(611 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of the transport medium for preserving viral samples, with no mention of AI or ML technologies.
No
The device is described as a collection and transport system for clinical specimens containing respiratory viruses, intended for testing laboratories. It does not provide treatment or mitigation for a disease or condition.
No
The device is a transport medium for specimens, not a diagnostic device itself. It aids in the collection and safe transportation of samples for an eventual test, but it does not perform the diagnosis.
No
The device description clearly indicates it is a physical system including transport medium and collection swabs, not software.
Based on the provided information, the MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection and transport of upper respiratory clinical specimens, containing respiratory viruses, from the collection site to the testing laboratory." This is a key function in the process of diagnosing viral infections.
- Device Description: The description highlights its role in aiding "in the collection and safe transportation of biological samples that will be tested for viruses." This directly relates to the diagnostic process.
- Function: The medium is designed to "sustain infectivity of a plurality of clinically important viruses during transit to the testing laboratory," which is crucial for subsequent diagnostic testing (like culture-based methods mentioned in the intended use).
- Performance Studies: The performance studies described are focused on "Viral recovery studies," which are conducted to demonstrate the device's ability to maintain the integrity of the sample for diagnostic testing.
- Predicate Device: The predicate device listed, K042970; Copan Universal Transport Medium (UTM-RT) System, is also a transport medium for clinical specimens, and such devices are typically classified as IVDs.
While the device itself doesn't perform the diagnostic test, it is an essential component in the pre-analytical phase of an in vitro diagnostic procedure. It's designed to prepare and transport the sample in a way that allows for accurate and reliable diagnostic testing to be performed in a laboratory setting.
N/A
Intended Use / Indications for Use
MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is intended for the collection and transport of upper respiratory clinical specimens, contaming respiratory viruses, from the collection site to the testing laboratory.
MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System is a culture-based medium that can be processed using standard clinical laboratory operating procedures for the recovery of infectious viral particles.
Product codes
JSM
Device Description
The MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System ("MedSchenker STM") aids in the collection and safe transportation of biological samples that will be tested for viruses. MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System provides a universal transport medium for viruses. MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System includes a universal transporting medium that is room temperature stable, which can sustain infectivity of a plurality of clinically important viruses during transit to the testing laboratory. The formulation of the STM includes protein for stabilization, antimicrobial agents to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
The MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is provided in labeled, screw-cap tubes designed for transport of the clinical sample. MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is also supplied as a sample collection kit that contains one screw-cap tube of STM-RT (room-temperature stable) medium and a peel pouch that contains a sterile specimen-collection swab.
- 1 screw-cap tube containing 1.5mL/2.0mL/3mL of transport medium
- One sterile specimen-collection swab
Configurations to be marketed:
| SKU | STM Tube Description | Pack size |
|---|---|---|
| STM15-A | 1.5 mL Screw cap with Tube | 50 Qty |
| STM20-A | 2.0 mL Screw cap with Tube | 50 Qty |
| STM30-A | 3.0 mL Screw cap with Tube | 50 Qty |
| SCS30-A | 3.0 mL Screw cap with Tube + Nasopharyngeal CavSwab Swabs | 50 Qty |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory
Indicated Patient Age Range
Not Found
Intended User / Care Setting
collection site to the testing laboratory.
standard clinical laboratory operating procedures
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)
Performance Study Type: Viral recovery studies
Sample Size: Not explicitly stated as a single total number for all tests; individual viral strains tested with 3 replicates for each condition (duration, temperature, media lot).
Data Source: Strains of HSV-1, HSV-2, VZV, Flu A, and Adenovirus mixed with negative nasopharyngeal clinical matrix.
Annotation Protocol: Viral viability assessed via cytopathic effects (CPE) using the MTT assay. Viral recovery represented as TCID50/mL and percent change over time.
Key Results:
- HSV-1, HSV-2, and Adenovirus: Demonstrated recovery in all replicates at tested incubation times and storage conditions (4-8°C or 20-25°C) for up to 72 hours.
- VZV and Flu A: Demonstrated recovery in all replicates at refrigerated (4-8°C) or room temperature (20-25°C), up to 24 hours.
- Mycoplasma: Data was insufficient to support use of this medium for transport of specimens for mycoplasma testing.
