Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)

K231510 · Xiantao Zhibo Non-Woven Products Co., Ltd. · FYA · Aug 22, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231510
• Device Name: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL)
• Applicant: Xiantao Zhibo Non-Woven Products Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Aug 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

Surgical Gown and Reinforced Surgical Gown; protective apparel for operating room personnel. Body, sleeve, and belt constructed from SMMS non-woven material; cuffs made of cotton. Reinforced version includes PP/PE composite breathable film on front chest and sleeves. Available in sizes S through XXXL. Device acts as physical barrier to microorganisms, body fluids, and particulate matter. Used in clinical settings during surgical procedures. Meets ANSI/AAMI PB70:2012 Level 3 liquid barrier performance. Provided sterile; single-use, disposable.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D1683M-17 (seam strength), ASTM D5034-09 (breaking strength), ASTM D5587-15 (tear strength), ISO 9073-10 (linting), 16 CFR 1610 (flammability), AATCC 42 (water impact), and AATCC 127 (hydrostatic pressure). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Materials: SMMS non-woven, cotton cuffs, PP/PE composite film (reinforced version). Barrier performance: ANSI/AAMI PB70:2012 Level 3. Sterilization: Ethylene Oxide (EO). Standards: ASTM D5587-15, ASTM D5034-09, ASTM D1683/D1683M-17, ISO 10993, AATCC 42, AATCC 127.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and staff from transfer of microorganisms, body fluids, and particulate matter. Single-use, disposable, sterile device.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Gown, Reinforced Surgical Gown (K212861)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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: [phone] Mail: [e-mail] Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### 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-<br>WOVEN PRODUCTS CO.,LTD. | Wuhan Zonsen Medical Products<br>Co.,Ltd | - |
| 510K number | K231510 | K212861 | - |
| Model Name | Surgical Gown,<br>Reinforced Surgical Gown, | Surgical Gown,<br>Reinforced Surgical Gown, | Same |
| Classification | Class II Device, FYA (21<br>CFR878.4040) | Class II Device, FYA<br>(21CFR878.4040) | Same |
| Intend use/<br>Indications for<br>use | Surgical Gown is intended to be<br>worn by room personnel during<br>surgical procedures or other<br>invasive tests to protect both the<br>surgical patient and operating room<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material. This is single<br>use, disposable device, provided<br>sterile. | Surgical Gown is intended to be<br>worn by room personnel during<br>surgical procedures or other<br>invasive tests to protect both the<br>surgical patient and operating<br>room personnel from the transfer<br>of microorganisms, body fluids<br>and particulate material. This is<br>single use, disposable device,<br>provided sterile. | Same |
| | Per ANSI/AAMI PB70:2012<br>Liquid barrier performance and<br>classification of protective apparel<br>and drapes intended for use in<br>health care facilities, the Surgical<br>Gown and Reinforced Surgical<br>Gown met the requirements for<br>Level 3 classification | Per ANSI/AAMI PB70:2012<br>Liquid barrier performance and<br>classification of protective<br>apparel and drapes intended for<br>use in health care facilities, the<br>surgical gown met the<br>requirements for Level 2<br>classification, and the reinforced | |

## Table 1 General Comparison

{5}------------------------------------------------

| | | surgical gowns met the<br>requirements for Level 3<br>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<br>per<br>square (g) | Surgical Gown: 50g/ m2;<br>Reinforced Surgical Gown: 50g/<br>m2 | Surgical Gown: 45g/ m2;<br>Reinforced Surgical Gown: 45g/<br>m2 | Difference<br>resolved<br>by<br>performance testing |
| Size | S、M、L、XL、XXL、<br>XXXL | M, L, XL | Different.<br>No affect<br>on safety<br>or efficacy |
| Flammability | Class I | Class I | Same |
| Hydrostatic<br>pressure | Surgical Gown: >50 cm;<br>Reinforced Surgical<br>Gown: >50 cm | Surgical Gown: >20 cm;<br>Reinforced Surgical<br>Gown: >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking<br>strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Seam<br>Strength | >30N | >30N | Same |
| EO residue | EO ≤ 4mg/d<br>ECH ≤ 9mg/d | EO ≤ 4mg/d<br>ECH ≤ 9mg/d | Same |
| Shelf life | 3 years | 3 years | Same |
| Barrier<br>protection level | Level 3 per AAMI PB 70 | Level 2 and 3 per AAMI PB 70 | Similar |
| | Surgical Gown:<br>SMMS non-woven, Cotton, | Surgical Gown:<br>SMMS non-woven, Cotton, and | |

