(281 days)
Not Found
No
The summary describes a surgical gown and its material properties and performance characteristics, with no mention of AI or ML technology.
No
This device is a surgical gown intended to protect operating room personnel from liquid migration, not to diagnose, treat, or prevent disease in a patient.
No
Explanation: The device described is a surgical gown, which is a protective barrier worn by operating room personnel. It is not used to diagnose any medical conditions or diseases.
No
The device description clearly states it is a surgical gown made of fabric components, which is a physical product, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting operating room personnel by inhibiting liquid migration. 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 and physical properties of the gown, again emphasizing its barrier function.
- Performance Studies: The performance studies listed are related to the physical properties and durability of the gown (flammability, barrier performance tests, strength, air permeability, lint, toxicity, sterilization, durability, colorfastness). None of these are diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
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
ComPel MLR Surgical gowns are medical devices that are intended to be worn by operating room personnel 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 MLR Surgical gowns will function and perform as a various gowns. They are manufactured and distributed as non-sterile surgical gowns and are reusable through 75 wash, dry, and 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 ComPel 3000 Surgical Gowns are made from 100% polyester, solution luble outer for the outer ComPel 3000 layer and non-dyed filaments with carbon yarns for the inner layer, and are treated with a fluorochemical finish.
ComPel 3000 Surgical Gowns will function as a surgical attire when processed according to instructions through 75 complete 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.
ComPel 3000 Surgical Gowns are intended to be worn by personnel functioning in the surgical theater and will be put in all critical areas of the product where liquid protection is needed. The liquid barrier properties with minon the migrated "inverted" 2-ply sleeve designs are classified as a Level 3 Barrier.
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 in healthcare facilities.
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:
Flammability CFR 1610 (CS-191-53).
Barrier Performance
Suter Hydrostatic Testing AATCC #127-1985
Impact Penetration Testing AATCC #42-1980
Water Repellency: Spray Test #22-1980
Bacterial Filtration Efficiency Nelson Laboratories Procedure #SOP/ARO/007C
Strength ASTM D-1682-75
Air Permeability ASTM #737-80
Lint IST 160.0-83
Toxicity Cytotoxicity MEM Elution (MG023)
Primary Skin Irritation (FHSA)
Sterilization Product sold non-sterilized using prevacuum or gravity steam cycles.
Durability through 75 processing (wash, dry and sterilization).
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.
ComPel "O" Surgical Gowns #K921889
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
Page 2
STANDARD TEX ge
COMPEL MLR™ SURGICAL GOWNS SAFETY AND EFFECTIVNESS SUMMARY
MAR 1 6 /11/2
BOX 371805 00 3 2 - 1 8 0 1
13 761 9545
The following information is being supplied in accordance with the Safe Medical Device Act of 1990.
807.92(a)
- Standard Textile Co., Inc. ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ One Knollcrest Drive Cincinnati, Ohio 45237 Contact Person: Brad Bushman (513) 761-9255 Ext.455
- ComPel 3000 Surgical Gowns (Developmental Name) Device Name: 2. ComPel MLR Surgical Gowns (Marketing Name) Non-sterile Surgical Gowns, Operating Room Gowns and Surgical Attire. Common/Usual Name: Surgical Apparel Classification Name:
- ComPel® "O" Surgical Gowns #K921889 Predicate Device: 3.
- All fabric components used in ComPel® 3000 Surgical Gowns are made from 100% polyester, solution 4. All luble outer for the outer ComPel 3000 layer and non-dyed filaments with carbon yarns for the inner layer, and are treated with a fluorochemical finish.
ComPel® 3000 Surgical Gowns will function as a surgical attire when processed according to instructions through 75 complete 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.
- ComPel® 3000 Surgical Gowns are intended to be worn by personnel functioning in the surgical theater న్. and will be put in all critical areas of the product where liquid protection is needed. The liquid barrier and will be pat in an the migration of liquids across its surface. Per ANSI/AAMI PB70:2003, ComPel properties with minon the migrated "inverted" 2-ply sleeve designs are classified as a Level 3 Barrier.
- The tests that have been successfully completed include: 6.
- Flammability CFR 1610 (CS-191-53). a.
- Barrier Performance b.
- Suter Hydrostatic Testing AATCC #127-1985 . ...
- Impact Penetration Testing AATCC #42-1980 ii.
- Water Repellency: Spray Test #22-1980 111.
- Bacterial Filtration Efficiency Nelson Laboratories Procedure #SOP/ARO/007C iiii.
- Strength ASTM D-1682-75 C.
- Air Permeability ASTM #737-80 d.
- Lint IST 160.0-83 e.
- Toxicity Cytotoxicity MEM Elution (MG023) f.
- Primary Skin Irritation (FHSA) g.
- Sterilization Product sold non-sterilized using prevacuum or gravity steam h. cycles.
- Durability through 75 processing (wash, dry and sterilization). i.
- Colorfastness to Commercial Laundering AATCC #61-1993(4A). J.
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 6/4/04
Bradley J. Bushman
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Mr. Bradley J. Bushmen Vice President, Technical Affairs Standard Textile Company, Incorporated One Knollcrest Drive P.O. Box 371805 Cincinnati, Ohio 45222-1805
Re: K041541
Trade/Device Name: ComPel MLR Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FY A Dated: February 7, 2005 Received: February 8, 2005
Dear Mr. Bushman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaler over is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in Indications for use stated in the environment date of the Medical Device Interstate commerce prior to ria] 20, 12, 12, 12, 12, 12, 20, 20, 2017 10, 2017 10, 2017 Amendinents, or to do roos and Cosmetic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmene 110 (Antone, market the device, subject to the general approval approvision (1177).). The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (see assnow to relations) controls. Existing major regulations affecting (1 MA), it may of suched in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher 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
es were and the management and assuss device complies with other requirement Please be advised that FDA s Issuance of a subscurances with other requirements
mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a determination introl interest by other Federal agencies.
of the Act or any Federal statutes and regulations and not himited to registration of the Act or any Federal statules and reginations and limited to: registration
You must comply with all the Act's requirements, and monutacturing practice You must comply with an the Act Stequilenents, introducing on the manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practi and listing (21 CFR Part 807); labelling (21 CFR Parts (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality systems (QB) regalable (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)
the success of the subservation in the tisk spiralence of your device to a This letter will allow you to begin malicomig your acce of your device of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, per premarket notification. The FDA midnig of substantial of in the results and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), If you desire specific advice for your device at (240) 276-0115. Also, please note the regulation please contact the Office of Comphanes as (210) - 107 - 107.97). You
entitled, "Misbranding by reference to premarket notification" (2107). You entitled, "Misoranding by reference to premaintent on your responsibilities under that in the may obtain other general miormation on your a and Consumer Assistance at its toll-free Division of Shias-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.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):
ComPel MLR Surgical Gowns Device Name:
Indications For Use:
ComPel MLR Surgical gowns are medical devices that are intended to be worn by operating Compel MLR Surgical govins are medical 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 Sulgical gowns may provide antereials used and the placement of such materials in the final design of the gown.
When processed according to instructions, ComPel MLR Surgical gowns will function and within processed according to the ComPel MLR Surgical gowns are reusable through 75 wash, perform as a vargious goves. They are manufactured and distributed as non-sterile surgical dry, and mermized to be sterilized and processed by health care facilities and/or contract sterilization/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) | |
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