(24 days)
No
The summary describes a turbidimetric immunoassay kit and its performance characteristics, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No.
The device is an in vitro diagnostic (IVD) kit used for the quantitative determination of human IgM, aiding in diagnosis. It does not directly provide therapy or treatment.
Yes
The kit is intended for "quantitative in vitro determination of human IgM" which "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents," explicitly stating its role in diagnosis.
No
The device description clearly states it is a "kit" comprising "reagents" (Antiserum, Calibrator and Controls, Reaction Buffer), which are physical components, not 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 kit is intended for the "quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma". The term "in vitro" is a key indicator of an IVD.
- Purpose: The intended use also states that the measurement of IgM "aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This indicates the device is used to provide information for diagnostic purposes.
- Sample Type: The device analyzes human biological samples (serum, plasma).
- Device Description: The description details reagents used to perform a test on these samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings. The intended use is the same as the cleared kit and has not been changed.
Product codes
CFN
Device Description
The SPAPlus IgM Kit comprises the following reagents:
Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
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
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/Reproducibility: A precision study (repeatability and within laboratory) was performed over 20 working days, with 2 runs per day and 2 reps per run. 3 different samples were assessed using 1 reagent lot on 1 analyser. A between instrument precision study was performed over 6 working days. 2 instruments were tested each day, with 2 replicates per instrument. 3 different samples were assessed using 1 reagent lot on a total of 3 different instruments. The between lot precision study was performed over 6 working days. 2 lots were tested each day, with 2 replicates per lot. 3 different samples were assessed using 2 reagent lots on 1 analyser. Key results for repeatability and within laboratory study: Level 1 (Mean 0.344 mg/L, Total CV 6.1%), Level 2 (Mean 2.949 mg/L, Total CV 4.0%), Level 3 (Mean 5.975 mg/L, Total CV 2.9%). Key results for between instrument study: Level 1 (Mean 0.340 mg/L, Between Instrument CV 2.4%), Level 2 (Mean 2.994 mg/L, Between Instrument CV 5.4%), Level 3 (Mean 6.184 mg/L, Between Instrument CV 4.8%). Key results for between lot study: Level 1 (Mean 0.318 mg/L, Between Lot CV 3.0%), Level 2 (Mean 3.007 mg/L, Between Lot CV 3.0%), Level 3 (Mean 6.236 mg/L, Between Lot CV 4.7%). The results do not indicate any change in performance compared to the predicate device.
Linearity/assay reportable range: A linearity study produced a linear regression equation of y = 0.9904x - 0.1583 g/L, with an r value of 0.999. These results are comparable to those currently presented in the product insert and do not indicate any change in performance compared to the predicate device.
Kit Stability: Accelerated stability studies were carried out to verify that the stability of the kit is unchanged in accordance with ISO 23640:2015. 6 replicates of controls, internal reference and samples were tested over a period equivalent to 13-months. Stability was passed for all tested parameters (IR, Control Low, Control High, Sample 1, Sample 2, Sample 3) with equivalent days at 4 degC ranging from 384 to 465 days, meeting the required 365 days. Real time stability study is currently being carried out. On board stability studies showed no difference in the cleared on board stability claim.
Detection limit: The limit of quantitation (LoQ) for this assay is defined as the bottom of the measuring range, 0.1 g/L at minimum (1/10) sample dilution, which is equivalent to 0.2 g/L at standard (1/20) dilution. The LoQ validation study was based on CLSI EP17-A2. Four samples were tested using two reagent lots. The LoD was estimated as 0.004 g/L and the LoB was estimated to be 0.001g/L. The results do not indicate any change in performance compared to the predicate device.