Specific Recovery Data:
HSV-1
- 0 hours: 4.77 x 10^5 (4-8°C), 4.28 x 10^5 (20-25°C)
- 24 hours: 4.18 x 10^5 (-12.40% at 4-8°C), 2.87 x 10^5 (-32.91% at 20-25°C)
- 48 hours: 3.20 x 10^5 (-32.89% at 4-8°C), 4.09 x 10^5 (-4.47% at 20-25°C)
- 72 hours: 3.32 x 10^5 (-30.30% at 4-8°C), 2.71 x 10^5 (-36.57% at 20-25°C)
HSV-2
- 0 hours: 1.49 x 10^5 (4-8°C), 1.52 x 10^5 (20-25°C)
- 24 hours: 1.45 x 10^5 (-2.88% at 4-8°C), 1.24 x 10^5 (-18.60% at 20-25°C)
- 48 hours: 1.54 x 10^5 (+3.78% at 4-8°C), 1.26 x 10^5 (-14.35% at 20-25°C)
- 72 hours: 7.56 x 10^4 (-49.24% at 4-8°C), 8.13 x 10^4 (-46.55% at 20-25°C)
Adenovirus
- 0 hours: 1.11 x 10^5 (4-8°C), 1.03 x 10^5 (20-25°C)
- 24 hours: 9.95 x 10^4 (-10.72% at 4-8°C), 1.00 x 10^5 (-2.57% at 20-25°C)
- 48 hours: 9.26 x 10^4 (-16.89% at 4-8°C), 8.76 x 10^4 (-14.62% at 20-25°C)
- 72 hours: 7.87 x 10^4 (-29.33% at 4-8°C), 5.97 x 10^4 (-41.77% at 20-25°C)
VZV
- 0 hours: 1.23 x 10^6 (4-8°C), 1.08 x 10^6 (20-25°C)
- 24 hours: 4.33 x 10^5 (-64.85% at 4-8°C), 1.43 x 10^6 (+32.13% at 20-25°C)
Influenza A
- 0 hours: 7.11 x 10^6 (4-8°C), 5.52 x 10^6 (20-25°C)
- 24 hours: 5.79 x 10^6 (-18.57% at 4-8°C), 2.21 x 10^6 (-60% at 20-25°C)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.2390 Transport culture medium.
(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 3, 2023
MedSchenker, Inc. % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, Virginia 23456
Re: K212743
Trade/Device Name: MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: Class I, reserved Product Code: JSM Dated: December 16, 2022 Received: December 19, 2022
Dear Rhonda Alexander:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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 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.
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212743
Device Name
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
Indications for Use (Describe)
MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is intended for the collection and transport of upper respiratory clinical specimens, contaming respiratory viruses, from the collection site to the testing laboratory.
MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System is a culture-based medium that can be processed using standard clinical laboratory operating procedures for the recovery of infectious viral particles.
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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510(k) Summary
Date Prepared: April 25, 2023
1. SUBMITTER
MedSchenker Inc. 10 Industrial Ave Suite 4 Mahwah NJ. 07430 USA Tel: +1 201 458 9835 E-mail: info@medschenker.com Website: www.medschenker.com
Contact Person: Dr. Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC PO Box 56436 Virginia Beach, VA 23456 Tel: +1-757-582-4337 Email: ralexander(@juvoconsulting.com Website: www.iuvoconsulting.com
2. DEVICE
| Name of Device: | MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/
SCS30-A) System |
|----------------------|---------------------------------------------------------------------------------|
| Classification Name: | Culture Media, Non-Propagating Transport |
| Regulatory Class: | Class I |
| Product Code: | JSM |
| Regulation: | 21 CFR 866.2390 |
3. PREDICATE DEVICE
Copan Universal Transport Medium (UTM-RT) System (K042970) Manufacturer: Copan Diagnostics Inc.
4. DEVICE DESCRIPTION
The MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System ("MedSchenker STM") aids in the collection and safe transportation of biological samples that will be tested for viruses. MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System provides a universal transport medium for viruses. MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System includes a universal transporting medium that is room temperature stable, which can sustain infectivity of a plurality of clinically important viruses during transit to the testing laboratory. The formulation of the STM includes protein for stabilization, antimicrobial agents to minimize bacterial and fungal contamination, and a buffer to maintain a neutral pH.
The MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is provided in labeled, screw-cap tubes designed for transport of the clinical sample. MedSchenker Smart Transport Medium (STM15-A/STM20-A/SCS30-A) System is also supplied as a sample collection kit that
4
contains one screw-cap tube of STM-RT (room-temperature stable) medium and a peel pouch that contains a sterile specimen-collection swab.
