(89 days)
Not Found
No
The 510(k) summary describes a physical surgical gown made of standard materials, with no mention of software, data processing, or any technology related to AI or ML.
No.
The device, a surgical gown, is intended to protect against the transfer of microorganisms, body fluids, and particulate matter, not to treat or diagnose a disease or condition.
No
Explanation: The device described is a surgical gown, which is a protective barrier worn during surgical procedures. Its intended use is to prevent the transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device described is a physical surgical gown made of non-woven materials and cotton, with specific sizes and barrier properties. It is a tangible, disposable medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the surgical gowns are for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description focuses on the materials, construction, and barrier performance (Level 3 classification). There is no mention of analyzing samples from the human body or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
- Using reagents or calibrators
The device is a protective barrier intended for use in a surgical setting, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
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
operating room personnel / operating room
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 subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
The tests performed include:
- Seam strength (ASTM D1683M-17): The test was performed in accordance with ASTM D1683M-17 Standard. Test Method for Seam Strength of Textile Fabrics (Grab Test) to evaluate Failure in Sewn Seams of the test sample. Acceptance Criteria: ≥30N(7lbf) per standard F2407-20 for level 3. Result: PASS (59.21 N, average from 30 samples).
- Breaking strength (ASTM D5034-09 (2017)): The test was performed in accordance with D5034-09 (2017). Standard. Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) to evaluate the breaking strength of the test sample. Acceptance Criteria: ≥ 30N(7lbf) per standard F2407-20 for level 3. Result: PASS (MD: 144.87N, CD: 88.89N, average from 30 samples).
- Tear strength (ASTM D5587-15): The test was performed in accordance with ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure to evaluate the tearing strength of the test sample. Acceptance Criteria: ≥ 10N. Result: PASS (MD: 69.61N, CD: 32.25N, average from 30 samples).
- Lint and other generation in the dry state (ISO 9073-10:2003(E)): The test was performed in accordance with ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State to evaluate the linting of the test sample. Acceptance Criteria: Log10(particle count)
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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.
August 22, 2023
Xiantao Zhibo Non-Woven Products Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K231510
Trade/Device Name: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXL,XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: April 25, 2023 Received: May 25, 2023
Dear Jarvis Wu:
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) K231510
Device Name Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S.M.L.XL.XXL.XXXL)
Indications for Use (Describe)
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
| 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 K231510
Document prepared date: 2023/8/22
A. Applicant:
Name: XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD. Address: No.8 Hefeng Industrial Park, Pengchang Town, Xiantao City, Hubei Province, China. Contact Person: Fen Peng Tel: +86 18872609993 Mail: 260993463@qq.com Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Gown, Reinforced Surgical Gown Common Name: Surgical Gown Model(s): S, M, L, XL, XXL, XXXL Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K212861 Surgical Gown, Reinforced Surgical Gown Wuhan Zonsen Medical Products Co.,Ltd
D. Intended use/Indications for use:
The Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
4
XIANTAO ZHIBO NON-WOVEN PRODUCTS CO.,LTD.
No.8 Hefeng Industrial Park, Pengchang Town, Xiantao City, Hubei Province, China
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Surgical Gown and Reinforced Surgical Gown met the requirements for Level 3 classification.
E. Device Description:
The proposed device Surgical Gown its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of cotton. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes . This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed device Reinforced Surgical Gown is its body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The reinforced and critical zone is front chest and sleeves. This zone is reinforced with PP/PE composite breathable film. The proposed device is available in S(110×130cm), M(120×140cm), L(130×150cm), XL(140×160cm), XXL(150×170cm), XXXL(155×180cm) sizes. This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
The proposed devices are disposable medical devices and provided in sterile.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | XIANTAO ZHIBO NON- | ||
| WOVEN PRODUCTS CO.,LTD. | Wuhan Zonsen Medical Products | ||
| Co.,Ltd | - | ||
| 510K number | K231510 | K212861 | - |
| Model Name | Surgical Gown, | ||
| Reinforced Surgical Gown, | Surgical Gown, | ||
| Reinforced Surgical Gown, | Same | ||
| Classification | Class II Device, FYA (21 | ||
| CFR878.4040) | Class II Device, FYA | ||
| (21CFR878.4040) | Same | ||
| Intend use/ | |||
| Indications for | |||
| use | Surgical Gown is intended to be | ||
| worn by room personnel during | |||
| surgical procedures or other | |||
| invasive tests to protect both the | |||
| surgical patient and operating room | |||
| personnel from the transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. This is single | |||
| use, disposable device, provided | |||
| sterile. | Surgical Gown is intended to be | ||
| worn by room personnel during | |||
| surgical procedures or other | |||
| invasive tests to protect both the | |||
| surgical patient and operating | |||
| room personnel from the transfer | |||