Method comparison with predicate device: A comparison study was performed by analysing 89 serum samples and 44 plasma samples using the modified IgM Kit for use on the SPAPLus and the unmodified kit. Bland Altman Mean Bias was -2.18% with 95% Limits of Agreement from -16.55% to 12.18%. Passing Bablok regression showed y= 0.964x + 0.008 with Slope 95% CI of 0.947 to 0.986 and Intercept 95% CI of -0.008 to 0.028. Correlation coefficient was 0.996. The results do not indicate any change in performance compared to the predicate device.
Expected values/Reference range: 20 samples from apparently healthy US donors were tested using the modified assay. 19 out of 20 samples gave results within the reference interval (0.35 - 2.42 g/L). One sample gave a result of 0.348 g/L, which is on the lower boundary of the reference interval. The results of this study meet the acceptance criteria and indicate that the reference interval can be transferred from the originally cleared device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Human IgM Kit for Use on SPAPlus (K082129)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 27, 2019
The Binding Site Group Ltd. Natasha Verhaak Regulatory Affairs Officer 8 Calthorpe Road Edgbaston, B15 1qt Gb UK
Re: K191465
Trade/Device Name: Human IgM Kit for use on SPAPlus Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A. G. M. D. and E immunological test system Regulatory Class: Class II Product Code: CFN Dated: May 28, 2019 Received: June 3, 2019
Dear Natasha Verhaak:
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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Doug Jeffery, Ph.D. Acting Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191465
Device Name Human IgM Kit for use on SPAPlus
Indications for Use (Describe)
This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Z Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Human IgM Kit for Use on SPAPIus Special 510(k) Submission Summary
Natasha Verhaak Regulatory Affairs Officer The Binding Site Group Ltd. 8 Calthorpe Road Edgbaston Birmingham, West Midlands, B15 1QT, UK Telephone: +44 (0)121 456 9500 Email: natasha.verhaak@bindingsite.com or regulatory.submissions@bindingsite.com
A. 510(k) Number:
B. Purpose for Submission:
Modification to an existing device
C. Measurand:
lgM
D. Type of Test:
Quantitative immunoturbidimetry
E. Applicant:
The Binding Site
F. Proprietary and Established Names:
Human IgM kit for use on SPAPLUS®
G. Regulatory Information:
-
- Regulation section: 21 CFR 866.5510, Immunoglobulins A, G, M, D, and E immunological test system
-
- Classification: Class II
-
- Product code: CFN - method, nephelometric, immunoglobulins (G, A, M)
-
- Panel: Immunology (82)
4
H. Intended use:
-
- Intended use(s):
This kit is intended for the quantitative in vitro determination of human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
- Intended use(s):
The intended use is the same as the cleared kit and has not been changed.
2. Indication(s) for use:
Same as Intended use.
-
- Special conditions for use statement(s):
Prescription use only
- Special conditions for use statement(s):
-
- Special instrument requirements:
The Binding Site SPAPIus analyser
- Special instrument requirements:
l. Device Description:
The SPAPlus IgM Kit comprises the following reagents:
Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
J. Substantial equivalence information:
-
- Predicate device name(s) and 510(k) number(s): Human IgM Kit for Use on SPAPIus (K082129)
5
2. Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | Modified device | Registered device |
| Intended Use | Quantitative in vitro measurement of | |
| IgM | Same | |
| Test Method | Turbidimetric | Same |
| Specimen Type | Serum, lithium heparin, EDTA plasma | Same |
| Assay type | Quantitative | Same |
| On-board Stability | 30 days | Same |
| Calibration traceability | DA470k | Same |
| Measuring Range | 0.2 - 7.5 (standard assay dilution) | Same |
| Reference Interval | 0.35 - 2.42 g/L | Same |
| Instrument | SPAPlus | Same |
| Antigen excess capacity | 56.4 g/L | Same |
| Calibration method | Pooled human sera | Same |
| Controls | Pooled human sera | Same |
| Open vial stability | 3 months | Same |
| Antibody processing | Affinity purification, specificity | |
| confirmed by IEP | Same |
| Differences | ||
|---|---|---|
| Item | Modified device | Registered device |
| Source of detection | ||
| antibody | Goat antibody | Sheep antibody |
| Antibody resting | ||
| buffer | GBS and PBS (50:50) | GBS |
K. Standards and Guidance documents referenced:
CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline
CLSI EP5-A3 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents- 1st Edition
L. Test Principle:
The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.
