(78 days)
The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.
The Bausch + Lomb VIS100 Injector System is a sterile, single-use device used to fold and insert an IOL into the 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 document describes a 510(k) submission for the Bausch + Lomb VIS100 Injector System. Here's an analysis of the acceptance criteria and study information:
Description of Acceptance Criteria and Study to Prove Device Meets Criteria:
The Bausch + Lomb VIS100 Injector System is a sterile, single-use device designed to fold and insert an intraocular lens (IOL) into the human eye. The submission aims to demonstrate substantial equivalence to a predicate device (K113852, Bausch + Lomb IOL Injector).
The acceptance criteria for this device primarily revolve around bench testing for mechanical properties and biocompatibility testing. There were no clinical studies performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Mechanical Properties | ISO 11979-3 | Bench testing was performed to determine compliance with ISO 11979-3 (Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods). (Implicitly met standards for substantial equivalence) |
| Biocompatibility | ISO 10993-5 | Biocompatibility testing was performed. The device was found to be biocompatible as per ISO 10993-5 (Biological Evaluation of medical devices – Part 3: Tests for in vitro cytotoxicity). |
| Biocompatibility | ISO 10993-10 | Biocompatibility testing was performed. The device was found to be biocompatible as per ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10 - Tests for Irritation and Skin Sensitization). |
| Sterility | (Implied) | Sterile, Method of Sterilization: Ethylene oxide, Sterility assurance level: 10-6. (Compliant with established medical device sterility standards) |
| Single Use | (Implied) | Single use (Matches predicate device) |
| Shelf Life | (Implied) | 1 month (Compared to predicate's 12 months, this is a difference, but within acceptable limits for substantial equivalence given the context of a sterile, single-use device for a surgical procedure). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for the bench testing or biocompatibility testing. It only states that these tests were "performed."
The data provenance is from non-clinical laboratory testing (bench and biocompatibility tests). There is no information about country of origin, and the data is inherently prospective for these types of tests (new tests performed on the device).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The ground truth for mechanical and biocompatibility testing is established by adherence to recognized international standards (ISO). There are no "experts" in the context of clinical interpretation or image review for this particular device's submission.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or diagnosis, which were not conducted for this device. The results of the bench and biocompatibility tests are objective measurements against established standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "A clinical study was not performed on the Bausch + Lomb VIS100 Injector System." This type of study is associated with AI-assisted interpretation or diagnostic tools, which this device is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The Bausch + Lomb VIS100 Injector System is a mechanical device for IOL insertion, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on established international standards for medical device mechanical properties (ISO 11979-3) and biocompatibility (ISO 10993-5, ISO 10993-10), as well as general medical device requirements for sterility and single-use functionality.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm. Hence, there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
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JAN - 3 2014
510(k) Summary
The submitter of the 510(k) is:
Shivani K. Chitalia Regulatory Affairs Specialist Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA - 92618 Phone: 949-398-5632 Fax: 949-398-5764
Date Summary Modified: January 02, 2014
1. Subject device
Trade name: Bausch + Lomb VIS100 Injector System Common Name: Intraocular lens Guide Classification Name: 21 CFR 886.4300
- Predicate Device:
K113852, Bausch + Lomb IOL Injector
3. Device Description:
The Bausch + Lomb VIS100 Injector System is a sterile, single-use device used to fold and insert an IOL into the human eye. The system provides a tubular pathway through an incision over the iris, allowing delivery of an IOL into the capsular bag.
4. Indications for Use:
The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.
The indications for use are identical to the indications for use of the predicate device.
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5. Brief Summary of Nonclinical Test and Results:
Bench testing was performed on the Bausch + Lomb VIS100 Injector System to determine compliance with ISO 11979-3 (Ophthalmic Implants - Intraocular Lenses -Part 3: Mechanical Properties and Test Methods).
Biocompatibility testing was performed on the Bausch + Lomb VIS100 Injector System and the device was found to be biocompatible.as per ISO 10993-5 (Biological Evaluation of medical devices – Part 3: Tests for in vitro cytotoxicity and ISO 10993 -10 (Biological Evaluation of Medical Devices - Part 10 - Tests for Irritation and Skin Sensitization).
6. Clinical Studies
A clinical study was not performed on the Bausch + Lomb VIS100 Injector System.
7. Comparative Analysis
A table comparing the proposed device to the predicate devices is provided below.
| Characteristic | Predicate K113852 | Subject |
|---|---|---|
| Bausch + Lomb IOLInjector, INJ100 | Bausch + Lomb VIS100 InjectorSystem | |
| Indications for use | The Bausch + Lomb IOLInjector is indicated forfolding and injection ofBausch + Lomb intraocularlenses approved for use withthis injector. | The Bausch + Lomb VIS100Injector System is indicated forfolding and injection of Bausch +Lomb intraocular lenses approvedfor use with this injector. |
| Contraindications | None | None |
| Fundamental Scientific Technology | A single use plunger with asilicone cushion tip is usedto push forward and insertthe IOL that has beenplaced in a single usecartridge into the capsularbag. The cartridge has a | A single use plunger with a siliconecushion tip is used to push forwardand insert the IOL that has beenplaced in a single use cartridge intothe capsular bag. The cartridge hasa hydrophilic coating. As the IOLenters the tip, it is compressed and |
Table 1: Comparison of Predicate Device to the Proposed Bausch + Lomb VIS100 Injector System
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| hydrophilic coating. As theIOL enters the tip, it iscompressed and folded. | folded. | |
|---|---|---|
| Materials | Cartridge tip: polyamide withMedicoat A coatingInjector body, plunger body:ABSPlunger tip: siliconeCartridge loading chamber:polypropyleneSpring: stainless steel | Cartridge: polyamide with MedicoatA coatingPlunger body, shooter: ABSPlunger tip: siliconeSpring: stainless steel |
| Single use? | Single use | Single use |
| Sterile? | Sterile | Sterile |
| Method of Sterilization | Ethylene oxide | Ethylene oxide |
| Sterility assurance level | 10-6 | 10-6 |
| Shelf life | 12 months | 1 month |
8. Conclusion
:
The Bausch + Lomb VIS100 Injector System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2014
Bausch + Lomb Ms. Shivani K. Chitalia Regulatory Affairs Specialist 50 Technology Drive Irvine, CA 92618
Re: K133146
Trade/Device Name: Bausch + Lomb VIS 100 Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: MSS Dated: December 4, 2013 Received: December 5, 2013
Dear Ms. Chitalia:
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 - Ms. Shivani K. Chitalia
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 (QS) 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.
Bradley S. Cunningham -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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BAUSCH + LOMB
30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com
Section 5 - Statement of Indications for Use
510(k) Number (if known):
Bausch + Lomb VIS100 Injector System Device Name:
Indications for Use: The Bausch + Lomb VIS100 Injector System is indicated for folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector.
Over-The-Counter Use AND/OR x Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tieuvi H. Nguyen 2013.12.30 12:09:32 -05'00'
Page 1 of 1
§ 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.