(361 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The performance studies describe standard clinical validation methods for a diagnostic device.
No.
The device is an in-vitro diagnostic test used to measure glycated hemoglobin, which monitors long-term glycemic control in individuals with diabetes. It is explicitly stated that this test is not for screening or diagnosis of diabetes, and its function is measurement, not treatment or therapy.
No.
The device's Intended Use explicitly states, "This test is not for screening or diagnosis of diabetes." While it measures HbA1c for monitoring long-term glycemic control in previously diagnosed individuals, it is not used for the initial diagnosis of a condition.
No
The device description explicitly states it consists of the "skyla Hi Analyzer" and "skyla Hi Hemoglobin A1c Reagent Kit," which are hardware components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is an "in-vitro diagnostic test".
- Measurement: It measures the percent concentration of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood, which is a biological sample taken from the body.
- Purpose: The measurement is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus, which is a medical condition.
- Setting: It is intended for clinical laboratory and point-of-care use, typical settings for IVD devices.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood.
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJE
Device Description
The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professionals and POC
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
A total of 243 samples were analyzed for the method comparison study. For skyla Hi Hemoglobin A1c System, both venous whole blood sample and finger-stick capillary sample were tested, while for Bio-Rad VARIANT II Hemoglobin testing system, only venous whole blood sample was tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests (Verification and Validation):
- Evaluations included: precision, linearity, interference, sample volume and hematocrit.
- POC precision data: Tabulated below indicating repeatability (within run), between run, between day, and total standard deviation and %CV for various patient samples (A15, A12, A20, A24, B01-7) and controls (Y1, Y2, L5) tested at three sites. Sample sizes for each patient/control at each site are 80, with combined N of 240.
- Patient 1 (A15) Combined (N=240, Mean=5.04%): Total SD = 0.095, %CV = 1.9%
- Patient 2 (A12) Combined (N=240, Mean=5.56%): Total SD = 0.110, %CV = 2.0%
- Patient 3 (A20) Combined (N=240, Mean=6.54%): Total SD = 0.135, %CV = 2.1%
- Patient 4 (A24) Combined (N=240, Mean=7.96%): Total SD = 0.198, %CV = 2.5%
- Patient 5 (B01-7) Combined (N=240, Mean=12.10%): Total SD = 0.292, %CV = 2.4%
- Control 1 (Y1) Combined (N=240, Mean=5.20%): Total SD = 0.130, %CV = 2.5%
- Control 2 (Y2) Combined (N=240, Mean=9.69%): Total SD = 0.260, %CV = 2.7%
- Calibrator 1 (L5) Combined (N=240, Mean=13.58%): Total SD = 0.138, %CV = 1.0%
Clinical Tests (Method Comparison / POC User Performance Study):
- Study Type: Method comparison study performed in POC sites by intended operators.
- Sample Size: A total of 243 samples.
- Key Results:
- Regression line for venous whole blood (skyla Hi vs. Bio-Rad VARIANT II): y = 0.9945x + 0.0779
- Regression line for finger-stick blood (skyla Hi vs. Bio-Rad VARIANT II): y = 0.9993x + 0.0589
- Conclusion: Venous whole blood samples and finger-stick capillary samples from the candidate device are both comparable to comparative device whole blood testing results. The test system is safe, effective, and substantially equivalent to the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in blue capital letters.
September 25, 2018
Skyla Corporation H.S.P.B. % Feng-Yu Lee, Regulatory Principal Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675
Re: K173127
Trade/Device Name: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin Alc Reagent Kit) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JJE Dated: August 10, 2018 Received: August 22, 2018
Dear Feng-Yu Lee:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173127
Device Name
The skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)
Indications for Use (Describe)
The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood.
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K173127.
APPLICANT INFORMATION: I.
