(198 days)
Not Found
No
The device description and performance studies focus on measuring tear fluid impedance and converting it to osmolarity using a calculation. There is no mention of AI/ML algorithms for analysis or interpretation.
No.
The device is intended to measure tear osmolarity to aid in the diagnosis of dry eye disease, not to treat it.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease." This directly indicates its role as a diagnostic device.
No
The device description explicitly lists multiple hardware components including a Reader, Pens, Electronic Check Cards, and Test Cards, which are integral to the device's function of collecting and measuring tear fluid impedance.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation." This clearly indicates a diagnostic purpose.
- Device Description: The device measures a biological sample (human tears) to provide a numerical value (osmolarity) that is used in the diagnostic process.
- Specimen Type: The device uses human tears, which is a biological specimen.
- Measurement: It measures a specific characteristic of the tears (osmolarity).
- Diagnostic Aid: The results are used to "aid in the diagnosis" of a specific condition (dry eye disease).
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Product codes (comma separated list FDA assigned to the subject device)
OND, JJX
Device Description
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the cliagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The device consists of the following components and accessories: One Tearl.ab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Sinqle Use TearLab Osmolarity Test Cards, and TearLab Control Solutions.
The TearLab Osmolarity Test Card, in conjunction with the TearLab Osmolarity System, provides a quick and simple method for determining tear osmolarity using nanoliter (nL) volumes of tear fluid collected directly from the eyelid margin.
To perform a test, a new Test Card containing a microfluidic capillary channel is attached onto the Pen. The tip of the Test Card is touched to the inferior tear meniscus located above the lower eyelid and collects 40-50 nanoliters of tear fluid by passive capillary action.
After a successful collection, the Pen in conjunction with the electrodes embedded on the Test Card, measures and stores the tear fluid impedance. The Pen is then docked to the Reader.
The Reader downloads impedance data from the Pen in order to calculate and display the final osmolarity as a numerical value displayed in units of mOsms/L.
The TearLab Osmolarity System simplifies the tear collection process by reducing the required specimen volume to nanoliters, eliminating the need to transfer tear fluid and reducing the risk of evaporation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human tears, eyelid margin
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)
Precision Studies:
-
Single Instrument Precision:
- Contrived tear specimens across 275–400 mOsms/L were used.
- Samples analyzed over 20 consecutive days.
- Results: Low (Average Osmolarity 280 mOsms/L, Total CV% 1.87%), Normal (Average Osmolarity 294 mOsms/L, Total CV% 2.47%), Moderate (Average Osmolarity 316 mOsms/L, Total CV% 2.08%), High (Average Osmolarity 345 mOsms/L, Total CV% 2.33%).
-
Between Instrument Precision:
- One site, five instruments.
- Results: Normal (Mean Osmolarity 296, Total CV% 1.64%), Moderate (Mean Osmolarity 316, Total CV% 1.68%).
-
Lot-to-Lot Precision:
- One site, three lots.
- Results: Low (Mean Osmolarity 277, Total CV% 1.39%), Normal (Mean Osmolarity 294, Total CV% 1.65%), Moderate (Mean Osmolarity 304, Total CV% 2.15%), High (Mean Osmolarity 329, Total CV% 2.28%).
-
Between Site Precision:
- Three sites, three instruments & four lots.
- Results: Low (Average Osmolarity 278, Total CV% 1.59%), Normal (Average Osmolarity 289, Total CV% 2.09%), Moderate (Average Osmolarity 308, Total CV% 2.05%), High (Average Osmolarity 336, Total CV% 2.61%).
Internal Method Comparison:
- Seven levels of contrived tear solution measured on predicate Wescor 5520 Vapro® Osmometer and TearLab Osmolarity System.
- Deming regression: y = 0.9146x + 23.061, Concordance coefficient = 0.9588. R-squared value of 0.9443.
External Method Comparison:
- Three physician office sites, forty contrived tear specimens across seven levels.
- Regression equation: y = 0.9402x + 12.512, R-squared value of 0.9515.
Performance on patients with objective signs of dry eye:
- Multicenter study with 140 subjects (n = 45 Normal, n = 95 Dry Eye).
