The Kaneka Trimotion™ Injector is indicated for insertion and placement of donor corneal tissue (diameter: ≤ 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.

Device Description

The Kaneka Trimotion™ Injector is a single-use pen-shaped injector made of stainless steel and biocompatible plastics. It is used to fold, insert, and place donor corneal tissue by means of a major surgical procedure into a human eye during the Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure. Two color-coded sliding controls, called "pushers", are used to control the delivery of the donor tissue. Irrigation with intraocular irrigating solution and an air injection are applied through the device to aid in tissue delivery and placement. The system provides a tubular pathway through an incision posterior to the cornea limbus, allowing delivery of the donor tissue into the human eye.

AI/ML Overview

The provided text is for a medical device (Kaneka Trimotion™ Injector) which is a physical instrument, not an AI/ML powered device. As such, it does not involve the typical AI/ML study design components such as ground truth establishment with experts, training/test sets, or comparative effectiveness studies with human readers.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this summary.

Here's the information that can be extracted relevant to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	The device is biocompatible (based on testing of direct/indirect tissue-contacting materials).
Effectiveness for intended use (simulated use)	The device is effective for its intended use (based on a simulated use test).
Substantial Equivalence to Predicate Device (Ocular System Inc. EndoSerter™) in terms of:
- Indications for Use	Yes, determined to be substantially equivalent.
- Operating Principle	Same as predicate device.
- Materials (biocompatible plastics and metal)	Yes, biocompatible plastics and metal.
- Sterility Status (Supplied sterile)	Same as predicate device (Supplied sterile).
- Single Use?	Yes, same as predicate device.

2. Sample size used for the test set and the data provenance:

Not applicable. This summary refers to "simulated use testing", but does not specify a sample size or data provenance in the context of an AI/ML test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of AI/ML is not relevant for this physical device.

4. Adjudication method for the test set:

Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical injector; it does not involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used:

Not applicable. The "ground truth" for this device's performance would be successful physical operation (e.g., proper tissue insertion without damage) during simulated use.

8. The sample size for the training set:

Not applicable.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Kaneka Trimotion™ Injector's conformance to acceptance criteria was demonstrated through two primary types of testing:

Biocompatibility Testing: All materials that directly or indirectly contact tissue were subjected to biocompatibility tests. The results confirmed that the device is biocompatible.
Simulated Use Testing: The device underwent testing in a simulated use environment to demonstrate its effectiveness for its intended purpose – the insertion and placement of donor corneal tissue in a DSAEK procedure. The results showed the device to be effective.

Additionally, the device's substantial equivalence to the predicate device (Ocular System Inc. EndoSerter™ corneal endothelium delivery instrument - K090626) served as a key component of its acceptance criteria. This was established through an analysis comparing their indications for use, operating principles, materials, fluid paths, sterility status, and single-use nature. The FDA determined the device to be substantially equivalent.

Summary

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510(k) SUMMARY

Daniel J. Dillon, M.S., RAC (US) Submitted By: Regulatory Scientist MED Institute, Inc. 1 Geddes Way West Lafayette, IN 47906 (765) 463-7537 December 26, 2011

Name of Device:

Trade Name:	Kaneka Trimotion™ Injector
Common/Usual Name:	Disposable corneal tissue transplant injector
Proposed Classification Name:	Intraocular Lens Guide21 CFR 886.4300 (OTZ)Class I reserved

Predicate Device:

The predicate device is the Ocular System Inc. EndoSerter™ corneal endothelium delivery instrument (510(k) No. K090626), cleared by the Food and Drug Administration on January 21, 2011.

Device Description:

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K1029999

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incision posterior to the cornea limbus, allowing delivery of the donor tissue into the human eye.

Substantial Equivalence:

The Kaneka Trimotion™ Injector is substantially equivalent to the Ocular System Inc. EndoSerter™ corneal endothelium delivery instrument as shown through an analysis of indications for use and the devices' technological characteristics.

	Kaneka Trimotion™ Injector(this 510(k))	EndoSerter™ corneal endotheliumdelivery instrument(510(k) No. K090626)
Indication	Insertion and placement of donor cornealtissue (diameter: ≤ 8.5 mm; thickness:0.115-0.200 mm) into the anteriorchamber of the recipient eye through aminimum 5.5 mm incision during aDescemet's Stripping with AutomatedEndothelial Keratoplasty (DSAEK)procedure.	To insert corneal endothelial allografttissue measuring less than or equal to8.5 mm in diameter and 175 micron incentral thickness into the anteriorchamber through a minimum 4 mmincision during endothelial keratoplastyprocedures.
OperatingPrinciple	The donor corneal tissue is loaded intothe device and delivered into the humaneye through an incision, then unfoldedand placed at the desired position.	Same as proposed device.
Materials	Biocompatible plastics and metal	Biocompatible plastics
Mechanism	Co-axial tubes manipulated by 2 pushers	Spatula and sheath manipulated bythumbscrew and deployment wheels
Fluid path	Separate paths for balanced salinesolution and air	Path for balanced saline solution only
Sterility Status	Supplied sterile	Same as proposed device.
Single Use?	Yes	Same as proposed device.

Discussion of Tests and Test Results:

The direct or indirect tissue contacting materials of the Kaneka Trimotion™ Injector have been subjected to biocompatibility testing. The results show that the device is biocompatible. The Kaneka Trimotion™ Injector has also been tested in a simulated use test that demonstrates the device to be effective for its intended use.

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Conclusions Drawn from the Tests:

The tests provide evidence of the Kaneka Trimotion™ Injector's suitability for use in the DSAEK procedure and its substantial equivalence to the predicate device in terms of intended use and technological characteristics.

K102999

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Kaneka Corporation c/o Mr. Tamiji Fujimoto Manager, Regulatory Affairs 5-1-1, Torikai-Nishi, Settsu Osaka 566-0072. Japan

DEC 2 9 2011

Re: K102999

Trade/Device Name: Kaneka Trimotion™ Injector Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I, reserved Product Code: OTZ Dated: December 19, 2011 Received: December 20, 2011

Dear Mr. Fujimoto:

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

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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 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.

Sinceret yours.

Eti thmm k
Melvin R. Feldman, M.D.

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

Enclosure

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Indications for Use

510(k) Number (if known): K102999

Device Name:	Kaneka Trimotion™ Injector
Indications for Use:	The Kaneka Trimotion™ Injector is indicated for insertion and placement of donor corneal tissue (diameter: ≤ 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.

Prescription Use XX

AND/OR

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801 Subpart D)

(Per 21 CFR 801 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

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510(k) Number K102999

Regulation Number and Section

§ 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.