Name: Skyla Corporation Hsinchu Science Park Branch
Address: 1F, No. 8, Dusing Road, Hsinchu Science Park, Hsinchu 300, Taiwan, R.O.C. +886-3-5787722 Phone: Fax: +886-3-5795393 Contact: Ian Lee
c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928
Date Summary Prepared: September 24th, 2018
II. DEVICES INFORMATION:
Trade Name:
The skyla Hi Hemoglobin Alc System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)
Classification name, product code, and regulation number:
| Regulation
Description | Product
Code | Device
Class | Regulation | Panel |
|----------------------------------------------------------------|-----------------|-----------------|--------------------|-------------------|
| Glycosylated Hemoglobin
Assay | LCP | II | 21 CFR
864.7470 | Hematology,
81 |
| Discrete photometric
chemistry analyzer for
clinical use | JJE | I | 962.2160 | Chemistry,
75 |
4
III. PREDICATE DEVICE
The following table identifies the legally marketed device to which Skyla claims equivalence.
Identification of Predicate Device
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | |
| skyla Hi Hemoglobin | |||
| A1c System | Alere Afinion Hba1c | ||
| and Alere Afinion | |||
| AS100 Analyzer | Alere Technologies AS | K151809 |
IV. DEVICE DESCRIPTION:
The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
INDICATIONS FOR USE v.
The skyla Hi Hemoglobin A 1 System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood
The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.
This system is intended for clinical laboratory and point-of-care use.
This test is not for screening or diagnosis of diabetes.
VI. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE
Below tables outline the technological characteristics of the skyla Hi Hemoglobin A 1 c System in comparison to the legally marketed predicate devices.
5
| Similarities | ||
|---|---|---|
| Item | Candidate Device | Predicate Device |
| skyla Hi | ||
| Hemoglobin A1c System | Alere Afinion Hba1c and Alere | |
| Afinion AS100 Analyzer | ||
| k number | K173127 | K151809 |
| Intended use | The skyla Hi Hemoglobin A1c | |
| System, consisting of the skyla Hi | ||
| Analyzer and skyla Hi | ||
| Hemoglobin A1c Reagent Kit is | ||
| an in-vitro diagnostic test for | ||
| quantitative measurement of the | ||
| percent concentration (%) of | ||
| glycated hemoglobin (HbA1c %) | ||
| in venous and finger-stick | ||
| capillary whole blood | ||
| The measurement of % HbA1c is | ||
| used to monitor long-term | ||
| glycemic control in persons | ||
| previously diagnosed with | ||
| diabetes mellitus. | ||
| This system is intended for | ||
| clinical laboratory and point-of- | ||
| care use. | ||
| This test is not for screening or | ||
| diagnosis of diabetes. | Alere Afinion™ AS100 | |
| Analyzer System, consisting of | ||
| the Alere Afinion™ AS100 | ||
| Analyzer or Alere Afinion™ | ||
| AS100 Analyzer Connect and | ||
| the Alere Afinion™ Test | ||
| Cartridges, is for in vitro | ||
| diagnostic use only. The Alere | ||
| Afinion™ AS100 Analyzer | ||
| Connect comprises of the Alere | ||
| Afinion™ AS100 Analyzer and | ||
| the Alere Afinion™ Data | ||
| Connectivity Converter. | ||
| Alere Afinion™ AS100 is a | ||
