(433 days)
Not Found
No
The device is a disposable sampling tube for specimen collection and transport, with no mention of computational analysis or algorithms.
No
The device is described as a "Dasky Disposable Sampling Tube" intended for the stabilization, transportation, and inactivation of samples for diagnostic testing, not for treating a disease or condition.
No
The device is a sampling tube intended for stabilization, transportation, and inactivation of samples for subsequent laboratory analysis, not for performing a diagnostic test itself.
No
The device description clearly states it consists of a plastic transport tube with medium, a nasopharyngeal swab, and an optional biosafety bag, which are all physical components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2." It also states that the specimens collected and stored are "suitable for use with compatible laboratory based molecular diagnostic devices." This clearly indicates its role in the pre-analytical phase of a diagnostic process performed in vitro (outside the body).
- Device Description: The device contains a "medium" designed to "inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen." This medium is specifically designed to prepare the biological sample for subsequent diagnostic testing.
- Performance Studies: The document describes performance studies related to "Limit of detection," "Specimen Stability," and "Inactivation." These are all relevant performance characteristics for a device used in the collection and preparation of samples for diagnostic testing.
- Predicate Device: The listed predicate device, K202641; DNA/RNA Shield Collection tube, is also a device used for the collection and stabilization of biological samples for molecular diagnostic testing, further supporting the classification of the Dasky Disposable Sampling Tube as an IVD.
While the device itself doesn't perform the diagnostic test, it is an essential component in the in vitro diagnostic process by preparing the sample for analysis. Therefore, it falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
Product codes (comma separated list FDA assigned to the subject device)
QBD
Device Description
The Dasky Disposable Sampling Tube (Model name: VSM02) consists of a plastic transport tube with medium which is supplied alone or in a kit with a nasopharyngeal (NP) swab, and an optional biosafety bag. The plastic transport tube contains 3 mL of the stabilization media. The media are intended to inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen between 39 °F and 73 °F (4°C - 23°C). The media is sold in the following configurations.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media and a NP nylon flocked swab for sample collection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal
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)
- Limit of detection:
- Study Type: LoD testing.
- Sample Size: 60 replicates for each concentration (20 tubes/lot for three lots), where virus was spiked into clinical NP swab specimens from healthy individuals testing negative for SARS-CoV-2.
- Key Results:
- ~78% detection at 63 GCE/mL (13/60 replicates).
- 20/20 replicates at concentrations 70 GCE/mL, 10^2 GCE/mL, 3x 10^2 GCE/mL, and 10^4 GCE/mL for each of the three lots.
- LoD testing at 70 GCE/mL resulted in 60/60 replicates for NP swabs, meeting pre-defined acceptance criteria.
- Specimen Stability:
- Study Type: Specimen stability study.
- Sample Size: Three Dasky Disposable Sampling Tubes from each of three lots were tested by RT-PCR.
- Key Results:
- Acceptable RNA stabilization demonstrated at 23°C for 48 hours or 4°C for 144 hours.
- The deviation between initial Ct measurement and Ct measurement of samples stored at either 23°C for a minimum of 48 hours or 4°C for a minimum of 144 hours was less than 2 Ct.
- Inactivation:
- Study Type: Inactivation assessment.
- Sample Size: Three lots of Dasky Disposable Sampling Tube. For the experimental group, 9 clinical nasopharyngeal (NP) swab specimens from healthy individuals who tested negative for SARS CoV-2 virus.
- Key Results:
- For SARS-CoV-2 virus at a titer of 10^3 GCE/mL, it was 100% inactivated at a minimum of 5 minutes in the Dasky Disposable Sampling Tube.
- In the control group (PBS), the virus could infect Vero-E6 cells.
- In the experimental group (Dasky Disposable Sampling Tube), the virus was inactivated and no longer able to infect Vero-E6 cells, and the intact morphology of the cells could be observed.
- Shelf life:
- Study Type: Realtime stability study.
- Sample Size: 9 samples (3 lots).
- Key Results: The shelf-life for the Dasky Disposable Sampling Tube is 1 year after the date of manufacture. Evaluation factors included appearance inspection, pH detection, RT-PCR test, and virus inactivation efficiency detection.
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
§ 866.2950 Microbial nucleic acid storage and stabilization device.
(a)
Identification. A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved.
(2) The labeling required under § 809.10(b) of this chapter must include the following:
(i) A detailed device description, including all device components;
(ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation;
(iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and
(iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies.
