(15 days)
FYA
Not Found
No
The device description and performance studies focus on the material properties and biological safety of a surgical gown, with no mention of AI or ML.
No
The device is a surgical gown intended to protect personnel and patients from microorganism transfer, not to treat or prevent a disease or condition in a patient.
No
Explanation: The device, Convertors® Breathable Gowns, is described as intended to be worn for protection against transfer of microorganisms, body fluids, and particulate material during surgical procedures. There is no indication that it is used to identify or analyze a condition or disease, which is the primary function of a diagnostic device.
No
The device description clearly states the gowns are comprised of physical materials (spunlaced nonwoven fabric laminated to a breathable impervious film), indicating it is a hardware device, not software-only.
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 function performed in vitro (outside the body).
- Device Description: The description details the materials and construction of a gown, which is a physical barrier.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Convertors® Breathable Gowns are considered a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Surgical apparel 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
FYA
Device Description
The gowns are comprised of a single layer of spunlaced nonwoven fabric laminated to a breathable impervious film.
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 / Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of this Convertors® Breathable Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". The biocompatibility tests performed were cytotoxicity, sensitization, 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.)
Not Found
Predicate Device(s)
Convertors® Breathable Gowns.
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
AUG 12 1999
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturer: | Allegiance Healthcare Corporation
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
1500 Waukegan Road MPWM
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | June, 1999 |
| Common Name: | Convertors® Breathable Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Breathable Gowns. |
| Description: | The gowns are comprised of a single layer of
spunlaced nonwoven fabric laminated to a
breathable impervious film. |
1
Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a stylized font. To the left of the word is a symbol that looks like a plus sign made up of small dots. The word is in black and the background is white.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Gowns
| Intended Use: | Surgical apparel 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. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Convertors® gowns are substantially
equivalent to the Convertors® Breathable
gowns in that: |
| | - the intended use is the same
- the performance attributes are the
similar |
| Summary of testing: | All materials used in the fabrication of this
Convertors® Breathable Gowns were evaluated
through biological qualification safety tests as
outlined in ISO 10993 Part-1 "Biological Evaluation
of Medical Devices". The biocompatibility tests
performed were cytotoxicity, sensitization, 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. |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road, Building MP-WM McGaw Park, Illinois 60085
K992514 Re :
Trade Name: Convertors® Breathable Surgical Gowns Requlatory Class: II Product Code: FYA Dated: July 27, 1999 Received: July 28, 1999
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 requirements for annual reqistration, listing of devices, qood 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 Regulations, 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 Requlation (QS) for Medical Devices: General regulation (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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
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 genera Other qeneral 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
4
Image /page/4/Picture/0 description: The image shows the word "Allegiance" in a stylized font. The word is written in black and appears to be the logo of a company or organization. To the left of the word is a graphic of a plus sign made up of small dots.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461
Page 1 of 1
| 510(k) Number (if known): | Unknown K992514 |
|---|---|
| Device Name: | Convertors® Breathable Gowns |
| Indications For Use: | The Convertors® Breathable 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) Over-The Counter Use Prescription Use or (Per 21 CFR 801.109) 19 (Division Sign-Off)
Stronon Sign-Off)
Vision of Dental, Infection Control,
d General Hospital, Devices and General Hospital Device 510(k) Number
19