(42 days)
BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The BARRIER® Surgical Gowns have been designed with an assortment of fabrics and have been on the market for a number of years cleared under predicate 510(k) notifications. BARRIER surgical gowns have been developed for general surgical procedures and for procedures which represent possible exposure to bloodborne pathogens and other potentially infectious materials which require increased levels of protection.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (AAMI Level) | Reported Device Performance (AAMI Level) |
|---|---|
| BARRIER® Standard and Standard Fabric Reinforced Surgical Gowns: Level 2 | Level 2 |
| BARRIER® Extra and Ultra Protection Gowns: Level 3 | Level 3 |
| BARRIER® Extra and Ultra Protection Plus Surgical Gowns: Level 4 | Level 4 |
| BARRIER® Surgical Gown II and BARRIER® Surgical Gown II, Fabric Reinforced: Level 3 | Level 3 |
| BARRIER® Fluid Protection Plus Surgical Gowns: Level 3 | Level 3 |
| BARRIER® Urology Gown: Level 4 | Level 4 |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "BARRIER® Surgical Gowns have been evaluated using the ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)."
- Sample Size for Test Set: The exact sample size for each gown type is not explicitly stated in the provided 510(k) summary. The AAMI PB-70:2003 standard likely specifies the minimum sample size required for testing.
- Data Provenance: The document does not provide details on the country of origin of the data or whether the study was retrospective or prospective. It only mentions the standard used for evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device (surgical gowns) and the testing performed. The "ground truth" here is objective physical testing against a recognized standard (ANSI/AAMI PB-70:2003) for liquid barrier performance, not subjective human assessment.
4. Adjudication Method for the Test Set:
This information is not applicable. As stated above, the evaluation is based on objective physical testing according to a published standard, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. Surgical gowns are protective apparel, and their performance is assessed through laboratory testing against industry standards.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable. There is no "algorithm" or AI component to the BARRIER® Surgical Gowns. Their performance is inherent to their material and construction, measured through physical tests.
7. The Type of Ground Truth Used:
The ground truth used is the objective measurements of liquid barrier performance as defined and specified by the ANSI/AAMI PB-70:2003 Standard. This standard outlines the specific test methods and criteria to classify protective apparel based on its barrier performance against liquids.
8. The Sample Size for the Training Set:
This question is not applicable. Since there is no AI or machine learning component, there is no "training set." The performance of the surgical gowns is determined through physical testing of manufactured samples.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
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510(k) SUMMARY
| Applicant: | Mölnlycke Health Care826 Newtown Yardley Rd.Newtown, PA 18940 |
|---|---|
| Contact Person: | John ClayRegulatory Affairs Officer |
| Tel.: | 267-685-2078 |
| Fax: | 267-685-2010 |
| Device Name: | |
| Proprietary Name: | Barrier® Surgical Gowns |
| Common/Usual Name: | Surgical Gowns |
| Device Classification: | Class II - 21 CFR 878.4040 |
| Substantial Equivalence: | For the purpose of Section 510(k) of the Federal Food, Drug andCosmetic Act, Mölnlycke Health Care considers the BARRIER®Surgical Gowns are substantially equivalent in composition,function and intended use to the previously marketed BARRIER®Surgical Gowns. |
| Intended Use: | BARRIER® surgical gowns are intended for single use to be wornby the Surgical Team Members in the operating room duringsurgical procedures to protect both the patient and the operatingroom personnel from the transfer of microorganisms, body fluidsand particulate material. |
| Description: | The BARRIER® Surgical Gowns have been designed with anassortment of fabrics and have been on the market for a number ofyears cleared under predicate 510(k) notifications. BARRIERsurgical gowns have been developed for general surgicalprocedures and for procedures which represent possible exposureto bloodborne pathogens and other potentially infectious materialswhich require increased levels of protection. |
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BARRIER 510(k) Summary, Page 2
The following chart highlights the current BARRIER surgical gown families and the predicate 510(k) notifications under which they are currently marketed.
| Description | Predicate 510(k) |
|---|---|
| BARRIER® Standard and StandardFabric Reinforced Surgical Gowns | K760903 |
| BARRIER® Extra and Ultra ProtectionGowns | K760903 |
| BARRIER® Extra and Ultra ProtectionPlus Surgical Gowns | K932731 |
| BARRIER® Surgical Gown II andBARRIER® Surgical Gown II , FabricReinforced | K920996 |
| BARRIER® Fluid Protection PlusSurgical Gowns | K990395 |
| BARRIER® Urology Gown | K760903 |
Summary of
Testing:
BARRIER® Surgical Gowns have been evaluated using the ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities) The chart represents the AAMI levels claimed for each gown family.
| Description | Level of Protection according to AAMI |
|---|---|
| BARRIER® Standard and StandardFabric Reinforced Surgical Gowns | Level 2 |
| BARRIER® Extra and Ultra ProtectionGowns | Level 3 |
| BARRIER® Extra and Ultra ProtectionPlus Surgical Gowns | Level 4 |
| BARRIER® Surgical Gown II andBARRIER® Surgical Gown II , FabricReinforced | Level 3 |
| BARRIER® Fluid Protection PlusSurgical Gowns | Level 3 |
| BARRIER® Urology Gown | Level 4 |
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Image /page/2/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 lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
MAY - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Clay Regulatory Affairs & Quality Officer-US Mölnlycke Health Care 826 Newtown-Yardley Road, Suite 300 Newtown, Pennsylvania 18940
Re: K050786
Trade/Device Name: BARRIER® Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 19, 2005 Received: April 22, 2005
Dear Mr. Clay:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have ro rowed your and have determined the device is substantially equivalent (for the relerenced above and nave attermclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Ameliuments, or to act roos that nortic 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 providents or 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 If your device to such additional controls. Existing major regulations affecting (I MA), it may be subject to back of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the reannouncements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not I least to advisod that 1 Da determination that your device complies with other requirements Incall that I D'I may Federal statutes and regulations administered by other Federal agencies. of the Act of any I oderal statuse and submitted to: but not limited to: registration 1 ou must comply with and 1); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RP art 867), laceling (QS) regulation (21 CFR Part 820); and if requirements as bet ferm nroduct 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) This letter will anow yourse bogan made of substantial equivalence of your device to a premarket notified.com - The PDF 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), If you desire specific at not 100 your 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 other generational and Consumer Assistance at its toll-free Divisor (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clair 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
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Indications for Use
510(k) Number (if known): K050786
Device Name: BARRIER® Surgical Gowns
Indications for Use:
BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Murphy, MD
of Anesthesiology, General Hospital, n Control, Dental Devices
Number: K050 786
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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.