| compact multi-assay analyzer | ||
| for point-of-care testing. It is | ||
| designed to analyze the Alere | ||
| Afinion™ Test Cartridges. The | ||
| Alere Afinion™ Analyzer | ||
| System is easy to use, rapid and | ||
| gives reliable and accurate | ||
| results. | ||
| Alere Afinion™ HbA1c is an in | ||
| vitro diagnostic test for | ||
| quantitative determination of | ||
| glycated hemoglobin | ||
| (hemoglobin A1c, HbA1c) in | ||
| human whole blood. | ||
| The measure of HbA1c is | ||
| recommended as a marker of | ||
| long-term metabolic control in | ||
| persons with diabetes mellitus. | ||
| Type of test | Quantitative in-vitro diagnostic | |
| test | Quantitative in-vitro diagnostic | |
| test | ||
| Intended users | Professionals and POC | Professionals and POC |
| Blood sampling | Standard phlebotomy techniques | |
| for obtaining venous blood | ||
| samples. Fingerstick by use of | ||
| lancet. | Standard phlebotomy techniques | |
| for obtaining venous blood | ||
| samples. Fingerstick by use of | ||
| lancet. | ||
| Design of sampling device | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge |
| Cartridge barcode | For cartridge expiration and test lot calibration of HbA1c test | For cartridge expiration and test lot calibration of HbA1c test |
| Differences | ||
| Item | Candidate Device | Predicate Device |
| skyla Hi | ||
| Hemoglobin A1c System | Alere Afinion Hba1c and | |
| Alere Afinion AS100 Analyzer | ||
| Test principle | Immunoturbidimetric assay | Boronate affinity assay |
| Sampling device | ||
| capillary material | Glass | Plastic |
| Fill volume of sampling | ||
| device capillary | $0.8 \mu L$ | $1.5 \mu L$ |
| Time to result | 6 minutes | 3 minutes |
6
Skyla Corporation H.S.P.B
VII. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:
Verification and validation activities were performed on skyla Hi hemoglobin A1c System to establish performance, functionality, and reliability of the device system. Evaluations included precision, linearity, interference, sample volume and hematocrit. POC precision data were tabulated below:
| Sample | Site | N | Mean
(%) | Repeatability
(within run) | | Between
Run | | Between
Day | | Total | |
|--------------------|----------|-----|-------------|-------------------------------|------|----------------|------|----------------|------|-------|------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Patient 1
(A15) | Site 1 | 80 | 5.04 | 0.097 | 1.9% | 0.000 | 0.0% | 0.032 | 0.6% | 0.103 | 2.0% |
| | Site 2 | 80 | 5.06 | 0.082 | 1.6% | 0.039 | 0.8% | 0.034 | 0.7% | 0.097 | 1.9% |
| | Site 3 | 80 | 5.03 | 0.075 | 1.5% | 0.062 | 1.2% | 0.000 | 0.0% | 0.097 | 1.9% |
| | Combined | 240 | 5.04 | 0.085 | 1.7% | 0.038 | 0.8% | 0.014 | 0.3% | 0.095 | 1.9% |
| | Site 1 | 80 | 5.55 | 0.097 | 1.7% | 0.045 | 0.8% | 0.000 | 0.0% | 0.107 | 1.9% |
7
Skyla Corporation H.S.P.B
| Patient 2
| (A12) | Site 2 | 80 | 5.59 | 0.095 | 1.7% | 0.032 | 0.6% | 0.000 | 0.0% | 0.100 | 1.8% |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site 3 | 80 | 5.56 | 0.100 | 1.8% | 0.065 | 1.2% | 0.000 | 0.0% | 0.119 | 2.1% | |
| Combined | 240 | 5.56 | 0.097 | 1.7% | 0.049 | 0.9% | 0.000 | 0.0% | 0.110 | 2.0% | |
| Patient 3 | |||||||||||
