FAMILY OF DISPOSABLE LENSES

K140368 · Sensor Medical Technology, LLC · HKS · Apr 29, 2014 · Ophthalmic

Device Facts

• Record ID: K140368
• Device Name: FAMILY OF DISPOSABLE LENSES
• Applicant: Sensor Medical Technology, LLC
• Product Code: HKS · Ophthalmic
• Decision Date: Apr 29, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.

Device Story

Family of 14 diagnostic/therapeutic contact lenses; includes mirror, iridotomy, capsulotomy, and retina lenses (various diopters). Used with slit lamp to provide binocular, stereoscopic visualization of ocular anatomy. Operated by clinicians in clinical settings. Provided sterile for single use. Enables eye examination and laser therapy of intraocular abnormalities; improves visualization for clinical decision-making.

Clinical Evidence

Bench testing only. Sterilization validation performed per protocol; shelf-life testing confirmed 24-month stability.

Technological Characteristics

Goldmann-style contact lens design; optical elements for ocular visualization. Provided sterile for single use. No electronic components or software.

Indications for Use

Indicated for diagnostic examination of the eye fundus, retina, iridocorneal, and vitreous bodies, and for laser therapy of intraocular abnormalities in patients requiring ophthalmic evaluation.

Regulatory Classification

Identification

A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

Predicate Devices

• Sensor Family of Ophthalmic Lenses (K102371)

Submission Summary (Full Text)

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#### 510(k) SUMMARY

# APR 2 9 2014

## Sensor Medical Technology LLC Family of Disposable Lenses

#### 510(k) Owner

Sensor Medical Technology LLC 23175 224th Place SE Maple Valley, WA 98038 [phone] Phone: Contact Person: Louise Culham, Ph.D.

### Submission Correspondent

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: [phone] Facsimile: [phone]

Date Prepared: February 11, 2014

#### Trade Name of Device

Sensor Medical Technology Family of Disposable Lenses

#### Common or Usual Name

Gonioscopic Prisms and Diagnostic Condensing Lens

#### Classification Name and Regulation

Gonioscopic Prisms 21 CFR 886.1660, HKS Ophthalmic Panel

Diagnostic Condensing Lens 21 CFR 886.1380, HJL Ophthalmic Panel

#### Predicate Devices

Sensor Family of Ophthalmic Lenses (K102371)

#### Device Description

The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses

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- 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D.
The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye.

The lenses are provided sterile for single use.

#### Intended Use / Indications for Use

The Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.

#### Substantial Equivalence

Sensor Medical Technology LLC believes that the Family of Disposable Lenses described in this notification and for use under the conditions of proposed labeling is substantially equivalent to the Sensor LLC Family of Ophthalmic Lenses found to be 510(k) Exempt in K102371. The Family of Disposable Lenses has the same indications for use and similar intended use, similar principles of operation, and similar technological characteristics as the prior version of this product that was found to be 510(k) Exempt. The major difference between the prior version of the product and the version presented in this 510(k) is that the Family of Ophthalmic Lenses described in K102371 were reusable while the lenses described here are provided sterile for single use. Sterility and shelf life testing is provided to demonstrate that the product is as safe and effective as the predicate device and is therefore, substantially equivalent.

#### Performance Data

Sterilization validation testing was performed which showed that the Family of Disposable Lenses met the sterilization requirements specified in the sterilization validation protocol. Shelf life testing was performed which confirmed a 24 month shelf life.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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April 29. 2014

Food and Drug Administration 118903 New Hampshire Avenue Document Control Center . WObliat 2009 Silver Spring, MID 20993-0002

Sensor Medical Technology, LLC % Ms. Maureen O`Connell Regulatory Consultant O'Connell Regulatory Consultants, Inc. 5 Timber Lanc North Reading. MA 01864

Re: K140368

Trade/Device Name: Sensor Medical Technology LLC Family of Disposable Lenses Regulation Number: 21 CFR 886,1660 Regulation Name: Gonioscopic Prisms Regulatory Class: Class I Product Code: HKS Dated: March 4. 2014 Received: March 5, 2014

Dear Ms. O'Connell.

We have reviewed vour 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. Iisting of devices. good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRI 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 111 (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 FIDA'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.

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Page 2 - Ms. Maureen O'Connell

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 (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Deborah L. Falls -S

for 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K140368

Device Name Sensor Medical Technology Family of Disposable Lenses

#### Indications for Use (Describe)

The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses I he school weather Formores) : annovely, retina and irido-comeal and vitreous bodies and for the laser therapy of intraocular abnormalities.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## Please do not write below this line – continue on a separate page if needed.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Leonid Livshitz -S 2014.04.25 14:21:08 -04'00'

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