The N95 Surgical Respirator AP0018 and AP0028 are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood and body fluids, and airborne particulate materials.

Device Description

SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the SHUENN BAO SHING Corp. N95 Surgical Respirator (types AP0018 and AP0028), based on the provided 510(k) summary document:

This document is a 510(k) summary for a medical device (N95 Surgical Respirator), which is typically used to demonstrate substantial equivalence to a legally marketed predicate device rather than to rigorously "prove" device performance against a novel set of acceptance criteria through a full-scale clinical trial. Therefore, the "study" referred to here encompasses the non-clinical tests performed to demonstrate equivalency.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for N95 Surgical Respirators are based on established regulatory standards and guidance for such devices, primarily from NIOSH and ASTM. The device's performance is demonstrated by its compliance with these standards, effectively making the performance metrics of the new device equivalent to or better than those of the predicate device for substantial equivalence.

Table 1: Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
NIOSH Exhalation Resistance	84.188	Complied with relevant requirements
NIOSH Inhalation Resistance	84.180	Complied with relevant requirements
NIOSH Sodium Chloride (NaCl) - N95	84.181	Complied with relevant requirements
Flammability	16 CFR 1610, Class I	Complied with relevant requirements
Biocompatibility	ISO 10993	Complied with relevant requirements
Regulatory Class	Class II (ASTM2100-04 Low Barrier)	Class II (ASTM2100-04 Low Barrier)
NIOSH Approval Number (AP0018)	(Predicate: TC-84A-006)	TC-84A-4049 (New Approval)
NIOSH Approval Number (AP0028)	(Predicate: TC-84A-2630)	TC-84A-4175 (New Approval)

Note: The "acceptance criteria" here are the requirements outlined in the specified standards, and "reported device performance" is the statement of compliance to these standards.

Study Details

1. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "sample size" in the context of a clinical test set, as no clinical tests were performed. The testing conducted was non-clinical (bench testing). For these bench tests (e.g., NIOSH, flammability, biocompatibility), the sample sizes would typically be determined by the specific test standards themselves, but these details are not provided in this summary.

Data Provenance: The document originates from SHUENN BAO SHING Co., Ltd. in Taiwan, R.O.C. The tests were performed in compliance with US regulatory standards (NIOSH, CFR, ISO). The data is retrospective in the sense that it represents lab test results conducted on the manufactured device models.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a non-clinical bench testing study, not requiring expert consensus for a "ground truth" in the way a clinical diagnostic study would. Compliance to engineering and material science standards was assessed.

3. Adjudication Method for the Test Set

Not applicable. As this was non-clinical bench testing against established standards, the results are typically objectively measured and compared to the standard's limits. No adjudication method in the context of expert review for clinical outcomes is mentioned.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A MRMC study is relevant for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This 510(k) pertains to a physical device (surgical respirator), for which such a study is not applicable.

5. Standalone Performance (Algorithm Only)

Not applicable. This is a physical N95 surgical respirator, not an AI algorithm. Its performance is inherent in the device itself, without a "human-in-the-loop" or standalone algorithm component.

6. Type of Ground Truth Used

For non-clinical tests, the "ground truth" is defined by the objective standards and test methods (e.g., NIOSH 84.188 for exhalation resistance, 16 CFR 1610 for flammability). The device's physical properties and performance characteristics are measured against the specified limits within these standards.

7. Sample Size for the Training Set

Not applicable. There is no training set in the context of machine learning or AI models, as this is a physical device submission.

8. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by the regulatory standards mentioned above.

Summary Takeaway:

The provided document is a 510(k) summary demonstrating substantial equivalence of a new surgical respirator to existing predicate devices. The "study" in this context refers to a series of non-clinical bench tests performed according to recognized national and international standards (NIOSH, CFR, ISO) to prove the new device meets the same performance characteristics as its predicates. It explicitly states that "no clinical tests were performed." Therefore, many of the typical questions for AI/diagnostic device studies (like sample size for test/training sets, expert ground truth, MRMC studies) are not applicable here.