- Diagnostic Performance for Dry Eye Disease (using ≤ 316 mOsms/L as cutoff):
- Specificity: 71%
- Sensitivity: 64%
- NPV: 48%
- PPV: 82%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Calibration Data (based on meta-analysis from older osmolarity devices, referent 316 mOsms/L seems to be used):
- Sensitivity: 69%
- Specificity: 92%
- Accuracy: 82%
- NPV: 80% (for ≤ 316)
- PPV: 87% (for > 316)
Performance on patients with objective signs of dry eye (using selection criteria and ≤ 316 mOsms/L cutoff):
- Specificity: 71%
- Sensitivity: 64%
- NPV: 48% (for ≤ 316)
- PPV: 82% (for > 316)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Wescor, Inc., 5520 Vapro® Vapor Pressure Osmometer (Class 1, Exempt), Alcon Laboratories, Inc., Schirmer Tear Test (Class I, Exempt), Touch Scientific, Inc., Touch Tear IgE Microassay Kit (Class II, K991316), Dia-Screen Corp., Diascreen Reagent Strips (Class I, Non-exempt, K971976)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1540 Osmolality test system.
(a)
Identification. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Section VI
OcuSense, Inc., TearLab Osmolarity System
1 4 2009
510(k) Summary Intended Use & Indications for Use
OcuSense, Inc. 12707 High Bluff Drive, Suite 200 San Diego, CA 92130
Phone: (858) 794-1422 Facsimile: (858) 794-1493 Contact Person: Michael Berg, VP Clinical & Regulatory Operations Date Prepared: May 5, 2009
Name of Device: TearLab™ Osmolarity System
Name/Address of Sponsor: OcuSense, Inc., 12707 High Bluff Drive, Suite 200, San Diego, CA 92130
Common or Usual Name: Osmometer
Classification Name: Osmometer for Clinical Use
Predicate Devices:
-
Wescor, Inc., 5520 Vapro® Vapor Pressure Osmometer (Class 1, Exempt)
-
Alcon Laboratories, Inc., Schirmer Tear Test (Class I, Exempt)
-
- Touch Scientific, Inc., Touch Tear IgE Microassay Kit (Class II, K991316)
-
- Dia-Screen Corp., Diascreen Reagent Strips (Class I, Non-exempt, K971976)
Intended Use & Indications for Use:
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Image /page/0/Picture/18 description: The image shows the word "OcuSense" in a stylized font. The word is slightly curved upwards, with a line underneath the left and right sides of the word. The font appears to be a serif font, and the letters are all connected.
Tear Testing Made Simple™
1
Section VI 510(k) Summary Technological Characteristics
Device Description
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the cliagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation. The device consists of the following components and accessories: One Tearl.ab Reader, Two TearLab Pens, Two TearLab Electronic Check Cards, Sinqle Use TearLab Osmolarity Test Cards, and TearLab Control Solutions.
The TearLab Osmolarity Test Card, in conjunction with the TearLab Osmolarity System, provides a quick and simple method for determining tear osmolarity using nanoliter (nL) volumes of tear fluid collected directly from the eyelid margin.
To perform a test, a new Test Card containing a microfluidic capillary channel is attached onto the Pen. The tip of the Test Card is touched to the inferior tear meniscus located above the lower eyelid and collects 40-50 nanoliters of tear fluid by passive capillary action.
After a successful collection, the Pen in conjunction with the electrodes embedded on the Test Card, measures and stores the tear fluid impedance. The Pen is then docked to the Reader.
The Reader downloads impedance data from the Pen in order to calculate and display the final osmolarity as a numerical value displayed in units of mOsms/L.
The TearLab Osmolarity System simplifies the tear collection process by reducing the required specimen volume to nanoliters, eliminating the need to transfer tear fluid and reducing the risk of evaporation.
Principles of the Procedure
The TearLab Osmolarity test utilizes an electrical impedance measurement to provide an indirect assessment of osmolarity. After applying a lot-specific calibration curve, osmolarity is calculated and displayed as a quantitative numerical value
2
Precision Studies
Contrived tear specimens distributed across the clinical range of interest', 275– 400 mOsms/L, were used for performance testing (see Section XIX, Rationale for Use of Contrived Tears during Performance Testing).
