← Product Code [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS) · K123736 # CRYSTALSERT DELIVERY SYSTEM (K123736) _Bausch & Lomb · MSS · May 16, 2013 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K123736 ## Device Facts - **Applicant:** Bausch & Lomb - **Product Code:** [MSS](/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS.md) - **Decision Date:** May 16, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4300 - **Device Class:** Class 1 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling. ## Device Story Sterile, single-use intraocular lens (IOL) guide; provides tubular pathway through iris incision for IOL insertion into capsular bag. Device consists of body, drawer, and plunger; operated by surgeon during cataract or lens replacement surgery. Surgeon manually manipulates device to fold and inject lens. Benefits include controlled, consistent delivery of IOL into eye. No electronic or automated components. ## Clinical Evidence Bench testing only. Device performance verified through functional testing in conformance with ISO 11979-3, section 5, demonstrating successful IOL delivery. ## Technological Characteristics Materials: Polypropylene (body, drawer, plunger), stainless steel (spring). Single-use, sterile (ethylene oxide, SAL 10^-6). Form factor: Tubular delivery system. No software, electronics, or energy source. ## Regulatory 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. ## Predicate Devices - Crystalsert Crystalens Delivery System ([K082944](/device/K082944.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # BAUSCH+LOMB 5 Pg. 1 of 2 30 Enterprise, Suite 450 www.bausch.com K123736 | 510(k) Summary | | | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Submitter: | Bausch & Lomb, Inc.
30 Enterprise, Suite 450
Aliso Viejo, CA 92656 | K123736 | | Contact Person: | Jason Smith
Global Regulatory Affairs Manager
Phone: 949-521-7804
Fax: 949-521-7760
Email: jason.smith@bausch.com | MAY 1 6 2013 | | Date Prepared: | December 4, 2012 | | | Trade name: | Crystalsert Delivery System | | | Classification
Name: | Intraocular lens guide (21 CFR 886.4300) | | | Predicate
Devices: | K082944 Crystalsert Crystalens Delivery System | | | Device
Description: | The Crystalsert Delivery System 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 Crystalsert Delivery System is intended to be used to
fold and deliver the Crystalens accommodating
intraocular lens and other intraocular lenses identifying
the Crystalsert Delivery System in their approved labeling. | | | Comparative
Analysis: | The Crystalsert Delivery System has been demonstrated
to be equivalent to the predicate device for its intended
use. | | | Functional/Safety
Testing: | The Crystalsert Delivery System has successfully
undergone functional testing and was found to deliver
IOLs in conformance with the requirements set forth in
ISO 11979-3, section 5. | | | Conclusion: | The Crystalsert Delivery System is substantially
equivalent to the predicate device. | | {1}------------------------------------------------ ## BAUSCH+LOMB Pg. 2 of 2 30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com | Characteristic | Predicate K082944
Crystalsert Crystalens Delivery
System | Crystalens Delivery System
(Proposed Device) | |------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The Crystalsert Crystalens delivery
system is intended to fold and deliver
the Crystalens (AT-52SE, AT-50SE,
HD520 and HD500) accommodating
intraocular lens into the capsular bag. | The Crystalsert delivery system is
intended to be used to fold and deliver
the Crystalens accommodating
intraocular lens and other intraocular
lenses identifying the Crystalsert
delivery system in their approved
labeling. | | Contraindications | None | None | | Materials | Body, drawer, plunger: polypropylene
Spring: stainless steel | Body, drawer, plunger: polypropylene
Spring: stainless steel | | Single use? | Single use | Single use | | Sterile? | Sterile | Sterile | | How sterilized | Ethylene oxide | Ethylene oxide | | Sterility assurance
level | 10-6 | 10-6 | | Shelf life | 12 months | 12 months | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with three wing-like shapes extending from its body. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service May 16, 2013 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Bausch & Lomb Inc. % Mr. Jason Smith Global Regulatory Affairs Manager 30 Enterprise, Suite 450 Aliso Viejo, CA 92656 Re: K123736 Trade/Device Name: Crystalsert Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I (reserved) Product Code: MSS Dated: April 4, 2013 Received: April 5, 2013 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 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 (reporting of medical {3}------------------------------------------------ Page 2 - Mr. Jason Smith 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/ReportalProblem/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. . Kesia Y. Alexander -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 {4}------------------------------------------------ ### BAUSCHELO 30 Enterprise, Suite 450 Aliso Viejo, CA 92656 800.393.6642 www.bausch.com ### Indications for Use Statement 510(k) Number (if known): Device Name: Crystalsert Delivery System Indications for Use: The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert delivery system in their approved labeling. Prescription Use ___X____ AND/OR (Part 21 CFR 801 Subpart D) 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) Image /page/4/Picture/11 description: The image shows the name "Tieuvi-H-Nguyen" at the top. Below the name, the date and time "2013:05:07 19:01:48" are displayed. The timezone offset "-04'00'" is located below the date and time. The text appears to be extracted from a document or a photograph. (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K123736 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K123736](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSS/K123736) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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