- . 1 screw-cap tube containing 1.5mL/2.0mL/3mL of transport medium
- One sterile specimen-collection swab ●
Configurations to be marketed:
| SKU | STM Tube Description | Pack size |
|---|---|---|
| STM15-A | 1.5 mL Screw cap with Tube | 50 Qty |
| STM20-A | 2.0 mL Screw cap with Tube | 50 Qty |
| STM30-A | 3.0 mL Screw cap with Tube | 50 Qty |
| SCS30-A | 3.0 mL Screw cap with Tube + | |
| Nasopharyngeal CavSwab Swabs | 50 Qty |
5. INDICATIONS FOR USE
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System is intended for the collection and transport of upper respiratory clinical specimens, containing respiratory viruses, from the collection site to the testing laboratory.
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System is a culture-based medium that can be processed using standard clinical laboratory operating procedures for the recovery of infectious viral particles.
6. SUMMARY OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices have the following similarities and differences:
5
| Device & Predicate Device(s): | Subject: K212743 | Predicate: K042970 |
|---|---|---|
| Device Trade Name | MedSchenker Smart Transport | |
| Medium (STM15-A/STM20- | ||
| A/STM30-A/SCS30-A) System | Copan Universal Transport Medium | |
| (UTM-RT) System | ||
| General Device Characteristic | ||
| Similarities | ||
| Intended Use/Indications For Use | MedSchenker Smart Transport | |
| Medium (STM15-A/STM20- | ||
| A/STM30-A/SCS30-A) System is | ||
| intended for the collection and | ||
| transport of upper respiratory clinical | ||
| specimens, containing respiratory | ||
| viruses, from the collection site to the | ||
| testing laboratory. MedSchenker Smart | ||
| Transport Medium (STM15- | ||
| A/STM20-A/STM30-A/SCS30-A) | ||
| System is a culture-based medium that | ||
| can be processed using standard | ||
| clinical laboratory operating | ||
| procedures for the recovery of | ||
| infectious viral particles. | Copan Universal Transport Medium | |
| (UTM-RT) System is intended for the | ||
| collection and transport of clinical | ||
| specimens containing viruses, | ||
| chlamydiae, mycoplasma or | ||
| ureaplasma from the collection site to | ||
| the testing laboratory. UTM-RT can be | ||
| processed using standard clinical | ||
| laboratory operating procedures for | ||
| viral, chlamydial, mycoplasma and | ||
| ureaplasma culture. | ||
| Media formulation | Amphotericin B | |
| Bovine Serum Albumin | ||
| Hank's Balanced Salt Solution | ||
| Vancomycin | ||
| Colistin | ||
| Gelatin | ||
| HEPES | ||
| L-cysteine | ||
| L-glutamic acid | ||
| Phenol Red | ||
| Sucrose | Same | |
| Container for medium | Plastic, conical bottom | Same |
| Product configuration | Medium Tubes; Kit with Medium | |
| Tubes and | ||
| Swab Option | Same | |
| Storage Temperature | 2 - 25℃ (refrigerated and room | |
| temperature) | Same | |
| Shelf Life | 12 months | Same |
| Single Use | Yes | Same |
| General Device Characteristic | ||
| Differences | ||
| Microorganisms Supported | Viruses: | |
| Influenza A (H1N1) | ||
| Type 5 Adenovirus | ||
| Herpes Simplex 1 | ||
| Herpes Simplex 2 | ||
| Varicella-Zoster Virus | Viruses: | |
| Adenovirus | ||
| Cytomegalovirus (CMV) | ||
| Echovirus Type 30 (Echo 30) | ||
| Herpes Simplex Virus Type 1 (HSV1) | ||
| HSV2 | ||
| Influenza A | ||
| Parainfluenza Type 3 | ||
| Respiratory Syncytial Virus (RSV) | ||
| Varicella Zoster Virus (VZV) | ||
| Chlamydiae: | ||
| Chlamydia pneumoniae Strain CM-1 | ||
| Chlamydia trachomatis Type 1 Strain | ||
| Mycoplasma: | ||
| Mycoplasma hominis | ||
| Mycoplasma pneumoniae | ||
| Ureaplasma: | ||
| Ureaplasma urealyticum | ||
| pH Stability | 7.3 ± 0.5 maintained up to 12 months | 7.3 ± 0.2 maintained up to 12 months |
| Swab material | Nylon tip with break point | Polyester |
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7. PERFORMANCE DATA
The following performance study data were provided in support of the substantial equivalence determination.
