(78 days)
Not Found
No
The summary describes a mechanical device for inserting an intraocular lens and does not mention any AI/ML components or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML.
No
This device is an injector system used to insert an intraocular lens; it does not itself provide therapy.
No
The device description states it is used to "fold and insert an IOL into the human eye," which is a surgical or therapeutic action, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use device used to fold and insert an IOL into the human eye," which describes a physical, hardware-based medical device, not software.
Based on the provided information, the Bausch + Lomb VIS100 Injector System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "folding and injection of Bausch + Lomb intraocular lenses approved for use with this injector." This describes a surgical procedure performed on the human eye, not a test performed on a sample taken from the body.
- Device Description: The description states it's used to "fold and insert an IOL into the human eye." This further reinforces its use in a surgical context.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided information does not mention any such use or interaction with biological samples.
Therefore, the Bausch + Lomb VIS100 Injector System is a surgical device used for implanting an intraocular lens, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MSS
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.
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)
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).
A clinical study was not performed on the Bausch + Lomb VIS100 Injector System.
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
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.
1
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 IOL | ||
| Injector, INJ100 | Bausch + Lomb VIS100 Injector | |
| System | ||
| Indications for use | The Bausch + Lomb IOL | |
| Injector is indicated for | ||
| folding and injection of | ||
| Bausch + Lomb intraocular | ||
| lenses approved for use with | ||
| this injector. | The Bausch + Lomb VIS100 | |
| Injector System is indicated for | ||
| folding and injection of Bausch + | ||
| Lomb intraocular lenses approved | ||
| for use with this injector. | ||
| Contraindications | None | None |
| Fundamental Scientific Technology | A single use plunger with a | |
| silicone cushion tip is used | ||
| to push forward and insert | ||
| the IOL that has been | ||
| placed in a single use | ||
| cartridge into the capsular | ||
| bag. The cartridge has a | A single use plunger with a silicone | |
| cushion tip is used to push forward | ||
| and insert the IOL that has been | ||
| placed in a single use cartridge into | ||
| the capsular bag. The cartridge has | ||
| a hydrophilic coating. As the IOL | ||
| enters the tip, it is compressed and |
Table 1: Comparison of Predicate Device to the Proposed Bausch + Lomb VIS100 Injector System
2
2
| | hydrophilic coating. As the
IOL enters the tip, it is
compressed and folded. | folded. |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Materials | Cartridge tip: polyamide with
Medicoat A coating
Injector body, plunger body:
ABS
Plunger tip: silicone
Cartridge loading chamber:
polypropylene
Spring: stainless steel | Cartridge: polyamide with Medicoat
A coating
Plunger body, shooter: ABS
Plunger tip: silicone
Spring: 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.
.
.
.
:
.
ന
·
3
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.
4
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
5
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