VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430

K101134 · Medicel AG · MSS · Aug 9, 2010 · Ophthalmic

Device Facts

• Record ID: K101134
• Device Name: VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
• Applicant: Medicel AG
• Product Code: MSS · Ophthalmic
• Decision Date: Aug 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

Device Story

The Visian® nanoPOINT™ 2.0 Injector System is a sterile, single-use manual surgical instrument used by ophthalmologists to deliver phakic intraocular lenses (IOLs) into the human eye. The system consists of a syringe-type injector, a silicone cushion tip plunger, a 33-degree bevel-down cartridge tip, and a loading block. In operation, the surgeon loads the IOL into the cartridge; the device then folds the lens and pushes it through a 2.2 mm corneal incision into the eye. This mechanical delivery system facilitates minimally invasive IOL implantation, reducing the need for larger incisions and potentially improving surgical outcomes and patient recovery. The device is used in a clinical or surgical setting.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through non-clinical bench testing, including biocompatibility, mechanical safety, and shelf-life validation, which were identical to the previously cleared predicate device.

Technological Characteristics

Manual syringe-type injector; materials include ABS, Polydimethilsiloxane (silicone), and Polypropylene with GMS additive. Features a 33-degree bevel-down cartridge tip and loading block. Sterile (EO). Single-use. No software or electronic components.

Indications for Use

Indicated for the folding and insertion of STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses (Model Visian® ICL) into the human eye during surgical procedures.

Regulatory Classification

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Predicate Devices

• Naviject Sub2-1P Injector Set (K092023)

Reference Devices

• K070669 (IOL injector set)

Submission Summary (Full Text)

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Medicel AG

# Visian® nanoPOINT™ 2.0 Injector System

KIO1134

## 510(k) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR & 807.92.

### Submitter Information:

Medicel AG Contact: Volker Dockhorn Chief Operating Officer Luchten 1262 Wolfhaden CH 9427 Switzerland Phone: [phone] Fax: [phone]

FDA Registration Number: 9681862

Medicel AG Contact: John Coggan (Official Correspondent) STAAR Surgical 1911 Walker Ave Monrovia, CA 91016 USA

Date Summary Prepared:

Submission Correspondent:

Classification Name:

Common/Usual Name:

April 5, 2010

Folders and Injectors, Intraocular Lens (IOL) (Class I) - MSS 21 CFR 886.4300

Intraocular Lens Guide

Device Trade Name:

Visian® nanoPOINT™ 2.0 Injector System

Equivalent legally-marketed devices: K092023, IOL Intraocular Injector Set,

Medicel AG (Naviject Sub2-1P Injector Set)

#### 1. Intended Use:

The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eve.

2. Description:

## AUG - 9 2010

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The Visian® nanoPOINT™2.0 Injector System is a sterile, single-use device intended to fold and insert a STAAR Surgical Collamer® Phakic One Piece Intraocular Leas. Model Visian® ICL through surgical procedure in a human eye. The system provides, a tubular pathway through a corneal incision allowing delivery of a phakic IOL into the human eye.

## 3. Technological Characteristics:

nanoPOINT™ 2.0 Injector System has substantially equivalent The Visian® technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material. There are no differences in any of the technological characteristics of this device as compared to the cleared predicate device and therefore the safety and effectiveness of this device are not compromised.

#### 4. Comparison Analysis:

The overall design of this Visian® nanoPOINT™ 2.0 Injector System is the same as the predicate device since it is the same injector. The indications for use and labeling were modified to clearly specify the lens model for which it is intended.

Performance Data

- Non Clinical Tests: All materials have been tested for biocompatibility. These (1) tests were performed in the previously cleared device, the K070669 injector set, which was substantially equivalent to K092023 and therefore equivalent to the newly submitted 510(k) device. These tests were all acceptable.
The validation (non-clinical) tests for the previously cleared K092023. Naviject Sub2-1P IOL Injector Set, are the same for this newly submitted device, the Visian® nanoPOINT™ 2.0 Injector System, since it is the anne injector and it is intended for the folding and insertion of the same lens. See Table 1 for a comparison of the new and the previous K092023, Naviject Sub2-1P IOL Injector Set.

Shelf Life for the previously submitted devices was set at three years based on tests performed on equivalent injectors. This new device will have the same shelf life. .