(3) Design verification and validation must include the following:
(i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures;
(ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and
(iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
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, 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.
Ningbo Dasky Life Science Co., Ltd. Wilson Wong Sales Manager No. 6, Donggong 1st Road, Yinzhou District Ningbo, Zhejiang 315000 China
August 8, 2022
Re: K211675
Trade/Device Name: Dasky Disposable Sampling Tube (Model name: VSM02) Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: May 25, 2021 Received: June 1, 2021
Dear Wilson Wong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Kristian Roth, Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211675
Device Name
Dasky Disposable Sampling Tube (Model name: VSM02)
Indications for Use (Describe)
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
| 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: August 7,2022
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | NINGBO DASKY LIFE SCIENCE CO.,LTD. |
|---|---|
| Address: | No.6, Donggong 1st Road, Yinzhou District,Ningbo, Zhejiang |
| 315000 China | |
| Contact person: | Wilson Wong |
| Title: | Sales manager |
| E-mail: | sales@daskymed.com |
| Tel: | +86-13566546046 |
2. Device Identification
| 510(K) number: | K211675 |
|---|---|
| Trade/Device Name: | Dasky Disposable Sampling Tube (Model name: VSM02) |
| Models: | VSM02 |
| Regulation Number: | 21 CFR 866.2950 |
| Regulation Description: | Microbial Nucleic Acid Storage And Stabilization Device |
| Regulation Class: | Class II |
| Panel: | Microbiology |
| Product Code: | QBD |
3. Predicate Device
| 510(K) number: | K202641 |
|---|---|
| Device Name: | DNA/RNA Shield Collection tube |
| Manufacturer: | Zymo Research |
| Regulation Description: | Microbial Nucleic Acid Storage And Stabilization Device |
| Regulation Number: | 21 CFR 866.2950 |
| Regulation Class: | Class II |
| Panel: | Microbiology |
| Product Code: | QBD |
4
4. Device Description
The Dasky Disposable Sampling Tube (Model name: VSM02) consists of a plastic transport tube with medium which is supplied alone or in a kit with a nasopharyngeal (NP) swab, and an optional biosafety bag. The plastic transport tube contains 3 mL of the stabilization media. The media are intended to inactivate SARS-CoV-2 virus, lyse the cells, disruptlyse the lipid membranes and denature proteins for storage of the specimen between 39 °F and 73 °F (4°C - 23°C). The media is sold in the following configurations.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media.
- . A plastic screw-cap tube filled with 3 mL of Dasky Disposable Sampling Tube media and a NP nylon flocked swab for sample collection.
5. Indication for use
The Dasky Disposable Sampling Tube (Model name: VSM02) is intended for the stabilization, transportation and inactivation of infectious unprocessed nasopharyngeal specimen samples suspected of containing SARS-CoV-2. These devices can be used for collection transport and storage of specimens from the collection site to the laboratory. The specimens collected and stored in a Dasky Disposable Sampling Tube (Model name: VSM02) are suitable for use with compatible laboratory based molecular diagnostic devices.
6. Summary of the technological characteristics of the device compared to the Predicate Device
Compared to the predicate device, the subject device has the similar intended use, product design, and performance as the predicate device, the summarized comparison is listed in following table 1:
5
| Device & Predicate
| Device(s): | Device: K211675 | Predicate: K202641 |
|---|---|---|
| Device Trade Name | Dasky Disposable Sampling Tube | |
| (Model name: VSM02) | DNA/RNA Shield Collection tube | |
| General Device Characteristic Similarities | ||
| Intended Use/Indications | ||
| For Use | The Dasky Disposable Sampling | |
| Tube (Model name: VSM02) is | ||
| intended for the stabilization, | ||
| transportation and inactivation of | ||
| infectious unprocessed | ||
| nasopharyngeal specimen | ||
