(135 days)
The FreedomAire II Surgical Helmet is intended to be worn by operating room personnel in order to provide a barrier between the operating environment and operating room personnel from in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM
I'm sorry, but without further details about specific studies or tests conducted on the "STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM" as described in the provided text, I cannot generate the requested information regarding acceptance criteria and performance data. The document provided is a 510(k) clearance letter from the FDA, which confirms substantial equivalence to a predicate device but does not typically include detailed study results or acceptance criteria tables.
To fulfill your request, I would need additional documentation that specifically outlines:
- Acceptance Criteria: What quantitative or qualitative benchmarks the device was required to meet.
- Study Design: The methodology, sample sizes, and specific outcomes measured in any performance studies.
- Data Provenance: The origin and nature of the data collected.
- Ground Truth Establishment: How the "truth" was determined for evaluation, including expert involvement.
- MRMC Studies or Standalone Performance: Whether these specific types of studies were conducted and their results.
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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.
MAR 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephanie Wasielewski Vice President, Regulatory Affairs/Quality VIASYS MedSystems 100 Chaddick Drive Wheeling, Illinois 60090
Re: K043004
Trade/Device Name: STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: March 1, 2005 Received: March 2, 2005
Dear Mr. Wasielewski:
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 recrenced above and has management 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 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 approvisions 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 - Mr. Wasielewski
Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast oe advisod that 1 DT 3 lestaines on that your device complies with other requirements Incall that I DA mas made a atutes and regulations administered by other Federal agencies. bit the Act of ally I ederal bates and registered. Including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 007), idoling systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the qualify sion 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) This letter will anow you to began made of substantial equivalence of your device to a premarket notified.com - The 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), rr you desire specific acritic 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 may obtain 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,
Clive
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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Indications for Use
510(k) Number (if known): K043004
Device Name: STACKHOUSE FREEDOMAIRE II SRUGICAL HELMET SYSTEM
Indications For Use. The FreedomAire II Surgical Helmet is intended to be worn by muludions i or So. "The Soc." The provide a barrier between the operating environment and operating foom personnely from in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chr L
(for -33) A Anaothosiology, General Hospitzi on Control, Dental Davice
umber A043004
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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.