(300 days)
An Earloop Procedure Mask is a disposable device intended for medical purposes that is r in Larrey i rexaminer's mouth and nose to prevent contamination between examiner and patient.
Earloop Procedure Mask ( BLUE, YELLOW)
This document is a 510(k) clearance letter for the Isosafe™ EarLoop Procedure Mask from the FDA. It declares the device substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, nor does it contain any of the specific details requested in the prompt.
The document primarily focuses on:
- The FDA's decision of substantial equivalence.
- Regulatory classifications and requirements.
- Contact information for compliance and assistance.
- A brief "Statement of Indications for Use" (page 2, Exhibit IV).
Therefore, I cannot extract the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval, not a performance study report.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1998
Mr. Anthony L. Giaccio 'Director, of Quality Systems and Regulatory Affairs Cypress Medical Products 1202 South Route 31 60050 McHenry, Illinois
Re : K972849 Isosafe™ EarLoop Procedure Mask (Blue, Yellow) Trade Name: Requlatory Class: II Product Code: FXX Dated: March 3, 1998 March 3, 1998 Received:
Dear Mr. Giaccio:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations; Title 21, Parts 800 to 895. . A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Giaccio
through 542 of the Act for devices under the Electronic enrough Sin or on Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA acboirson in your can 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
EXHIBIT IV
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known: K972849
Device Name: Earloop Procedure Mask ( BLUE, YELLOW)
An Earloop Procedure Mask is a disposable device intended for medical purposes that is r in Larrey i rexaminer's mouth and nose to prevent contamination between examiner and patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use_
(Optional Format 1-2-96)
Neorge 1. Miller fer Aini S.
(Division Sign-Off)
OR
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number _
§ 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.