The iScience Surgical Ophthalmic Viscoinjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.

Device Description

The iScience Surgical Ophthalmic Viscolnjector consists of a holder for a viscoelastic The loolorios bargreates a manually operated screw driven plunger. For use, a cantridge of viscoelastic solution is placed into the body of the Ophthalmic Viscolnjector. A needle inside the Ophthalmic Viscolnjector pierces the septum of the viscoelastic cartridge as it is seated within the body cavity. The cap from the Ophthalmic Cannage as it is connected to the body to secure the cartridge of viscoelastic solution inside the Viscolnjector. The thumbwheel is rotated clockwise thereby advancing the screw driven plunger to deliver viscoelastic solution. The end of the screw has a bushing that contacts the stopper in the viscoelastic cartridge. As the screw is advanced at a controlled rate the stopper displaces fluid out through the needle that has pierced the septum. The opposite, blunt end of the needle is embedded in a male Luer lock connector. This connector may be mated to a female Luer connector and the viscoelastic solution delivered. Markings on the thumbwheel, cap, and body of the Viscolnjector are provided to assist in determining the number of complete or partial thumbwheel rotations and thus relate to the amount of fluid delivered.

AI/ML Overview

The provided text describes the iScience Surgical Ophthalmic Viscoinjector, a manually operated device for precision delivery of small amounts of viscous fluid. The company submitted a 510(k) premarket notification to the FDA, and the device was determined to be substantially equivalent to previously marketed devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state numerical acceptance criteria with pass/fail values. Instead, it refers to general guidance and the intrinsic strength of materials. The performance section indicates that the device has been shown to conform to certain standards and practices.

Acceptance Criteria Category	Specific Standard/Guidance/Basis	Reported Device Performance
Sterilization	ANSI/AAMI/ISO 11137-1994 (Radiation Sterilization)	Conforms to standard.
Shelf-Life & Packaging Integrity	ANSI/AAMI/ISO 11607-1997 & AAMI TIR 1997	Conforms to standards.
Performance	ISO 7886-1 "Sterile hypodermic syringes for single use- Part 1: Syringes for manual use" (for general guidance); General experience with syringe-type devices; Intrinsic strength of Viscoinjector materials; Expected load during intended use.	Evaluated for: - Strength of device joints - Static pressure failure - Delivery of fluid (e.g., viscoelastic solution)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for performance testing (e.g., number of devices tested for joint strength, static pressure, or fluid delivery).

The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. The study focuses on the mechanical and functional performance of a medical device, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" in this context would be objective measurements of physical properties and fluid delivery.

4. Adjudication Method for the Test Set

This is not applicable and not provided. Performance testing involved objective measurements against established engineering principles and standards, not subjective assessments requiring adjudication.

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

This is not applicable. The device is a manually operated ophthalmic viscoinjector, a physical instrument for fluid delivery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a mechanical instrument, not an algorithm, and its operation inherently involves human interaction (manual operation).

7. The Type of Ground Truth Used

The "ground truth" for the performance testing appears to be based on:

Objective Measurements: Such as measurements of joint strength, static pressure at failure, and the volume or precision of fluid delivery.
Established Industry Standards and Guidance: ISO 7886-1-1994, ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 11607-1997, and AAMI TIR.
Engineering Principles: Related to the intrinsic strength of materials and the expected loads during use.

8. The Sample Size for the Training Set

This is not applicable. The device is a mechanical medical instrument, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

K060716

APR 2 1 2005

SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE 1. SUMMARY PREPARED

iScience Surgical Corporation APPLICANT 3696A Haven Avenue Redwood City, CA 94063 Ron Yamamoto Phone (650) 421-2700 FAX (650) 421-2701 Contact Person:

Contact Person:

Judy F. Gordon, D.V.M. 2 Delphinus Irvine, CA 92612 Phone (949) 854-6314 FAX (949) 854-9652

1. Name of Device, Including Trade Name and Classification Name:

TRADE/PROPRIETARY NAME:	iScience Surgical Ophthalmic Viscoinjector, abbreviated as VI
COMMON NAME:	ViscoInjector
CLASSIFICATION NAME:	Pump, Infusion, Ophthalmic

Device Description 3.

{1}------------------------------------------------

The end of the screw has a bushing that contacts the stopper in the viscoelastic cartridge. As the screw is advanced at a controlled rate the stopper displaces fluid out through the needle that has pierced the septum.

The opposite, blunt end of the needle is embedded in a male Luer lock connector. This connector may be mated to a female Luer connector and the viscoelastic solution delivered. Markings on the thumbwheel, cap, and body of the Viscolnjector are provided to assist in determining the number of complete or partial thumbwheel rotations and thus relate to the amount of fluid delivered.

4. INDICATION FOR USE

PREDICATE DEVICES 5.

The iScience Surgical Ophthalmic Viscolnjector is substantially equivalent to the following predicate devices:

Company:	Viscous Fluid Injector System Module (CX5700-
Device:	Bausch & Lomb Inc.
510(k):	K993039
Company:	Grieshaber & Co.
Device:	Grieshaber Viscoelastic Injection System
510(k):	K890783
Company:	D.O.R.C VFI VFE System
Device:	Dutch Ophthalmic USA, INC.
510(k):	K954842
Company:	Viscous Fluid System
Device:	Escalon Trek Medical
510(k):	K963434

Summary of Technological Characteristics 6.