6
M. Performance Characteristics (if/when applicable):
-
- Analytical performance:
- Precision/Reproducibility: a.
The precision studies were based on CLSI EP5-A3 Evaluation of Precision Performance of Clinical Quantitative Measurement Methods as was agreed in pre-submission meeting Q171503.
The repeatability and within laboratory study was performed over 20 working days, with 2 runs per day and 2 reps per run. 3 different samples were assessed using 1 reagent lot on 1 analyser.
| Repeatability and Within Laboratory Summary | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| N | Mean (mg/L) | Within run | Between run | Between day | Total | |||||
| SD | CV % | SD | CV % | SD | CV % | SD | CV % | |||
| Level 1 | 80 | 0.344 | 0.013 | 3.6 | 0.005 | 1.5 | 0.016 | 4.7 | 0.021 | 6.1 |
| Level 2 | 80 | 2.949 | 0.050 | 1.7 | 0.040 | 1.3 | 0.100 | 3.4 | 0.119 | 4.0 |
| Level 3 | 80 | 5.975 | 0.087 | 1.4 | 0.086 | 1.4 | 0.123 | 2.1 | 0.173 | 2.9 |
Repeatability and Within Laboratory Results:
The between instrument precision study was performed over 6 working days. 2 instruments were tested each day, with 2 replicates per instrument. 3 different samples were assessed using 1 reagent lot on a total of 3 different instruments.
Between Instrument Results:
| | N | Mean
(mg/L) | Between
Instrument | |
|---------|----|----------------|-----------------------|------|
| | | | SD | CV % |
| Level 1 | 24 | 0.340 | 0.008 | 2.4 |
| Level 2 | 24 | 2.994 | 0.162 | 5.4 |
| Level 3 | 24 | 6.184 | 0.288 | 4.8 |
The between lot precision study was performed over 6 working days. 2 lots were tested each day, with 2 replicates per lot. 3 different samples were assessed using 2 reagent lots on 1 analyser.
Between Lot Results:
| | N | Mean
(mg/L) | Between Lot | |
|---------|----|----------------|-------------|------|
| | | | SD | CV % |
| Level 1 | 24 | 0.318 | 0.009 | 3.0 |
| Level 2 | 24 | 3.007 | 0.090 | 3.0 |
| Level 3 | 24 | 6.236 | 0.291 | 4.7 |
The above results do not indicate any change in performance compared to the device cleared in K082129. The precision claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.
7
b. Linearity/assay reportable range:
A linearity study was carried out as per the original submission (K082129) where a dilution series was produced from a high pool with a known concentration of 8.64 g/L and a low pool with a concentration of 0.15g/L. Each diluted sample was tested in six replicates and a linear regression analysis was carried out. The linear regression equation was shown to be y = 0.9904x - 0.1583 g/L, with an r value of 0.999.
These results are comparable to those currently presented in the product insert and therefore do not indicate any change in performance compared to the device cleared in K082129. The linearity claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
i) Traceability:
The calibration of the assay is traceable to ERM-DA470k/IFCC.
ii) Kit Stability:
Accelerated Stability
Accelerated stability studies were carried out to verify that the stability of the kit is unchanged in accordance with ISO 23640:2015. 6 replicates of controls, internal reference and samples were tested over a period equivalent to 13-months and analysed in line with EP25-A with a maximum allowable difference of ±15% in order to verify the stability claim of 12 months. Reagents were stored at 37℃ to accelerate the study by a factor of 10.