| samples suspected of containing | ||
| SARS-CoV-2. These devices can | ||
| be used for collection transport | ||
| and storage of specimens from | ||
| the collection site to the | ||
| laboratory. The specimens | ||
| collected and stored in a Dasky | ||
| Disposable Sampling Tube | ||
| (Model name: VSM02) are | ||
| suitable for use with compatible | ||
| laboratory based molecular | ||
| diagnostic devices. | The DNA/RNA Shield collection | |
| tube is intended for the | ||
| stabilization and inactivation of | ||
| upper and lower respiratory | ||
| human specimens suspected of | ||
| containing SARS-CoV-2. | ||
| These devices can be used for | ||
| collection transport and storage of | ||
| specimens at ambient | ||
| temperatures (20-25°C). | ||
| Specimens collected and stored | ||
| in a DNA/RNA Shield collection | ||
| tube are suitable for use with | ||
| legally marketed molecular | ||
| diagnostic devices. | ||
| Microorganism nucleic | ||
| acids | ||
| preserved | Same | SARS-CoV-2 |
| Container | Same | Tube, plastic, screw cap vials |
| Medium Volume | 3 mL | 1 mL, 2 mL |
| Special conditions for | ||
| use | Same | 1. For in vitro diagnostic use only |
- For Prescription Use only |
| Sample source | Same | Human respiratory |
| General Device Characteristic Differences | | |
| RNA
stabilization at
refrigeration | 144 hours (4°C) | no refrigeration claims |
| RNA
stabilization
at ambient temperature | 48 hours (23°C) | 28 days |
| Specimen Type | Nasopharyngeal specimens for
SARS-CoV-2. | Lower and Upper Respiratory
Specimens for SARS-CoV-2. |
| Analyte | RNA | RNA and DNA |
| Shelf life | 1 year | 2 years |
Table 1: side by side comparison of subject device and predicate device
6
7. Performance Data
1) Limit of detection
The detection limit of SARS-CoV-2 nucleic acid (RNA) in 3 mL media in the Dasky Disposable Sampling Tube (Model name: VSM02) was determined. The detection limit concentration was verified to ensure that SARS-CoV-2 RNA could be repeatedly recovered from the disposable sample tube at the lowest detection concentration with an accuracy greater than 95%. LoD testing was conducted by spiking multiple volume of SARS-CoV-2 virus with a titer of 1x 10° GCE/mL into the clinical NP swab specimen, collected from healthy individuals who tested negative for SARS-CoV-2 virus, and then using the NP swab to transfer the sample into 3 mL of media in the Dasky Disposable Sampling Tube (Model name: VSM02) to achieve final concentrations of 63 GCE/mL, 70 GCE/mL, 102 GCE/mL, 3x 102 GCE/mL 103 GCE/mL, and 104 GCE/mL, for each of the 20 tubes/lot for three lot.
Purified RNA was extracted from 200 µL samples by using MagMAX Viral/Pathogen Nucleic Acid lsolation Kit manufactured by Thermo Fisher Scientific. RT-PCR was performed on the Applied Biosystems 7500 Quantitative Real-time PCR System and TaqPath COVID-19 Combo Kit manufactured by Thermo Fisher Scientific.
~78% detection (viral targets C; values are 144, respectively. Purified RNA was extracted from 200 µL samples by MagMAX Viral/Pathogen Nucleic Acid Isolation Kit manufactured by Thermo Scientific. RT-PCR was performed on the ABI7500 using the EUA-authorized TaqPath COVID-19 Combo kit of Thermo Scientific. The results for the specimen stability study are summarized in Table 3.
| Lot No. | Storage condition | Replicate | Ct | Interpretation | % Positive | ||
|---|---|---|---|---|---|---|---|
| ORF1ab | N gene | S gene | |||||
| 20100732-01 | T₀ | 1 | 28.6 | 28.7 | 28.4 | Positive | 100% |
| 2 | 29.7 | 29.6 | 29.2 | Positive | |||
| 3 | 28.3 | 28.2 | 28.1 | Positive | |||
| T₂₃->₄₈ | 1 | 30.9 | 30.1 | 30.3 | Positive | ||
| 2 | 30.5 | 30.9 | 29.8 | Positive | |||
| 3 | 29.9 | 29.3 | 29.9 | Positive | |||
| T₄->₁₄₄ | 1 | 29.0 | 29.4 | 29.0 | Positive | ||
| 2 | 30.7 | 30.1 | 29.5 | Positive | |||
| 3 | 29.8 | 30.1 | 30.9 | Positive | |||
| 21060732-02 | T₀ | 1 | 29.1 | 29.2 | 28.8 | Positive | |
| 2 | 29.0 | 30.5 | 29.8 | Positive | |||
| 3 | 28.3 | 28.7 | 29.6 | Positive | |||
| T₂₃->₄₈ | 1 | 29.2 | 28.9 | 29.8 | Positive | ||
| 2 | 29.4 | 29.8 | 30.5 | Positive | |||
