EYEFEEL OPHTHALMIC WARMER by BIO-LIPID, INC.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EyeFeel™ Ophthalmic Warmer, based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet. Instead, it presents performance data from a study and concludes that the device is "substantially equivalent to its claimed predicates under conditions of intended use." The P values for the clinical outcomes (0.028) suggest statistical significance, implying the observed improvements are unlikely due to chance.

However, we can infer the "acceptance criteria" were implied by the chosen clinical endpoints and the statistically significant improvement shown in these metrics.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Metric	Inferred Acceptance Criteria (e.g., significant improvement)	Reported Device Performance (Mean +/- SD)	P-Value
Tear Evaporation Rate (10-7g cm-2 sec-1)	Significant decrease in rate	Prior: 6.6 +/- 0.97 Following: 4.7 +/- 1.5	0.028
BUT (seconds)	Significant increase in time	Prior: 3.0 +/- 2.1 Following: 11.0 +/- 2.7	0.028
MG Lipid Expressibility Score	Significant decrease in score (indicating improvement)	Prior: 2.2 +/- 0.41 Following: 1.0 +/- 0.0	0.028
Eyelid Temperature Increase	Safe and effective temperature increase for therapeutic effect	Upper Eyelid: 34.4 to 40.0 °C (Δ 5.6 °C Avg.) Lower Eyelid: 34.2 to 40.4 °C (Δ 6.2 °C Avg.)	N/A
Corneal Temperature Increase	Safe temperature increase (not exceeding harmful levels)	34.0 to 37.7 °C (Δ 3.7 °C Avg.)	N/A

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Six patients with non-inflamed obstructive MGD for efficacy testing. Three patients with healthy eyes for safety testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the language "Six patients... tested the EyeFeel Product" suggests a prospective clinical observation or trial.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for the test set. The measurements (tear evaporation, BUT, MG lipid expressibility) are objective clinical assessments. The MG lipid expressibility score, while potentially involving a subjective grading, is based on a defined scale (Grade 0-3). It does not specify who performed these assessments or their qualifications.
Adjudication Method for the Test Set:
- Not applicable/Not mentioned. The study involved objective measurements and a subjective scoring system without an explicit mention of adjudication by multiple parties for the test set.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focuses on the device's direct impact on physiological parameters and clinical scores, not on human reader performance with or without AI assistance.
Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Not applicable. The EyeFeel™ Ophthalmic Warmer is a physical device, not an algorithm or AI product. The study evaluates the device's direct therapeutic effect.
Type of Ground Truth Used:
- The "ground truth" for the efficacy study was established through objective physiological measurements (tear evaporation rate, tear breakup time) and a clinical scoring system (meibomian gland lipid expressibility score) assessed by investigators. For the safety study, it involved direct temperature measurements of the eyelids and cornea.
Sample Size for the Training Set:
- Not applicable. The EyeFeel™ Ophthalmic Warmer is not an AI/ML algorithm requiring a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.

Summary

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3 2002 SEP

K021843

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 StreetSuite 203Miami, FL 33176
Contact Person:	David J. BlochRegulatory 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) # K982652Kwik Heat™ Perineal Warm Pack, 510(k) # K973770
Device Description:	The EyeFeel Ophthalmic Warmer is a simple device forapplication of heat therapy to the eye. It is shaped as a kindof "mask" to fit over the eyes, and consists of layers ofsynthetic paper, which surround a "sac" containing an ironpowder mixture. Oxidation of the iron powder mixturegenerates heat.

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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 toHeatTherapy	FollowingHeatTherapy	P Value
TearEvaporationRate (10-7gcm-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 lipidexpressibilityscore1	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

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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.

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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

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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

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510(k) Number: K021843

Device Name: EyeFeel™ Ophthalmic Warmer

INDICATIONS FOR USE:

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

Regulation Number and Section

§ 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.