The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.

Device Description

The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use.

AI/ML Overview

The provided text describes the iScience Interventional Canaloplasty Microcatheter and its regulatory clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding acceptance criteria, specific performance metrics, test set details (sample size, provenance, expert qualifications, adjudication), MRMC studies, or training set specifics for an AI/ML device.

This document describes a medical device clearance process for a physical surgical tool, not an AI/ML diagnostic or assistive device. Therefore, many of the questions related to AI/ML evaluation (like ground truth establishment, expert adjudication, MRMC studies, training set size) are not applicable or the information is not present in this type of submission.

Here's a breakdown of what can be extracted and what information is missing:

Acceptance Criteria and Device Performance for iScience Interventional Canaloplasty Microcatheter

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines conformity to established standards and general performance tests. It does not provide specific numerical acceptance criteria (e.g., "tensile strength must be >X Newtons") or corresponding quantitative results. Instead, it states that tests were performed "to ensure that performance requirements were met" and that "performance testing demonstrates that the iScience Interventional Canaloplasty Microcatheter is functionally equivalent to the predicate devices."

Acceptance Criteria Category	Reported Device Performance / Conformance
Sterilization	Conforms to ANSVAAMI/ISO 11137-1995
Biocompatibility	Conforms to ISO 10993-1, -5, -10, -12
Shelf-Life & Packaging	Conforms to ANSI/AAMI/ISO 11607-2000
Risk Management	Conforms to ISO 14971:2000
Dimensional & Mechanical	Passed tests for:
- Tensile Strength of Joints	Performance requirements met
- Static Burst	Performance requirements met
- Fluid Infusion Line Leakage	Performance requirements met
- Aspiration	Performance requirements met
- Light Transmission	Performance requirements met
Functional Equivalence	Functionally equivalent to predicate devices

Detailed Information Not Available in the Provided Text:

Questions 2, 3, 4, 5, 6, 7, 8, and 9 relate to the evaluation of AI/ML or diagnostic performance, which is not the primary focus of this 510(k) summary for a surgical microcatheter. Therefore, the specific details you requested are not present.

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

Information not available. The document mentions "Ex-vivo studies" and "A multi-center prospective study," but does not provide sample sizes for these studies or specific details on data provenance (e.g., country of origin, retrospective/prospective for test sets). The prospective study is a clinical study for safety and efficacy, not explicitly a "test set" for performance evaluation in the context you've outlined.

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

Information not available. This is typically relevant for diagnostic AI/ML devices where expert consensus defines ground truth. For a surgical device, "ground truth" relates to functional performance and safety, evaluated through engineering tests and clinical outcomes, rather than expert interpretation of images/data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Information not available. Adjudication methods are specific to diagnostic evaluations, especially in AI/ML performance studies. Not applicable here in the way you've framed it.

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 / Information not available. This device is a surgical microcatheter; it's a tool, not an AI assistant meant to improve human reader performance. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's evaluation.

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

Not applicable / Information not available. This is not an algorithm; it's a physical surgical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the engineering/performance tests, ground truth would be established by physical measurements and adherence to engineering specifications.
For the clinical study, the "ground truth" for efficacy would likely be outcomes data (e.g., reduction in intraocular pressure) and for safety, it would be adverse event reporting. The document doesn't detail the specific outcome measures beyond "reduce intraocular pressure".

8. The sample size for the training set:

Not applicable / Information not available. This is not an AI/ML device, so there is no "training set."

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

Not applicable / Information not available. As there is no AI/ML training set, this question is not relevant.

In summary, the provided document details the regulatory clearance for a physical medical device. While it lists adherence to various standards and types of performance testing, it does not provide the granular data points concerning specific acceptance thresholds, quantitative results, or the detailed methodology of test/training sets, experts, and adjudication that would be required for an AI/ML or diagnostic device evaluation.

Summary

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510(k) Summary 5.0

	JUL 1 8 2008
iScience Interventional Corporation
4055 Campbell Avenue
Phone (650) 421-2700
(650) 239-3697Fax
Grace Bartoo
June 11, 2008
iScience Interventional Canaloplasty Microcatheter
Ophthalmic Microcatheter

HMX, 21 CFR 886.4350 Manual ophthalmic surgical
instrument
Device Name	510(k) Number
iScience Surgical Ophthalmic	K041108
Microcannula
Endolight End Irrigating	K970882
Endoilluminator
True Light End Irrigating	K973293
Endoilluminator
	MPA, 21 CFR 876.1500 Endoscope and accessones

Description of the Device Subject to Premarket Notification:

Indications for Use

Technical Characteristics

The intended use and technological features of the iScience Interventional Canaloplasty Microcatheter do not substantially differ from the legally marketed predicate devices. The iScience Interventional Canaloplasty Microcatheter and the predicate device(s) have similar intended uses and methods of operation.

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Performance Data

The iScience Interventional Canaloplasty Microcatheter has been shown to conform to the following standards, practices, and guidance:

STERILIZATION

ANSVAAMI/ISO 11137-1995, Sterilization of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilization.

BIOCOMPATIBILITY

ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
ISO 10993-5, Biological Evaluation of Medical Devices Part 5: Tests for in Vitro Cvtotoxicity
ISO 10993-10, Biological Evaluation of Medical Devices Part 10: Test for Irritation and Delayed-Type Hypersensitivity
ISO 10993-12, Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials

SHELF-LIFE AND PACKAGING INTEGRITY

ANSI/AAMI/ISO 11607-2000, Packaging for Terminally Sterilized Medical Devices.

RISK MANAGEMENT

ISO 14971:2000. Medical Device Application of Risk Management to Medical Devices.
The device also underwent testing to ensure that performance requirements were met.

DIMENSIONAL AND MECHANICAL TESTING

Tensile Strength of Joints
Static Burst
Fluid Infusion Line Leakage
Aspiration
Light Transmission

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PRECLINICAL STUDIES

Ex-vivo studies of accessing Schlemm's canal using Canaloplasty Microcatheter

Clinical Studies

A multi-center prospective study to evaluate the safety and efficacy of circumferential viscodilation and tensioning of the inner wall of Schlemm's canal with the Canaloplasty Microcatheter to reduce intraocular pressure in adult patients with open angle glaucoma.

Basis for Determination of Substantial Equivalence:

The indications for use for the iScience Interventional Canaloplasty Microcatheter are similar to the predicate devices cited in this application. The safety of the materials used for the manufacture of the iScience Interventional Canaloplasty Microcatheter has been demonstrated with biocompatibility testing. Performance testing demonstrates that the iScience Interventional Canaloplasty Microcatheter is functionally equivalent to the predicate devices.

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JUL 1 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

iScience Interventional Corporation % Grace Bartoo, Ph.D., RAC, CBA Regulatory Consultant 4055 Campbell Avenue Menlo Park, CA 94025

Re: K080067

Trade/Device Name: iScience Interventional Canaloplasty Microcather Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: MPA, HMX Dated: June 11, 2008 Received: June 13, 2008

Dear Dr. Bartoo:

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. Iisting 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 such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sincercly vours.

M. B. Egorluns, mD

Malvina B. Evdelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 Indication for Use

510(k) Number (if known): K080067

Device Name: iScience Interventional Canaloplasty Microcatheter

Indications for Use:

The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery.

The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Fivaluation (ODE)

Sac Cellaurn
(Division Sign Off)

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

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510(k) Number K080067

ISCIENCE INTERVENTIONAL 510(x) SUBMISSION CANALOPLASTY MICROCATHETER 4- |

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.