(52 days)
Not Found
No
The device is a physical exam glove and the summary describes its material properties and testing against chemical permeation, with no mention of software, algorithms, or data processing.
No
This device is described as a non-sterile disposable glove worn for prevention of contamination, not for treating any condition or disease.
No
The device is a non-sterile disposable glove intended to prevent contamination between a patient and an examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical glove made of nitrile, intended to be worn on the hand. It is a tangible hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of Diagnostic Function: The description of the Rhino gloves does not mention any function related to testing samples or providing diagnostic information. Its purpose is purely protective.
Therefore, the Rhino Non-Sterile Powder-Free Nitrile Exam Gloves are classified as a medical device, but not specifically as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 |
| Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 |
| Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 43.2 |
| Fentanyl Tested as Follows: | ||
| Fentanyl Citrate Injection (100 mcg/2mL) | > 240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in three sizes, extra small, small, and extra large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:
| Glove Size | Part Numbers |
|---|---|
| XS | RHI-UNB5XS100BX1 |
| S | RHI-UNB5S100BX1 |
| XL | RHI-UNB5XL100BX1 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands/Fingers of examiner
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards: ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11, ASTM D6978-05. All test parameters passed.
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
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
February 13, 2023 Rhino Health Inc. % Lisa Capote Regulatory Counsel Capote Law Firm 13818 SW 152 Street Suite 375 Miami, Florida 33177
Re: K223859
Trade/Device Name: Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, QDO Dated: December 12, 2022 Received: December 23, 2022
Dear Lisa Capote:
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); 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.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223859
Device Name
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl.
Indications for Use (Describe)
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are as follows:
| Chemotherapy Drug | Concentration | Minimum Breakthrough Detection Time | |
|---|---|---|---|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 | |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 | |
| Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 | |
| Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 | |
| Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 | |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 | |
| Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 | |
| Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 | |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 43.2 | |
| Fentanyl Tested as Follows: | |||
| Fentanyl Citrate Injection (100 mcg/2mL) | > 240 |
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
510(K): K223859
Date Prepared: 02/13/2023
I. Submitter:
| Company Name: | Rhino Health Inc. |
|---|---|
| Establishment Reg. No: | 3014572471 |
| Address: | 309A East, Route 66 |
| Church Rock, New Mexico 87311 | |
| Phone Number: | 1-833-898-8989 |
| Contact Person: | Mark Lee |
| Title: | CEO |
| Phone Number: | 1-833-898-8989 |
| Fax Number: | N/A |
| Email Address: | MLee@RhinoHealth.net |
II. Device
| Type of 510(k): | Traditional |
|---|---|
| Proprietary Name: | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color |
| Tested for Use with Chemotherapy Drugs and Fentanyl | |
| Common Name: | Polymer Patient Examination Glove |
| Trade Name: | |
| Classification Name: | Non-Powdered Patient Examination Glove |
| Review Panel: | General Hospital |
| Product Code: | LZA, LZC, OPJ, QDO |
| Regulatory Class: | Class 1, reserved |
| Regulation Number: | 21 CFR 880.6250 |
III. Predicate Device
| Applicant | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Rhino Health, Inc | Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl | K221082 | November 30, 2022 |
4
IV. Device Description
