(137 days)
Not Found
No
The device is a reusable surgical gown and the description focuses on material properties, durability, and barrier performance, with no mention of AI or ML.
No.
The device, a surgical gown, is intended to protect personnel and patients from microorganisms and fluids during surgical procedures, not to treat or cure a disease or condition.
No
This device is a surgical gown, which is a protective barrier worn by operating room personnel. It does not perform any kind of diagnosis or analyze any biological data to identify a disease or condition.
No
The device is a physical surgical gown made of polyester fabric, not software.
Based on the provided information, the TriMax Surgical Gown is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a surgical gown made of polyester fabric. Its function is described in terms of its physical properties and durability through processing cycles.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on barrier properties, strength, flammability, toxicity, sterilization, durability, and colorfastness – all characteristics relevant to a protective garment, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples from the human body to diagnose, monitor, or screen for diseases or conditions. The TriMax Surgical Gown does not fit this description.
N/A
Intended Use / Indications for Use
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
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 / health care facilities and/or contract sterilization/laundry companies
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)
The tests that have been successfully completed include:
a. Flammability 16 CFR Part 1610.
b. Barrier Performance
i. Viral Resistance ASTM #1671-97b
ii. Suter Hydrostatic Testing AATCC #127-1989
iii. Mullens Hydrostatic Testing ASTM D751-95 Procedure A
c. Strength ASTM #D-1682-87
d. Lint EDANA 220.0-96
e. Toxicity Cytotoxicity MEM Elution (MG023) Acute Systemic Toxicity (ISO 10993)
f. Primary Skin Irritation (ISO 10993))
g. Sterilization Product sold non-sterile; can be sterilized using prevacuum steam cycles.
h. Durability through 75 processing (wash, dry and sterilization).
i. Colorfastness to Commercial Laundering AATCC #61-1993(4A).
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.
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
Image /page/0/Picture/0 description: The image shows a black and white emblem. The emblem is in the shape of a shield with a thick border. Inside the shield are the letters 'S' and 'T' intertwined.
Page 93
HEALTHCARE TEXTILE COMPANY
DEC 0 3 2001
vorld headquarter NE KNOLLCREST D O BOX 371805 CINCINNATI, OHIO 5222-1805 13-761-9255 3-761-0467 FA
012268
510(k) Summary
This summary of 510(k) safety and effectiveness is being supplied in accordance with the Safe Medical Device Act of 1990 and 21 C.F.R.
807.92(a)
| 1. | Standard Textile Co., Inc.
One Knollcrest Drive
Cincinnati, Ohio 45237 | Contact Person: Brad Bushman
(513) 761-9255 Ext. 455
Summary Prepared on 6/29/01 | | | | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|---------------|----------------------|---------------------------------------|
| 2. | Device Name:TriMax Surgical Gown, non-sterile (75X reusable)Common/Usual Name:Surgical GownClassification Name:Surgical Apparel 21 C.F.R. § 878.4040 | Device Name: | TriMax Surgical Gown, non-sterile (75X reusable) | Common/Usual Name: | Surgical Gown | Classification Name: | Surgical Apparel 21 C.F.R. § 878.4040 |
| Device Name: | TriMax Surgical Gown, non-sterile (75X reusable) | | | | | | |
| Common/Usual Name: | Surgical Gown | | | | | | |
| Classification Name: | Surgical Apparel 21 C.F.R. § 878.4040 | | | | | | |
| 3. | Predicate Device: | ComPel XTR® Surgical Gowns #K922753 | | | | | |
-
All fabric components used in TriMax Surgical Gowns are made from 100% polyester. 4.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions These products will be manufactured and through 75 complete wash, dry and sterilization cycles. distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies -
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical procedures ર. to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
There are no critical differences in the use of this product from currently marketed ComPel XTR® Surgical Gowns except for higher liquid resistance claims, additional viral resistance claims and sleeve seam performance claims. TriMax Surgical Gown have demonstrated that they will perform as intended when used as labeled. -
The tests that have been successfully completed include: 6.
- Flammability 16 CFR Part 1610. a.
- Barrier Performance b.
- Viral Resistance ASTM #1671-97b i.
- Suter Hydrostatic Testing AATCC #127-1989 ii.
- Mullens Hydrostatic Testing ASTM D751-95 Procedure A iii.
- Strength ASTM #D-1682-87 C.
- Lint EDANA 220.0-96 d.
- Toxicity Cytotoxicity MEM Elution (MG023) e. Acute Systemic Toxicity (ISO 10993)
- Primary Skin Irritation (ISO 10993)) f.
- Sterilization Product sold non-sterile; can be sterilized using prevacuum steam cycles. g.
- Durability through 75 processing (wash, dry and sterilization). h.
- Colorfastness to Commercial Laundering AATCC #61-1993(4A). i.
To the best of my knowledge, all data and information in the 510(k) are truthful and accurate, and that no material fact has been omitted.
Bradley J. Bushman
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and resemble a human figure in motion or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bradley J. Bushman Director, Technical Resources Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45237-1600
Re: K012268
Trade/Device Name: Trimax Regulation Number: 878.4040 Regulation Name: Surgical Gown Regulatory Class: II Product Code: FYA Dated: October 15, 2001 Received: October 19, 2001
Dear Mr. Bushman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
DEC 0 3 2001
2
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rict of any I outh all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (2) roquicellents as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section This letter with and w you're cognification. 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and additionally 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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
3
To be issued KO12268 510(k) NUMBER:
TriMax Surgical Gown DEVICE NAME:
INDICATIONS FOR USE:
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
Chis tom
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1)