(274 days)
Not Found
No
The summary describes a mechanical device for inserting an intraocular lens and contains no mention of AI, ML, or related concepts.
No
The device is described as an injector used to deliver an intraocular lens during surgery, not a device that directly treats a condition or restores function.
No.
The device is used to insert an intraocular lens during a surgical procedure, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use device used to fold and insert an intraocular lens, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical folding and injection of an intraocular lens into a human eye. This is a surgical procedure performed directly on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description clearly states it's a device used to insert an intraocular lens through a surgical procedure into a human eye. This is an in-vivo application (within a living organism), not an in-vitro application (in glass or outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool for implanting a medical device.
N/A
Intended Use / Indications for Use
The Bausch + Lomb IOL injector is indicated for folding and injection of Bausch + Lomb IOLs approved for use with this injector.
Product codes
MSS
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K092023 Medicel Naviject Sub2-1P IOL Injector Set, K063155 Alcon Monarch III IOL Delivery System
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.
0
pog 1 .42
510(k) Summary
. .
| (k) Summary | SEP 2 8 2012 |
|---|---|
| Submitter: | Bausch & Lomb, Inc. |
| 30 Enterprise, Suite 450 | |
| Aliso Viejo, CA 92656 | |
| Contact Person: | Jason Smith |
| Global Regulatory Affairs Manager | |
| Phone: 949-521-7804 | |
| Fax: 949-521-7760 | |
| Email: jason.smith@bausch.com | |
| Date Prepared: | September 27, 2012 |
| Trade name: | Bausch + Lomb IOL Injector, INJ100 |
| Classification | |
| Name: | Intraocular lens guide (21 CFR 886.4300) |
| Predicate | |
| Devices: | 1. |
| K092023 Medicel Naviject Sub2-1P IOL Injector Set |
K063155 Alcon Monarch III IOL Delivery System |
| Device
Description: | 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. |
| Indications for
Use: | The Bausch + Lomb IOL injector is indicated for folding
and injection of Bausch + Lomb IOLs approved for use
with this injector. |
| Comparative
Analysis: | The Bausch + Lomb IOL Injectors have been
demonstrated to be equivalent to the predicate devices
for their intended use. |
| Functional/Safety
Testing: | 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. |
| Conclusion: | The Bausch + Lomb IOL Injectors are substantially
equivalent to the predicate devices. |
1
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
2
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
3
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
4
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
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