| Parameter | IR | Control | Sample | |||
|---|---|---|---|---|---|---|
| Low | High | 1 | 2 | 3 | ||
| Accelerated stability | ||||||
| achieved (days) | 39 | 39 | 39 | 39 | 47.3 | 39 |
| Equivalent at 4ºC (days) | 384 | 384 | 388 | 390 | 465 | 390 |
| Stability required at 4ºC | ||||||
| (days) | 365 | 365 | 365 | 365 | 365 | 365 |
| Decision | Pass | Pass | Pass | Pass | Pass | Pass |
Accelerated Stability Results
Real Time Stability
To further support the results of the accelerated stability testing, a real time stability study is currently being carried out in accordance with EP25-A and as was agreed in pre-submission meeting Q171503.
8
On Board Stability
On board stability studies were carried out as per the original 510(k) submission and showed no difference in the cleared on board stability claim
d. Detection limit.
The limit of quantitation (LoQ) for this assay is defined as the bottom of the measuring range, 0.1 g/L at minimum (1/10) sample dilution, which is equivalent to 0.2 g/L at standard (1/20) dilution. The LoQ validation study was based on CLSI EP17-A2 Evaluation of the Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - 2nd Edition in accordance with pre-submission meeting Q171503. Four samples were tested using two reagent lots. The LoQ claim was validated by all the samples reporting within the acceptance criteria of an allowable CV of 10%.
The limit of detection (LoD) represents the lowest measurable analyte level that can be distinguished from zero, this was estimated as 0.004 g/L in the original submission and the limit of blank (LoB) was estimated to be 0.001g/L. Additional testing was carried out following the antisera change and no change in performance was observed.
The results generated do not indicate any change in performance compared to the device cleared in K082129. The LoB, LoD and LoQ claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.
e. Analytical specificity:
As per original submission (K082129)
f. Assay cut-off:
Not determined
3. Comparison studies:
a. Method comparison with predicate device:
A comparison study was performed by analysing 89 serum samples and 44 plasma samples using the modified IgM Kit for use on the SPAPLus and the unmodified kit which is already commercially available. The study was carried out in accordance with pre-submission meeting Q171503. Bland Altman and Passing Bablok regression analysis generated the following results:
| Bland Altman Mean Bias | 95% Limits of Agreement | |
|---|---|---|
| -2.18% | -16.55% to 12.18% | |
| Passing Bablok | Slope 95% CI | Intercept 95% CI |
| y= 0.964x + 0.008 | 0.947 to 0.986 | -0.008 to 0.028 |
9
| Correlation coefficient |
|---|
| 0.996 |
| Predicate Sample Ranges | Test Samples Ranges |
|---|---|
| 0.107 - 11.780 | 0.116 - 11.066 |
The above results do not indicate any change in performance compared to the device cleared in K082129. The comparison claims in the product insert therefore still accurately represent the performance of the modified kit and do not need to be amended.
b. Matrix comparison:
As per the original submission (K082129), no difference between matrices were observed.
3. Clinical studies:
a. Clinical Sensitivity: None determined
b. Clinical specificity: None determined
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable
-
- Clinical cut-off:
None determined
- Clinical cut-off:
5. Expected values/Reference range:
Following the protocol agreed in Q171503, 20 samples from apparently healthy US donors were tested using the modified assay. The acceptance criteria for the transfer is ≤2 samples falling outside of the limits of the reference interval to be transferred.
Of the 20 samples tested, 19 gave results within the reference interval, ranging from 0.364 to 1.736 g/L. One sample gave a result of 0.348 g/L, which is on the lower boundary of the reference interval (0.35 g/L). The results of this study therefore meet the acceptance criteria and indicate that the reference interval can be transferred from the originally cleared device.
This is further supported by the results of the comparison study. When considering the lower limit of the reference interval, all samples tested gave clinically concordant results.
10
N. Proposed Labelling:
The labelling is sufficient, and it satisfies the requirements of 21 CFR Part 809.10.
The labelling is the same as the cleared kit and has not been changed.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.