(21 days)
Not Found
Not Found
No
The 510(k) summary describes a surgical gown made of fabric and film, with no mention of software, data processing, or any terms related to AI/ML. The performance studies focus on material biocompatibility and physical properties, not algorithmic performance.
No
The device is a surgical gown, which is intended to protect against the transfer of microorganisms and fluids during surgical procedures, not to treat or diagnose a disease or condition.
No
Explanation: The provided text describes "Surgical Gowns" which are protective barriers intended to prevent the transfer of microorganisms and fluids during surgery. There is no mention of the device being used to identify, monitor, or diagnose a disease or condition. The performance studies focus on biocompatibility and material safety, not diagnostic accuracy.
No
The device description clearly states it is comprised of fabric and film, indicating it is a physical product, not software.
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 details the materials and construction of a garment, not a device designed to analyze samples or provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
- Performance Studies: The performance studies focus on biocompatibility and material testing, which are relevant for a medical device worn on the body, but not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not fit that description.
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.
The Convertors® Surgical 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 (comma separated list FDA assigned to the subject device)
FYA
Device Description
The gowns are comprised of a single layer of spunlaced nonwoven fabric with a polyethylene reinforcement in the chest area and a breathable monolithic film in the sleeves.
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 / operating room
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® 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Convertors® Optima Gowns.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP 2 2 1999
4 Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500
FAX: 847.785.2461
SMDA REQUIREMENTS XII.
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: | July, 1999 |
| Common Name: | Convertors® Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® Optima Gowns. |
| Description: | The gowns are comprised of a single layer of
spunlaced nonwoven fabric with a polyethylene
reinforcement in the chest area and a
breathable monolithic film in the sleeves. |
1
Allegiance
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® 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® 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 shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of a bird or eagle with three curved lines representing its wings or feathers. The bottom of the seal has a wavy line design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1999
Ms. Sharon Robbins Regulatory Affairs Manager Alleqiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re : K992951 Covertors® Surgical Gowns Trade Name: Regulatory Class: II Product Code: FYA August 31, 1999 Dated: Received: September 1, 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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general 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 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. ਬੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of
3
Page 2 - Ms. Robbins
the Act for devices under the Electronic Product Radiation 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 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) 594-4690. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Susan Runner
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 473.1500 X: 847.785.2461
Page 1 of 1
510(k) Number (if known):
K942951 Unknown
Device Name:
Convertors® Surgical Gowns
Indications For Use:
The Convertors® Surgical 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.
Olin S. Lim
ivision of Dental, Infection Control, Anaral Hosni
(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