27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA

K110951 · Alcon Research, Ltd. · HQB · Oct 17, 2011 · Ophthalmic

Device Facts

• Record ID: K110951
• Device Name: 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
• Applicant: Alcon Research, Ltd.
• Product Code: HQB · Ophthalmic
• Decision Date: Oct 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses: 27+ UltraVit Probe: Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.) 27+ Flex-Tip Laser Probe: Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.) 27+ Endoilluminator Probe: Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System) 27+ Valved Entry System: Scleral incision; Canulae for posterior segment instrument access; Venting (of valved cannulae) 27+ Infusion Cannula: Posterior segment infusion (liquid or gas)

Device Story

27+ Retina Instrument Set comprises five surgical accessories: UltraVit probe, Flex-Tip laser probe, endoilluminator, valved entry system, and infusion cannula. Devices are modified versions of larger-gauge (25+) CONSTELLATION accessories, featuring smaller diameter tips for less invasive vitreoretinal surgery. Used in clinical settings by ophthalmologists during posterior segment procedures. Instruments interface with Alcon CONSTELLATION Vision System or PurePoint Laser System. Laser probe delivers 532 nm laser energy for photocoagulation; UltraVit probe performs mechanical vitreous cutting/aspiration. Devices facilitate access, illumination, infusion, and tissue manipulation. Benefits include reduced invasiveness due to smaller gauge size. Single-use, sterile, EO-sterilized.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity). Sterilization validated per EN ISO 11135-1:2007. Functional testing confirmed performance requirements met.

Technological Characteristics

Vitreoretinal surgical instruments; 27-gauge diameter. Materials compliant with ISO 10993. Energy sources: pneumatic (aspiration/cutting), 532 nm laser (photocoagulation), light source (endoillumination). Single-use, EO-sterilized (SAL 10^-6). Manufactured per 21 CFR 820 and ISO 14971.

Indications for Use

Indicated for patients requiring vitreoretinal surgery, including treatment of proliferative/nonproliferative retinopathy (diabetic), age-related macular degeneration, retinal tears/detachments, macular edema, retinopathy of prematurity, glaucoma (COAG/POAG/refractory), retinal vein occlusion, and other vascular/structural retinal/choroidal abnormalities.

Regulatory Classification

Identification

An ophthalmic photocoagulator is an AC-powered device intended to use the energy from an extended noncoherent light source to occlude blood vessels of the retina, choroid, or iris.

Predicate Devices

• Enhanced UltraVit® Probe (K093305)
• Next Generation Laser and accessories (PurePoint® laser) (K062624)
• Alcon Vision System (and accessories) (K063583)
• CONSTELLATION® Vision System (and accessories) (K101285)

Submission Summary (Full Text)

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OCT 1 7 2011

Alcon Research, Ltd. Traditional 510(k) Premarket Notification 27+ Retina Instrument Set

March 31, 2011

## PREMARKET NOTIFICATION 510(k) SUMMARY 5.

This 510(k) Summary is provided here and is also included in Attachment B.

The submitter of the 510(k) is:

Martin A. Kaufman Director, Regulatory Affairs Alcon Research, Ltd. 18500 Alton Parkway Irvine, CA 92618 Phone: [phone] Fax: [phone]

Devices Subject to this 510(k):

Trade Name: 27+ Retina Instrument Set Common Name: Vitreoretinal Surgical Accessories Classification Name: See below

| Modified<br>Instrument | 21 CFR | Classification name | Class | Product<br>Code | Predicate<br>510(k) | Date<br>Cleared |
|---------------------------------|----------|-----------------------------------------------|-------|-----------------|---------------------|----------------------|
| 27+ UltraVit®<br>Probe | 886.4150 | Vitreous aspiration and<br>cutting instrument | II | HQE | K093305 | 04/02/10 |
| 27+ Flex-Tip<br>Laser Probe | 886.4390 | Ophthalmic laser | II | HQB | K062624 | 11/05/07 |
| 27+<br>Endoilluminator<br>Probe | 876.1500 | Endoscope and<br>accessories | II | MPA | K063583<br>K101285 | 05/09/08<br>11/12/10 |
| 27+ Valved Entry<br>System | 886.4350 | Manual ophthalmic<br>surgical instrument | I | NGY | n/a | |
| 27+ Infusion<br>Cannula | 886.4350 | Manual ophthalmic<br>surgical instrument | I | HMX | n/a | |

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Alcon Research, Ltd. Traditional 510(k) Premarket Notification 27+ Retina Instrument Set

#### 5.1. Predicate Devices:

The legally marketed devices(s) to which we are claiming equivalence to are:

| Predicate Date<br>510(k)<br>Cleared | Predicate Device | Predicate Instrument | Modified Instrument |
|--------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------|------------------------------|
| K093305<br>04/02/10 | Enhanced UltraVit® Probe | 25+ UltraVit®<br>Probe | 27+ UltraVit® Probe |
| K062624<br>11/05/07 | Next Generation Laser and<br>accessories (PurePoint®<br>laser) | 25+ Flex-Tip Laser<br>Probe | 27+ Flex-Tip Laser<br>Probe |
| K063583<br>05/09/08<br>K101285<br>11/12/10 | Alcon Vision System (and<br>accessories)<br>CONSTELLATION® Vision<br>System (and accessories) | 25+<br>Endoilluminator<br>Probe | 27+ Endoilluminator<br>Probe |
| n/a | n/a | 25Ga Valved<br>Entry System | 27+ Valved Entry<br>System |
| n/a | n/a | 25Ga Infusion<br>Cannula | 27+ Infusion Cannula |

#### 5.2. Device Description

The five instruments comprising the 27+ Retina Instrument Set are modified versions of approved larger gauge CONSTELLATION accessories but with smaller diameter instrument tips for less invasive surgery. All other features are exactly the same as the respective predicate devices cleared in K093305, K062624, K063583, and K101285.

