(379 days)
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Not Found
No
The summary describes a surgical gown made of fabric and its physical performance characteristics. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a surgical gown designed to protect operating room personnel by inhibiting liquid migration, not to treat a medical condition.
No
The device description clearly states "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 across critical areas of the gown." This indicates a protective function, not a diagnostic one.
No
The device is a physical surgical gown made of fabric, not software. The description details material composition and physical performance testing.
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 across critical areas of 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 description focuses on the material composition and durability of the gown for its intended protective function.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests in vitro (outside the body) on biological samples to gain diagnostic information. 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 across 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 devices that are intended to be processed through 100 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. All the ComPel® fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 100 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
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel / health care facilities and/or contract 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. 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 100 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.)
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.
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
K04/653
STANDARD TEXT ! LI
JUL 0 1 2005
O HORI D HEADDIA P.O. BOX 371805 CINCINNATI, OHIO 45222-1805
Page 2
513-761-9255
513-761-0467 FAX
1-800-990-0400
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)
- Standard Textile Company 1 -One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9256 Extension 455
- ComPel® 1-Ply Surgical Gowns Device Name: 2. ComPel® 'O' Surgical Attire/Gowns Developmental Name: Surgical Attire Common/Usual Name: Surgical Attire Classification Name:
- All the components used in these ComPel® Gowns are made from 100% Dacron 3. All the ouripented acomPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 100 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.
- The tests that have been successfully completed include: ട്.
- 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 100 processings (wash, dry and sterilization). d.
- Strength ASTM D-1682-75 e.
- Lint IST 160.0-83 f,
- Toxicity பு.
- 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.
Bradley J. Bushman
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it, topped by a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 0 1 2005
Mr. Bradley J. Bushman Standard Textile Company Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45222-1805
Re: K041653
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: June 17, 2005 Received: June 20, 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 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.
2
Page 2- Mr. Bradley J. 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 (OS) 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 vours,
Syllie H. Michaux M.D.
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): K041653
ComPel 1-Ply Surgical Gowns Device Name:
Indications For Use:
ComPel 1-Ply Surgical gowns are medical devices that are intended to be wor by operating of light ComPel 1-Ply Surgical govers at included to protect them by inhibiting the migration of liquids
room personnel during surgical procedures to protect them by inhibiting the mi room persomici during surgritical areas of the gown.
When processed according to instructions, ComPel I-Ply Surgical gowns will function and When processed according to Institutions, Courselle through 100 wash, dry, and sterilization
perform as protective apparel. The gowns are resile mades that are intended to be perform as protective apparel. List gownload as non-sterily products that are intended to be cycles. They are manufactured and or contract laundry companies.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Shule A. Moyerkey P.
Page 1 of _
(Division Sign-Off) (Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K041653