| of microorganisms, body fluids | |||
| and particulate material. This is | |||
| single use, disposable device, | |||
| provided sterile. | Same | ||
| Per ANSI/AAMI PB70:2012 | |||
| Liquid barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| health care facilities, the Surgical | |||
| Gown and Reinforced Surgical | |||
| Gown met the requirements for | |||
| Level 3 classification | Per ANSI/AAMI PB70:2012 | ||
| Liquid barrier performance and | |||
| classification of protective | |||
| apparel and drapes intended for | |||
| use in health care facilities, the | |||
| surgical gown met the | |||
| requirements for Level 2 | |||
| classification, and the reinforced |
Table 1 General Comparison
5
| | | surgical gowns met the
requirements for Level 3
classification. | |
|----------|-----------------------------|-----------------------------------------------------------------------|------|
| Style | Non-reinforced/Reinforced | Non-reinforced/Reinforced | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
Table 2 Safety and Performance Comparison
| Item | Proposed Device | Predicate Device(K212861) | Remark |
|---|---|---|---|
| Weight | |||
| per | |||
| square (g) | Surgical Gown: 50g/ m2; | ||
| Reinforced Surgical Gown: 50g/ | |||
| m2 | Surgical Gown: 45g/ m2; | ||
| Reinforced Surgical Gown: 45g/ | |||
| m2 | Difference | ||
| resolved | |||
| by | |||
| performance testing | |||
| Size | S、M、L、XL、XXL、 | ||
| XXXL | M, L, XL | Different. | |
| No affect | |||
| on safety | |||
| or efficacy | |||
| Flammability | Class I | Class I | Same |
| Hydrostatic | |||
| pressure | Surgical Gown: >50 cm; | ||
| Reinforced Surgical | |||
| Gown: >50 cm | Surgical Gown: >20 cm; | ||
| Reinforced Surgical | |||
| Gown: >50 cm | Same | ||
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking | |||
| strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Seam | |||
| Strength | >30N | >30N | Same |
| EO residue | EO ≤ 4mg/d | ||
| ECH ≤ 9mg/d | EO ≤ 4mg/d | ||
| ECH ≤ 9mg/d | Same | ||
| Shelf life | 3 years | 3 years | Same |
| Barrier | |||
| protection level | Level 3 per AAMI PB 70 | Level 2 and 3 per AAMI PB 70 | Similar |
| Surgical Gown: | |||
| SMMS non-woven, Cotton, | Surgical Gown: | ||
| SMMS non-woven, Cotton, and |
6
| and Nylon | Nylon | ||
|---|---|---|---|
| Material | Reinforced Surgical Gown: | ||
| SMMS non-woven, Cotton, Polypropylene and Polyethylene | Reinforced Surgical Gown: | ||
| SMMS non-woven, Cotton, Nylon, Polypropylene and Polyethylene | Different | ||
| Sterility | Sterile | Sterile | Same |
| Biocompatibility | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Same |
Analvsis
The subject surgical gowns are substantially equivalent to the predicate device, in terms of general in tended use, performance testing, and configuration. The weight per square (g) ,size and material are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard.
Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility and performance tests have been conducted to verify the safety and effectiveness of the gowns. Under the conditions of each study, the subject surgical gowns are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.
G. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strength | |||
| ASTM D1683M- | |||
| 17 Standard Test | |||
| Method for | |||
| Failure in Sewn | |||
| Seams of Woven | |||
| Fabrics. | The test was performed | ||
| In accordance with | |||
| ASTM D1683M-17 | |||
| Standard. Test Method | |||
| for Seam Strength of | |||
| Textile Fabrics (Grab | |||
| Test) to evaluate Failure | |||
| in Sewn Seams of the test | |||
| sample. | ≥30N(7lbf) | ||
| per standard | |||
| F2407-20 for level 3 | PASS |
59.21 N
(Average result from 30
samples) |
| Breaking
strength
ASTM D5034-09
(2017)
Standard Test
Method for
Breaking Strength
and Elongation of
Textile Fabrics
(Grab Test) | The test was performed
In accordance with
D5034-09 (2017) .
Standard. Test Method
for Breaking Strength
and Elongation of Textile
Fabrics (Grab Test) to
evaluate the
breaking strength of the
test sample. | $\ge$ 30N(7lbf)
per standard
F2407-20 for level 3 | PASS
MD: 144.87N
CD: 88.89N
(Average result from 30
samples) |
| Tear strength(N)
ASTM D5587-15,
Standard Test
Method for
Tearing Strength
of Fabrics by
Trapezoid
Procedure | The test was performed
in accordance with
ASTM D5587:
2015(2019) Standard
Test Method for Tearing
Strength of Fabrics by
Trapezoid Procedure to
evaluate
the tearing strength of the
test sample. | $\ge$ 10N | PASS
MD: 69.61N
CD: 32.25N
(Average result from 30
samples) |
| Lint and other
generation in the
dry state
ISO 9073-
10:2003(E) | The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10: Lint
and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample. | Log10(particle count)
EO and ECH
sterilization
residual
ISO 10993-
7:2008
Ethylene oxide
sterilization
residuals | The test was performed
in accordance with ISO
10993-7:2008
Ethylene oxide
sterilization residuals to
determine the EO and
ECH residuals of the test
sample. | $EO \le 4mg/d$
$ECH \le 9mg/d$ | PASS
$EO \le 4mg/d$
$ECH \le 9mg/d$ |
| Cytotoxicity
ISO 10993-5
Biological
evaluation of
medical devices
— Part 5: Tests
for in vitro
cytotoxicity | The test was performed
in accordance with ISO
10993-10 to determine
cytotoxicity of the test
sample | Non-Cytotoxic | PASS
Under the conditions of the
study, the device is non-
cytotoxic. |
| Irritation
ISO 10993-10
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And
Skin Sensitization | The test was performed
in accordance with ISO
10993-5 to determine
Irritation of the test
sample | Non-Irritating | PASS
Under the conditions of the
study, the device is non-
irritating. |
| Sensitization
ISO 10993-10
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And
Skin Sensitization | The test was performed
in accordance with ISO
10993-10 to determine
skin sensitization of the
test sample | Non-Sensitizing | PASS
Under the conditions of the
study, the device is non-
sensitizing |
7
8
H. Summary of Clinical Test
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device under K212861.