ENDOSERTER

K090626 · Ocular Systems, Inc. · OTZ · Jan 21, 2011 · Ophthalmic

Device Facts

• Record ID: K090626
• Device Name: ENDOSERTER
• Applicant: Ocular Systems, Inc.
• Product Code: OTZ · Ophthalmic
• Decision Date: Jan 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures.

Device Story

EndoSerter™ is a mechanical surgical instrument designed for the delivery of corneal endothelial allograft tissue into the anterior chamber of the eye. Used by ophthalmic surgeons during endothelial keratoplasty procedures, the device facilitates the insertion of donor tissue through a minimum 4mm incision. It functions as a guide to assist in the controlled placement of the graft, minimizing tissue manipulation and potential trauma during the surgical procedure. The device is a manual tool; it does not involve electronic processing, software, or automated algorithms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; intraocular lens guide. Dimensions accommodate corneal endothelial allograft tissue up to 8.5mm diameter and 175 micron thickness. Designed for use through a minimum 4mm incision. Non-powered, mechanical device.

Indications for Use

Indicated for insertion of corneal endothelial allograft tissue (≤8.5mm diameter, ≤175 micron central thickness) into the anterior chamber during endothelial keratoplasty procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ocular Systems, Inc. c/o Mr. Kurt Weber 101 North Chestnut Street, Suite 301 Winston-Salem, NC 27101

Re: K090626

Trade/Device Name: EndoSerter™ Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: OTZ Dated: November 17, 2010 Received: November 23, 2010

Dear Mr. Weber:

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 Frond, Or to 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 1 177). general controls provisions of the Act include requirements for annual registration, listing of v devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not musileding.

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 devine 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

A Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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## Indications for Use

510(k) Number (if known): K090626

Device Name: EndoSenter ™

Indications for Use:

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"The EndoSerter™ is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.5mm in diameter and 175 micron in central thickness into the anterior chamber through a minimum 4mm incision during endothelial keratoplasty procedures."

[Amended: 12.20.2010]

**Prescription Use**
X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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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(Posted November 13, 2003)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K090626