The Epiphany Injector System is a device intended to fold and insert STAAR Surgical Company aspheric three piece Collamer®, Model CQ2015A, and aspheric three piece silicone intraocular lenses, Model AQ2015A, for surgical placement in the human eye.

Device Description

The single use, disposable Epiphany Injector System is a delivery system for intraocular lenses (IOLs) for surgical placement in the human eye. The two main materials used in the manufacturer of this injector system will be polycarbonate and polypropylene. All product is also supplied "STERILE."

AI/ML Overview

The provided text describes the Epiphany Injector System, a disposable intraocular lens injector. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the way requested by the prompt.

Instead, the document serves as a 510(k) summary for regulatory submission, primarily focusing on demonstrating substantial equivalence to predicate devices. It references "test results" for "Mechanical Safety" but does not elaborate on these results or the acceptance criteria used.

Therefore, I cannot fulfill many of the requested sections as the information is not present in the provided text. I will indicate where information is missing.

Epiphany Injector System

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list specific performance acceptance criteria for the Epiphany Injector System. It largely relies on a comparison to predicate devices to establish substantial equivalence.

Feature	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (From "Mechanical Safety" - Test Results)
Mechanical Safety	(Implied to be "Similar" to predicate devices)	"See test results" (Details not provided in the document)
Product Description	A delivery system for intraocular lenses (IOLs)	"Same" as predicate devices
Intended Use	As described in Directions for Use	"Similar" to predicate devices
Design	As per prints	"Similar" to predicate devices
Main Materials	Polypropylene and polycarbonate	"Similar" to predicate devices
Manufacturing	Per internal operating procedures	"Similar" to predicate devices
Operating Principle	An injector system that utilizes delivery mechanism for the insertion of an IOL	"Similar" to predicate devices
Packaging	Labeled pouches and a tray with Directions for Use	"Similar" to predicate devices, except MSI-P1 model is "Same"
Sterility	Sterile	"Same" as predicate devices, but different sterilization method for one

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

The document states, "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration." This indicates that no clinical test set was used. The brief mention of "Mechanical Safety: See test results" implies some form of engineering or bench testing, but the sample size and data provenance are not provided.

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

Not applicable. No clinical studies or human expert-based test sets are described.

4. Adjudication method for the test set

Not applicable. No clinical studies or human expert-based test sets are described.

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 mechanical injector system, not an AI or imaging device that would typically involve MRMC studies with human readers.

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

Not applicable. This device is a mechanical injector system, not an algorithm. Bench testing would be analogous to "standalone" performance for a mechanical device, but details are not provided.

7. The type of ground truth used

The primary "ground truth" for this submission appears to be the established performance and safety of legally marketed predicate devices, against which the Epiphany Injector System demonstrated "substantial equivalence." For "Mechanical Safety," internal test results are referenced, implying engineering specifications or performance benchmarks as ground truth, but these are not detailed.

8. The sample size for the training set

Not applicable. This device is a mechanical injector system, not an AI system requiring a training set in the conventional sense.

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

Not applicable.

Summary

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Epiphany Injector System

KOQ0161

510(k) SUMMARY

Pursuant to 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR 807.92.

Submitter Information:

STAAR Surgical Company Contact: John Santos, Vice President Quality Assurance, Regulatory, and Clinical Affairs 1911 Walker Avenue Monrovia, CA 91016 Phone: 626-303-7902 Fax: 626-303-2962

2023826 Company Registration Number:

Submission Correspondent:

STAAR Surgical Company Contact: John Santos. Vice President Quality Assurance, Regulatory, and Clinical Affairs 1911 Walker Avenue Monrovia, CA 91016 Phone: 626-303-7902 Fax: 626-303-2962

Date Summary Prepared:

Classification Name:

January 21, 2009

Folders and Injectors, Intraocular Lens (IOL) (Class I) - MSS 21 CFR 886.4300

Disposable Intraocular Lens Injector

Common/Usual Name:

Device Trade Name:

Epiphany Injector System

The primary devices used for comparison in this summary are Rayner Surgical, Inc.'s R-INJ-02 Single Use Disposable Injector (K052651), Chiron Vision Corp.'s Mport™ Foldable Lens Placement System (K970727), Pharmacia & Upjohn's EASYSERT Intraocular Lens Injector (K002556), and STAAR Surgical Company's MicroSTAAR MSI Injector System (K940593, K954600, and K073591).

1. Intended Use:

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2. Description:

3. Technological Characteristics:

The Epiphany Injector System has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, specifications, and materials.

4. Comparison Analysis:

The overall design of the Epiphany Injector System is substantially equivalent to the predicate devices. See Table 1 on the following page for a design comparison of the Epiphany Injector System and the predicate devices.

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Epiphany Injector System

PREDICATE DEVICE COMPARISON SUMMARY TABLE
Feature	EpiphanyInjector System	R-INJ-02Single UseDisposableInjector	MportTMFoldableLensPlacementt System	EASYSERTIntraocularLensInjector	MicroSTAARMSI InjectorSystem	SubstantiallyEquivalent
ProductDescription	A delivery systemfor intraocularlenses (IOLs)	Same	Same	Same	Same	Yes
Intended Use	See Directions forUse	Similar	Similar	Similar	Similar	Yes
Design	See prints	Similar	Similar	Similar	Similar	Yes
MainMaterials	Polypropylene andpolycarbonate	Similar	Similar	Similar	Similar	Yes
MechanicalSafety	See test results	Similar	Similar	Similar	Similar	Yes
Manufacturing	Per internaloperatingprocedures	Similar	Similar	Similar	Similar	Yes
OperatingPrinciple	An injector systemthat utilizesdeliverymechanism for theinsertion of anIOL.	Similar	Similar	Similar	Similar	Yes
Packaging	Labeled pouchesand a tray withDirections for Use	Similar	Similar	Similar	Same(MSI-P1model)	Yes
Sterility	Sterile	Same	Same	Same, butdifferentmethod isused	Same(MSI-P1model)	Yes
Manufacturer	STAAR SurgicalCompany	RaynerSurgical, Inc.	ChironVisionCorp.	Pharmacia &Upjohn	STAARSurgicalCompany	NA

. .

Table 1: Summary of Design Comparison

. .

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Epiphany Injector System

A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.
For submission claiming substantial equivalence to a device which has been (i) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (Class III Summary). The 510(k) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94. This information does not refer to information that already has been submitted to the Food and Drug Administration (FDA) under section 519 of the act. FDA may require the submission of the adverse safety and effectiveness data described in the Class III Summary or Citation.

A Class III Certification and Summary is not needed for this submission as the products under consideration are Class I.

A statement that the submitter believes, to the best of his or her knowledge, (k) that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Public Health Service

JUL 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

STAAR Surgical Company c/o Mr. John Santos Vice President Quality Assurance, Regulatory, and Clinical Affairs 1911 Walker Avenue Monrovia, CA 91016

Re: K090161

Trade/Device Name: Epiphany Iniector System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: June 9, 2009 Received: June 9, 2009

Dear Mr. Santos:

This letter corrects our substantially equivalent letter of June 9, 2009.

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 (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.

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

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forth in the quality systems (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely, Tate,

Kesia Alexander for

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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Indications for Use Statement

510(k) Number (if known): KO9 0 l & l

Device Name: Epiphany Injector System

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

Over-The-Counter-Use (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)

Danise Slampton

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_KO900161

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.