- 2) Clinical Tests: (Not required)
- 3) Conclusions: In conclusion the newly submitted device is as safe, as effective and performs as safely and effectively as the legally marketed device as it is

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the same device and there were no changes to the technological characteristics of the device.

| Feature | Visian® nanoPOINTTM 2.0 Injector<br>System | K092023 | Substantially<br>Equivalent |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Product<br>Description | This Injector and Cartridge System is<br>a sterile, single-use device intended<br>to fold and insert a STAAR Surgical<br>Collamer® phakic one piece<br>intraocular lens, Model Visian® ICL<br>through surgical procedure in a<br>human eye. The system provides a<br>tubular pathway through a corneal<br>incision allowing delivery of a phakic<br>IOL into the human eye. | Identical | Yes |
| Intended Use | The Visian® nanoPOINTTM 2.0<br>Injector System is a device intended<br>to fold and insert a STAAR Surgical<br>Collamer® phakic one piece<br>intraocular lens, Model Visian® ICL,<br>for surgical placement in the human<br>eye. | The Naviject SUB2-1P IOL<br>Injector and Cartridge Set for<br>intraocular lenses is indicated<br>for the insertion only of models<br>of intraocular lenses that allow<br>use of this injector in their<br>approved labeling. | Yes, the only<br>difference is in<br>the inclusion of<br>the specific lens<br>name for which<br>it is intended |
| Design | This device has 3 basic components: a<br>syringe type injector with a silicone<br>cushion tip plunger, a 33º bevel down<br>cartridge tip and a loading block. | Identical | Yes |
| Materials | Plastic materials: ABS,<br>Polydimethilsiloxane (Silicone) and<br>Polypropylene with GMS additive | Identical | Yes |
| Mechanical<br>Safety | Validated for STAAR Surgical<br>Collamer® Phakic One Piece<br>Intraocular Lenses, Model Visian®<br>ICL (V08-138) | Identical | Yes |
| Manufacturing | Per internal operating procedures | Identical | Yes |
| Operating<br>Principle | A phakic IOL is loaded into the<br>cartridge, then pushed through the<br>cartridge and delivered into a human<br>eye through a 2.2 mm surgical<br>incision. | Identical | Yes |
| Packaging | Blister trays with pre-printed labeling<br>on Tyvek material lids and boxes | Blister trays with labeled<br>Tyvek material lids and labeled<br>boxes | Yes |
| Biocompatibility | Injector materials are the same as the<br>previously cleared K070669 IOL<br>injector. Biocompatibility tests for<br>that injector were acceptable. | Biocompatibility for<br>K092023, substantially<br>equivalent to K070669, shall<br>be identical to the newly<br>submitted device | Yes |
| Shelf Life | Three years | Identical | Yes |
| Sterility | Sterile (EO) | Identical | Yes |
| Manufacturer | Medicel AG | Medicel AG | Yes |

Table 1: Summary of Design Comparison

:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

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

Medicel AG c/o Mr. John Coggan Director of Regulatory Affairs STAAR Surgical Company 1911 Walker Avenue Monrovia, CA 91016

AUG - S 2010

Re: K101134

Trade/Device Name: Visian® nanoPOINT™ 2.0 Injector System Regulation Number: 21 CFR 886.4300 Regulation Name: Folders and Injectors, Intraocular Lenses Regulatory Class: Class I (reserve) Product Code: MSS Dated: July 14, 2010 Received: July 16, 2010

Dear Mr. Coggan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); 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/ReportalProblem/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

Image /page/4/Picture/7 description: The image shows a portion of a document with some text and a signature. The text includes the words "Malv", "Dire", "Divi", and "Office". To the left of the text is a handwritten signature, which appears to be in cursive. The document seems to be an official or formal paper, possibly related to a business or organization.

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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Visian® nanoPOINT™ 2.0 Injector System

Medicel AG

Indications for Use Statement

AUG - 9 2010

510(k) Number (if known): ___K 101134

Device Name: Visian® nanoPOINT™2.0 Injector System

The Visian® nanoPOINT™ 2.0 Injector System is a device intended to fold and insert STAAR Surgical Collamer® Phakic One Piece Intraocular Lenses, Model Visian® ICL, for surgical placement in the human eye.

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)

Signature

Page I of I

Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K101134