The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 – 220 µm of thickness into the anterior chamber of the eye during endothelial keratoplasty.
For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm)
For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

Device Description

The Endothelial Keratoplasty Injector is a single-use, disposable device that allows an ophthalmic surgeon to insert a previously prepared disc of posterior donor cornea into the eye of a recipient patient through a small incision during a posterior comeal transplant surgical procedure. The function of the device is to insert the flat disc of donor comeal tissue within a cylindrical tube that is sized to fit into 5.1 mm or larger corneal or scleral incision, and to pull or push this donor corneal tissue into the anterior chamber of the eye as part of a Endothelial Keratoplasty procedure. This device was designed to insert donor posterior corneal tissue ≤ 8.5 mm in diameter, 100um to 220um in thickness, through a 5.1 mm or larger corneal incision.

The EK Delivery device consists of four components: (1) the Trocar which is used to hold the graft material and introduce it into the anterior chamber of the recipient eye, (2) the Trocar Holder, which is used to close the proximal end of the Trocar and as an ergonomic handle to aid the surgeon handling the device, (3) the Injector Assembly, which is a plunger to push the endothelial keratoplasty tissue out of the Trocar and into the anterior chamber of the recipient eye, and (4) End Plug used during shipping. Delivers a circular endothelial tissue button in a rolled configuration.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the TDAK Medical, Inc. EK Delivery Device, focusing on acceptance criteria and study details:

Device: TDAK Medical, Inc. EK Delivery Device

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary is for a Class I (reserved) medical device, specifically an Endothelial Keratoplasty (EK) Injector. For such devices, the "acceptance criteria" are primarily related to meeting performance specifications and demonstrating substantial equivalence to a predicate device, rather than statistical performance metrics (like sensitivity/specificity) typically seen in diagnostic AI/ML devices.

The acceptance criteria are inferred from the comparison table and the description of testing performed to demonstrate equivalence and safety.

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Indications for Use	Aid insertion of donor posterior lamellar endothelial graft.	"An aid facilitating the insertion of donor posterior lamellar endothelial graft of 100µm to 220µm in thickness into the anterior chamber of the eye during endothelial keratoplasty." "For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm)."
	Loading and storage of donor tissue.	"For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours."
Device Design/Function	Deliver circular endothelial tissue in a rolled configuration.	"Delivers a circular endothelial tissue button in a rolled configuration." (Matches predicate)
Material/Processing	Sterility	"Sterile Radiation" (Matches predicate)
Device Performance	Mechanical Strength	"Mechanical Strength" testing completed, implicitly demonstrating acceptable performance (no specific values provided, but conclusion states device is equivalent and poses no new safety issues).
	Tissue Handling and Stability	"Tissue Handling and Stability" testing completed, implicitly demonstrating acceptable performance (no specific values provided, but conclusion states device is equivalent and poses no new safety issues). Intended for donor tissue ≤ 8.5 mm in diameter, 100µm to 220µm in thickness.
Safety	Biocompatibility	"Biocompatibility" testing completed, implicitly demonstrating acceptable performance (conclusion states device is equivalent and poses no new safety issues).
Shelf Life	Maintain integrity and functionality for specified period.	"Shelf Life" testing completed, implicitly demonstrating acceptable performance in line with the 72-hour storage claim.
Sterilization	Effective sterilization method.	"Sterilization Validation" completed, implicitly demonstrating acceptable performance.

Study Information

The document describes pre-market testing to demonstrate substantial equivalence to a predicate device (EndoSerter™ K090626), rather than a clinical efficacy study with human subjects. The studies are primarily engineering and bench-top tests.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many devices were tested for mechanical strength, or how many tissue samples for tissue handling). These would typically be detailed in the full test reports, which are not part of this summary document.
- Data Provenance: The studies were conducted by TDAK Medical, Inc. The nature of the device (a delivery tool) means the "data" is primarily performance data from pre-clinical, bench-top testing, not clinical data from patients or tissue banks in a specific country. The studies are retrospective in the sense that they are validations conducted before market entry.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device. The "ground truth" for a mechanical device like this is whether it performs its intended function (e.g., inserts tissue without damage, maintains sterility, has adequate mechanical strength). This is established through engineering specifications, material science, and performance testing, not through expert human interpretation or diagnosis. No "test set" in the diagnostic sense is described that would require expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in studies involving human interpretation or clinical endpoints (e.g., a panel of radiologists reviewing images). This is a device for physical delivery of tissue.
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 is not an AI/ML device, nor is it a diagnostic device that involves human readers interpreting cases. It is a surgical delivery tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering principles, material standards, and functional testing against design specifications. For example:
  - Mechanical Strength: Demonstrated by testing to failure or against defined load limits.
  - Tissue Handling: Demonstrated by successful insertion of donor tissue surrogates or actual tissue samples without damage, and maintenance of tissue viability (implied by "Tissue Handling and Stability" testing and 72-hour storage claim).
  - Biocompatibility: Established through standardized in vitro and/or in vivo tests to ensure the device materials do not cause adverse biological reactions.
  - Sterilization: Validated using methods like "Sterilization Validation" to ensure a certain sterility assurance level (SAL).
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K121579

ОСТ

3 2012

510(k) Summary

TDAK Medical, Inc.