{6}------------------------------------------------

| | and Nylon | Nylon | |
|------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------|
| Material | Reinforced Surgical Gown:<br>SMMS non-woven, Cotton, Polypropylene and Polyethylene | Reinforced Surgical Gown:<br>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<br>ASTM D1683M-<br>17 Standard Test<br>Method for<br>Failure in Sewn<br>Seams of Woven<br>Fabrics. | The test was performed<br>In accordance with<br>ASTM D1683M-17<br>Standard. Test Method<br>for Seam Strength of<br>Textile Fabrics (Grab<br>Test) to evaluate Failure<br>in Sewn Seams of the test<br>sample. | ≥30N(7lbf)<br>per standard<br>F2407-20 for level 3 | PASS<br><br>59.21 N<br><br>(Average result from 30<br>samples) |
| Breaking<br>strength<br>ASTM D5034-09<br>(2017)<br>Standard Test<br>Method for<br>Breaking Strength<br>and Elongation of<br>Textile Fabrics<br>(Grab Test) | The test was performed<br>In accordance with<br>D5034-09 (2017) .<br>Standard. Test Method<br>for Breaking Strength<br>and Elongation of Textile<br>Fabrics (Grab Test) to<br>evaluate the<br>breaking strength of the<br>test sample. | $\ge$ 30N(7lbf)<br>per standard<br>F2407-20 for level 3 | PASS<br>MD: 144.87N<br>CD: 88.89N<br>(Average result from 30<br>samples) |
| Tear strength(N)<br>ASTM D5587-15,<br>Standard Test<br>Method for<br>Tearing Strength<br>of Fabrics by<br>Trapezoid<br>Procedure | The test was performed<br>in accordance with<br>ASTM D5587:<br>2015(2019) Standard<br>Test Method for Tearing<br>Strength of Fabrics by<br>Trapezoid Procedure to<br>evaluate<br>the tearing strength of the<br>test sample. | $\ge$ 10N | PASS<br>MD: 69.61N<br>CD: 32.25N<br>(Average result from 30<br>samples) |
| Lint and other<br>generation in the<br>dry state<br>ISO 9073-<br>10:2003(E) | The test was performed<br>in accordance with ISO<br>9073-10: 2003 Textiles-<br>Test Methods for<br>Nonwovens-Part 10: Lint<br>and Other Particles<br>Generation in the Dry<br>State to evaluate the<br>linting of the test<br>sample. | Log10(particle count)<br>< 4 | PASS<br>1.9<br>(Average result from 6<br>samples ) |
| Flammability<br>CPSC 16 CFR<br>Part<br>1610-2008,<br>Standard for the<br>Flammability of<br>clothing textiles | The test was performed<br>in accordance with 16<br>CFR Part 1610<br>Standard for the<br>Flammability of Clothing<br>Textiles to evaluate the<br>flammability of the test<br>sample. | Class I | PASS<br>Class I |
| Water<br>Penetration<br>Resistance<br>AATCC 42-2013,<br>Impact<br>Penetration Test | The test was performed<br>in accordance with<br>AATCC 42: 2013<br>Water Resistance: Impact<br>Penetration Test to<br>evaluate the water impact<br>of the test sample. | $\le$ 1.0g AQL: 4%<br>Level 3 per standard<br>ANSI/AAMI<br>PB70:2012 for level 3 | PASS<br>$\le$ 1.0g |
| Static<br>hydrostatic<br>resistance<br>AATCC 127-<br>2014 | The test was performed<br>in accordance with<br>AATCC 127: 2014<br>Water Resistance:<br>Hydrostatic Pressure Test | $\ge$ 50 cmH2O per<br>standard ANSI/AAMI<br>PB70:2012 for level 3<br>AQL: 4% | PASS<br>$\ge$ 50 cm |
| Water Resistance:<br>Hydrostatic<br>Pressure Test; | to determine the<br>hydrostatic pressure of<br>the test sample. | | |
| <b>EO and ECH<br/>sterilization<br/>residual</b><br>ISO 10993-<br>7:2008<br>Ethylene oxide<br>sterilization<br>residuals | The test was performed<br>in accordance with ISO<br>10993-7:2008<br>Ethylene oxide<br>sterilization residuals to<br>determine the EO and<br>ECH residuals of the test<br>sample. | $EO \le 4mg/d$<br>$ECH \le 9mg/d$ | PASS<br>$EO \le 4mg/d$<br>$ECH \le 9mg/d$ |
| <b>Cytotoxicity</b><br>ISO 10993-5<br>Biological<br>evaluation of<br>medical devices<br>— Part 5: Tests<br>for in vitro<br>cytotoxicity | The test was performed<br>in accordance with ISO<br>10993-10 to determine<br>cytotoxicity of the test<br>sample | Non-Cytotoxic | PASS<br>Under the conditions of the<br>study, the device is non-<br>cytotoxic. |
| <b>Irritation</b><br>ISO 10993-10<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And<br>Skin Sensitization | The test was performed<br>in accordance with ISO<br>10993-5 to determine<br>Irritation of the test<br>sample | Non-Irritating | PASS<br>Under the conditions of the<br>study, the device is non-<br>irritating. |
| <b>Sensitization</b><br>ISO 10993-10<br>Biological<br>Evaluation of<br>Medical Devices -<br>Part 10: Tests For<br>Irritation And<br>Skin Sensitization | The test was performed<br>in accordance with ISO<br>10993-10 to determine<br>skin sensitization of the<br>test sample | Non-Sensitizing | PASS<br>Under the conditions of the<br>study, the device is non-<br>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.