(58 days)
None
None
No
The summary describes a surgical mask, which is a physical barrier device and does not mention any software, image processing, or AI/ML terms.
No
A surgical mask is used to protect individuals from the transfer of microorganisms and fluids, not to treat a disease or condition.
No
A surgical mask is used for protection from transfer of microorganisms, body fluids, and particulate materials, not for diagnosing conditions or diseases.
No
The device description clearly identifies the device as a "Surgical Mask," which is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of a surgical mask is to act as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate materials between people during surgical procedures. This is a physical barrier function, not a diagnostic function.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The surgical mask does not involve testing any samples from the body.
The description clearly indicates the device's purpose is protective and preventative in a surgical setting, not diagnostic.
N/A
Intended Use / 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.
Product codes
FXX
Device Description
Not Found
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
operating room 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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