(203 days)
Convertors® SMS Polyolefin Standard Gown, Kimberly-Clark Standard, Fabric and Poly-reinforced Gowns
Not Found
No
The 510(k) summary describes surgical gowns made of fabric and film, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on material biocompatibility.
No
The device, surgical apparel, is intended to protect personnel and patients from contamination, not to treat a medical condition or disease.
No
The device, "Surgical apparel," is described as protective clothing for operating room personnel, designed to prevent the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly states it is comprised of fabric and polyolefin film, indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting surgical patients and personnel 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 surgical gown, which is a physical barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility and safety for contact with the body, not on diagnostic accuracy or performance.
IVD devices are 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 definition.
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
Not Found
Device Description
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
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 / surgical procedures
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
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of of Medical Devices". The biocompatibility tests were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Key Metrics
Not Found
Predicate Device(s)
Convertors® SMS Polyolefin Standard Gown and the Kimberly-Clark Standard, Fabric and Poly-reinforced 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
OCT 28 1996
Surgical Group
Baxter Healthcare Corn 1.500 Waukegan Road McGave Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460
Baxter
1
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Polyolefin Gowns
| Manufacturer: | Baxter Healthcare Corporation
Surgical Group
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Richter
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | March, 1996 |
| Common Name: | Convertors® SMS Polyolefin Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® SMS Polyolefin Standard
Gown and the Kimberly-Clark Standard, Fabric
and Poly-reinforced Gowns |
| Description: | The standard, fabric- and poly-reinforced
gowns are comprised of a single layer of SMS
Polyolefin fabric. The fabric-reinforced
gowns have an additional layer of SMS
Polyolefin fabric in the sleeve and body
areas; the poly-reinforced gowns have an
additional layer of polyolefin film in the
sleeve and body areas. |
1
XII. SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Polyolefin Gowns
Intended Use:
Substantial Equivalence:
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® SMS Polyolefin gown is substantially equivalent to the Convertors® SMS Polyethylene standard gown and Kimberly-Clark standard, fabric- and polyreinforced gowns in that:
- the intended use is the same
- the performance attributes are the same
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of of Medical Devices". The biocompatibility tests were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Summary of testing:
2
XIII. SAMPLE
A prototype of a standard SMS gown has been provided (enclosed) to visually assist with the review. (See Appendlx 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 pack. This premarket notification (510(k)) is to introduce standard, fabric and poly-reinforced gowns constructed of SMS fabric. There is no change to the towel contained within this pack.
XV. 21 CFR 807.95 -CONFIDENTIALITY
The Surgical Group of Baxter Healthcare Corporation regards its intent to market the Convertors® SMS Polyolefin gown as confidential commercial information. Baxter has not divulged this intent to market information to anyone other than Baxter employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.