1. Single Instrument Precision
Precisions calculated as defined in CLS/EPS-A2, Evaluation of Precision Performance of Quantitative Measurement Methods. Tear samples were analyzed over 20 consecutive days
| Sample | Average
Osmolarity
(mOsms/L) | Within Run
(SD) | Within Run
(CV%) | Total
(SD) | Total
(CV%) |
|----------|------------------------------------|--------------------|---------------------|---------------|----------------|
| Low | 280 | 3.8 | 1.34% | 5.2 | 1.87% |
| Normal | 294 | 5.5 | 1.85% | 7.3 | 2.47% |
| Moderate | 316 | 4.5 | 1.41% | 6.6 | 2.08% |
| High | 345 | 4.5 | 1.30% | 8.0 | 2.33% |
2. Between Instrument Precision
One site, five instruments
| Sample | Mean
Osmolarity | Total
(SD) | Total
(CV%) |
|----------|--------------------|---------------|----------------|
| Normal | 296 | 4.9 | 1.64% |
| Moderate | 316 | 5.3 | 1.68% |
3. Lot-to-Lot Precision
One site, three lots
| Sample | Lot 1 | Lot 2 | Lot 3 | Mean
Osmolarity | Total
(SD) | Total
(CV%) |
|----------|-------|-------|-------|--------------------|---------------|----------------|
| Low | 279 | 276 | 277 | 277 | 3.8 | 1.39% |
| Normal | 295 | 296 | 291 | 294 | 4.9 | 1.65% |
| Moderate | 307 | 303 | 301 | 304 | 6.5 | 2.15% |
| High | 338 | 326 | 324 | 329 | 7.5 | 2.28% |
4. Between Site Precision
Three sites, three instruments & four lots
| Sample | Average
Osmolarity | Total
(SD) | Total
(CV%) |
|----------|-----------------------|---------------|----------------|
| Low | 278 | 4.4 | 1.59% |
| Normal | 289 | 6.0 | 2.09% |
| Moderate | 308 | 6.3 | 2.05% |
| High | 336 | 8.8 | 2.61% |
3
Internal Method Comparison
Seven levels of contrived tear solution, distributed throughout the clinically significant range of osmolarity', were prepared and measured on the predicate Wescor 5520 Vapro® Osmometer and the TearLab Osmolarity System. The Deming regression between the individual Wescor values (x) and individual Tearlab values (y) is shown below. The red dotted line represents a line with a slope of 1.0.
| Parameter | Coefficient | Std Error | 95%CI |
|---|---|---|---|
| Intercept | 23.061 | 8.470 | 6.201 to 39.920 |
| Slope | 0.9146 | 0.0276 | 0.8597 to 0.9694 |
| Concordance coefficient | 0.9588 | ||
| Regression Equation | y=0.9146x + 23.061 |
Internal Method Comparison - TearLab vs. Wescor Osmolarity
Image /page/3/Figure/5 description: This image is a scatter plot comparing TearLab Osmolarity and Wescor Osmolarity. The x-axis represents Wescor Osmolarity, and the y-axis represents TearLab Osmolarity, both ranging from 260 to 400. A regression line is plotted through the data points, with the equation y = 0.9146x + 23.061 and an R-squared value of 0.9443, indicating a strong positive correlation between the two variables.
18 - Confidential
4
External Method Comparison
At each of three physician office sites, forty contrived tear specimens across seven levels of the clinically significant range were prepared and measured on the TearLab Osmolarity System. The physician office laboratories did not have access to the Wescor 5520 Vapro® vapor pressure osmometer. Wescor values were determined by an average of 2-3 measurements on each level of osmolarity immediately prior to the beginning of the study.
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Image /page/4/Figure/4 description: This image is a scatter plot comparing TearLab Osmolarity and Wescor Osmolarity. The x-axis represents Wescor Osmolarity, ranging from 260 to 400, while the y-axis represents TearLab Osmolarity, also ranging from 260 to 400. The plot includes a regression line with the equation y = 0.9402x + 12.512 and an R-squared value of 0.9515, indicating a strong positive correlation between the two osmolarity measurements.
External Method Comparison - TearLab vs. Wescor Osmolarity
19 - Confidential
5
Expected Values & Reference Ranqes
Reference tear osmolarity values for normal and dry eve disease patients: Normal: 288-331 mOsms/L (90% Cl 288-331, mean 309.9 ± 11.0) Dry Eye Disease: 291-382 mOsms/L (90% Cl 284-392, mean 324 ± 20.8) Osmolarity may differ from left and right eye, and each eye should be tested and assessed to determine which eye represents the higher osmolarity.
Calibration Data
To determine clinical performance for tear film hyperosmolarity in the diagnosis of Dry Eye Disease (DED) a meta-analysis was performed on historical published data for tear osmolarity in samples of normal and dry eye subjects. An osmolarity referent 316 mOsms/L was found to yield sensitivity of 69%, specificity of 92%, and an overall predictive accuracy of 82% for the diagnosis of dry eye syndrome. Studies in the meta-analysis used earlier osmolarity devices, not TearLab.
