Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.

Therapeutic

No
The device is a surgical mask intended for protection and infection control, not for treating a disease or condition.

Diagnostic

No

Explanation: The device is a surgical mask intended to prevent the transfer of microorganisms and fluids, which is a protective function, not a diagnostic one. It does not analyze or detect medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (spunbond polypropylene, melt-blown polypropylene, spandex, polyamide, iron wire, zinc) and its function is based on physical filtration, not software processing.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
Device Description: The description details the physical construction and materials of the mask, which are designed for filtration and barrier protection.
Performance Studies and Key Metrics: The performance studies and key metrics focus on the mask's ability to filter particles and resist penetration by fluids, as well as its biocompatibility. These are all related to its function as a physical barrier.
Lack of Diagnostic Elements: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status or disease.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This mask does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Paneffort 3-ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Product codes (comma separated list FDA assigned to the subject device)

FXX

Device Description

The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on.

Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later.

Paneffort 3-ply Surgical and Procedural masks are available in blue colour.

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

Healthcare personnel

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 Testing:
The following performance tests, in accordance with ASTM F2100 were conducted for the subject device:

Bacterial filtration efficiency - ASTM F2100-19e1 Clause 9.1 (ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus.)
Differential Pressure ASTM F2100-19e1 Clause 9.2 (EN 14683:2019 Medical face masks Requirements and test methods Annex C - Method for determination of breathability (differential pressure))
Sub-micron particulate filtration efficiency at 0.1 micron ASTM F2100-19e1 Clause 9.3 (ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres)
Resistance to Penetration by Synthetic Blood- ASTM F2100-19e1 Clause 9.4 (ASTM F1862 Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity))
Flammability - ASTM F2100-19e1 Clause 9.5 (16 CFR Part 1610 Standard for The Flammability of Clothing Textiles)

Biocompatibility tests:

Cytotoxicity (ISO 10993-5)
Irritation or Intracutaneous Reactivity (ISO 10993-10)
Sensitization (ISO 10993-10)

Key Results:

Resistance to penetration by synthetic blood: Pass at 160mm Hg (Acceptance Criteria: 160mm Hg)
Flammability of Clothing Textiles: Class I (Acceptance Criteria: Class I)
Differential Pressure (Delta-P): Delta-P 99% (Acceptance Criteria: >=98%)
Bacterial filtration efficiency: Pass at >98% (Acceptance Criteria: >=98%)
Cytotoxicity: Pass - ISO 10993-5:2009/ under the conditions of study the subject device was non-cytotoxic. (Acceptance Criteria: Non-cytotoxic)
Irritation and Sensitization: Pass ISO 10993-10:2010/ under the conditions of the study, the subject device was non-irritating and non-sensitizing. (Acceptance Criteria: Non-irritating and non-sensitizing)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Bacterial filtration efficiency: Pass at >98%
Differential pressure (Delta-P): 3.175 mmH2O/cm squared (against acceptance criteria =99.20%
Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result: >= 120 mm Hg
Flammability: Class 1 as per 16 CFR Part 1610

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.

K202594, K160269

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

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

July 25, 2022

Paneffort, LLC % Vardhini Kirthivas Regulatory Correspondent Freyr Solutions Level 4, Building No. H-08, Phoenix SEZ, Phase 2, Gachibowli Hyderabad, Telangana 500081 India

Re: K221409

Trade/Device Name: Paneffort 3-ply Surgical and Procedural Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 8, 2022 Received: June 10, 2022

Dear Vardhini Kirthivas:

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.

for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K221409

Device Name Paneffort 3-Ply Surgical and Procedural Masks

Indications for Use (Describe)

Paneffort 3-Ply Surgical and Procedural Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

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

Traditional 510(k) Paneffort 3-Ply Surgical and Procedural Masks

K221409 Page 1 of 8 PANEFFORT, LLC

510(k) Summary

Submitter Information:

Application Correspondent (US agent): Vardhini Kirthivas

| | Freyr Global Regulatory Solutions and Services
Level 4, Building No. H-08, Phoenix SEZ,
Phase 2, Gachibowli, Hyderabad,
Telangana, India, 500081 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | +91 - 9940445965 |
| E-mail: | usagent@freyrsolutions.com |
| Manufacturer: | Paneffort (Cambodia) Garment Co. Ltd.,
National Road No.2, Kleang Sambatt,
Pot Sar Ward, Bati District,
Takeo 21309, Cambodia |
| Legal Manufacturer: | PANEFFORT, LLC
700 Elmridge Center Drive
Rochester, NY 14626 |
| Phone: | +855 12284810 |
| Contact Person: | Harry |

E-mail: Fax Number (including area code): Date Prepared:

Phil@paneffort.com +855 12284810 11 May 2022

Device Identification:

Device Trade Name:	Paneffort 3-ply Surgical and Procedural Masks
Device Classification name:	Surgical Mask
Regulation Name:	Surgical Apparel
Regulation Medical Specialty:	General & Plastic Surgery
Device Class:	II
Regulation Number:	21 CFR 878.4040
Product Code:	FXX

4

Predicate Devices:

Table 1 List of Predicate Devices

Device Name	510(k) Number
Medical surgical Masks-Non-sterile	K202594	Primary Predicate
Surgical Face Masks (Ear loops and Tie-on)	K160269	Additional Predicate Device

Device Description

The Paneffort 3-Ply Surgical and Procedural masks are flat pleated 3-ply device, which consist of three layers, i.e., Outer layer is made of Spunbond Polypropylene, Middle/Filter layer is made of Melt-blown Polypropylene and Inner layer is made of Spunbond Polypropylene. There are two options for the mask to be secured on the user, viz. earloops or tie-on.

Earloops are made of spandex and polyamide and the tie-on model are made of spunbond polypropylene. The nosepiece is made up of Iron wire, polypropylene and Zinc, and is encased between Outer and Middle later.

Paneffort 3-ply Surgical and Procedural masks are available in blue colour.

| Sr.
No. | Variants | ASTM
Level | Mask style | Colors | Item Number |
|------------|------------------------------|---------------|--------------------|--------|-----------------|
| 1. | Paneffort
Procedure Masks | Level 2 | 3-ply Earloop Mask | Blue | (3PML2-EXEL-11) |
| 2. | Paneffort
Procedure Masks | Level 3 | 3-ply Earloop Mask | Blue | (3PML3-EXEL-11) |
| 3. | Paneffort Surgical
Masks | Level 2 | 3-ply Tie-On Mask | Blue | (3PML2-SRTB-11) |
| 4. | Paneffort Surgical
Masks | Level 3 | 3-ply Tie-On Mask | Blue | (3PML3-SRTB-11) |

Models:

Intended Use & Indications for Use

Paneffort 3-ply Surgical and Procedural masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

5

Comparison of Technological Characteristics

Table 2 Substantial Equivalence Table

S.No	Parameters		Subject device	Primary Predicate	Additional Predicate Device	Comments
1.	Product Name		Paneffort 3-ply Surgical and
Procedural mask	Medical surgical Masks-Non-
sterile	Surgical Face Masks (Ear
loops and Tie-on)	N/A
2.	510(k) Number		To be assigned	K202594	K160269	N/A
3.	Manufacturer		PANEFFORT
(CAMBODIA) GARMENT
CO. LTD.	Shandong T&F Nonwoven Co.
Ltd	SAN - M PACKAGE CO.,
LTD	N/A
4.	Product Code		FXX	FXX	FXX	Same
5.	Regulation Number		878.4040	878.4040	878.4040	Same
6.	Intended Use/Indications of Use		Paneffort 3-ply Surgical and
Procedural Masks are
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These face masks
are intended for use in
infection control practices to
reduce the potential
exposure to blood and body
fluids. This is a single use,
disposable device provided
non-sterile.	The Medical Surgical Masks-
Non-Sterile is intended to be worn
to protect both the patient and
healthcare personnel from the
transfer of microorganisms, body
fluids, and particulate material.
The Medical Surgical Masks -
Non-Sterile is intended for use in
infection control practices to
reduce the potential exposure to
blood and body fluids. This is a
single use, disposable device(s),
provided non-sterile	The Surgical face masks are
intended to be worn to protect
both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids, and particulate
material. These face masks
are intended for use in
infection control practices to
reduce the potential exposure
to blood and body fluids this
is a single use, disposable
device, provided non-sterile.	Same
7.	Material of
Construction	Inner
Layer	Spunbound polypropylene	Polypropylene non-woven fabric	Polypropylene	Same
		Outer
Layer	Spunbound polypropylene	Polypropylene non-woven fabric	Polypropylene	Same
		Middle
Layer	Melt blown polypropylene
filter	Polypropylene meltblown fabric	1. Polypropylene Spunbound

