(324 days)
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Not Found
No
The device description and performance studies focus on the physical properties and durability of surgical gowns, with no mention of AI or ML technology.
No
A therapeutic device is used to treat a disease or condition, whereas this device is a surgical gown designed to protect operating room personnel by inhibiting the migration of liquids.
No
The device is a surgical gown intended to protect operating room personnel by inhibiting liquid migration, not to diagnose medical conditions.
No
The device is a physical surgical gown made of fabric, not software. The description details material composition, physical properties, and performance testing related to barrier function and durability, all characteristic of a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gowns are for protecting operating room personnel by inhibiting the migration of liquids. This is a physical barrier function, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the materials, construction, and performance characteristics related to its function as a surgical gown (barrier properties, durability, sterilization compatibility). There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed are related to the physical properties and durability of the gown (hydrostatic testing, impact penetration, flammability, strength, lint, toxicity, sterilization compatibility). These are not diagnostic performance metrics.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
In summary, the ComPel Surgical Gowns are classified as medical devices that provide a physical barrier during surgical procedures. They do not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ComPel Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
Surgical gowns may provide different levels of protection dependent upon the fabric materials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel Surgical gowns will function and perform as a surgical gown. The ComPel Surgical gowns are reusable through 75 wash, dry, and sterilization cycles. 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
All the components used in ComPel® Surgical Gowns are made from 100% Dacron ® polyester filaments. ComPel 'O' fabrics are dyed and treated with a fluorocarbon finish.
ComPel® 'O' Surgical Gowns will function as surgical attire when processed according to instructions through 75 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed (wash/dried) by health care facilities and/or contract sterilization/laundries companies.
Mentions image processing
Not Found
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 / operating theater, health care facilities and/or contract sterilization/laundries companies.
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)
The tests that have been successfully completed include:
a. Suter Hydrostatic Testing AATCC #127-1980
b. Impact Penetration Testing AATCC 42-2000
c. Flammability Code of Federal Regulations 1610 (CS-191-53)
d. Durability through 75 processings (wash, dry and sterilization).
e. Strength ASTM D-1682-75
f. Lint IST 160.0-83
g. Toxicity
i. Cytotoxicity MEM Elution (MG023)
ii. Primary Skin Irritation (FHSA)
h. Compatibility with Steam Sterilization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The 2-ply gowns with the flat felled seam design are classified as a Level 2 Barrier per ANSI/AAMI PB70:2003 standard.
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.
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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.
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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).
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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.
0
Image /page/0/Picture/0 description: The image shows the words "STANDARD TEXTILE" in a stylized font. The word "STANDARD" is in a simple, sans-serif font, while the word "TEXTILE" is in a bold, blocky font with a black background. The letters in "TEXTILE" are white, creating a strong contrast. The overall design is clean and modern.
INCINNATI, OHIO
513 - 761 - 4255
COMPEL® SURGICAL GOWNS SAFETY AND EFFECTIVNESS SUMMARY
The following information is being supplied in accordance with the Safe Medical Device Act of 1990.
807.92(a)
-
- Standard Textile Company One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9256 Extension 455
- ComPel® Surgical Gowns 2. Device Name: ComPel® 'O' Surgical Attire/Gowns Developmental Name: Common/Usual Name: Operating Room Gowns Classification Name: Surgical Attire
- All the components used in ComPel® Surgical Gowns are made from 100% Dacron റു. polyester filaments. ComPel 'O' fabrics are dyed and treated with a fluorocarbon finish.
ComPel® 'O' Surgical Gowns will function as surgical attire when processed according to instructions through 75 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed (wash/dried) by health care facilities and/or contract sterilization/laundries companies.
- ComPel® 'O' Surgical Gowns are intended to be used as surgical attire in an operating 4. theater. The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 2-ply gowns with the flat felled seam design are classified as a Level 2 Barrier.
- The tests that have been successfully completed include: 5.
- Suter Hydrostatic Testing AATCC #127-1980 a.
- Impact Penetration Testing AATCC 42-2000 b.
- Flammability Code of Federal Regulations 1610 (CS-191-53) C.
- Durability through 75 processings (wash, dry and sterilization). ದ.
- Strength ASTM D-1682-75 e.
- Lint IST 160.0-83 ん
- Toxicity ਧੂ.
- Cytotoxicity MEM Elution (MG023) .. -
- Primary Skin Irritation (FHSA) ii.
- Compatibility with Steam Sterilization h.
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.
APR 2 8 2015
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract shapes resembling birds in flight or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Mr. Bradley J. Bushman Vice President, Technical Affairs Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45237-1600
Re: K041539
Trade/Device Name: ComPel "O" Surgical Gowns with PB 70 Claims Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 8, 2005 Received: April 11, 2005
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 Ameralie ents, 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 approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 Wri), it may of bacyses to 2017.
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be roundsh further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Bushman
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 mount that I Drima mad regulations administered by other Federal agencies. or the Act of any I outhall the Act's requirements, including, but not limited to: registration r ou intest compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and insing (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as ectronic 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 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), rr you desire specific at the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/industry/support/index.html.
Sincerely yours,
Smitte Y. Michie Ovens
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): #K041539
ComPel Surgical Gowns Device Name:
Indications For Use:
ComPel Surgical gowns are medical devices that are intended to be worn by operating room Comfel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
Surgical gowns may provide different levels of protection dependent upon the fabric materials Surgical gowns may provide ansterials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel Surgical gowns will function and perform as which processor accoraing to instraited gowns are reusable through 75 wash, dry, and a surgical gown. The Comil of Bargical ged and distributed as non-sterile surgical gowns that are storingation oyotes. "The same processed by health care facilities and/or contract sterilization/laundry companies.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
X Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shiela H. Murphy
Infaction Control. Dental Devices
510(k) Number ..
ാഗ്ദേഹം Sign-Chi)
Sivision of Anesthesiology, General Hospital,
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