(447 days)
Not Found
No
The description focuses on the mechanical function of the injector and does not mention any AI/ML components or capabilities.
Yes
The device is used to insert and place donor corneal tissue during a surgical procedure (DSAEK), which is a treatment to restore corneal function.
No
Explanation: The device is described as an injector for placing donor corneal tissue during a surgical procedure, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical, single-use, pen-shaped injector made of stainless steel and plastic, used for a surgical procedure. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside of the living body ("in vitro").
- Device Function: The Kaneka Trimotion™ Injector is a surgical instrument used to directly insert and place donor corneal tissue into the human eye during a surgical procedure. This is an in vivo (within the living body) procedure, not an in vitro diagnostic test.
- Intended Use: The intended use clearly describes a surgical procedure for tissue transplantation, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the Kaneka Trimotion™ Injector is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
OTZ
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chamber of the recipient 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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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 Guide |
| 21 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:
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.
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
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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 endothelium
delivery instrument
(510(k) No. K090626) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication | 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. | To insert corneal endothelial allograft
tissue measuring less than or equal to
8.5 mm in diameter and 175 micron in
central thickness into the anterior
chamber through a minimum 4 mm
incision during endothelial keratoplasty
procedures. |
| Operating
Principle | The donor corneal tissue is loaded into
the device and delivered into the human
eye through an incision, then unfolded
and 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 by
thumbscrew and deployment wheels |
| Fluid path | Separate paths for balanced saline
solution 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.
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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
4
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
5
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