Rhino Non-sterile Powder-Free Nitrile Exam Glove - Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are offered in three sizes, extra small, small, and extra large. The color for all sizes is periwinkle. The model number is RHI-UNB5 with specific part sizes based on size as follows:
| Glove Size | Part Numbers |
|---|---|
| XS | RHI-UNB5XS100BX1 |
| S | RHI-UNB5S100BX1 |
| XL | RHI-UNB5XL100BX1 |
V. Intended Use/Indications for Use:
Rhino Non-Sterile Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl is non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner
| Chemotherapy Drug | Concentration | Minimum Breakthrough
Detection Time |
|-----------------------------|-------------------------|----------------------------------------|
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 14.2 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | (20 mg/mL 20,000 ppm) | > 240 |
| Dacarbazine | (10 mg/mL 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride | (2.0 mg/mL 2,000 ppm) | > 240 |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | > 240 |
| Flurouracil | (50.0 mg/mL 50,000 ppm) | > 240 |
| Paclitaxel (Taxol) | (6.0 mg/mL 6,000 ppm) | > 240 |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 43.2 |
| Fentanyl Tested as Follows: | | |
| Fentanyl Citrate Injection | (100 mcg/2mL) | > 240 |
Test Results Follow:
Note: Carmustine and Thiotepa have extremely low permeation times of 14.2 and 43.2 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
5
VI. Comparison of Technological Characteristics with Predicate Device
| Characteristic | Standard | Subject Device
K223859 | Predicate Device
K221082 | Comparison |
|----------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name &
Model: | | Non-sterile, Powder-Free
Nitrile Exam Glove
Model: RHI-UNB5 | Non-sterile, Powder-Free
Nitrile Exam Glove
Model: RHI-UNB5 | Identical |
| 510(k) Number: | | K223859 | K221082 | Different |
| Product Codes: | | LZA, LZC, OPJ, QDO | LZA, LZC, OPJ, QDO | Identical |
| Regulation Number: | | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Regulation Class: | | Class I | Class I | Identical |
| Sterile vs. Non-Sterile: | | Non-Sterile | Non-Sterile | Identical |
| Prescription or OTC: | | OTC | OTC | Identical |
| Single-use Disposable: | | Yes | Yes | Identical |
| Intended Use: | N/A | This device is a non-sterile
disposable device intended
for medical purposes that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner. | This device is a non-sterile
disposable device intended
for medical purposes that
is worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner. | Identical |
| Indications for Use: | N/A | Rhino Non-Sterile Powder-
Free Nitrile Exam Gloves –
Periwinkle Color Tested
for Use with
Chemotherapy Drugs and
Fentanyl is non-sterile
disposable device intended
for medical purposes that is
worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner. The
tested chemotherapy drugs
are as follows:
Carmustine (BCNU)
(3.3mg/mL 3,300 ppm)
14.2
Cisplatin (1.0 mg/mL
1,000 ppm) > 240
Cyclophosphamide
(Cytoxan) (20 mg/mL
20,000 ppm) > 240
Dacarbazine (10 mg/mL
10,000 ppm) > 240
Doxorubicin
Hydrochloride (2.0 mg/mL
2,000 ppm) > 240
Etoposide (Toposar) (20.0 | Rhino Non-Sterile
Powder-Free Nitrile Exam
Gloves - Periwinkle Color
Tested for Use with
Chemotherapy Drugs and
Fentanyl is non-sterile
disposable device intended
for medical purposes that
is worn on the examiner's
hand or finger to prevent
contamination between
patient and examiner. The
tested chemotherapy drugs
are as follows:
Carmustine (BCNU)
(3.3mg/mL 3,300 ppm)
14.2
Cisplatin (1.0 mg/mL
1,000 ppm) > 240
Cyclophosphamide
(Cytoxan) (20 mg/mL
20,000 ppm) > 240
Dacarbazine (10 mg/mL
10,000 ppm) > 240
Doxorubicin
Hydrochloride (2.0
mg/mL 2,000 ppm) > 240
Etoposide (Toposar) (20.0 | Identical |
| | | mg/mL 20,000 ppm) > 240 | mg/mL 20,000 ppm) > 240 | |
| | | Flurouracil (50.0 mg/mL
50,000 ppm) > 240
Paclitaxel (Taxol) (6.0
mg/mL 6,000 ppm) > 240
Thiotepa(10.0 mg/mL
10,000 ppm) 43.2
Fentanyl Tested as
Follows:
Fentanyl Citrate Injection
(100 mcg/2mL) > 240
Note: Carmustine and
Thiotepa have extremely
low permeation times of
14.2 and 43.2 minutes
respectively.
Warning: Do Not Use with
Carmustine, Thiotepa | 240
Flurouracil (50.0 mg/mL
50,000 ppm) > 240
Paclitaxel (Taxol) (6.0
mg/mL 6,000 ppm) > 240
Thiotepa(10.0 mg/mL
10,000 ppm) 43.2
Fentanyl Tested as
Follows:
Fentanyl Citrate Injection
(100 mcg/2mL) > 240
Note: Carmustine and
Thiotepa have extremely
low permeation times of
14.2 and 43.2 minutes
respectively.
