(158 days)
No
The device description and intended use clearly define a physical surgical gown with barrier properties. There is no mention of software, data processing, or any technology that would involve AI or ML.
No.
The device description clearly states its purpose is to protect against transfer of microorganisms and fluids, not to treat or diagnose a disease or condition.
No
Explanation: The device is a surgical gown, which is a protective barrier worn during surgical procedures, not a tool used for diagnosing medical conditions. Its purpose is to prevent the transfer of microorganisms and bodily fluids, not to detect, monitor, or analyze health parameters.
No
The device description clearly indicates it is a physical surgical gown made of fabric and film, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gown is "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." This describes a barrier device used for protection during a medical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This surgical gown does not perform any such testing.
- Device Description: The description details the materials and construction of a garment, not a diagnostic test kit or instrument.
The information provided consistently describes a medical device used for barrier protection, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or nonsterile single use 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. Sterile surgical gowns are to be sold directly to users after E.O sterlization and validated to ISO 11135-1:2007.
The Exact Medical Manufacturing Surgical Gowns with AAMI Level IV Liquid Barner are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization according to ISO 11135-1:2007
Product codes
FYA
Device Description
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV are sterile or non-sterile single use 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.
Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV is comprised of a 3 ply laminate non woven material - outer layers are nonwoven fabric - inner layer AAMI PB:70 Level 4 capable film. The gowns consist of 100% polyester cuffs sewn to the end of the sleeves using nylon thread. The gowns have a manual closure system.
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 during surgical procedures.
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
Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Convertors SmartGown K992514
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Exact Medical Manufacturing, Inc. The logo consists of the letters "EMM" in bold, black font, with the words "Exact Medical Manufacturing, inc." written in a smaller font size below the letters. To the left of the letters is a black and white graphic.
Sec. 6: 510(k) Summary – EMM Surgical Gown with AAMI Liquid Barrier Level IV
120045
| Date Summary was Prepared | December 31, 2011 |
|---|---|
| 510(k) Submitter | David Nowicki, President |
| Exact Medical Manufacturing Inc. | |
| 4917 William Street, Suite C | |
| Lancaster, NY 14086 | |
| dnowicki@exactmm.com | |
| (p)716-681-0866, (f) 716-681-4110 | |
| Primary Contact for this 510(k) | |
| Submission | David Nowicki, President |
| Exact Medical Manufacturing Inc. | |
| 4917 William Street, Suite C | |
| Lancaster, NY 14086 | |
| dnowicki@exactmm.com | |
| (p)716-681-0866, (f) 716-681-4110 | |
| Device Common Name | Surgical Gown |
| Trade Name | Surgical Gown with AAMI Liquid Barrier Level IV |
| Device Product Codes and | |
| Classification Name | FYA, 21CFR878.4040, Surgical Apparel |
| Predicate Device | Convertors SmartGown K992514 |
| Device Description | Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV |
| are sterile or non-sterile single use 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. | |
| Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV | |
| is comprised of a 3 ply laminate non woven material - outer layers are | |
| nonwoven fabric - inner layer AAMI PB:70 Level 4 capable film. The | |
| gowns consist of 100% polyester cuffs sewn to the end of the sleeves | |
| using nylon thread. The gowns have a manual closure system. | |
| Intended Use | Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV |
| are sterile or non-sterile single use 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. | |
| The Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier | |
| Level IV are also sold as bulk non-sterile, single use items, to | |
| repackager/relabeler establishments for further packaging and ethylene | |
| oxide sterilization. | |
| Technological Characteristics | Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV |
| has the same design, material and performance characteristics of the | |
| predicate device. | |
| Summary of Testing | Exact Medical Manufacturing Surgical Gown with AAMI Liquid Barrier Level IV |
| is substantially equivalent and meets the same acceptance criteria as the | |
| predicate device/gown in K992514 Non-clinical performance testing | |
| includes: Biocompatibility (cytotoxicity, irritation, sensitization) in | |
| compliance with the methods of ISO 10993, Barrier properties- AAMI | |
| PB:70 Level 4, tensile, tear strength, flammability, linting and sterility. All | |
| results of the testing met acceptance criteria. | |
| Substantial Equivalence | The surgical gowns described in this 510(k) submission are substantially |
| equivalent in all specifications and performance compared to the predicate | |
| device indentified in K992514. |
4917 William Street - Suite C ・ Lancaster, NY 14086 ・ (716) 681-0866
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 consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David Nowicki President Exact Medical Manufacturing, Incorporated 4917 William Street, Suite C Lancaster, New York 14086
JUN 1 2 2012
Re: K120045
Trade/Device Name: Exact Medical Manufacturing Surgical Gown with AAMI Level IV Liquid Barrier, Model # 19-121, Sizes L, XL, XXL, XLXL Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: June 1, 2012 Received: June 4, 2012
Dear Mr. Nowicki:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Nowicki
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Fr
Anthony D. Watson, B.S., M.S., M.B.A. 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 Form
Indications for Use:
510(k) Number (if known):