K Number

Device Name

EPIPHANY INJECTION SYSTEM

Manufacturer

STAAR SURGICAL CO.

Date Cleared

2009-06-09

(138 days)

Product Code

MSS

Regulation Number

886.4300

Intended Use

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."

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K052651, K970727, K002556, K940593, K954600, K073591

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical injector system for intraocular lenses and contains no mention of AI, ML, image processing, or data-driven performance metrics.

Therapeutic

No
The Epiphany Injector System is described as a delivery system for intraocular lenses (IOLs) for surgical placement, which is a tool used during a surgical procedure, not a device that itself provides therapy or treatment to a patient.

Diagnostic

No
The device is described as an "Injector System" and a "delivery system for intraocular lenses (IOLs) for surgical placement in the human eye." Its function is to fold and insert lenses, which is a therapeutic or interventional function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "single use, disposable Epiphany Injector System" made of "polycarbonate and polypropylene," indicating it is a physical hardware device for delivering intraocular lenses.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is for "folding and inserting... intraocular lenses... for surgical placement in the human eye." This describes a surgical tool used directly on a patient during a procedure.
Device Description: The description reinforces this by calling it a "delivery system for intraocular lenses... for surgical placement in the human eye."
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with any biological specimens for diagnostic purposes.

Therefore, the Epiphany Injector System is a surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

MSS

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human 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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K052651, K970727, K002556, K940593, K954600, K073591

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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:

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.

। ਰੇ

Epiphany Injector System

PREDICATE DEVICE COMPARISON SUMMARY TABLE
Feature	Epiphany
Injector System	R-INJ-02
Single Use
Disposable
Injector	MportTM
Foldable
Lens
Placement
t System	EASYSERT
Intraocular
Lens
Injector	MicroSTAAR
MSI Injector
System	Substantially
Equivalent
Product
Description	A delivery system
for intraocular
lenses (IOLs)	Same	Same	Same	Same	Yes
Intended Use	See Directions for
Use	Similar	Similar	Similar	Similar	Yes
Design	See prints	Similar	Similar	Similar	Similar	Yes
Main
Materials	Polypropylene and
polycarbonate	Similar	Similar	Similar	Similar	Yes
Mechanical
Safety	See test results	Similar	Similar	Similar	Similar	Yes
Manufacturing	Per internal
operating
procedures	Similar	Similar	Similar	Similar	Yes
Operating
Principle	An injector system
that utilizes
delivery
mechanism for the
insertion of an
IOL.	Similar	Similar	Similar	Similar	Yes
Packaging	Labeled pouches
and a tray with
Directions for Use	Similar	Similar	Similar	Same
(MSI-P1
model)	Yes
Sterility	Sterile	Same	Same	Same, but
different
method is
used	Same
(MSI-P1
model)	Yes
Manufacturer	STAAR Surgical
Company	Rayner
Surgical, Inc.	Chiron
Vision
Corp.	Pharmacia &
Upjohn	STAAR
Surgical
Company	NA

. .

Table 1: Summary of Design Comparison

. .

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.

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

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

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