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## 5.3. Indications for Use:

The 27+ Retina Instrument Set instruments, along with the CONSTELLATION Vision System or Next Generation Laser System, are intended for the following uses:

| 27+ UltraVit® Probe | Vitreous aspiration & cutting. Membrane cutting & aspiration. Remove a crystalline lens. Dissect tissues in the eye. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 27+ Flex-Tip Laser<br>Probe | Retinal photocoagulation, panretinal photocoagulation and<br>intravitreal photocoagulation of vascular and structural<br>abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including diabetic); Choroidal neovascularization secondary to age-related macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open Angle<br>Glaucoma (COAG, POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle<br>Glaucoma (COAG, POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. |
| 27+ Endoilluminator<br>Probe | Endoillumination |
| 27+ Valved Entry<br>System | Scleral incision |
| 27+ Infusion Cannula | Posterior segment infusion |

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## 5.4. Brief Summary of Nonclinical test and Results:

Biocompatibility evaluations of materials coming in contact with the patient or patient fluid path have been performed to the following standards:

| Standard # | Title |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 10993-1: 2009<br>AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 1: Evaluation and<br>testing within the Risk Management Process |
| 10993-5: 2009<br>AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro<br>Cytotoxicity |
| 10993-7: 2008<br>AAMI/ANSI/ISO | Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide<br>Sterilization Residuals |
| 10993-10:<br>2002/R:2008<br>AAMI/ANSI/BE78 | Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation<br>and Delayed-type Hypersensitivity |
| 10993-10:2009<br>EN ISO | Biological Evaluation of Medical Devices - Part 10: Tests for Irritation<br>and Delayed -type Hypersensitivity |
| 10993-11:2009<br>AAMI/ANSI/ISO | Biological Evaluation of Medical Devices -- Part 11: Tests for systemic<br>toxicity |
| 10993-12:2009<br>AAMI/ANSI/ISO | Biological Evaluation of Medical Devices --Part 12: Sample Preparation<br>and Reference.Materials |

These accessories are provided sterile and are intended for single use only. These products are EO sterilized and the process has been validated to a SAL of 106 per FDA Recognized Consensus Standard EN ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed. The 27+ Retina Instrument Set has been developed and will be manufactured in compliance with 21 CFR 820 and ISO 14971:2007. Non-clinical testing noted above has demonstrated that the functional requirements have been met and that the modified devices are equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the snakes and a base representing the staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Alcon Research, Ltd. c/o Mr. Martin Kaufman, RAC Director, Regulatory Affairs 15800 Alton Parkway Irvine, CA 92816

0CT 1 7 2011

Re: K110951

Trade/Device Name: 27+ Retina Instrument Set Regulation Number: 21 CFR 886.4150 Regulation Name: Vitreous aspiration and cutting instrument Regulatory Class: II Product Codes: HQE, HMX, HQB, MPA, NGY Dated: October 6, 2011 Received: October 7, 2011

Dear Mr. Kaufman:

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, Dr to 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. Please note: CDRH does not evaluate information related to contractly und warranties. We remind you, however, that device labeling must be truthful and not midlers]

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 madon a color incant 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

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Page 2 - Mr. Martin Kaufman, RAC

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Kesia Alexander

for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological,

and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K110951

Device Name: 27+ Retina Instrument Set

Indications for Use:

The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses:

| 27+ UltraVit Probe | Vitreous aspiration & cutting. Membrane cutting & aspiration. Lens removal. Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon<br>Constellation Vision System.) |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 27+ Flex-Tip Laser<br>Probe | Retinal photocoagulation, panretinal photocoagulation and<br>intravitreal photocoagulation of vascular and structural<br>abnormalities of the retina and choroid including: Proliferative and nonproliferative retinopathy (including<br>diabetic); Choroidal neovascularization secondary to age-related<br>macular degeneration; Retinal tears and detachments; Macular edema; Retinopathy of prematurity; Choroidal neovascularization; Leaking microaneurysms. Iridotomy/Iridectomy for treatment of Chronic/Primary Open<br>Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. Trabeculoplasty for treatment of Chronic/Primary Open Angle<br>Glaucoma (COAG,POAG) and refractory Glaucoma. And other laser treatments including: Internal sclerostomy; Lattice degeneration; Central and Branch Retinal Vein Occlusion; Suturelysis; Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser<br>systems such as the Alcon Constellation Vision System, or the<br>Alcon PurePoint Laser System.) |

Bob

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

510(k) Number K110951

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Page 2/2

| 27+ Endoilluminator<br>Probe | • Endoillumination<br>(The 27+ Endoilluminator Probe is intended to be used with the<br>Alcon Constellation Vision System) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| 27+ Valved Entry<br>System | • Scleral incision<br>• Canulae for posterior segment instrument access<br>• Venting (of valved cannulae) |
| 27+ Infusion Cannula | • Posterior segment infusion (liquid or gas) |

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rk

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

510(k) Number K110951