Warning: Do Not Use
with Carmustine, Thiotepa | |
| Caution/Warning | N/A | WARNING – Not for | WARNING – Not for | Identical |
| Statements: | | use with Carmustine | use with Carmustine | |
| | | and Thiotepa | and Thiotepa | |
| | | | | |
| Dimensions: Overall | ASTM D6319 | X-Small: 239 mm | X-Small: N/A | |
| Length: | Minimum: | Small: 235 mm | Small: N/A | Similar |
| | XS: 220 mm | Medium: N/A | Large: 235 mm | |
| | S: 220 mm | Large: N/A | Medium: 230 mm | |
| | | X-Large: 237 mm | X-Large: N/A | |
| Dimensions: Palm | XL: 230 mm
ASTM D6319 | | | |
| Width (mm): | Minimum: | | | |
| | XS: 70 ± 10 | | | |
| | S: 80 ± 10 | XS: 80 | XS: N/A | Similar |
| | M: 95 ± 10 | S: 85 | S: N/A | |
| | L: 110 ± 10 | M: N/A
L: N/A | M: 90 - 100
L: 103 - 113 | |
| | XL: 120 ± 10 | XL: 112 | XL: N/A | |
| | | | | |
| Dimensions: Palm &
Finger Thickness | ASTM D6319
Minimum | XS: | | |
| (mm): | Palm: 0.05 | Palm: 0.07 mm | XS: N/A | Similar |
| | Finger: 0.05 | Finger: 0.11 mm | S: N/A | |
| | | Small: | Medium:
Palm: 0.07 mm | |
| | | Palm: 0.06 mm | Finger: 0.10 mm | |
| | | Finger: 0.11 mm | Large: | |
| | | M: N/A | Palm: 0.07 mm | |
| | | L: N/A
XL: | Finger: 0.10 mm | |
| | | Palm: 0.07 mm | XL: N/A | |
| | | Finger: 0.11 mm | | |
| | | | | |
| Tensile strength: | ASTM D6319 | XS: | XS: N/A | |
| Before & After aging: | Min. Before: | Before: 35.9 MPa | S: N/A | Similar |
| | 14MPa After: | After: 38.7 MPa | Medium: | |
| | 14MPa | S: | Before: 40.9 MPa | |
6
7
| | | | Before: 33.7 MPa
After: 35.5 MPa
M: N/A
L: N/A
XL:
Before: 31.1 MPa
After: 34.1 MPa | After: 35.5 MPa
Large:
Before: 33.4 MPa
After: 39.0 MPa
XL: N/A | | |
|----------------------------------------------|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Ultimate elongation
Before & After aging: | ASTM D6319
Minimum:
Before: 500%
After: 400% | XS:
Before: 535%
After: 523%
S:
Before: 535%
After: 520%
M: N/A
L: N/A
XL:
Before: 535%
After: 520% | XS: N/A
S: N/A
Medium:
Before: 550%
After: 510%
Large:
Before: 520%
After: 520%
XL: N/A | Similar | | |
| Freedom from holes: | ASTM D6319
G1, AQL 2.5 | Pass
XS: No leakers in 50
S: 3 leakers in 100
XL: No leakers in 50 | Pass
Medium: 2 leakers in 50
3 leakers in 100
Large: 4 leakers in 50
4 leakers in 100
4 leakers in 150 | Similar | | |
| Powder-Free | ASTM D6319
Maximum
240
min on all three (3) specimens. | All drugs,
except
Carmustine and
Thiotepa, had
permeation time
of > 20 minutes.
Carmustine
permeation time
was 14.2
minutes and
Thiotepa
permeation time
was 43.2
minutes |
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6978-05(2019), Standard Practice for Assessment of Resistance of Medical ● Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices - Part11:Tests for Systemic Toxicity
VIII. Clinical Studies
No clinical study is included in this submission.
10
IX. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the Subject Device is as safe, as effective, and performs as well as or better than the legally marketed Predicate Device.