(190 days)
Not Found
No
The summary describes a mechanical device for fluid infusion, aspiration, and viscodilation, with an optical fiber for illumination. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for "catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma," which treats a medical condition.
No
The device is indicated for fluid infusion and aspiration during surgery, and for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure. These are interventional/therapeutic uses, not diagnostic.
No
The device description clearly details a physical microcatheter with an optical fiber, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The iScience Interventional Canaloplasty Microcatheter is a surgical tool used directly within the eye during surgery. Its functions are:
- Fluid infusion and aspiration during surgery.
- Catheterization and viscodilation of Schlemm's canal.
- Surgical illumination and guidance.
- No Specimen Analysis: The device does not collect or analyze specimens from the body to provide diagnostic information. It is an interventional device used for a surgical procedure.
Therefore, based on its intended use and description, this device falls under the category of a surgical or interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HMX, MPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Schlemm's canal in the eye.
Indicated Patient Age Range
adult patients
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) Summary 5.0
| JUL 1 8 2008 | |
|---|---|
| iScience Interventional Corporation | |
| 4055 Campbell Avenue | |
| Phone (650) 421-2700 | |
| (650) 239-3697 | |
| Fax | |
| 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:
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.
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.
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.
1
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
2
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.
3
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
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.
4
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
5
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- |