Polypropylene Meltblown | Same | |
| S.No | Parameters | Subject device | Primary Predicate | Additional Predicate Device | Comments | | |
| | Ear loops | Spandex and polyamide | Polyamide and Polyurethane | Ear loops: Polyester, polyurethane | Different, does not raise any concerns with safety and effectiveness. Note 1 | | |
| | Tie-On/Tie strip | Spunbound polypropylene | NA | Tie tapes: Polypropylene Spunbound or polyester Spunbound | Same | | |
| | Nose Piece | Iron wire+Polypropylene+Zinc | PP + Iron wire | Polyethylene coated steel wire | Different, does not raise any concerns with safety and effectiveness. Note 2 | | |
| 8. | Dimensions | $(9.5 ±3) cm x (17.5 ± 5) cm$ | Length 17.5±5mm
Width 9.5±5mm | Length : 90± 3 mm
Width : 175± 5 mm
Length : 90 ± 3 mm
Width : 180 ± 5 mm | Similar, does not raise any concerns with safety and effectiveness. Note 1 | | |
| 9. | Mask Style | Flat pleated | Flat Pleated | Flat - pleated | Same | | |
| 10. | Design Features | Ear loop, tie-on | Ear loops | Ear loop and Tie-On | Same | | |
| 11. | Sterility | Non- Sterile | Non-sterile | Non- Sterile | Same | | |
| 12. | Use | Single Use | Single use | Single Use | Same | | |
| 13. | Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Not made with Natural Rubber Latex | Same | | |
| 14. | ASTM E2100 Level | Level 2 and Level 3 | Level 2 | Level 2 and Level 3 | Same | | |
| S.No | Parameters | Subject device | | Primary Predicate | Additional Predicate Device | Comments | |
| | | Level 2 | Level 3 | | | | |
| 15. | Bacterial filtration efficiency | Pass at >
99.9 %
(ASTM
F2101) | Pass at >
99.9 %
(ASTM
F2101) | >99%
(ASTM F2101) | Pass at > 98%
(ASTM
F2101) | Similar, Note
3 | |
| 16. | Differential pressure (Delta-P) | 3.175
mmH2O/cm²
(EN 14683) | 3.182
mmH2O/cm²
(EN 14683) | 99% | Pass at 99.6%
(ASTM
F2299) | Similar, Note
5 | |
| 18. | Resistance to penetration by
synthetic blood, minimum
pressure in mm Hg for pass
result | ≥ 120 mm
Hg (ASTM
F1862) | ≥ 160 mm
Hg
(ASTM
F1862) | Pass at 120mm Hg (ASTM
F1862) | Pass at 120
mm Hg
(ASTM
F1862) | Same | |
| 19. | Flammability | Class 1 as per 16 CFR Part
1610 | | Class 1
(16 CFR Part 1610) | Class 1 (16 CFR Part 1610) | Same | |
| 20. | Biocompatibility | Cytotoxicity,
ISO 10993-
5:2009 | Pass ISO 10993-5:2009/
under the conditions of
study the subject device was
non-cytotoxic | | Not Cytotoxic | Pass ISO 10993-5:2009/
under the conditions of study
the subject device was non-
cytotoxic. | Same |
| | | Irritation,
ISO 10993-
10:2010 | Pass ISO 10993-10:2010/
under the conditions of the
study, the subject device
was non-irritating | | Not an irritant | Pass ISO 10993-10:2010/
under the conditions of the
study, the subject device was
non-irritating. | Same |
| | | Sensitization,
ISO 10993-
10:2010 | Pass ISO 10993-10:2010/
under the conditions of
study, the subject device
was non-sensitizing | | Not Sensitive | Pass ISO 10993-10:2010/
under the conditions of study,
the subject device was non-
sensitizing. | Same |

6

PANEFFORT, LLC

Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks

7

PANEFFORT, LLC

Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks

Notel & Note2: The differences in the materials do not any and effectiveness. Performance testing including biocompatibility evaluation mentioned in Section 14 has been performed on the final finished device which includes all construction materials.

8

PANEFFORT, LLC

Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks

Note 3: The performance requirement for BPE as per ASTM F2100 is >9%. The subject device meets the requirements of FDA recognized consensus standard [Rec# 6-425] ASTM F2100-19. The subject device meets the criteria.

Note 4: We understand that ML-M-36945C is the FDA recommended standard for differential pressure. However, the conformance to FDA Recognized conservass standard [Rec# 6-425], ASTM F2100-19 requires that Differential pressure be performed as per EN 14683:2019, Annex C.

Table 3 Table of Non-clinical Testing Standards

FDA's guidance, "Surgical Masks - Premarket Notification [510(k)] Submissions ", recommends evaluating the biocompatibility as described in the standard ISO10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" for limited contact devices, contacting intact skin.

The following Biocompatibility End points have been identified and tested in accordance appropriate biocompatibility standards.

-Cytotoxicity (ISO 10993-5)

10

Traditional 510(k) Paneffort 3-Ply Surgical and Procedural masks

Irritation or Intracutaneous Reactivity (ISO 10993-10) -
-Sensitization (ISO 10993-10)

| Biological
endpoint | Test
Method/Standard | Purpose | Acceptance
Criteria | Results |
|------------------------------------|-------------------------|---------------------------------------------------------------------------|-------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5 | Verify Cytotoxicity
potential of the subject
device | Non-cytotoxic | Pass - ISO 10993-5:2009/ under the
conditions of study
the subject device
was non-cytotoxic. |
| Irritation
and
Sensitization | ISO 10993-10 | Verify irritation and
sensitization potential of
the subject device | Non-irritating
and non-
sensitizing | Pass ISO 10993-10:2010/ under the
conditions of the
study, the subject
device was non-
irritating. |

Table 4 Biocompatibility Testing – Summary

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.