ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100

K062259 · Iscience Surgical · MPA · Aug 15, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K062259
• Device Name: ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
• Applicant: Iscience Surgical
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

Device Story

Portable fiberoptic illuminator; provides light for anterior and posterior segment ophthalmic surgery. Used exclusively with iScience Surgical iTrack Ophthalmic Microcannula. Device consists of splash-proof sheet metal enclosure, panel-mounted switches, and custom light output connector. Houses laser diode illumination source; utilizes redundant safety interlock switches in connector to ensure laser light only emanates when microcannula is fully engaged. Battery-powered; output power 200 µW. Operated by surgeons in clinical/surgical environments. Benefits include elimination of harmful wavelength filtering and reduced power requirements compared to traditional metal halide sources.

Clinical Evidence

Bench testing only. In-vitro study comparing iScience Surgical FI and HEXON Illuminator using iScience Surgical iTrack Ophthalmic Microcannula in enucleated cadaver eyes. Results demonstrated equivalent illumination at the microcannula tip, sufficient for advancement into intraocular structures.

Technological Characteristics

Portable fiberoptic illuminator; laser diode light source; battery-powered. Features splash-proof sheet metal enclosure. Includes custom light output connector with two redundant electronic safety interlock switches. Maximum output power 200 µW. Non-sterile device.

Indications for Use

Indicated for illumination during anterior and posterior segment ophthalmic surgery. Intended for use by clinicians in a surgical setting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Synergetics Synerlight Fiberoptic (K964005)
• HEXON Illumination System (K973229)

Submission Summary (Full Text)

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# 510(k) Summary K062259

K973229

### 510(k) Summary

| Submitter's Name: | iScience Surgical Corporation | | | | |
|----------------------------|-----------------------------------------------------------------------|--|--|--|--|
| Submitter's Address: | 4055 Campbell Avenue, Menlo Park, CA 94025 | | | | |
| Submitter's Telephone: | Phone [phone] | | | | |
| Contact Name: | Grace Bartoo | | | | |
| Date Summary was Prepared: | May 3, 2006 | | | | |
| Trade or Proprietary Name: | iScience Surgical Fiberoptic Illuminator | | | | |
| Common or Usual Name: | Fiberoptic Illuminator (FI) | | | | |
| Classification Name: | Endoilluminator | | | | |
| Predicate Devices: | Device Name 510(k) Number Synergetics Synerlight Fiberoptic K964005 | | | | |

HEXON Illumination System

## Description of the Device and Summary of the Technological Characteristics:

Illuminator

The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment.

The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure.

The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.

### Substantial Equivalence:

The product's technical features are substantially equivalent to the Synergetics Synerlight Fiberoptic Lightsource (K964005) marketed by Synergetics, Inc., and the HEXON lllumination System (K973229) marketed by Dutch Ophthalmic Research Center. Like the iScience Surgical Fiberoptic Illuminator, these predicate devices also are indicated for illumination during anterior and posterior segment ophthalmic surgery.

The iScience Surgical Fiberoptic Illuminator is designed to be used exclusively with the iScience Surgical iTrack Ophthalmic Microcannula. The iScience Surgical Fl differs from the predicate devices by utilizing a laser diode as the light source as compred to a metal halide light source. The use of a laser diode illumination source eliminates the need for filtering out potentially harmful wavelengths and lowers the power requirements of the device. The maximum output power of the device is 200 µW, significantly less than either the Synerlight or HEXON Illumination Systems. Additionally the iScience Surgical FI is battery powered compared to AC powered.

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In-vitro testing of the iScience Surgical Fl and the HEXON Illuminator, both used with the iScience Surgical iTrack Ophthalmic Microcannula in enucleated cadaver eyes, demonstrated equivalent results. Both illumination sources provided sufficient illumination at the tip of the iScience Surgical iTrack Ophthalmic Microcannula to advance it into intraocular structures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2006

iScience Surgical c/o Neil E. Devine Jr. Intertek Testing Services 2307 East Aurora Rd., Unit B7 Twinsburg, OH 44087

Re: K062259

Trade/Device Name: iScience Surgical Fiberoptic Illuminator Regulation Number: 21 CFR 876.1500 Regulation Name: Fiberoptic Illuminator Regulatory Class: II Product Code: MPA Dated: August 3, 2006 Received: August 4, 2006

Dear Mr. Devine:

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, 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 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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#### Page 2 - Neil E. Devine Jr.

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, percents 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 [phone]. Also, please note the regulation only) fed "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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

M.B. Egelnisi MD

Malvina B. Eydelman, 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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Indications for Use

510(k) Number (if known): Device Name: iScience Surgical Fiberoptic Illuminator

Indications for Use:

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The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.

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 OF NEEDED)

ffice of Device Evaluation (ODE)

O'Terin L. McCarthy
Division Sign Off

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

510(k) Number K062259

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