the same as the primary predicate device.
4
5. Brief Summary of Nonclinical Test and Results:
Nonclinical tests listed below were completed on the proposed Easy-Load Lens Delivery System (Model EZ-24) and results show the system to be in conformance with the requirements set forth by accepted ISO standards (ISO 11979-2, ISO 11979-3, and ISO 11135) where applicable.
| Item | TEST | Acceptance Criteria | RESULTS | |
|---|---|---|---|---|
| Function | ||||
| Performance | (Before and after | |||
| insertion) IOL surface & | ||||
| bulk homogeneity | Free from surface and bulk defects and all | |||
| edges should appear smooth when viewed at | ||||
| 10X magnification | Pass | |||
| (Before and after | ||||
| insertion) IOL lens power | The diopter power of the lenses shall be | |||
| within the allowed tolerance | Pass | |||
| (Before and after | ||||
| insertion) IOL image | ||||
| quality | The image quality of the lenses shall meet | |||
| or exceed the minimum resolution group | ||||
| element of the Air Force target specified in | ||||
| the protocol. | Pass | |||
| (Before and after | ||||
| insertion) IOL dimensions | The lenses must meet the dimensional | |||
| requirements specified in the protocol. | Pass | |||
| IOL delivery outcome | The IOLs do not flip over upon delivery; | |||
| The IOL must exit inserter upon completion | ||||
| of delivery; No cosmetic defects to the | ||||
| IOL's haptic from folding and/or delivery | Pass | |||
| Damage to insertion | ||||
| device | No damage to the insertion device due to | |||
| lens delivery | Pass | |||
| Lubricant transfer study | No detectable transfer | Pass | ||
| Particle study | Comparable to or lower than control | Pass | ||
| Sterilization | ||||
| verification | Comparative Resistance | |||
| Performance | ||||
| Determination | For a given exposure time the average | |||
| recovery of viable test organisms from | ||||
| biological indicators placed within the | ||||
| barrel of either the EZ-24 or the EZ-28 shall | ||||
| differ by no more than one logarithm of the | ||||
| average of the values determined for both | ||||
| inserters. Alternatively, the average | ||||
| recovery of viable test organisms from | ||||
| biological indicators placed within the | ||||
| barrel of the EZ-24 may be less than the | ||||
| average recovery of viable test organisms | ||||
| from biological indicators placed within the | ||||
| barrel of the EZ-28 inserters | Pass | |||
| EO transfer test | $\le$ 0.5μg EO per IOL | Pass | ||
| Endotoxin test | $\lt$ 0.2 EU/device | Pass | ||
| Packaging | ||||
| verification | Plunger push force and | |||
| cartridge detachment | ||||
| testing | Cartridge detachment force is greater than | |||
| the force to disengage the plunger from the | ||||
| detents in the injector body. | Pass |
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6. Comparative Analysis
A table comparing the proposed device to the primary predicate device is provided below.
| Characteristic | Primary Predicate Device
EZ-28 (K132481) | Proposed Device
EZ-24 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 |
| Anatomical site | Eye | Eye |
| Injector configuration | Body, drawer, haptic puller, plunger | Body, cartridge, drawer, haptic puller,
plunger, bearing |
| Materials | Body, drawer, haptic puller, plunger:
Polypropylene | Body: drawer, haptic puller, plunger,
bearing: Polypropylene
Cartridge: Polyimide |
| How is the device
used | 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. | 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. |
| Single use? | Yes | Yes |
| Is the product sterile? | Sterile | Sterile |
| How sterilized | Ethylene oxide | Ethylene oxide |
| Sterility assurance
level | 10-6 | 10-6 |
Table 6-1: Comparison of Primary Predicate Device (Model EZ-28) to the Proposed Easy-Load Lens Delivery System (Model EZ-24)
7. Conclusion
The results obtained from nonclinical tests performed on the proposed Easy Load Lens Delivery System have demonstrated that the proposed device is as effective, and performs at least as safely and effectively as the predicate devices, therefore the proposed Easy Load Lens Delivery System is substantially equivalent to the predicate devices.