(43 days)
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No
The summary describes a surgical gown made of polyester with a fluorocarbon finish, intended for protection during surgery and reusable through multiple cycles. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and durability.
No
The device, ComPel 1-Ply Surgical gowns, is intended for protection and to function as protective apparel during surgical procedures, not for treating or diagnosing a medical condition.
No
The device is a surgical gown, which is personal protective equipment, not a device used to diagnose medical conditions.
No
The device is a physical surgical gown made of fabric, not software. The description focuses on material composition, physical properties, and performance through processing cycles.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect operating room personnel by inhibiting the migration of liquids through the gown during surgical procedures. This is a protective function for the user, not a diagnostic test performed on a sample from the human body.
- Device Description: The device is a surgical gown made of fabric. It is described in terms of its material composition and durability through processing cycles. This aligns with personal protective equipment, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties of the gown (liquid resistance, flammability, durability, strength, lint, toxicity, compatibility with sterilization), which are relevant to its function as protective apparel, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
ComPel 1-Ply 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.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
Mentions image processing
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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 / health care facilities and/or contract sterilization/laundry 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 125 processings (wash, dry and sterilization).
e. Strength ASTM D-1682-75
f. Lint IST 160.0-83
g. Toxicity
-Cytotoxicity MEM Elution (MG023)
-Primary Skin Irritation (FHSA)
h. Compatibility with Steam Sterilization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The liquid barrier properties will inhibit the migration of liquids across its surface. Per ANSI/AAMI PB70:2003 standard, the 1-ply surgical gowns with the flat felled seam design are classified as a Level 2 Barrier.
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.
Not Found
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
STANDARD TE
MAR 7 2006
Image /page/0/Picture/2 description: The image shows a series of handwritten alphanumeric characters. The characters appear to be 'Ko60181', written in a cursive style. The writing is in black ink and stands out against a white background.
COMPEL® 1-PLY 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)
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- Standard Textile Company One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9256 Extension 455
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- Device Name: ComPel® 1-Ply Surgical Gowns ComPel® 'O' Surgical Attire/Gowns Developmental Name: Common/Usual Name: Surgical Attire Classification Name: Surgical Attire
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- All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
- ComPel® 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 1-ply surgical gowns with the flat felled seam design are classified as a Level 2 Barrier.
- ട്. The tests that have been successfully completed include:
- a. Suter Hydrostatic Testing AATCC #127-1980
- b. Impact Penetration Testing AATCC 42-2000
- Flammability Code of Federal Regulations 1610 (CS-191-53) C.
- d. Durability through 125 processings (wash, dry and sterilization).
- Strength ASTM D-1682-75 e.
- f. Lint IST 160.0-83
- Toxicity ದು.
- . -Cytotoxicity MEM Elution (MG023)
- Primary Skin Irritation (FHSA) 11.
- 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.
Bradley J. Bushman
INCINNATI, OH C
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, and a bowl. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 7 2006
Mr. Bradley Bushman Vice President, Technical Affairs Standard Textile Company, Incorporated One Knollcrest Drive PO Box 371805 Cincinnati, Ohio 45237
Re: K060181
Trade/Device Name: ComPel® 1-Ply Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 19, 2006 Received: January 23, 2006
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.
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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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration . and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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), please contact 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 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/industry/support/index.html.
Sincerely yours,
Susan Ruoner
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
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Indications for Use
510(k) Number (if known):
Device Name:
ComPel 1-Ply Surgical Gowns
Indications For Use:
ComPel 1-Ply 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.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Shirl. L. Murphy, R. 3/4/64
May, General Hospital
Services