(55 days)
Not Found
No
The summary describes a physical surgical tool (microcannula) for fluid management and illumination during eye surgery. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on sterilization, biocompatibility, packaging, and meeting performance requirements, not algorithmic performance.
No.
The device is used for fluid infusion/aspiration and illumination during surgery, which are supportive functions for the surgery itself, not for treating a condition directly.
No.
The device is indicated for fluid infusion and aspiration, as well as illumination, during surgery, which are therapeutic and procedural functions, not diagnostic ones.
No
The device description clearly states it is a "flexible microcannula" that "incorporates an optical fiber," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluid infusion and aspiration, as well as illumination, during surgery." This describes a surgical tool used directly on the patient during a procedure.
- Device Description: The description details a "flexible microcannula designed to allow atraumatic cannulation of spaces in the eye... for infusion and aspiration of fluids during surgery." This further reinforces its role as a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the iScience Surgical Ophthalmic Microcannula does not mention any such use or analysis of biological samples.
Therefore, the iScience Surgical Ophthalmic Microcannula is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.
Product codes
MPA
Device Description
The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
The iScience Surgical iTRACK Ophthalmic Microcannula has been shown to conform to the following standards, practices, and quidances:
- STERILIZATION
- A ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilization .
- A ANSI/AAMI/ISO 10993; Biological Evaluation of Medical Devices-Part 1.
- SHELF-LIFE AND PACKAGING INTEGRITY
- A 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.
The device also underwent testing to ensure that performance requirements were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
10.0
Summary of Safety and EFFECTIVENESS
K041108
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.
| APPLICANT | iScience Surgical Corporation
3696A Haven Avenue
Redwood City, CA 94063
Ron Yamamoto
Phone (650) 421-2700
FAX (650) 421-2701 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| TRADE NAME: | Ophthalmic Microcannula |
| COMMON NAME: | Ophthalmic Microcannula |
| CLASSIFICATION
NAME: | Ophthalmic Cannula
Endoilluminator |
DEVICE DESCRIPTION
The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
INDICATION FOR USE
The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.
PREDICATE DEVICES
The iScience Surgical Ophthalmic Microcannula is substantially equivalent to the following predicate devices:
| Company: | American Medical Devices, Inc |
|---|---|
| Device: | Endolight End Irrigating Endoilluminator |
| 510(k): | K970882 |
| Company: | Syntec, Inc. |
| Device: | True Light End Irrigating Endoilluminator |
| 510(k): | K973293 |
| Company: | Micron Surgical, Inc. |
| Device: | Weiss Retinal Cannula |
| 510(k): | K010305 |
1
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
The intended use and technological features of the iScience Surgical iTRACK Ophthalmic Microcannula do not differ from the legally marketed predicate devices. Both the iScience iTRACK and the predicate device(s) utilize similar materials and methods of operation.
SUMMARY OF PERFORMANCE DATA
The iScience Surgical iTRACK Ophthalmic Microcannula has been shown to conform to the following standards, practices, and quidances:
STERILIZATION
- A ANSI/AAMI/ISO 11137-1994, Sterilization of Health Care Products -Requirements for Validation and Routine Control - Radiation Sterilization .
- A ANSI/AAMI/ISO 10993; Biological Evaluation of Medical Devices-Part 1.
SHELF-LIFE AND PACKAGING INTEGRITY
- A 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.
The device also underwent testing to ensure that performance requirements were met.
CONCLUSION
Since the iScience Surgical iTRACK Ophthalmic Microcannula 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2004
iScience Surgical Corporation c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92612
Re: K041108
Trade/Device Name: iScience Surgical Ophthalmic Microcannula Regulation Number: 21 CFR 886.1500 Regulation Name: Endoilluminator Regulatory Class: Class II Product Code: MPA Dated: April 27, 2004 Received: April 30, 2004
Dear Ms. Gordon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t); premised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the chelosury to tegars actuent date of the Medical Device Amendments, or to commerce phot to may 20, 1978, in eccordance with the provisions of the Federal Food, Drug, devices mat have occh rechasined in assess approval of a premarket approval application (PMA). alle Cosmette Act (1107) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, maines of the Act include requirements for annual registration, listing of general controls provisions of the rest 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 If your device is olassinou (controls. Existing major regulations affecting your device can may be subject to such additions, 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 r rease oc advised that i Drivedance or our device complies with other requirements of the Act that I DT has made a coved regulations administered by other Federal agencies. You must of any I edelul statutes uncreogirements, including, but not limited to: registration and listing Comply with and I the Frequirements Part 801); good manufacturing practice requirements as set (21 CFR Part 807), adoming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Judy F. Gordon, D.V.M.
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A Kalgi Rosenthal
A. Ralph Rosenthal, 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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Page 1 of 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
iScience Surgical Ophthalmic Microcannula Device Name:
Indications for Use:
The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, with illumination, during surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR Over-The-Counter Use __ (Optional Format 1-2-96)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number. K041108