(58 days)
A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for an "Earloop Procedure Mask", which primarily confirms that the device is substantially equivalent to a legally marketed predicate device.
It details:
- The applicant, device name, regulation number, and classification.
- The FDA's review and determination of substantial equivalence.
- General controls and additional controls that may apply to the device.
- Contact information for specific advice from the FDA.
- The "Indications for Use" for the surgical mask, stating its purpose to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate materials.
- A checkbox indicating "Over-The-Counter Use".
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or ground truth establishment.
- Details about expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or training set details.
Therefore, I cannot fulfill your request based on the provided text.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
FEB 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medipack Medical Packaging Manufacturing Company C/O Mr. Antonio L. Giaccio, Director Regulatory & Quality Affairs Cypress Medical Products, LP 1202 South Route 31 McHenry, Illinois 60050
Re: K034015
Trade/Device Name: Earloop Procedure Mask Regulation Number: 878.4040 Regulation Name: Surgical Apparcl Regulatory Class: II Product Code: FXX Dated: February 2, 2004 Received: February 4, 2004
Dear Mr. Giaccio:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaller some is substantially cquivalent (for the itelevelocal above and have attennelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Antichtinents, or to de roos and Cosmetic Act (Act) that do not require approval of a premarket the Fouchal I vou, Drag, and Counmay, therefore, market the device, subject to the general approval application (1 Mr ). - The general controls provisions of the Act include controls providents of the engistration, 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 (FMA), it may of subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Seas nouncements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Giaccio
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA 3 issualles of a bassaanties with other requirements mean that FDA has made a decemination until Jour Journalisms administered by other Federal statistic of the Act of any Federal statutes and regurements, including, but not limited to: registration You must comply with an the 7et 3 roquitements art 801); good manufacturing practice and listing (21 CFR 1 at 607), laooling (21 CFR Part 820), and if 1 CFR Part 820), and if requirements as set form in the quality systems (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) This letter will anow you to begin manceans your alence of your device to a premarket notification. The PDF intelligence of color 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), If you desire specific advice for your device et (301) 594-4618_ Also, please note the regulation please contact inc Office or Comphanes are (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Bina8-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
{2}------------------------------------------------
Indications for Use
Applicant: Medipack Medical Packaging Mfg., Co Clo Antonio L. Giaccio 1202 S. Rte. 31 McHenry, IL 60050
510(k) Number (if known): K034015
Device Name: Earloop Procedure Mask ClassIfication Name: Surgical Mask
Indications For Use: A Surgical Mask is a device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate materials.
Susanna Faruto
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K03 4015
| Labels | Values |
|---|---|
| Prescription Use(Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use(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)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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.