Table 1. Performance of Osmolarity in meta-analysis
| Normal | Dry Eye | Total | |||
|---|---|---|---|---|---|
| ≤ 316 | 750 | 192 | 942 | 80% | NPV |
| > 316 | 65 | 429 | 494 | 87% | PPV |
| Total | 815 | 621 | 1,436 | ||
| Specificity | Sensitivity | Accuracy | |||
| 92% | 69% | 82% |
[ Lominson A, Khanal S, Ramaesh K, Diaper C, McFadyen A. Tear Film Osmolality: Determination of a Referent for Iny Eve Diacrosis; Investigative Ophthalmology & Visual Science, October 2006; 47(10) 4309-4315]
Performance on patients with objective signs of dry eye
140 subjects were enrolled in a multicenter study (n = 45 Normal, n = 95 Dry Eye). To qualify as a Dry Eye patient, subjects were required a positive score on the Ocular Surface Disease Index (OSDI) and 2 or more positive indications of Tear Film Breakup Time (TBUT), Schirmer Test, Corneal Staining, Conjunctival Staining, or Meibomian Gland Dysfunction. Performance of the TearLab™ Osmolarity System using these selection criteria are shown below in Table 2:
Table 2. TearLab Osmolarity Diagnostic Performance for Dry Eye Disease
| Normal | Dry Eye | Total | |||
|---|---|---|---|---|---|
| ≤ 316 | 32 | 34 | 66 | 48% | NPV |
| > 316 | 13 | 61 | 74 | 82% | PPV |
| Total | 45 | 95 | 140 | ||
| Specificity | Sensitivity | ||||
| 71% | 64% |
20 - Confidential
6
Figure 1. Distribution of Osmolarities in Normal and Dry Eye Disease subjects.
Image /page/6/Figure/2 description: The image contains two plots comparing osmolarity in normal eyes versus dry eye disease. The first plot is a scatter plot showing individual osmolarity measurements for normal eyes and eyes with dry eye disease. The average osmolarity for normal eyes is around 309.9 mOsms/L, while the average osmolarity for dry eye disease is around 324.3 mOsms/L. The second plot shows the probability distribution of osmolarity for normal eyes and dry eyes, with normal eyes having a mean of 309.9 ± 11.0 and dry eyes having a mean of 324.3 ± 20.1.
Substantial Equivalence
The intended use of the TearLab Osmolarity System, like the predicate Wescor osmometer, is to measure the osmolarity of body fluid. Although the TearLab System is specifically indicated for use in the measurement of osmolarity of human tears, while the Wescor osmometer is indicated for use more generally in body fluids, the indications for use of the Wescor encompass the indications for use of the TearLab. In addition, compared to the other predicate devices, the TearLab System has similar indications for use in assessing human tears as the predicate Schirmer strips and Touch IgE microassay, which are also indicated for evaluation of human tears. The TearLab Osmolarity System has the same technological characteristics as its predicate devices, and any technological differences between the TearLab and the predicates do not raise new questions of safety or effectiveness. Performance data demonstrate that the TearLab is as safe and effective as the Predicate Devices. Thus, the TearLab Osmolarity System is substantially equivalent to other leqally marketed tear collection and measurement devices.
- 275-400 mOsms/L, ref: Tomlinson, A, Khanal, K, Ramaesh, C et al, Diaper et al, Tear Film Osmolarity: Determination of a Referent for Dry Eye Diagnosis. IOVS. 2006;47(10)
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OcuSense, Inc. c/o Janice M. Hogan Hogan & Hartson LLP 1835 Market St., 29th Floor Philadelphia, PA 19103
2 2009 llink
Re: K083184 Trade/Device Name: TearLab Osmolarity System Regulation Number: 21 CFR 862.1540 Regulation Name: Osmolality test system Regulatory Class: Class I Product Code: OND, JJX Dated: April 23, 2009 Received: April 23, 2009
Dear Ms. Hogan:
This letter corrects our substantially equivalent letter of Mav 14, 2009.
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page - 2
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 Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indication for Use
510(k) Number (if known): K083184
Device Name: TearLab™ Osmolarity System
Indication For Use:
The TearLab Osmolarity System is intended to measure the osmolarity of human tears to aid in the diagnosis of dry eye disease in patients suspected of having dry eye disease, in conjunction with other methods of clinical evaluation.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro'Diagnostic Device Evaluation and Safety
510(k) K083/84
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