FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES

K022228 · Iridex Corp · GEX · Oct 8, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K022228
• Device Name: FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
• Applicant: Iridex Corp
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

Device Story

Family of ophthalmic laser handpieces; components include universal SMA input connector, glass fiber optic, PVC jacket, and medical-grade stainless steel needle. Illuminating models include additional fiber optic. Used by ophthalmologists in clinical settings to deliver laser energy to intraocular treatment sites. Aspiration function removes fluid causing refraction/scattering; illumination function provides visualization. Handpieces connect to compatible laser systems (e.g., IRIS Medical, Lumenis). Device facilitates precise laser delivery, improving treatment efficacy and patient safety during ophthalmic surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: glass fiber optic, PVC (vinyl) jacket, medical-grade stainless steel needle. Energy: laser energy delivery via fiber optic. Connectivity: universal SMA connector for compatibility with external laser systems. Form factor: straight or angled handpiece styles.

Indications for Use

Indicated for ophthalmic laser treatment delivery, fluid aspiration to prevent laser beam scattering, and interior eye illumination. Used in conjunction with compatible laser systems for patients requiring ophthalmic laser procedures.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• IRIS Medical EndoProbe (K020374)
• Alcon Endolaser Probes (K962592)
• HGM Illuminating and Aspirating Probes (K931784)
• HGM Illuminating and Aspirating Probes (K925663)
• STI Aspirating Endo Ocular Probe with Illumination (K921488)
• Infinitech Aspirating Laser Probe (K946135)

Submission Summary (Full Text)

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#### 510(k) Summary xnaza20 IRIDEX® Corporation Family of IRIS Medical® EndoProbe® Handpieces

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043

| Contact Person: | John D'Angelo<br>[phone] ext. 3905 |
|-----------------|-------------------------------------------|
|-----------------|-------------------------------------------|

July 9, 2002 Date Prepared:

#### Device Information

| Trade Name: | Family of IRIS Medical EndoProbe Handpiece |
|----------------------|--------------------------------------------|
| Classification Name: | Laser, Ophthalmic, Accessory |
| CFR Section: | 886.4390 |
| Product Code: | HQF |

### Predicate Devices

The family of IRIS Medical EndoProbe handpieces is substantially equivalent in intended use and/or method of operation to other currently legally marketed laser probes including IRIDEX Corporation's IRIS Medical EndoProbe (K020374), the Alcon Endolaser Probes (K962592), the HGM Illuminating and Aspirating Probes (K931784 and K925663), the STI Aspirating Endo Ocular Probe with Illumination (K921488), and the Infinitech Aspirating Laser Probe (K946135).

#### Device Description

The family of IRIS Medical EndoProbe handpieces is comprised of the following main components: a universal SMA style input connector, a glass fiber optic protected by a PVC (vinyl) jacket, a handle, and a medical grade stainless steel needle. The Illuminating EndoProbe has an additional illumination fiber optic with jacket.

#### Intended Use

The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

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## Conclusion

The family of IRIS Medical EndoProbe handpieces shares similar indications for use, materials, and similar performance characteristics as, and thus is substantially equivalent to, the currently marketed predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The logo is black and white.

OCT 0 8 2002

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .

Mr. John D'Angelo Vice President, Regulatory Affairs and Quality Assurance IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043

Re: K02228

Trade/Device Name: Family of IRIS Medical EndoProbe Handpieces Regulation Number: 886.4390 Regulation Name: Opthalmic Laser Regulatory Class: II Product Code: GEX Dated: July 9, 2002 Received: July 10, 2002

Dear Mr. D'Angelo:

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 - Mr. John D'Angelo

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Styph Ewdn
A. Galis M. Witter, Ph.D., M.D.

elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

Krizadd 510(k) Number (if known): Pending

Device Name: Family of IRIS Medical® EndoProbe® Handpieces

Indications For Use:

The family of IRIS Medical EndoProbe handpieces is intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the aspiration function is indicated for use when unwanted fluid is present in the eye causing refraction or scattering of the laser beam from the intended treatment site, and the illumination function is indicated for use to illuminate the interior of the eye. The handpieces are offered in straight or angled styles, and with a universal SMA connector that allows the family of EndoProbe handpieces to be used with compatible laser systems, such as IRIS Medical and Lumenis. The handpieces are cleared for use for the particular indications of the laser system to which they are attached.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Neurological Devices

KOZZZZ 8 510(k) Number -

Prescription Use

OR (Per 21 CFR 801.109) Over-The-Counter Use