MASTEL 1 FOLDER IMPLANTATION SYSTEM

K022723 · Mastel Precision, Inc. · KYB · Dec 26, 2002 · Ophthalmic

Device Facts

• Record ID: K022723
• Device Name: MASTEL 1 FOLDER IMPLANTATION SYSTEM
• Applicant: Mastel Precision, Inc.
• Product Code: KYB · Ophthalmic
• Decision Date: Dec 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

Device Story

Mastel 1 Folder Implantation System is a reusable ophthalmic surgical device designed to fold and assist in the insertion of the SENSAR model AR40e intraocular lens (IOL) into the capsular bag. The system consists of a medical-grade titanium handpiece that accepts a single-use cartridge. During surgery, the IOL is loaded into the cartridge; the handpiece mechanism then pushes the lens through the cartridge to deliver it into the eye. The device is intended for use by ophthalmic surgeons in a clinical setting. The handpiece is reusable and compatible with standard in-office steam autoclaving. By facilitating controlled lens delivery, the device assists the surgeon in IOL implantation, potentially improving surgical efficiency and lens placement accuracy.

Clinical Evidence

Bench testing only. In vitro performance testing evaluated 130 SENSAR model AR40e IOLs (6.0 D to 23.0 D) delivered via the Mastel 1 Folder. Endpoints included diopter, astigmatism, resolution, visual acuity, overall diameter, loop angles, and sagitta. Results confirmed acceptable performance for all tested lenses.

Technological Characteristics

Medical-grade titanium handpiece; reusable; non-sterile; compatible with steam autoclaving. Mechanical delivery system using a plunger mechanism to express IOLs through a single-use cartridge. No patient-contacting components on the handpiece itself.

Indications for Use

Indicated for folding and inserting the SENSAR model AR40e intraocular lens into the capsular bag during ophthalmic surgery.

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

• AMO PhacoFlex II Insertion System (K961242)
• Monarch II IOL Delivery System (K001157)

Submission Summary (Full Text)

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# DEC 2 6 2002

# SECTION 11

### 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.

### 1. Submitter's name, address, telephone number, contact person, and date summary prepared;

- a. Applicant: Mastel Precision, Inc. 2843 Samco Road, Suite A Rapid City, SD 57702 [phone]
- Maureen Weiner b. Contact Person: Regulatory Consultant to Mastel Precision, Inc. 53 Barcelona Irvine, CA 92614 [phone]

Maureen Weiner

c. Date Summary Prepared: December 17, 2002

#### 2. Name of device, including trade name and classification name:

- Trade/Proprietary Name: Mastel 1 Folder™ Implantation System a.
- b. Classification Name: Intraocular Lens Guide

### 3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:

| Company: | Allergan, Inc. |
|---------------|-----------------------------------|
| Device: | AMO PhacoFlex II Insertion System |
| 510(k): | K961242 |
| Date Cleared: | June 17, 1996 |

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| Company: | Alcon Research, Ltd. |
|---------------|--------------------------------|
| Device: | Monarch II IOL Delivery System |
| 510(k): | K001157 |
| Date Cleared: | June 27, 2000 |

### 4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The Mastel 1 Folder is an ophthalmic surgical device designed for use in inserting a foldable intraocular lens into the eye. The materials, basic scientific concepts, physical properties and intended use of the Mastel 1 Folder are similar to those of the predicate devices.

The Mastel 1 Folder Implantation System is comprised of a medical-grade titanium handpiece, a material commonly used in reusable surgical devices. The handpiece rod is designed to accept a single-use cartridge. The handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The handpiece is provided to the customer in a plastic case in a non-sterile state.

#### న. Statement of intended use:

The Mastel 1 Folder™ Insertion System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

### 5. Statement of how the technological characteristics of the device compare to those of the predicate or legally marketed device.

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| CHARACTERISTICS | | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | Mastel Precision<br>Mastel 1 Folder | Allergan<br>AMO PhacoFlex II | Alcon<br>Monarch II IOL |
| | Implantation System | Insertion System | Delivery System |
| Indication for use | To fold and assist in inserting<br>the SENSAR, model AR40e<br>intraocular lens, ONLY into the<br>capsular bag | To fold and assist in inserting<br>the AMO PhacoFlex II (SLM-<br>2/UV) family of intraocular<br>lenses, specifically the SI-<br>30NB and SI-40NB, into the<br>eye | To fold and deliver Alcon<br>ACRYSOF intraocular lenses<br>into the eye for replacement of<br>the human crystalline lens |
| Operating Principle | The handpiece delivers the<br>loaded IOL into the eye | IOL is loaded into the cartridge<br>and the IOL is pushed through<br>the cartridge and delivered into<br>the eye | The handpiece accepts the<br>cartridge (loaded with the IOL)<br>and delivers the IOL by using a<br>plunger to express the lens into<br>the eye |
| Patient Contact Portion of<br>Device | No patient contact | Cartridge contacts eye,<br>cartridge material is<br>polypropylene | Cartridge contacts eye,<br>cartridge material is<br>polypropylene |
| Handpiece Material | Titanium | Titanium | Titanium |
| Reusable/Disposable | Reusable | Reusable | Reusable |
| Handpiece Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile |

T

Comparison of Devices for Substantial Equivalence

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#### 7. Brief summary of nonclinical tests and results:

In vitro performance testing was conducted on the Mastel 1 Folder Insertion System. The intraocular lenses (IOLs) were delivered using the Mastel 1 Folder handpiece and then evaluated for diopter, astigmatism, resolution, visual acuity, overall diameter, loop angles, and sagitta. The results revealed that all Mastel 1 Folders provided acceptable results when delivering 130 intraocular lenses, ranging from 6.0 D to 23.0 D.

Based on the performance testing, Mastel Precision concludes that this system is a safe and effective device for folding and assisting in inserting the SENSAR™, model AR40e intraocular lens into the eye.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its wing and body. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mastel Precision Inc. c/o Maureen Weiner Regulatory Affairs Consultant 53 Barcelona Irvine, CA 92614

### Re: K022723

Trade/Device Name: Mastel 1 Folder™ Implantation System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular lens guide Regulatory Class: Class I Product Code: KYB Dated: December 17, 2002 Received: December 18, 2002

Dear Ms. Weiner:

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 - Ms. Maureen Weiner

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/cdrlv/dsma/dsmamain.html

Sincerely yours,

A. Ralph 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

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Mastel Precision. Inc. Mastel 1 Folder™

· K022723 Confidential

Page 1 of 1

# 510(k) Number (if known): K022723

Device Name: Mastel 1 Folder™ Implantation System

Indications for Use:

.

The Mastel 1 Folder™ Implantation System is intended to fold and assist in inserting the SENSAR™, model AR40e intraocular lens, ONLY into the capsular bag.

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K022723 |
|---------------|---------|
|---------------|---------|

| Prescription Use | | OR | Over-The-Counter Use |
|----------------------|--|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |