(169 days)
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum wire. All the materials used in the construction of the Modern Healthcare Corp. Surgical Face Mask are being used in currently marked devices.
The provided text is a 510(k) summary for a surgical face mask. It indicates that no clinical tests were performed to establish acceptance criteria or to prove that the device meets those criteria. Instead, the device's substantial equivalence to a predicate device (K060776) was demonstrated through bench testing.
Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.
Here's a breakdown of what can be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document states "Discussion of Clinical Tests Performed: Not Applicable". Performance targets and results from clinical studies are not provided. The substantial equivalence is based on meeting the same technological characteristics as the predicate device, which implies compliance with relevant standards through bench testing, not clinical performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data provenance is mentioned. The submission relies on "bench testing" which is typically laboratory-based and doesn't involve human subjects for performance evaluation in the way a clinical study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set requiring expert ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a surgical face mask, not an AI-assisted diagnostic device. No MRMC study or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical face mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth is mentioned. The evaluation is based on bench testing of the product's physical and filtration properties, comparing them to established standards and the predicate device.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for a training set is mentioned.
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MODERN HEALTHCARE CORP.
公司:彰化縣田中鎮中州路二段751號
751 CHUNG CHOU RD., SEC. 2. TIEN CHUNG.
CHANG HWA. TAIWAN R.O.C
TEL: 886-4-8752115~8 ; FAX : 886-8743139
MAR 2 1 2007
510(k) SUMMARY "
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : K 063043
Submitter's Name: MODERN HEALTHCARE CORP.
No.751, Chung Chou Rd., Sec. 2, Tien Chun County, Chang-Hwa, 52045, Taiwan, R.O.C.
Date summary prepared:
September 29, 2006
Device Name:
- Classification name: Mask, Surgical .
- FXX, Class II Classification number:
- 878.4040 Regulation Number:
- Surgical Face Mask, Type: Tie-on, Ear-loop . Proprietary name:
- Common name of device: Surgical Face Mask, Disposable .
- . Predicate Device: Surgical Face Mask, K060776
- . 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:
Modern Healthcare Corp. Surgical Face Mask, type: Tie-on and Ear-loop, are flat pleated 3-ply (at least) masks with an inner and outer layer (spunbonded polypropylene) that sandwich a melt blown polypropylene filter material, also with elastic loops and / or strip. The nosepiece for all Modern Healthcare Corp. Surgical Face Mask is malleable aluminum All the materials used in the construction of the Modern Healthcare Corp. Surgical wire. Face Mask are being used in currently marked devices.
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 the word "Modern" in a stylized font. The "M" is designed to look like a heart shape. There is a registered trademark symbol to the right of the word.
一粒候,工 MODERN HEALT 公司:彰化縣田中鎮中 751 CHUNG CHOURD TEL : 886-4-8752115-8 : FAX : 886
Discussion of Clinical Tests Performed:
Not Applicable
Conclusions:
Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop, has the same intended use and technological characteristics as the predicated devices (K060776). Moreover, bench testing contained in this submission supplied demonstrates that the technological characteristics do not raise any new question of safety or effectiveness. Modern Healthcare Corp., Surgical Face Mask, type: Tie-on and Ear-loop, is substantially equivalent to the predicated device.
Thus the new device is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Modern Healthcare Corporation C/O Dr. Ke-Min Jen Official Correspondent ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City 30067 TAIWAN, ROC
MAR 2 1 2007
Re: K063043
Trade/Device Name: Surgical Face Mask, Type: Tie-on, Ear Loop Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: January 23, 2007 Received: January 29, 2007
Dear Dr. Jen:
We have reviewed vour 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-Lien, 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
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Image /page/4/Picture/0 description: The image shows the word "Modern" in a stylized font. The "M" is designed to look like a heart shape. There is a circled R symbol next to the word, indicating a registered trademark.
新橡膠工業股份有限公司
MODERN HEALTHCARE CORP.
公司:彰化縣田中鎮中川路二段751號
751 CHUNG CHOU RD.. SEC. 2. TIEN CHUNG
CHANG HWA TAIWAN R.O.C
TEL: 886-4-8752115-8 FAX: 886-8743139
Indications for Use
510 (K) Number ( If Known ):
Device Name: Surgical Face Mask, Type: Tie-on, Ear-loop
Indications for Use:
The Surgical Face Mask of different colors (Green, White, Blue and Pink) is a device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluid and particulate material.
! CAUTION:
This Surgical Face Mask is non-sterilized and disposable 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)
Shake It Mugler D
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§ 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.