| 3 | 28.5 | 29.6 | 29.9 | Positive | |||
| T₄->₁₄₄ | 1 | 29.8 | 29.5 | 29.0 | Positive |
| Table 3. Specimen Stability | ||
|---|---|---|
| -- | ----------------------------- | -- |
8
| 2 | 29.2 | 29.0 | 29.5 | Positive | ||
|---|---|---|---|---|---|---|
| 3 | 30.2 | 30.5 | 30.9 | Positive | ||
| 21121032-01 | T0 | 1 | 28.1 | 28.9 | 29.7 | Positive |
| 2 | 29.8 | 28.7 | 28.3 | Positive | ||
| 3 | 28.1 | 29.5 | 29.8 | Positive | ||
| T23->48 | 1 | 30.0 | 30.9 | 29.7 | Positive | |
| 2 | 29.3 | 29.8 | 28.7 | Positive | ||
| 3 | 29.0 | 28.3 | 29.5 | Positive | ||
| T4->144 | 1 | 29.4 | 29.0 | 29.3 | Positive | |
| 2 | 29.1 | 29.4 | 29.6 | Positive | ||
| 3 | 29.4 | 29.3 | 29.1 | Positive |
The deviation between the initial C+ measurement value and the C+ measurement value of samples stored at either 23°C for a minimum of 48 hours or 4°C for a minimum of 144 hours is less than 2 C. The results demonstrated acceptable RNA stabilization at 23°C for 48 hours or 4°C for 144 hours.
3) Inactivation
Three lots of Dasky Disposable Sampling Tube (Model name: VSM02) were used for the inactivation assessment. In the experimental group, 30 µL SARS-CoV-2 virus at 1×105 Genomic Copy Equivalents (GCE)/mL (determined by real-time qPCR) was added to clinical nasopharyngeal (NP) swab specimens, collected from 9 healthy individuals who tested negative for SARS CoV-2 virus, then using the NP swab to transfer the virus sample into the Dasky Disposable Sampling Tube (Model name: VSM02), containing 3 mL media to achieve the final concentration 103 GCE/mL. In the control group, 30 µL SARS-CoV-2 virus with a titer of 1×105 GCE/mL was added to clinical NP swab specimens, collected from healthy individuals who tested negative for SARS CoV-2 virus, then using the NP swab to transfer the virus sample into 3 mL PBS (phosphoric acid buffer). The experimental group and the control group were incubated at room temperature for five (5) minutes. After 5 minutes, the samples of the experimental group and the control group were diluted 1:1000 with ultrapure water; 30 µL of diluted samples from the experimental group and control group were incubated with Vero-E6 cells (the cells were implanted in 96-well plates one day in advance, each well includes 30 µL Vero-E6 cells at 1x 105 GCE/mL), respectively. After 4 days of infection, the morphology of the cells was observed under an electron microscope to determine the cytological changes. By observing the cell morphology of the infected Vero-E6 cells, it was found that the virus in the control group could infect Vero-E6 cells. In the experimental group, the virus was inactivated and was no longer able to infect Vero-E6 cells. The intact morphology of the cells
9
K211675
could be observed under the microscope. The results for the inactivation assessment are summarized in Table 4.
| Sample type (SARS-CoV-2 virus at 1x 103 GCE/mL) | Test number | LOT No.
20100732-01 | LOT No.
21060732-02 | LOT No.
21121032-01 |
|-------------------------------------------------|-------------|------------------------|------------------------|------------------------|
| Experimental group | 1# | uninfected | uninfected | uninfected |
| | 2# | uninfected | uninfected | uninfected |
| | 3# | uninfected | uninfected | uninfected |
| Control group | 1# | infected | | |
Table 4. Virus inactivation assessment
In the inactivation assessment, three batches of media in the Dasky Disposable Sampling Tube (Model name: VSM02) were tested. For the SARS-CoV-2 virus at a titer of 103 GCE/mL, it can be 100% inactivated at a minimum of 5 minutes in the Dasky Disposable Sampling Tube (Model name: VSM02).
4) Shelf life
The Shelf-life for the Dasky Disposable Sampling Tube (Model name: VSM02) is 1 year after the date of manufacture. The stability of the Dasky Disposable Sampling Tube (Model name: VSM02) was performed using Realtime stability study on a total of 9 samples (3 lots). The item appearance inspection, pH detection, RT-PCR test, virus inactivation efficiency detection and Limit of detection are considered as the factor of evaluation.
8. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicated device (K202641).