Viral recovery studies. Strains of HSV-1, HSV-2, VZV, Flu A, and Adenovirus were used for transport media validation. Each viral strain was mixed with negative nasopharyngeal clinical matrix, followed by a 1:2 dilution with 0.85% saline to obtain diluted viral samples for testing. CavSwabs were used to soak up 100 uL of each concentration of viruses in three replicates. Three replicates of the inoculated swabs were then transferred into tubes with the MedSchenker STM, one swab per tube, and incubated at room temperature (20-25°C) or refrigerated (4-8°C) for 0, 24, 48, and 72 hours for HSV-1, HSV-2, and Adenovirus, and for 0 and 24 hours for Flu A and VZV. Each time point was assessed using 3 lots of media. After each time point, the swabs were centrifuged and then removed from the transport media tube and a 50 uL aliquot of the test suspension was seeded onto the appropriate host cell monolaver and incubated at 37℃ (5% CO2) for 3-5 days. Viral viability was assessed via cytopathic effects (CPE) using the MTT assay. The table below shows the summary and recovery of the 1:2 dilution of each viral strain at the indicated times and temperatures. Viral recovery is represented as TCID50 mL and percent change over time.
| 4-8°C | 20-25°C | ||||
|---|---|---|---|---|---|
| Viral strains | Duration | ||||
| (hours) | TCID50/mL | Percent change (%) | |||
| (-ve indicates reduction) | TCID50/mL | Percent change (%) | |||
| (-ve indicates reduction) | |||||
| HSV-1 | 0 | 4.77 x 105 | 0 | 4.28 x 105 | 0 |
| 24 | 4.18 x 105 | -12.40 | 2.87 x 105 | -32.91 | |
| 48 | 3.20 x 105 | -32.89 | 4.09 x 105 | -4.47 | |
| 72 | 3.32 x 105 | -30.30 | 2.71 x 105 | -36.57 | |
| HSV-2 | 0 | 1.49 x 105 | 0 | 1.52 x 105 | 0 |
| 24 | 1.45 x 105 | -2.88 | 1.24 x 105 | -18.60 | |
| 48 | 1.54 x 105 | +3.78 | 1.26 x 105 | -14.35 | |
| 72 | 7.56 x 104 | -49.24 | 8.13 x 104 | -46.55 | |
| Adenovirus | 0 | 1.11 x 105 | 0 | 1.03 x 105 | 0 |
| 24 | 9.95 x 104 | -10.72 | 1.00 x 105 | -2.57 | |
| 48 | 9.26 x 104 | -16.89 | 8.76 x 104 | -14.62 | |
| 72 | 7.87 x 104 | -29.33 | 5.97 x 104 | -41.77 | |
| VZV | 0 | 1.23 x 106 | 0 | 1.08 x 106 | 0 |
| 24 | 4.33 x 105 | -64.85 | 1.43 x 106 | +32.13 |
Summary of recovered viral viability at 4-25°C
7
| Influenza A | 0 | 7.11 x 106 | 0 | 5.52 x 106 | 0 |
|---|---|---|---|---|---|
| 24 | 5.79 x 106 | -18.57 | 2.21 x 106 |
Conclusion of the culture-based viral recovery study: The MedSchenker STM demonstrated the recovery of HSV-1, HSV-2, and Adenovirus in all replicates at tested incubation times and storage conditions. These data support the transportation of HSV-1, HSV-2, and Adenovirus in MedSchenker STM at refrigerated (4-8°C) or room temperature (20-25°C) for up to 72 hours.
The MedSchenker STM also demonstrated the recovery of VZV and Flu A in all replicates at refrigerated (4-8°C) or room temperature (20-25°C), up to 24 hours.
The MedSchenker STM was also evaluated for mycoplasma viability at different incubation times and temperatures. Data was insufficient to support use of this medium for transport of specimens for mycoplasma testing
8. CONCLUSION
Based on the indications for use, technological characteristics, safety, and performance testing, the subject device, the MedSchenker Smart Transport Medium (STM15-A/STM30-A/SCS30-A) System, meets the requirements that are considered essential for its intended use and supports a decision of substantial equivalence to a legally marketed device.