(87 days)
Exact Medical Manufacturing Surgical Gown SMS w/PE Layer 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. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization
Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.
The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer met the acceptance criteria by demonstrating substantial equivalence to its predicate device (K023117) through a series of non-clinical performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| Design | Same as predicate device (K023117) |
| Material | Same as predicate device (K023117) |
| Performance Characteristics | Same as predicate device (K023117) |
| Biocompatibility (ISO 10993): | |
| Cytotoxicity | Met acceptance criteria |
| Irritation | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Barrier Properties (AAMI PB:70): | |
| Level 3 (Fluid resistance, microbial barrier, particulate matter) | Met acceptance criteria |
| Physical Strength: | |
| Tensile Strength | Met acceptance criteria |
| Tear Strength | Met acceptance criteria |
| Other Performance: | |
| Flammability | Met acceptance criteria |
| Linting | Met acceptance criteria |
| Sterility (for sterile versions/post-sterilization) | Met acceptance criteria |
All results of the testing met acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "All results of the testing met acceptance criteria," implying that sufficient samples were tested for each criterion according to standard testing protocols for medical devices.
- Data Provenance: The data is generated from non-clinical performance testing conducted by Exact Medical Manufacturing, Inc. It is internal testing performed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a non-clinical device (surgical gown) and does not involve human interpretation of data where expert consensus would be required to establish ground truth such as in diagnostic imaging. The "ground truth" is established by adherence to recognized national and international standards (e.g., ISO 10993, AAMI PB:70).
4. Adjudication method for the test set:
- Not applicable. As noted above, this involves objective, quantifiable laboratory tests against established standards, not interpretation or adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a surgical gown, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical gown, not an algorithm.
7. The type of ground truth used:
- The ground truth is based on accepted national and international standards and specifications for surgical gowns and medical device materials, including:
- ISO 10993 for biocompatibility.
- AAMI PB:70 for barrier properties (Level 3).
- Other specific test methods for tensile strength, tear strength, flammability, linting, and sterility.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable, for the reason stated above.
{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 company name written in a smaller font size underneath. To the left of the text is a geometric design that is partially shaded.
101593
эс. 6: 510(k) Summary -- EMM Surgical Gown SMS w/PE Layer
.Page
Technological Characteristics Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device. Summary of Testing Exact Medical Manufacturing Surgical Gown SMS w/PE Layer is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K023117. Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 3, 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 K023117.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, rendered in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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 14186
2010 SEE 3
Re: K101593
Trade/Device Name: Exact Medical Manufacturing Surgical Gowns SMS w/PE Layer Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: June 4, 2010 Received: June 8, 2010
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 yours.
Anthony D. West
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}------------------------------------------------
SEP 3 2010
Page 26
Indications for Use Form
Indications for Use:
510(k) Number (if known):
Device Name: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer
Indications for Use: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer 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.
The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
الماركة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة الم
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Provinsion of Anesthesional Payines Division Control, Dental Devices
510(k) Number. K101593
§ 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.