(50 days)
Not Found
No
The device description and intended use focus on a passive heat therapy mechanism using a chemical reaction, with no mention of AI or ML components or functions.
Yes
The device is intended for "localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids" and states it "may relieve accommodative fatigue and may help recover baseline visual acuity levels," which are therapeutic applications.
No.
The device is described as an ophthalmic warmer for applying localized heat therapy to treat chronic inflammatory and cystic conditions of the eyelids, meibomian gland dysfunction, and chalazia, and to relieve accommodative fatigue and help recover visual acuity. Its function is therapeutic, not diagnostic.
No
The device description clearly states it is a disposable pack containing an iron powder mixture, which is a physical, hardware component.
Based on the provided information, the EyeFeel ophthalmic warmer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the application of localized heat therapy to the eyelids for conditions like MGD and chalazia, and for relieving accommodative fatigue. This is a therapeutic application directly on the body.
- Device Description: The device is a hot pack containing a chemical mixture that generates heat. It is applied externally to the eyelids.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The EyeFeel warmer does not interact with or analyze any bodily specimens.
Therefore, the EyeFeel ophthalmic warmer falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
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.
Product codes
IMD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyelids, periocular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5710 Hot or cold disposable pack.
(a)
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.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
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: 305-412-4430 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
1
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.
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
4
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) |
|---|
| -------------------------------------------------------- |
Miz-Ouren Shul
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
K082085
510(k) Number K 082087
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