(28 days)
The Bausch + Lomb Injector System is indicated for the folding and insertion of Bausch + Lomb intraocular lenses cleared or approved for use with this IOL Injector system.
The Bausch + Lomb Injector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.
This document is an FDA 510(k) premarket notification for a medical device (Bausch + Lomb Injector System) and does not contain the detailed information necessary to answer the request.
The request asks for specific details about acceptance criteria, study design (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), and performance metrics (reported and a comparative effectiveness study with AI assistance). This type of information is typically found in study reports, clinical trial summaries, or detailed technical documentation that usually accompanies a 510(k) submission, but is not present in the summary provided.
The document primarily focuses on establishing "substantial equivalence" to a predicate device, which usually involves comparing design, materials, and intended use, rather than presenting new detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The text only states:
- "Performance bench testing was completed on the Bausch + Lomb Injector System and results show the system to be in conformance with the requirements set forth in respective standards." (Section 5, page 4)
This statement indicates that testing was done and standards were met, but it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance.
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study with AI (the device appears to be a physical injector system, not an AI-assisted diagnostic tool).
- Standalone algorithm performance (again, not applicable to this type of device).
- Type of ground truth (not explicitly stated beyond "respective standards").
- Training set sample size (not applicable as this is not an AI/ML model being trained).
- How ground truth for the training set was established (not applicable).
To answer your request, you would need access to the actual "performance bench testing" report and "respective standards" referenced in the document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Bausch + Lomb Inc. Ms. Joyce Zhong Regulatory Affairs Specialist 50 Technology Drive Irvine, CA 92618
Re: K151102
Trade/Device Name: Bausch + Lomb Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: April 23, 2015 Received: April 24, 2015
Dear Ms. Zhong:
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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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Kesia Y. Alexander -A
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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Image /page/2/Picture/1 description: The image is a logo for Valeant Pharmaceuticals International, Inc. The logo features a purple and gray geometric shape on the left, followed by the word "VALEANT" in a serif font. Below the word "VALEANT" is the text "Pharmaceuticals International, Inc." in a smaller, sans-serif font. The logo is simple and professional, and the colors are eye-catching.
Valeant Pharmaceuticals International, Inc. 50 Technology Drive, Irvine CA 92618 Tel: 949-398-5594, Fax: 949-398-5764
5 Indications for Use Statement
510(k) Number (if known):
Device Name: Bausch + Lomb Injector System
Indications for Use:
The Bausch + Lomb Injector System is indicated for the folding and insertion of Bausch + Lomb intraocular lenses cleared or approved for use with this IOL Injector system.
Prescription Use X______________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
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Image /page/3/Picture/1 description: The image shows the logo for Valeant Pharmaceuticals International, Inc. The logo features a stylized purple and gray graphic to the left of the company name. The text "VALEANT" is in a serif font, with "Pharmaceuticals International, Inc." in a smaller font below.
Valeant Pharmaceuticals International, Inc. 50 Technology Drive, Irvine CA 92618 Tel: 949-398-5594, Fax: 949-398-5764
6 510(k) Summary
This summary document has been prepared in accordance with section 21 CFR 807.92(c).
The submitter of the 510(k) is:
Joyce Zhong Regulatory Affairs Specialist Bausch & Lomb, Inc. 50 Technology Drive Phone: 949-398-5594 Fax: 949-398-5764
Date Summary Prepared: April 23, 2015
1. Subject Device:
| Trade name: | Bausch + Lomb Injector System |
|---|---|
| Common Name: | Intraocular lens Guide |
| Classification Name: | 21 CFR 886.4300 |
2. Predicate Device:
K131958, Bausch + Lomb Injector System
3. Device Description:
The Bausch + Lomb Injector System is used for folding and delivering validated IOLs into the eye. The system is composed of two items: a single-use, sterile, disposable cartridge and a reusable handpiece. The handpiece has two elements: a plunger and a body. The cartridge snaps into the handpiece.
Indications for Use: 4.
The BLIS is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the BLIS in their approved labeling.
This is the same exact indications for use as the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for Valeant Pharmaceuticals International, Inc. The logo features a stylized "V" shape in purple and gray, followed by the company name in a serif font. Below the company name is the text "Pharmaceuticals International, Inc." in a smaller font size.
Valeant Pharmaceuticals International, Inc. 50 Technology Drive, Irvine CA 92618 Tel: 949-398-5594, Fax: 949-398-5764
5. Brief Summary of Nonclinical Test and Results:
Performance bench testing was completed on the Bausch + Lomb Injector System and results show the system to be in conformance with the requirements set forth in respective standards.
Comparative Analysis 6.
A table comparing the proposed device to the predicate device is provided below.
| Characteristic | K131958, (Predicate Device)Bausch + Lomb Injector System | (Proposed Device)Bausch + Lomb Injector System |
|---|---|---|
| Indications for use | The BLIS is indicated for the foldingand injection of Bausch + Lombintraocular lenses identifying the BLISin their approved labeling. | The BLIS is indicated for the foldingand injection of Bausch + Lombintraocular lenses identifying the BLISin their approved labeling. |
| Contraindications | None | None |
| Anatomical site | Eye | Eye |
| Injector configuration(reusable) | Titanium body, plunger tip, knob;stainless steel plunger shaft, plungerthreads | Titanium body, plunger tip, knob;stainless steel plunger shaft, plungerthreads |
| Injector configuration(single use) | Coated polyamide cartridge | Coated polyamide cartridge |
| How is the deviceused | The IOL is placed in the loadingcartridge. The cartridge is snapped intothe handpiece. The screw plungeradvances the IOL through the cartridge,which folds the IOL and advances itinto the eye. | The IOL is placed in the loadingcartridge. The cartridge is snapped intothe handpiece. The screw plungeradvances the IOL through the cartridge,which folds the IOL and advances itinto the eye. |
| Single use? | Handpiece: NoCartridge: Yes | Handpiece: NoCartridge: Yes |
| Is the product sterile | Handpiece: shipped nonsterile, to becleaned and sterilized/resterilized by userCartridge: shipped sterile | Handpiece: shipped nonsterile, to becleaned and sterilized/resterilized by userCartridge: shipped sterile |
| How sterilized | Handpiece: steam (by user)Cartridge: Ethylene oxide (bymanufacturer) | Handpiece: steam (by user)Cartridge: Ethylene oxide (bymanufacturer) |
Table 6-1: Comparison of Predicate Device to the Proposed Bausch + Lomb Injector System
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BAUSCH+LOMB See better. Live better.
Image /page/5/Picture/1 description: The image shows the logo for Valeant Pharmaceuticals International, Inc. The logo features a stylized purple and gray geometric shape on the left, followed by the word "VALEANT" in purple, sans-serif font. Below the word "VALEANT" is the text "Pharmaceuticals International, Inc." in a smaller, sans-serif font.
Valeant Pharmaceuticals International, Inc. 50 Technology Drive, Irvine CA 92618 Tel: 949-398-5594, Fax: 949-398-5764
| Characteristic | K131958, (Predicate Device)Bausch + Lomb Injector System | (Proposed Device)Bausch + Lomb Injector System |
|---|---|---|
| Coating | Handpiece: None | Handpiece: None |
| Cartridge: Hydrophilic coating(Medicoat A) | Cartridge: Hydrophilic coating(Medicoat A) | |
| How Supplied | Handpiece: single | Handpiece: single |
| Cartridge: Packs of 10 | Cartridge: Packs of 10 |
7. Conclusion
The Bausch + Lomb Injector System is substantially equivalent to the predicate device.
§ 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.