(90 days)
NOT FOUND
No
The device description and performance studies indicate a simple heat therapy device with no mention of AI or ML components.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including meibomian gland dysfunction (MGD)... and chalazia," which describes a therapeutic purpose.
No
The device is described as a hot disposable pack for applying localized heat therapy, not for diagnosing conditions. The performance studies measure the effects of the heat therapy, not the device's diagnostic capabilities.
No
The device description clearly states it is a physical "mask" containing an iron powder mixture that generates heat, indicating it is a hardware device, not software.
Based on the provided information, the EyeFeel™ Ophthalmic warmer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for applying localized heat therapy to the eyelids for conditions like MGD and chalazia. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a simple heat pack that generates heat through a chemical reaction. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies measure the effects of the heat therapy (tear evaporation, BUT, lipid expressibility) and the temperature changes, not the presence or absence of a disease or condition based on analyzing a biological sample.
- Predicate Devices: The predicate devices listed are also heat therapy devices (mattress and perineal warm pack), further indicating a therapeutic rather than diagnostic purpose.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The EyeFeel™ Ophthalmic warmer is a therapeutic device that applies heat externally.
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 eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
Product codes
IMD
Device Description
The EyeFeel Ophthalmic Warmer is a simple device for application of heat therapy to the eye. It is shaped as a kind of "mask" to fit over the eyes, and consists of layers of synthetic paper, which surround a "sac" containing an iron powder mixture. Oxidation of the iron powder mixture generates heat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye lids
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
Six patients with noninflamed obstructive MGD tested the EyeFeel Product. Each applied the EyeFeel for 5 minutes. Before and after the heat therapy, the investigators performed the following measurements: (1) a tear evaporation test: (2) a measurement of tear breakup time (BUT), and (3) an assessment of orifice obstruction and meibomian gland (MG) lipid expressibility.
Three patients with healthy eyes were examined, to measure the impact of heat treatment on the eyelids and cornea, and confirm the safety of the EyeFeel. The upper and lower eyelid temperature was measured before and after heat therapy using the EyeFeel with the eyes closed. The mean upper and lower eyelid temperatures increased from 34.4+/-0.25℃ to 40.0+/-0.38℃ and from 34.2+/-0.31℃ to 40.4+/-0.10℃ respectively. Corneal temperature was measured before and after heat therapy using the EyeFeel with the eyes open. The mean corneal temperature increased from 34.0+/-0.86℃ to 37.7+/-0.51℃. The temperature difference, pre and post warming, was 3.7+/-1.37℃ and 6.1+/-0.25℃.
Key Metrics
| | Prior to
Heat
Therapy | Following
Heat
Therapy | P Value |
|---------------------------------------------------|-----------------------------|------------------------------|---------|
| Tear
Evaporation
Rate (10-7g
cm-2 sec-1) | 6.6+/- 0.97 | 4.7 +/- 1.5 | 0.028 |
| BUT
(seconds) | 3.0+/- 2.1 | 11.0+/-2.7 | 0.028 |
| MG lipid
expressibility
score1 | 2.2+/-0.41 | 1.0+/-0.0 | 0.028 |
Score was based on the following scale:
Grade 0 - clear meibum easily expressed
Grade 1 cloudy meibum expressed with mild pressure
Grade 2 cloudy meibum expressed with more than moderate pressure
Grade 3 meibum cannot be expressed, even with hard pressure
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
3 2002 SEP
APPENDIX E
510(k) SUMMARY EyeFeel™ Ophthalmic Warmer Bio-Lipid, Inc.