11575 Sorrento Valley Road Suite 214 San Diego, CA 92121

SUMMARY

Submitter's name:

TDAK Medical Inc. 11575 Sorrento Valley Road Suite 214 San Diego, CA 92121

Name of contact person:

Greg Holland Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 greg@regulatoryspecialists.com

Date the summary was revised:

September 12, 2012

Name of the device: Trade or proprietary name Common or usual name Classification Panel

EK Delivery Device EK Delivery Device Endothelial Keratoplasty (EK) Injector Ophthalmic

Product Code	Classification Regulation	Classification Name
OTZ	886.4300	Lens, Guide, Intraocular

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

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510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K090626	EndoSerter ™	Ocular Systems, Inc.

Indications:

The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

· An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 - 220 um into the anterior chamber of the eve during endothelial keratoplasty.
· For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of . ≤ 8.5 mm).

· For loading and storage of donor tissue during transport to the surgeon by trained eve bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

Comparison to Predicate: .

The EK Delivery Device is similar to its predicate in basic functionality of inserting corneal tissue during endothelial keratoplasty (EK) procedure. Both are intended to be an aid to delivering the corneal tissue in a convenient form for the ophthalmic physician.

The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

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An aid facilitating the insertion of donor posterior lamellar endothelial graft of . 100µm to 220µm in thickness into the anterior chamber of the eye during endothelial keratoplasty.
For loading and storage of donor tissue during transport to the surgeon by . trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

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: 上

Product Name	Proposed:	Predicate:
	EK Delivery Device	K090626
		EndoSerter™
Indications for Use	The EK Delivery Device is tobe used by ophthalmicsurgeons trained inEndothelial Keratoplasty (EK)procedures and trained in theuse of the EK DeliveryDevice as:An aid facilitating theinsertion of donor posteriorlamellar endothelial graft of100µm to 220µm in thicknessinto the anterior chamber ofthe eye during endothelialkeratoplasty. For use in a 5.1 mm orlarger incision and amaximum donor tissuediameter of ≤ 8.5 mm). For loading and storage ofdonor tissue during transportto the surgeon by trainedeye bank technicians, andfor storage of donor tissuefor up to a maximum of 72hours.	The EndoSerter™ isused to insert cornealendothelial allografttissue measuring lessthan or equal to 8.5mm indiameter and 175 micronin central thickness intothe anterior chamberthrough a minimum 4mmincision duringendothelial keratoplastyprocedures
Product Code	OTZ	OTZ
Regulation Number	886.4300	886.4300
Class	1, reserved	1, reserved
Review AdvisoryCommittee	Ophthalmic	Ophthalmic
Target Population	Patients requiring EndothelialKeratoplasty	Patients requiringEndothelial Keratoplasty
Anatomical Site	Eye	Eye
Product Name	Proposed:	Predicate:
	EK Delivery Device	K090626EndoSerter™
Design	The EK Delivery deviceconsists of four components:(1) the Trocar which is usedto hold the graft material andintroduce it into the anteriorchamber of the recipient eye,(2) the Trocar Holder, whichis used to close the proximalend of the Trocar and as anergonomic handle to aid thesurgeon handling the device,(3) the Injector Assembly,which is a plunger to pushthe endothelial keratoplastytissue out of the Trocar andinto the anterior chamber ofthe recipient eye, and (4) EndPlug used during shipping.	The EndoSerter®consists of theinstrument's body and itsinternal mechanism andcarrier. The EndoSerter®is a sterile, disposable,single use only device.
	Delivers a circular endothelialtissue button in a rolledconfiguration.	Delivers a circularendothelial tissue buttonin a rolled configuration.
Sterility	Sterile Radiation	Sterile Radiation
Storage Capability	Yes 72 hours	No

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the comments of the comments of

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Testing has been completed showing the following:

Sterilization Validation

Shelf Life

Mechanical Strength

Tissue Handling and Stability

Biocompatibility

This testing shows that the predicate and TDAK device are equivalent and pose no new safety issues.

__ and the other one is the same. I'm sorry.

__ and, and the list goes on.

lity

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Public Health Service

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

OCT

3 2012

TDAK Medical. Inc. c/o Mr. Greg Holland Regulatory Specialist, Inc. 3722 Ave. Sausalito Irvine, CA 92606

Re: K121579

Trade/Device Name: EK Delivery Device Regulation Number: 21 CFR 886.4300 Regulation Name: Graft Insertion Instrument for Endothelial Keratoplasty Regulatory Class: Class I (reserved) Product Code: OTZ Dated: September 12, 2012 Received: September 13, 2012

Dear Mr. Holland:

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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Page 2 – Mr. Greg Holland

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.

Sincerely yours,
Kesia Alexander

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 Statement Indications for Use

510(k) Number (if known): K121579

Device Name: EK Delivery Device

Indications for Use:

The EK Delivery Device is to be used by ophthalmic surgeons trained in Endothelial Keratoplasty (EK) procedures and trained in the use of the EK Delivery Device as:

· An aid facilitating the insertion of donor corneal posterior lamellar endothelial graft of 100 – 220 µm of thickness into the anterior chamber of the eye during endothelial keratoplasty.
· For use in a 5.1 mm or larger incision and a maximum donor tissue diameter of ≤ 8.5 mm)

· For loading and storage of donor tissue during transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 72 hours.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) ==============================================================================================================================================================================

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

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

510(k) Number K121579

Page 1 of 1

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.