(10 days)
The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Handan HY8510 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the inner and outer cover. The polypropylene melt blown filter media and polyester filter fabric are layered between the inner and outer cover. The head strap is made of polyester elastic(for single head strap) which is circled to the mask. The inside nosepiece is a PU foam.
Handan HY9810 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the outer cover, polyester filter fabric used in the inner cover. The polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of polyester elastic(for double headband) which is welded to the mask. The inside nosepiece is a PU foam.
Both items are no - sterilized and only for single use.
Acceptance Criteria and Study for Handan N95 Particulate Respirators and Surgical Masks (HY8510 & HY9810)
The provided document describes the Handan N95 Particulate Respirators and Surgical Masks (HY8510 & HY9810) and their substantial equivalence to predicate devices, rather than a standalone AI/algorithm-based device requiring detailed performance metrics typical of AI/ML studies. Therefore, the information provided below is adapted to reflect the nature of the submitted 510(k) summary for a medical device that relies on established material and physical property testing.
The acceptance criteria for the Handan N95 Particulate Respirators and Surgical Masks are based on established NIOSH (National Institute for Occupational Safety and Health) standards for N95 respirators and flammability standards. The study demonstrates that the device meets these criteria through non-clinical bench testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| NIOSH Standards | |
| Exhalation Resistance | Met relevant requirements |
| Inhalation Resistance | Met relevant requirements |
| Sodium Chloride (NaCl) | Met relevant requirements |
| Flammability Standard | |
| 16 CFR 1610 Class I | Complied (Class I) |
| Biocompatibility | |
| ISO 10993 | Met relevant requirements |
Note: The document explicitly states, "It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (Exhalation Resistance, Inhalation Resistance, NaCl, Flammability, Biocompatibility). These are non-clinical bench tests performed on physical samples of the manufactured respirators. The data provenance is from the manufacturer's internal testing or contracted laboratories, performed for the purpose of demonstrating compliance with the specified standards. The nature of these tests is prospective for the device being submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable in the context of this device and study. The ground truth for these tests is established by objective, standardized measurement protocols defined by NIOSH and other regulatory bodies (e.g., 16 CFR 1610, ISO 10993). The "experts" involved would be technicians and engineers qualified in performing these specific tests accurately according to the established methodologies, rather than clinical experts establishing a ground truth based on medical interpretations.
4. Adjudication Method for the Test Set
Adjudication methods like "2+1" or "3+1" are not applicable here. The tests involve objective measurements against predefined thresholds. The results are either compliant or non-compliant, based on the measured values falling within the acceptable ranges specified by the standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. The Handan N95 respirators are physical devices whose performance is evaluated through material and physical property testing, not through human reader interpretation.
6. Standalone Performance Study
Yes, a standalone performance was done in the sense that the device's performance was evaluated independently against established standards through a series of bench tests. The algorithm, in this context, is the physical design and material composition of the respirator itself. The device (respirator) was tested on its own to demonstrate its intrinsic performance characteristics, without direct human-in-the-loop assistance for its primary function (filtration, resistance, etc.).
7. Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements against pre-defined regulatory and industry standards. For example:
- NIOSH standards: Specify acceptable levels of inhalation and exhalation resistance, and filtration efficiency for particulate matter (e.g., NaCl aerosol).
- 16 CFR 1610: Defines flammability performance classes based on burn time.
- ISO 10993: Defines biocompatibility requirements through various tests (e.g., cytotoxicity, irritation, sensitization).
8. Sample Size for the Training Set
This concept is not applicable to the evaluation of this device. The Handan N95 respirators are physical products, not AI/ML algorithms. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process of the respirators would be analogous to the development phase, but not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a training set and its ground truth is not applicable for this type of medical device submission. The design and engineering of the respirators would be guided by the requirements of the standards (NIOSH, ISO, etc.), and the performance is then verified through the mandated non-clinical tests.
{0}------------------------------------------------
Handan Hengyong Protective &Clean Proc
1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Tel: 86-311-83032925 Fax: 86-311-83995076
APR - 4 2008
Page 1 of 3
510(k) Summary
This summary of 510K safety and effectiveness information is being submitted in accrodance with the requirements of 21 CFR 807.92.
The assigned 510K number is K080827
- Submitter's Identification:
Handan Hengyong Protective & Clean Products Co.,Ltd
1-1-1201,455 Gongnong Road, Shijiazhuang,
Hebei Province, P.R.China
Contact:
Maggie Zhong Tel:+86-21-33907930 Fax:+86-21-33907932 Mail: maggie-zhong2001@vip.sina.com Date of Summary: April 2, 2008
-
- Device Name:
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810
- Device Name:
-
- Classification Name: Surgical N95 Mask
-
4.. Device Description
Handan HY8510 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the inner and outer cover. The polypropylene melt blown filter media and polyester filter fabric are layered between the inner and outer cover. The head strap is made of polyester elastic(for single head strap) which is circled to the mask. The inside nosepiece is a PU foam.
