EYEFEEL OPHTHALMIC WARMER

K082087 · Bio-Lipid, Inc. · IMD · Sep 11, 2008 · Physical Medicine

Device Facts

• Record ID: K082087
• Device Name: EYEFEEL OPHTHALMIC WARMER
• Applicant: Bio-Lipid, Inc.
• Product Code: IMD · Physical Medicine
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.

Device Story

Disposable hot pack for localized heat therapy to eyelids. Device consists of front layer, two oval sacks containing iron powder mixture, and back inner layer for facial contact. Iron powder mixture (iron powder, sodium chloride, water, activated carbon, sodium polyacrylate, vermiculite) generates heat. Used by patients to treat MGD, chalazia, and accommodative fatigue from screen use. No electronic components or active processing.

Clinical Evidence

Small clinical study conducted to assess effect of EyeFeel Warmer on periocular accommodation fatigue and visual acuity following prolonged work on visual display terminals. Results support expanded indications for use.

Technological Characteristics

Disposable hot pack. Materials: iron powder, sodium chloride, filtrated water, powdered/granular activated carbon, sodium polyacrylate powder, exfoliated vermiculite. Form factor: front layer, two oval sacks, back inner layer. Heat generation via exothermic oxidation of iron powder. No software or electronic components.

Indications for Use

Indicated for patients with chronic inflammatory and cystic eyelid conditions, including meibomian gland dysfunction (MGD/evaporative dry eye/lipid deficiency dry eye) and chalazia. Also indicated for relief of accommodative fatigue and recovery of baseline visual acuity following prolonged visual display terminal use.

Regulatory Classification

Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Predicate Devices

• EyeFeel Ophthalmic Warmer (K021834)

Submission Summary (Full Text)

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K082087

SEP 1 1 2008

#### 510(k) SUMMARY

#### Bio-Lipid EyeFeel Ophthalmic Warmer

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

Bio-Lipid, Inc. 7000 SW 97th Avenue Suite 212 Miami, FL 33173 Phone: [phone] Facsimile: 305-412-4429

Contact Person: Dr. Scheffer Tseng

Date Prepared: July 15, 2008

#### Name of Device and Name/Address of Sponsor

EyeFeel Ophthalmic Warmer

Bio-Lipid, Inc. 7000 SW 97th Avenue Suite 212 Miami, FL 33173

## Common or Usual Name

Hot or Cold Disposable Pack

#### Classification Name

21 C.F.R. § 890.5710 (Hot or Cold Disposable Pack)

#### Predicate Devices

EyeFeel Ophthalmic Warmer Bio-Lipid, Inc. K021834

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## Intended Use / Indications for Use

The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.

#### Technological Characteristics

The EyeFeel Warmer consists of a front layer, two oval shaped sacks that hold the iron powder mixture, and a back inner layer that is placed on the face. The iron powder mixture consists of iron powder, sodium chloride, filtrated water, powdered activated carbon, granular activated carbon, sodium polyacrylate powder, and exfoliated vermiculite.

#### Performance Data

A small clinical study was conducted to assess the effect of the EyeFeel Warmer on periocular accommodation fatigue and visual acuity after prolonged work on visual display terminals. The results of the study support the expanded indications of the EyeFeel Warmer.

## Substantial Equivalence

The EyeFeel Warmer that is subject of this premarket notification is identical to the predicate EyeFeel Warmer that was cleared under K021834 with the exception of the indications for use. Both the proposed and predicate EyeFeel Warmer devices have the same intended use and same technological characteristics. Therefore the proposed EyeFeel Warmer is substantially equivalent to its predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio-Lipid, Inc c/o Pamela Furman King & Spalding, LLP 1700 Pennsylvania Ave., NW Washington, DC 20006

Re: K082087

Trade/Device Name: EyeFeel Ophthalmic Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: IMD Dated: July 23, 2008 Received: July 23, 2008

Dear Ms. Furman:

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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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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egorlums, mD

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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# Indications for Use

510(k) Number (if known): _K082087

Device Name: EyeFeel Ophthalmic Warmer

Indications for Use:

The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.

The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.

## JIDENTIFY WHETHER THE DEVICE IS INTENDED FOR PRESCRIPTION USE AND/OR OVER-THE-COUNTER USE.]

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Miz-Ouren Shul

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K082085

510(k) Number K 082087

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