Summary

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SHUENN BAO SHING CO., LTD. No. 90.HSIN KUNG 6 RD., FIEN CHUNG CHEN.CHANG HW A HISTEN. Taiwan, ROC Tel 886-4-875-6141 Fax 886-4-875-0145 E-mail:shuennba(@ms17.hinet.net http://www.aeropro.com w

510(k) SUMMARY "

JAN -8 2008

July 20, 2007

The assigned 510(k) number is : K 072067

Submitter's Name: SHUENN BAO SHING CORPORATION

No. 90. Hsin Kung 6 Rd., Tien Chung Chen, Chang Hua Hsien, 52046, Taiwan, R.O.C.

Date summary prepared:

Device Name:

Respirator, Surgical ● Classification name:
Classification number: MSH, Class II
Regulation Number: 878.4040
N95 Surgical Respirator, Type: AP0018, AP0028 ● Proprietary name:
. Common name of device: Surgical Respirator
Predicate Device: Surgical N95 Respirator, K041855
. Official Correspondent: Dr. Jen, Ke-Min

E-mail: ceirs.jen@msa.hint.net (Tel) 886-3-5208829; (Fax) 886-3-5209783

Address: No.58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan, ROC

Description of the device:

SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to the bridge of the wearer's nose. No fiberglass media is used in this product.

Labels/Labeling:

This device will be marked to medical device suppliers, Dentist and Doctor Officers, clinics, Emergency Response Professionals, Hospitals and other healthcare professional for the Intended Use purpose below:

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Image /page/1/Picture/0 description: The image shows a logo with the words "AERO PRO" in a bold, sans-serif font at the bottom. Above the text is a stylized graphic that resembles the letters "A" and "P" combined, with three curved lines extending upwards from each letter. The logo has a textured, slightly distressed appearance, giving it a vintage or industrial feel.

SHIENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., ITEN CHUNG CHEN.CHANG HWA HSIEN. Taiwan, ROC Tel. 886-4-875-6141 Fax 886-4-875-0145 E-mail:shuennba@ms17.hinet.net http://www.aeropro.com w

Intended Use:

Comparison to Predicate Devices:

SHUENN BAO SHING Corporation N95 Surgical Respirator AP0018 and AP0028 are substantially equivalent is safety and effectiveness to the predicate device: AEARO Company, K041855, Pleats Plus N95 Respirator 1050 and 1050S for Reference: FXX, 878.4040, Class II 1) SHUENN BAO SHING Surgical Mask, K990719 2)3M Surgical Mask, K955382

Manufacturer	Shuenn Bao Shing Corporation(New Device)	Aearo Company(Predicate Device)
Device	AP0028 N95 Surgical Respirator	Pleats Plus N95 Respirator 1050and 1050S
510(k) Number	TBA	K041855
Product Code	MSH, 878.4040	SAME
Device Description	1. N95 Class particulate respirator2. Multi-Layer Filtering media(White spunbond polypropylene,Meltblown polypropylene)3. Plastic Nose Wire- with Aluminum4. Transparent PU headband5. Dimensions:24.5x8.5x8.7 cm6. Flat pleated mask7. Dual elastic head strap	1. N95 Class particulate respirator2. Multi-Layer Filtering media(White spunbond polypropylene,Meltblown polypropylene)3. Tie wire nose piece4. White Elastic headband5. Dimensions:1) Small (13.5" circumference)2) Large (15.5" circumference)6. Flat pleated mask7. Dual elastic head strap
NIOSH Approval Number	TC-84A-4175	TC-84A-2630
Regulatory Class	Class II (ASTM2100-04 Low Barrier)	SAME

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Image /page/2/Picture/0 description: The image shows a logo with the words "AERO PRO" in a stylized font. Above the text, there is a symbol that resembles the letters "A" and "P" combined, with curved lines suggesting movement or aerodynamics. The overall design appears to be for a company or product related to aviation or aerodynamics.