| (A20) | Site 1 | 80 | 6.57 | 0.105 | 1.6% | 0.062 | 0.9% | 0.057 | 0.9% | 0.134 | 2.0% |
| Site 2 | 80 | 6.53 | 0.111 | 1.7% | 0.086 | 1.3% | 0.000 | 0.0% | 0.141 | 2.2% | |
| Site 3 | 80 | 6.54 | 0.110 | 1.7% | 0.057 | 0.9% | 0.040 | 0.6% | 0.130 | 2.0% | |
| Combined | 240 | 6.54 | 0.109 | 1.7% | 0.070 | 1.1% | 0.038 | 0.6% | 0.135 | 2.1% | |
| Patient 4 | |||||||||||
| (A24) | Site 1 | 80 | 7.93 | 0.126 | 1.6% | 0.099 | 1.3% | 0.067 | 0.8% | 0.174 | 2.2% |
| Site 2 | 80 | 7.95 | 0.132 | 1.7% | 0.112 | 1.4% | 0.112 | 1.4% | 0.207 | 2.6% | |
| Site 3 | 80 | 7.99 | 0.150 | 1.9% | 0.097 | 1.2% | 0.115 | 1.4% | 0.212 | 2.7% | |
| Combined | 240 | 7.96 | 0.137 | 1.7% | 0.103 | 1.3% | 0.100 | 1.3% | 0.198 | 2.5% | |
| Patient 5 | |||||||||||
| (B01-7) | Site 1 | 80 | 12.07 | 0.243 | 2.0% | 0.188 | 1.6% | 0.000 | 0.0% | 0.308 | 2.5% |
| Site 2 | 80 | 12.10 | 0.250 | 2.1% | 0.189 | 1.6% | 0.000 | 0.0% | 0.313 | 2.6% | |
| Site 3 | 80 | 12.13 | 0.212 | 1.7% | 0.138 | 1.1% | 0.096 | 0.8% | 0.270 | 2.2% | |
| Combined | 240 | 12.10 | 0.236 | 2.0% | 0.173 | 1.4% | 0.000 | 0.0% | 0.292 | 2.4% | |
| Control 1 | |||||||||||
| (Y1) | Site 1 | 80 | 5.24 | 0.092 | 1.8% | 0.085 | 1.6% | 0.033 | 0.6% | 0.130 | 2.5% |
| Site 2 | 80 | 5.18 | 0.115 | 2.2% | 0.000 | 0.0% | 0.055 | 1.1% | 0.128 | 2.5% | |
| Site 3 | 80 | 5.20 | 0.118 | 2.3% | 0.067 | 1.3% | 0.000 | 0.0% | 0.136 | 2.6% | |
| Combined | 240 | 5.20 | 0.109 | 2.1% | 0.060 | 1.2% | 0.029 | 0.6% | 0.130 | 2.5% | |
| Contro2 | |||||||||||
| (Y2) | Site 1 | 80 | 9.70 | 0.200 | 2.1% | 0.142 | 1.5% | 0.143 | 1.5% | 0.284 | 2.9% |
| Site 2 | 80 | 9.71 | 0.208 | 2.1% | 0.022 | 0.2% | 0.096 | 1.0% | 0.230 | 2.4% | |
| Site 3 | 80 | 9.68 | 0.228 | 2.4% | 0.000 | 0.0% | 0.171 | 1.8% | 0.285 | 3.0% | |
| Combined | 240 | 9.69 | 0.213 | 2.2% | 0.052 | 0.5% | 0.140 | 1.4% | 0.260 | 2.7% | |
| Calibrator 1 | |||||||||||
| (L5) | Site 1 | 80 | 13.59 | 0.085 | 0.6% | 0.100 | 0.7% | 0.000 | 0.0% | 0.131 | 1.0% |
| Site 2 | 80 | 13.57 | 0.084 | 0.6% | 0.132 | 1.0% | 0.000 | 0.0% | 0.156 | 1.2% | |
| Site 3 | 80 | 13.60 | 0.081 | 0.6% | 0.094 | 0.7% | 0.000 | 0.0% | 0.124 | 0.9% | |
| Combined | 240 | 13.58 | 0.083 | 0.6% | 0.110 | 0.8% | 0.000 | 0.0% | 0.138 | 1.0% |
VIII. Discussion of Clinical Tests Performed:
Method Comparison (POC User Performance Study)
The method comparison study was performed in POC sites by intended operators. It is concluded that either venous whole blood samples or finger-stick capillary samples from candidate device are both comparable to comparative device whole blood testing results.
A total of 243 samples were analyzed. For skyla Hi Hemoglobin A1c System, both venous whole blood sample and finger-stick capillary sample were tested, while for
8
Bio-Rad VARIANT II Hemoglobin testing system, only venous whole blood sample was tested.
Result for POC Methoad Comparison Study:
Regression line for venous whole blood: y = 0.9945x + 0.0779
Regression line for finger-stick blood: y = 0.9993x + 0.0589
IX. CONCULSIONS
The clinical and non-clinical tests performed for skyla Hi Hemoglobin A1c System, demonstrate that the test system is safe, effective and substantially equivalent to the legally marketed device identified above.