(85 days)
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.
Imprevious Isolation Gown
I’m sorry, but this document does not contain the information you are looking for regarding the acceptance criteria and study details for a device. The provided text is a letter from the FDA concerning a 510(k) premarket notification for an "Imprevious Isolation Gown," stating that the device is substantially equivalent to legally marketed predicate devices.
The document discusses:
- The FDA's determination of substantial equivalence.
- Regulatory classifications and requirements (general controls, GMP).
- Information on labeling regulations and compliance.
- The intended use of the device (to protect patients and healthcare personnel from transfer of micro-organisms, body fluids, and particulate material).
There is no information about:
- Specific acceptance criteria tables or reported device performance.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
This type of information is usually found in a separate study report or a more detailed section of a 510(k) submission, not in the FDA's decision letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nari Sadarangani President Kentron Health Care, Incorporated 3604 Kelton Jackson Road Springfield, Tennessee 37172
Re : K972410 Trade Name: Imprevious Isolation Gown Requlatory Class: II Product Code: FYC Dated: August 11, 1997 Received: August 13, 1997
SEP 1 9 1997
Dear Mr. Sadarangani:
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 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 qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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) 594-4618. 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 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/dsmamain.html".
Sincerely yours,
Patricia Cucioffor
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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510(k) Number (if known) Device Name: I Soh A
Indications For Use:
This device is intended to be worn to protect both the patient and healthcare personnel from transfer of micro-organisms, body fluids and particulate material.
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ohm S. Lin
510(k)
Preseription Use (Per 21 CER 801 199) ુક્ષ
Over-The-Counter Use X
(Optional Formal 1-2-96)
§ 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.