I landan HY9810 N95 particulate respirators and surgical mask is constructed from a polypropylene spunbond used in the outer cover, polyester filter fabric used in the inner cover. The polypropylene melt blown filter media is layered between the inner and out cover. The head straps are made of polyester elastic(for double headband) which is welded to the mask. The inside nosepiece is a PU foam.
Both items are no - sterilized and only for single use.
-
- Intended Use:
Handan type N95 respirators are intended for single use by operating room personnel or general health care workers for protection against microscopic organisms, body fluids and particulates. These would include use as procedure mask, isolation mask or dental face mask.
- Intended Use:
-
- Comparison to Predicate Devices
{1}------------------------------------------------
Handan Hengyong Protective &Clean Products Co.,Ltd
1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Fax: 86-311-83995076 Tel: 86-311-83032925
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 are substantially equivalent is safety and effectiveness to the predicate device. Aearo Company-- K041855 Pleated plus 1050 and 1050S Gerson Isolair Compay - K960778 APR Type N95 model 2735 for reference: FXX, 878, 4040. Class II
| Manufacturer | Handan Hengyong Protective & CleanProducts Co.,Ltd | Aearo CompanyPredicate device-for reference |
|---|---|---|
| Device | HY8510 N95 Surgical Mask(New device) | Pleated plus 1050 and 1050S |
| 510KNumber | K080827 | K041855 |
| Product code | MSH, 878.4040 | SAME |
| DeviceDescription | 1. N95 Class Particuliar respirator2. Multi-layer filteirng media(white polypropylene spundbond,polypropylene, meltblown, polyester,polypropylene)3. Plastic nose wire with steel4. White elastic headband5. Dimension15.5" circumference6. Flat pleated mask7. Single elastic head strap | 1. N95 Class Particuliar respirator2. Multi-layer filteirng media(White spundbond polypropylene,meltblown polypropylene)3. Tic wire nose piece4. White elastic headband5. DimensionSmall (13.5" circumference)Large(15.5" circumference)6. Flat pleated mask7. Dual elastic head strap |
| NIOSHcertification# | TC-84A-4276 | TC-84A-2630 |
| Manufacturer | Handan Hengyong Protective & CleanProducts Co.,Ltd | Gerson Isolair APR CompanyPredicate device-for reference |
|---|---|---|
| Device | HY9810 N95 Surgical Mask(New device) | N95 model 2735 |
| 510KNumber | K080827 | K960778 |
| Product code | MSH, 878.4040 | SAME |
| DeviceDescription | 1. N95 Class Particuliar respirator2. Multi-layer filteirng media(white polyester, polypropylenemeltblown, polypropylene)3. Plastic nose wire with steel4. White elastic headband5. Dimension15.75" circumference6. Molded Cup7. Dual elastic head strap | 1. N95 Class Particuliar respirator2. Multi-layer filteirng media(White nonwoven polyestermeltblown polypropylene)3. Plastic nose wire4. Yellow elastic, latex free5. DimensionSmall (13.75" circumference)6. Molded Cup7. Dual elastic head strap |
| NIOSHcertification# | TC-84A-4521 | TC-84A-160 |
Discussion of Non-clinical Test Performed for Determination of Substantial Equivalence
{2}------------------------------------------------
Handan Hengyong Protective &Clean Products Co.,Ltd
1-1 1201, 455 Gongnong Road, Shijiazhuang, Hebei, P.R.China Fax: 86-311-83995076 Tel: 86-311-83032925
are as follows:
- NIOSH, Exhalation of Resistance Test, 84.180 I.
- NIOSH Inhalation of Resistance Test, 84.180 ][.
- NIOSH Sodium Chloride (Nacl) -N95 84.181 III.
- Flammibility, Complied with 16 CFR 1610 Class I, IV.
- V. Biocompatibility per ISO 10993
It is our conclusion that performance testing meet all relevant requirements of the aforementioned test standard.
Disscussion of Clinical Tests Performed
Not Applicable
-
- Conclusions
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 has the same intended use and technology characterisitics as the predicate devices (K041855, K960778). Moreover, the bench testing contained in this submission supplied domonstrate that the technological characterisistics do not raise any new question of safety or effectiveness.
- Conclusions
Handan N95 Particulate Respirators and Surgical Masks, HY8510 & HY9810 are substantially equivalent to the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
Ms. Maggie Zhong Consultant Handan Hengyong Protective & Clean Products Company, Limited 1-1 1201, 455 Gongnong Road, Shijiazhuang Hebei Province P.R.CHINA
Re: K080827
Trade/Device Name: Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 Surgical N95 Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: March 15, 2008 Received: March 25, 2008
Dear Ms. Zhong:
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.
{4}------------------------------------------------
Page 2 - Ms. Zhong
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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
{5}------------------------------------------------
INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME:
080827 Handan Hengyong Protective & Clean Products Co.,Ltd Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 Surgical N95 Respirator
INDICATION FOR USE:
The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.
Prescription Use __ (Part 21 CFR 801 Subpart D)
ア Over-The-Counter Use AND/OR (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)
Clue
Page 1 of _
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080827
§ 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.