(48 days)
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No
The 510(k) summary describes surgical gowns and their material properties and biocompatibility testing. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
The device is a surgical gown intended to protect against the transfer of microorganisms, body fluids, and particulate matter, but it does not treat or cure any medical condition, which is the primary function of a therapeutic device.
No
Explanation: The device is a surgical gown, which is intended to protect patients and personnel from the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.
No
The device description clearly states it is a physical gown made of spunbonded, flashspun polyolefin, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description is for a surgical gown, a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility and material testing, which are relevant for a medical device that comes into contact with skin, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical gown does not fit that definition.
N/A
Intended Use / Indications for Use
The Convertors® Spunbonded, Flashspun Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Product codes
FYC
Device Description
All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin aowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were sensitization, cvtotoxicity, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel / surgical procedures
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of testing: All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin aowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were sensitization, cvtotoxicity, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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AUG 2 4 1998
Allegiance
Park, Illinois 60085-678
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Spunbonded, Flashspun Polyolefin Gowns
Intended Use:
Substantial Equivalence:
patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Convertors® Spunbonded, Flashspun
surgical procedures to protect both the surgical
Surgical apparel are devices intended to be
worn by operating room personnel during
Polyolefin gowns are substantially equivalent to the Convertors® Optima standard, fabric- and poly-reinforced gowns in that:
- the intended use is the same
- the performance attributes are the similar
All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin evaluated through biological aowns were qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were sensitization, cvtotoxicity, and irritation/ intracutaneous reactivity. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use.
Summary of testing:
1
XIII. SAMPLE
A drawing of the standard, fabric- and poly-reinforced gowns are enclosed to visually assist with the review. (See Appendix D).
XIV. KIT INFORMATION
Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown This premarket notification (510(k)) is to introduce standard, pack. fabric and poly-reinforced gowns constructed of Spunbonded, Flashspun Polyolefin fabric. There is no change to the towel contained within this pack.
XV. 21 CFR 807.95 -CONFIDENTIALITY
Allegiance Healthcare Corporation regards its intent to market the Convertors® Spunbonded, Flashspun Polyolefin gown as confidential commercial information. Allegiance Healthcare Corporation has not divulged this intent to market information to anyone other than Allegiance employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design of a human figure with three arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 1998
Ms. Sharon Robbins Requlatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road MPWM McGaw Park, Illinois 60085-6787
Re : K982369 Convertors® Spunbonded, Flashspun Trade Name: Polyolefin Gowns, Sterile Regulatory Class: II Product Code: FYC Dated: July 1, 1998 Received: July 7, 1998
Dear Ms. Robbins:
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 reguirements 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 regulation may result in regulatory 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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Page 2 - Ms. Robbins
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 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,
S. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... ......
4
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 7.473.1500 AX: 847.785.2461
Page 1 of 1
510(k) Number (if known):
Device Name:
Convertors® Spunbonded, Flashspun Polyolefin Gowns, Sterile
Indications For Use:
The Convertors® Spunbonded, Flashspun Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) or
Over-The Counter Use
Chim S. f.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number