The intended use and technological features of the iScience Surgical Ophthalmic Viscoinjector do not differ from the legally marketed predicate devices. Both the Ophthalmic Viscoinjector and the predicate device(s) utilize similar materials and methods of operation.

{2}------------------------------------------------

SUMMARY OF PERFORMANCE DATA 7.

The iScience Surgical Ophthalmic Viscoinjector has been shown to conform to the following standards, practices, and guidances:

STERILIZATION

ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilization .

SHELF-LIFE AND PACKAGING INTEGRITY

ANSI/AAMI/ISO 11607-1997, Packaging for Terminally Sterilized Medical Devices.
AAMI TIR, Guidance for ANSI/AAMI/ISO 11607-1997, Packaging for Terminally Sterilized Medical Devices, 1997.

PERFORMANCE

In the absence of performance standards for viscoelastic injectors or pumps, ISO 7886-1 "Sterile hypodermic syringes for single use- Part 1: Syringes for manual use" was used for general guidance in design evaluation and performance testing of the iScience Surgical Ophthalmic Viscoinjector. Performance testing was designed to evaluate strength of the device joints, static pressure failure, and delivery of fluid such as a viscoelastic solution. Determination of acceptance criteria was based on general experience with syringe-type devices, intrinsic strength of the Viscoinjector materials, and the load to which the iScience Surgical Ophthalmic Viscoinjector would be subjected during intended use.

8. CONCLUSION

Since the iScience Surgical Ophthalmic Viscoinjector meets the requirements of the stated standards and embodies technological characteristics similar to the predicate devices, the device has been shown to be substantially equivalent to the predicate devices, is as safe and effective and performs as well as the predicate devices.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

iScience Surgical Corporation c/o Judy Gordon, DVM ClinReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92612

K050716 Re:

K050716
Trade/Device Name: iScience Ophthalmic Viscoelastic Injector
Trade/Device Name: 11 SED 900 5725 Trade/Doviesumber: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRH Dated: March 16, 2005 Received: March 21, 2005

Dear Dr. Gordon:

We have reviewed your Section 510(k) premarket notification of intent to market the device is
t the indication works and the device is substantially equivalent (for the indic We have reviewed your Section 5 IQ(x) premiation of the maintelly equivalent (for the indications
referenced above and have and a linerarkated devices marked in interstate referenced above and have detemined the usevices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally markets device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device America Food, Drug, commerce prior to May 28, 1976, the enactment and of the Frovisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fe devices that have been reclassities in accordance while provided on over and application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act and Cosmetic Act (Act) that do not require approval or approvisions of the Act. The Act. The
You may, therefore, market the device, subject to the general contralient of t You may, therefore, market the device, subject or the general vonmul registration, listing of
general controls provisions of the Act Indude requirements for annual misbrandin general controls provisions of the Act Include requirements for the only of the subjections and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
ed in the can and the cases of the cases of - Exigting major regulatio If your device is classified (see above) into eluci cass if ependrions affecting your device can
may be subject to such additional controls. Existing major regulations FDA m may be subject to such additional controls. Existing major regal to 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In add be found in the Code of Federal Regulations, Trite By F.
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 Please be advised that FDA's issuance of a substantial with requirements of the Act
that FDA has made a determination that your device complies with other requirements of the that FDA has made a determination that your useved by other Federal agencies. You must
or any Federal statutes and regulations administered by other for registration and li or any Federal statutes and repulsions administered by outsit in the station and listing (21)
comply with all the Act SEP Pres 801): good manufacturing practice requirements comply with all the Act's requirements, including, out minines world.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicely, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applic planet forth in the quality systems (QS) regulation (21 CFR Part obs) and 11 - 11
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2 - Judy Gordon, DVM

This letter will allow you to begin marketing your device as described in your Section 510(k)
I has began and a controlled of alies of substential equivalence of your devic This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device and premarket notification. The FDA finding of substantal equivalies of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1 (1 ) (1 (1 ) (1 ) (1 ) (1 ) (1 (10 ) (10 ) (1 (1 ) (1 ) (1 ) (1 ) (1 If you desire specific advice for your device on our accembe the regulation entitled,
contact the Office of Compliance at (301) 827-8910. Also, please not 91). You may obt contact the Office of Compliance at (301) 627-8710. Year 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket notification " (21 cm the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number (80 Manufacturers, International and Consumer Assistance at ps corner of the comments (1) (1) 443-6597 or at its (1) 1) 443-6597 or at its

Sincerely yours,

David M. Whipple

David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

PAGE 1 OF 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

iScience Surgical Ophthalmic Viscolnjector Device Name:

Indications for Use:

The iScience Surgical Ophthalmic Viscolnjector is a manually operated device for The iScience Surgical Ophthalmic viscous fluid such as a sterile viscoelastic
precision delivery of small amounts of viscous fluid such as a sterile viscoelastic precision delivery of small amounts of viscous null salon, HealonGV and Healon5
solution pre-packaged in a cartridge, for example_HealonGV and Healon5
condition in and the co solution pre-packaged in a cartruge, for example Housin, Now
manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
------------------	---

Over-The-Counter Use
----------------------	--

(Optional Format 1-2-96)
--------------------------	--

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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).