(59 days)
Not Found
No
The document describes a mechanical device for inserting an intraocular lens and makes no mention of AI or ML.
No
Explanation: The device is an inserter used to fold and insert intraocular lenses during surgery. It is a surgical tool, not a device that provides therapy or treats a condition.
No
The device is described as an inserter for intraocular lenses during surgical procedures, facilitating the delivery of an IOL into the capsular bag. Its function is to fold and insert a lens, not to diagnose a condition or disease.
No
The device description clearly states it is a "sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye," indicating it is a physical, hardware-based medical device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EyeGility Inserter is a surgical tool used to physically insert an intraocular lens (IOL) into the human eye during a surgical procedure. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's for "folding and inserting of enVista IOL models." This is a surgical function, not a diagnostic one.
- Device Description: The description reinforces its role as a "sterile, single-use device used to fold and insert an intraocular lens through surgical procedure."
The device is a surgical instrument, not a diagnostic test.
N/A
Intended Use / Indications for Use
The EyeGility Inserter for enVista preloaded is indicated for folding and inserting of enVista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
Product codes
MSS
Device Description
The EyeGility Inserter is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The Inserter provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
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
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 EyeGility Inserter has successfully undergone functional testing in conformance with the requirements set forth in ISO 11979-3. Additional nonclinical testing information is provided in Table 1. All acceptance criteria were met, demonstrating the subject device is substantially equivalent to the predicate devices. No clinical testing was completed in support of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 10, 2024
Bausch & Lomb Incorporated Renee Stoffel Associate Director, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609
Re: K242389
Trade/Device Name: EyeGility™ Inserter for Preloaded enVista® IOLs Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, reserved Product Code: MSS Dated: August 12, 2024 Received: August 12, 2024
Dear Renee Stoffel:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ginny Liu
For Bennett Walker, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K242389
Device Name
EyeGility™ Inserter for Preloaded enVista® IOLs
Indications for Use (Describe)
The EyeGility Inserter for en Vista preloaded is indicated for folding and inserting of en Vista IOL models approved for use with this IOL insertion device as indicated in the IOL approved labeling.
| Type of Use (Select one or both , as applicable) | |
|---|---|
| --------------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter: | Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Renee Stoffel
Associate Director, Regulatory Affairs
(651) 392-4619 |
| Date Prepared: | September 20, 2024 |
| Trade Name: | EyeGility™ Inserter for Preloaded enVista® IOLs |
| Classification Name: | Intraocular lens guide (21 CFR 886.4300) |
| FDA Product Code: | MSS |
| Predicate Devices: | Primary Predicate Device
Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005) |
| | Predicate Device
Bausch + Lomb IOL Injector, INJ 100 (K113852) |
| Device Description: | The EyeGility Inserter is a sterile, single-use device used to fold and
insert an intraocular lens through surgical procedure into a human eye.
The Inserter provides a tubular pathway through an incision over the
iris, allowing delivery of an IOL into the capsular bag. |
| Indications for Use: | The EyeGility Inserter for enVista preloaded is indicated for folding
and inserting of enVista IOL models approved for use with this IOL
insertion device as indicated in the IOL approved labeling. |
| Summary of Performance
and Non-clinical Testing: | The EyeGility Inserter has successfully undergone functional testing in
conformance with the requirements set forth in ISO 11979-3.
Additional nonclinical testing information is provided in Table 1. All
acceptance criteria were met, demonstrating the subject device is
substantially equivalent to the predicate devices. |
| Clinical Testing: | No clinical testing was completed in support of the subject device. |
| Comparative Analysis: | The EyeGility Inserter has been demonstrated to be equivalent to the
predicate devices for its intended use. Table 2 includes a detailed
comparison of the subject and predicate devices. |
| Conclusion: | The EyeGility Inserter is substantially equivalent to the predicate
devices. |
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| Testing Category | Test | Standards | Results |
|---|---|---|---|
| Delivery Verification | |||
| Testing and Stability | |||
| Testing | Fold and Recovery Test | ISO 11979-3 | Pass |
| Dioptric Power and Image Quality Post | |||
| Delivery | ISO 11979-2 | Pass | |
| Lens Dimensions Post Delivery | ISO 11979-3 | Pass | |
| Surface and Bulk Homogeneity | ISO 11979-3 | Pass | |
| Cosmetic Inspection | N/A | Pass | |
| Biocompatibility | Biocompatibility Assessment | ISO 10993-1 | Pass |
| Particulate Study | ISO 10993-1 | Pass | |
| Coating Transfer Study | ISO 10993-1 | Pass | |
| Leachable Extractions | ISO 10993-18 | Pass | |
| EO Sterilization | Validation Product Adoption Analysis | ISO 11135 | Pass |
| EO Residuals | ETO/ECH Transfer Engineering Study | ISO 10993-7 | Pass |
| Bacterial Endotoxin | Bacterial Endotoxin Test | ANSI/AAMI ST72 | Pass |
| Packaging | Transport Stability Testing | ISO 11607-1 | |
| ISO 11979-6 | |||
| ASTM F2096 | Pass |
Table 1. Nonclinical Testing Summary
Table 2. Comparison of the subject and predicate device.
| Technological
Similarities | Subject Device – EyeGility
Inserter | Primary Predicate Device -
Bausch + Lomb PreVue
Inserter (K192005) | Predicate Device - Bausch +
Lomb IOL Injector, INJ100
(K113852) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For
Use | The EyeGility Inserter for
enVista preloaded is indicated
for folding and inserting of
enVista IOL models approved
for use with this IOL insertion
device as indicated in the IOL
approved labeling. | The Bausch +Lomb PreVue
inserter for en Vista preloaded
is indicated for folding and
inserting of enVista IOLs
(Model MX60PL) and IOL
models approved for use with
this IOL insertion device as
indicated in the IOL approved
labeling. | The Bausch + Lomb IOL
Injector is indicated for
folding and injection of
Bausch + Lomb IOLs
approved for use with this
injector |
| How device is
used | The preloaded IOL shuttle is
snapped into loading chamber
of the enVista inserter body.
The push-type plunger
advances the IOL through the
shuttle into the cartridge which
folds the IOL and advances it
into the eye. | The preloaded IOL shuttle is
snapped into loading chamber
of the PreVue inserter. The
screw plunger advances the
IOL through the shuttle into
the cartridge which folds the
IOL and advances it into the
eye. | The IOL is placed in the
loading chamber. A plunger
pushes the IOL into the tip,
which folds the IOL.
Pushing the plunger further
advances
the IOL out through the tip
into the eye. |
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| Technological
Similarities | Subject Device - EyeGility
Inserter | Primary Predicate Device -
Bausch + Lomb PreVue
Inserter (K192005) | Predicate Device - Bausch +
Lomb IOL Injector, INJ100
(K113852) |
|-------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Inserter
Components | ABS Body
Pebax Cartridge (Medicoat A)
PPA Plunger
Silicone Soft tip | ABS Body
Pebax Cartridge (Medicoat A)
PPA Plunger
ABS Thread Bushing and
Screw Spindle | ABS Body
ABS Plunger
Polyamide Cartridge
Medicoat A Coating |
| Single Use | Injector: Yes
Cartridge: Yes | Inserter: Yes
Cartridge: Yes | Inserter: Yes
Cartridge: Yes |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf Life | 22 months | 36 months | 24 months |