SHI ENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., FIEN CHUNG CHEN.CHANG INVA HSIEN. Taiwan, ROC Tel 886-4-875-6141 Fax 886-4-875-6145 E-mail shuennba(dims) 7.hinet.net http://www.aeropro.com/w

Manufacturer	Shuenn Bao Shing Corporation(New Device)	3M(Predicate Device)--for reference
Device	AP0018 N95 Surgical Respirator	Model 1860 Health Care Respirator
510(k) Number	TBA	K955382
Product Code	MSH, 878.4040	FXX, 878.4040
Device Description	1. N95 Class particulate respirator2. Multi-Layer Filtering media3. Wire nose clip4. Foam nose piece inside mask5. Yellow elastic headband6. White colored7. Molded cup mask8. Protruded wings prevent punching staple holes on the mask.	1. N95 Class particulate respirator2. Multi-Layer Filtering media3. Fluid resistant barrier4. Wire nose clip5. Foam nose piece inside mask6. White elastic headband7. Blue colored8. Molded cup mask
NIOSH Approval Number	TC-84A-4049	TC-84A-006
Regulatory Class	Class II (ASTM2100-04 Low Barrier)	SAME

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

I.	NIOSH, Exhalation Resistance Test	84.188
----	-----------------------------------	--------

II. NIOSH, Inhalation Resistance Test 84.180
NIOSH, Sodium Chloride (NaCl)--N95 III. 84.181
Flammability, complied with16 CFR 1610, class I IV.
Biocompatibility per ISO 10993 V.

It was our conclusion that performance testing met all relevant requirements of the aforementioned test standard.

Discussion of Clinical Tests Performed:

Not Applicable

Conclusions:

SHUENN BAO SHING Corp., Surgical Respirator, type: AP0018 and AP0028, has the same intended use and technological characteristics as the predicated devices (K041855). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. SHUENN BAO SHING Surgical Respirator type AP0018 and AP0028 are substantially equivalent to the predicated device.

Thus the new device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows a logo for "AERO PRO". The logo features a stylized design above the text, resembling curved lines that form the letters "A" and "P". The text "AERO PRO" is written in a simple, sans-serif font below the design. The entire logo has a textured, slightly distressed appearance.

SHUENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD.,TIEN CHUNG CHEN,CHANG HWA HSIEN. Taiwan, ROC Tel: 886-4-875-6141 Fax 886-4-875-6145 E-mail:shuennba@ms17.hinei.net http://www.aeropro.com tw

DEVICE DESCRIPTION 6.

6.1 Vision Appearance

Product Picture :

We present the N95 Surgical Respirator, type: AP0018 and AP0028, appearance as the following pages.

Note: Relevant specification per Class II (ASTM2100-04 Low Barrier).

Product Description:

· SHUENN BAO SHING Corp. N95 Surgical Respirator AP0018 and AP0028 are flat pleated 3-ply masks with a center layer of polypropylene meltblown material by inner and outer layers of nonwoven material. The mask has 2 braided synthetic elastic headbands and a flexible wire tie nosepiece that allows the respirator to form to the bridge of the wearer's nose. No fiberglass media is used in this product.
· Non-Sterilized.
· For single use.

Product Directions:

Please refer to the Instruction as the following pages.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus symbol.

JAN - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shuenn Bao Shing Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu Chiun Street Hsin Chu City CHINA (TAIWAN) 30067

Re: K072067

Trade/Device Name: N95 Surgical Respirators, Type: AP0018, AP0028 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: December 22, 2007 Received: December 31, 2007

Dear Dr. Jen:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 – Dr. Jen

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows a logo for "AERO PRO". The logo consists of a stylized letter "P" above the words "AERO PRO". The letter "P" is made up of three curved lines that resemble wings. The text "AERO PRO" is in a sans-serif font.

SHUENN BAO SHING CO., LTD. No. 90,HSIN KUNG 6 RD., TIEN CHUNG CHEN,CHANG HWA HSIEN. Taiwan. ROC Tel: 886-4-875-6141 Fax: 886-4-875-6145 E-mail:shuennba(@ms17.hinet.net http://www.aeropro.com.tw

Indications for Use

012067 510 (K) Number ( If Known ):__________________________________________________________________________________________________________________________________________________

Device Name: N95 Surgical Respirator, Type: AP0018, AP0028

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use √

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Murphy MD
Division Sign Off

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K072067

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.