(274 days)
The Bausch + Lomb IOL Injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.
The Bausch + Lomb IOL Injector is a sterile, single-use device used to fold and insert an intraocular lens through surgical procedure into a human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
The provided text describes a 510(k) premarket notification for the Bausch + Lomb IOL Injector, INJ100. The submission aims to demonstrate substantial equivalence to predicate devices, primarily through functional and safety testing. However, the provided document does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria with quantifiable metrics, sample sizes for test and training sets, details about ground truth establishment, or any information about multi-reader multi-case studies or standalone algorithm performance.
Based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The Bausch + Lomb IOL Injectors have successfully undergone functional testing and are found to deliver the Bausch + Lomb IOLs in conformance with the requirements set forth in ISO 11979-3, section 5."
Without access to ISO 11979-3, section 5, the specific acceptance criteria and their associated performance metrics cannot be reported in detail. However, the general performance reported is "successful delivery of Bausch + Lomb IOLs in conformance with requirements."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Testing (ISO 11979-3, section 5) | Successfully delivers Bausch + Lomb IOLs in conformance with requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified, but implied to be from functional/safety testing conducted by Bausch & Lomb, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing appears to be functional and mechanical, not related to expert interpretation of medical images or data requiring ground truth established by medical professionals.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given the nature of functional/safety testing for a medical device (IOL injector), adjudication methods as typically understood in the context of diagnostic AI tools (e.g., 2+1, 3+1) are unlikely to be relevant or applicable. The testing would likely involve objective measurements and observations of the injector's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study was mentioned or implied. This type of study is typically relevant for diagnostic AI tools that assist human readers in interpreting medical images or data. The Bausch + Lomb IOL Injector is a physical device for delivering intraocular lenses, not a diagnostic imaging or data interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
The device is a physical injector; therefore, the concept of a "standalone algorithm" is not applicable. The "functional testing" mentioned can be considered a form of standalone performance evaluation for the device's mechanical and operational capabilities.
7. The Type of Ground Truth Used:
The ground truth for this device would be based on objective measurements and observations of the injector's performance against predefined engineering and performance specifications outlined in standards like ISO 11979-3, section 5. This would involve criteria such as:
- Successful folding and insertion of the IOL.
- Absence of IOL damage.
- Smoothness of injection.
- Consistency of delivery.
- Absence of device malfunction.
It is not expert consensus, pathology, or outcomes data in the traditional sense, but rather engineering and functional performance criteria.
8. The Sample Size for the Training Set:
This information is not provided in the document. The concept of a "training set" is usually applicable to machine learning algorithms. For a physical device like an IOL injector, the "training set" might loosely correspond to the R&D and design verification activities, but specific sample sizes for such a "training set" are not mentioned.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. Similar to point 8, the concept of "ground truth for a training set" is typically for AI/ML. For this device, the design and performance parameters would have been established through engineering design, material science considerations, and iterative testing, guided by relevant industry standards and clinical needs.
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pog 1 .42
510(k) Summary
. .
| (k) Summary | SEP 2 8 2012 |
|---|---|
| Submitter: | Bausch & Lomb, Inc.30 Enterprise, Suite 450Aliso Viejo, CA 92656 |
| Contact Person: | Jason SmithGlobal Regulatory Affairs ManagerPhone: 949-521-7804Fax: 949-521-7760Email: jason.smith@bausch.com |
| Date Prepared: | September 27, 2012 |
| Trade name: | Bausch + Lomb IOL Injector, INJ100 |
| ClassificationName: | Intraocular lens guide (21 CFR 886.4300) |
| PredicateDevices: | 1.K092023 Medicel Naviject Sub2-1P IOL Injector Set2.K063155 Alcon Monarch III IOL Delivery System |
| DeviceDescription: | The Bausch + Lomb IOL Injector is a sterile, single-usedevice used to fold and insert an intraocular lens throughsurgical procedure into a human eye. The systemprovides a tubular pathway through an incision over theiris, allowing delivery of an IOL into the capsular bag. |
| Indications forUse: | The Bausch + Lomb IOL injector is indicated for foldingand injection of Bausch + Lomb IOLs approved for usewith this injector. |
| ComparativeAnalysis: | The Bausch + Lomb IOL Injectors have beendemonstrated to be equivalent to the predicate devicesfor their intended use. |
| Functional/SafetyTesting: | The Bausch + Lomb IOL Injectors have successfullyundergone functional testing and are found to deliver theBausch + Lomb IOLs in conformance with therequirements set forth in ISO 11979-3, section 5. |
| Conclusion: | The Bausch + Lomb IOL Injectors are substantiallyequivalent to the predicate devices. |
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Characteristic Predicate K092023 Predicate K063155 Bausch + Lomb Medicel Naviject Sub2-Alcon Monarch III IOL IOL Injector 1P IOL. Injector Set Delivery System (Proposed Device) Indications for use Insertion only of models of Implantation of Alcon The Bausch + Lomb intraocular lens that allow use qualified Acrysof intraocular IOL injector is of this injector in their labeling lenses into the eye following indicated for folding cataract removal and injection of Bausch + Lomb IOLs approved for use with this injector. Contraindications The use of this injector None None system with other intraocular implants or cartridges, that have not been tested or approved for use by STAAR Surgical Company. Injector User has to assemble three User has to assemble two No user assembly configuration items: items: the cartridge, tip, Injector with plunger 1. Cartridge and injector are all 1. 2. Cartridge/tip 2. Handpiece one unit assembly 3. Loader Single use? All three pieces are single-The cartridge is single use, Single use use only. the handpiece is reusable. Sterile? Sterile Sterile Sterile How sterilized Ethylene oxide (cartridge) Ethylene oxide Ethylene oxide Steam (handpiece) Coating? No Hydrophilic coating Hydrophilic coating How sold? Packs of ten Cartridges are sold in packs Packs of ten of ten
Comparison of Predicate Devices to the Proposed Bausch + Lomb IOL Injector
KIL 3852 125 2 = 2 = 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 28 2012
Bausch & Lomb, Inc. c/o Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viego, CA 92656
Re: K113852
Trade/Device Name: Bausch + Lomb IOL Injector. INJ100 Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I, Reserved Product Code: MSS Dated: September 13, 2012 Received: September 14, 2012
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
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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: Bausch + Lomb IOL Injector
Indications for Use:
The Bausch + Lomb IOL Injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use (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)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K113852
Page 1 of
§ 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.