This 510(k) summary of safety and effectiveness for the EyeFeel™ Ophthalmic Warmer is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | Bio-Lipid, Inc. |
|---|---|
| Address: | 8780 SW 92 Street |
| Suite 203 | |
| Miami, FL 33176 | |
| Contact Person: | David J. Bloch |
| Regulatory Counsel | |
| Telephone: | (202) 414-9209 (telephone) |
| (202) 414-9209 (fax) | |
| Preparation Date: | May 2002 |
| Device Trade Name: | EyeFeel™ |
| Common Name: | Ophthalmic Warmer |
| Classification Name: | Hot or Cold Disposable Pack (see 21 C.F.R. § 890.5710) |
| Product Code: | IMD |
| Predicate Devices: | Porta-Warm™ Mattress, 510(k) # K982652 |
| Kwik Heat™ Perineal Warm Pack, 510(k) # K973770 | |
| Device Description: | The EyeFeel Ophthalmic Warmer is a simple device for |
| application of heat therapy to the eye. It is shaped as a kind | |
| of "mask" to fit over the eyes, and consists of layers of | |
| synthetic paper, which surround a "sac" containing an iron | |
| powder mixture. Oxidation of the iron powder mixture | |
| generates heat. |
1
- The EveFeel™ is a hot disposable pack for the application of Intended Use: localized heat therapy in cases of chronic inflammatory and cvstic conditions of the eye lids, including meibomian gland dysfunction and chalazia.
- Performance Data: Six patients with noninflamed obstructive MGD tested the EyeFeel Product. Each applied the EyeFeel for 5 minutes. Before and after the heat therapy, the investigators performed the following measurements: (1) a tear evaporation test: (2) a measurement of tear breakup time (BUT), and (3) an assessment of orifice obstruction and meibomian gland (MG) lipid expressibility.
The results are depicted graphically below:
| | Prior to
Heat
Therapy | Following
Heat
Therapy | P Value |
|---------------------------------------------------|-----------------------------|------------------------------|---------|
| Tear
Evaporation
Rate (10-7g
cm-2 sec-1) | 6.6+/- 0.97 | 4.7 +/- 1.5 | 0.028 |
| BUT
(seconds) | 3.0+/- 2.1 | 11.0+/-2.7 | 0.028 |
| MG lipid
expressibility
score1 | 2.2+/-0.41 | 1.0+/-0.0 | 0.028 |
Three patients with healthy eyes were examined, to measure the impact of heat treatment on the eyelids and cornea, and confirm the safety of the EyeFeel. The upper and lower eyelid temperature was measured before and after heat therapy using the EyeFeel with the eyes closed. The mean upper and lower eyelid temperatures increased from 34.4+/-0.25℃ to 40.0+/-0.38℃ and from 34.2+/-0.31℃ to 40.4+/-0.10℃ respectively. Corneal temperature was measured before and after heat therapy using the EyeFeel with the
- Grade 1 cloudy meibum expressed with mild pressure
- Grade 2 cloudy meibum expressed with more than moderate pressure
- Grade 3 meibum cannot be expressed, even with hard pressure
' Score was based on the following scale:
Grade 0 - clear meibum easily expressed
2
eyes open. The mean corneal temperature increased from 34.0+/-0.86℃ to 37.7+/-0.51℃. The temperature difference,
pre and post warming, was 3.7+/-1.37℃ and 6.1+/-0.25℃.
CONCLUSIONS: Based on the foregoing and other information in this application, Bio-Lipid, Inc. believes that the EyeFeel™ is substantially equivalent to its claimed predicates under conditions of intended use.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract design featuring three stylized human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 SEP
Bio-Lipid Inc. c/o David J. Bloch Reed Smith, L.L.P. 1301 K Street, N.W. Suite 1100 Washington, DC 20005
Re: K021843
Trade/Device Name: EyeFeel Ophthalmic Warmer Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: I Product Code: IMD Dated: June 5, 2002 Received: June 5, 2002
Dear Mr. Bloch:
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
4
Page 2 - Mr. David J. Bloch
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. 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
R. Mark N-Millmann
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K021843
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 eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 801.109) OR Over-the-Counter Use _____________
for Mark A. Melkerson
(Division Sign f)
Division of General, Restorative
and Neurological Devices
510(k) Number K021848