(269 days)
No
The device is a physical isolation gown and the summary does not mention any software, AI, or ML components.
No.
The device is an isolation gown intended to provide barrier protection, not to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The device, isolation gowns, are intended to provide barrier protection from microorganisms, body fluids, and particulate material. It is not designed to diagnose any condition or disease.
No
The device is a physical isolation gown made of SMS non woven material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the gowns are for providing barrier protection to healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the material, construction, and physical properties of the gown, all related to its barrier function.
- Performance Studies and Key Metrics: The performance studies and key metrics listed (liquid barrier performance, flammability, strength, biocompatibility) are all related to the physical and safety characteristics of a protective garment, not to the diagnosis of a disease or condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PRIMAGARD Isolation Gowns do not perform any of these functions. They are a form of personal protective equipment (PPE).
N/A
# Intended Use / Indications for Use
PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material.
The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL),
- PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)
# Product codes
FYC
# Device Description
PRIMAGARD AAMI PB70:2012 Level 3 gowns are non-sterile, single use isolation gowns intended to be worn by healthcare professionals in isolations. These gowns are made of SMS non woven material, contain ultrasonic seams, provide full coverage (level 3 as per PB70) and are not made with natural rubber latex. The proposed isolation gowns come in 5 different models as described in the Indications for Use.
# 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
healthcare personnel in isolations
# 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)
Performance, safety and physical properties were tested according to ASTM F2407:2013, AAMI PB70:2012, AATCC 42: 2013, AATCC 127: 2014, ISO 10993-5: 2009, ISO 10993-10: 2010, 16 CFR PART 1610, ASTM D5034:2009 (2013), ASTM D5587:2015, NWSP 160.1R0 (15), ASTM E96:2015, ASTM F1868 part C: 2014, ASTM D737: 04 (2012), ASTM D5035:11 (2015), ASTM D3776: 2009 (2013) to ensure the proposed isolation gown meet the applicable requirements.
Key Results:
- Liquid barrier performance: Hydrostatic Pressure AATCC 127 >= 50 cm, Impact Penetration AATCC 42
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
priMED Medical Products Inc. Mr. Richard Roy Vice President Quality and Product Development #301, 1259 91 Street SW Edmonton, Alberta, Canada T6X 1E9
Re: K160361
Trade/Device Name: PRIMAGARD Isolation Gown (AAMI PB70 Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: October 5, 2016 Received: October 7, 2016
Dear Richard Roy:
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K160361
Device Name:
PRIMAGARD Isolation Gown (AAMI PB70 level 3)
Indications for Use (Describe)
PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolations to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material.
The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL),
- PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
× | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for PrimeMed. The logo has the word "priMED+" in blue font. The word "pri" is in a lighter blue than the rest of the word. Underneath the word is the phrase "MANUFACTURE * DELIVER * PROTECT".
priMED Medical Products Inc. 3rd Floor, 1259-91 Street SW Edmonton, Alberta, Canada T6X 1E9
T 1.877.877.4633 P 780.497.7600 F 780.497.7670 www.primed.ca
510(K) Summary
| Summary Date: | November 3, 2016 (Revised) |
|---|---|
| Manufacturer: | priMED Medical Products Inc. |
| Address: | # 301, 1259 91 St. SW, Edmonton, AB, |
| Canada T6X 1E9 | |
| Phone Number: | 1 780 497 7600 |
| Fax Number: | 1 780 497 7670 |
| Contact person: | Richard Roy |
| richard.roy@primed.ca | |
| Product Common Name: | Non-Sterile Isolation gown |
| Trade or proprietary name: | PRIMAGARD Isolation Gown (AAMI PB70 level 3) |
| Classification Regulation: | 21 CFR 878.4040: Surgical Apparel |
| Class: | II |
| Product code: | FYC (Gown, Isolation, Surgical) |
| Primary Predicate: | Kimberly-Clark MicroCool Isolation Gown |
| (K981393) | |
| Reference Predicate: | XuChang Surgical Gown (K141467) |
| 510(k) number: | K160361 |
Product Description
PRIMAGARD AAMI PB70:2012 Level 3 gowns are non-sterile, single use isolation gowns intended to be worn by healthcare professionals in isolations. These gowns are made of SMS non woven material, contain ultrasonic seams, provide full coverage (level 3 as per PB70) and are not made with natural rubber latex. The proposed isolation gowns come in 5 different models as described in the Indications for Use.
Indications for Use
PRIMAGARD Level 3 Isolation Gowns are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material.
The PRIMAGARD Isolation Gowns of this 510(k) meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only.
4
PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below:
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown. AAMI PB70 Level 3. Hook and Loop Closure (Universal. XL).
- PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL),
- PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)
Summary of the Technological Characteristics of PRIMAGARD Isolation Gowns, the Predicate and Reference Product
As per FDA guidance documents: "Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings" and "Premarket Notification [510(K)] Submissions for Surgical Gowns and Surgical Drapes", performance, safety and physical properties were tested according to the following standards to ensure the proposed isolation gown meet the applicable requirements.
| ASTM F2407:2013 | Standard Specification for Surgical Gowns Intended for Use in Healthcare
Facilities |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| AAMI PB70:2012 | Liquid barrier performance and classification of protective apparel and drapes
intended for use in health care facilities |
| AATCC 42: 2013 | Water Resistance: Impact Penetration Test |
| AATCC 127: 2014 | Water Resistance: Hydrostatic Pressure Test |
| ISO 10993-5: 2009 | Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity |
| ISO 10993-10: 2010 | Biological evaluation of medical devices -- Part 10: Tests for irritation and skin
sensitization |
| 16 CFR PART 1610 | Standard for the Flammability of Clothing Textiles |
| ASTM D5034:2009 (2013) | Standard Test Method for Breaking Strength and Elongation of Textile Fabrics
(Grab Test) |
| ASTM D5587:2015 | Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure |
| NWSP 160.1R0 (15) | Standard Test Method for Resistance to Linting of Nonwoven Fabrics (Dry)
(considered equivalent to IST 160.1 and ISO 9073-10) |
| ASTM E96:2015 | Standard Test Methods for Water Vapor Transmission of Materials |
| ASTM F1868 part C: 2014 | Standard Test Method for Thermal Resistance of Clothing Materials Using a
Sweating Hot Plate - Heat Loss |
| ASTM D737: 04 (2012) | Standard Test Method for Air Permeability of Textile Fabrics (tested as per
equivalent standard for nonwoven material: NWSP 070.1.R0 (15)) |
| ASTM D5035:11 (2015) | Standard Test Method for Breaking Force and Elongation of Textile Fabrics
(Strip Method) |
| ASTM D3776: 2009 (2013) | Standard Test Methods for Mass Per Unit Area (Weight) of Fabric |
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Table: Summary of Comparison of Proposed Isolation Gown with Predicate Devices
| Elements of comparison | Proposed: PRIMAGARD Isolation Gown (AAMI Level 3), Non-sterile | Predicate: MICROCOOL Isolation Gown, Non-sterile | Reference Predicate: Surgical Gown, Level 3, Sterile | |
|---|---|---|---|---|
| Manufacturer | priMED Medical Products Inc. | Kimberly-Clark Corporation | XuChang ZhengDe | |
| Environstar Medical Products Co., Ltd. | ||||
| 510(K) Number | K160361 | K981393 | K141467 | |
| Product Code | FYC | FYC | FYA | |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | |
| Intended Use | PRIMAGARD Isolation Gowns are non-sterile, single use isolation gowns intended to be worn by health care professionals to help protect both the patient and health care worker from the transfer of microorganisms, body fluids and particulate material | The MicroCool isolation gown (non sterile) is a single use item of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from the transfer of microorganisms, body fluids and particulate matter | Disposable surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect both surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. | |
| Material | Non woven Polypropylene (SMS) | Non woven polypropylene fabric | SMS Reinforced and non reinforced non-woven fabric | |
| Color | Blue, Yellow | Unknown | Unknown | |
| Sterility | Non-Sterile | Non-Sterile | Sterile | |
| Durability | Single use | Single use | Single use | |
| Size | Universal, XL | Various | Various | |
| Critical Zone | Entire gown | Met the Isolation gowns' requirements for critical zone | Critical zones as defined by AAMI PB70 (surgical gown) | |
| Level of Barrier Protection AAMI PB70 | Level 3 | Equivalent to level 4 | Level 3 | |
| Liquid barrier performance | Hydrostatic Pressure AATCC 127 | $Fluid Penetration (ASTM 1670-97 and ASTM F903-96)$ | Hydrostatic Pressure AATCC 127 | |
| $\geq 50 cm$ | ||||
| Impact Penetration AATCC 42 $\leq 1 g$ | $Viral Penetration (ASTM F 1671-97a)$ | |||
| Met the requirement | $\geq 50 cm$ | |||
| Impact Penetration AATCC 42 $\leq 1 g$ | ||||
| Flammability | 16 CFR Part 1610 | |||
| Class 1 | Class 1 | Class 1 | ||
| Physical Specification | Breaking Strength | |||
| Tested to ASTM D5034. | ||||
| Met acceptance criteria | Unknown | Met Acceptance Criteria | ||
| Elements of comparison | Proposed: PRIMAGARD | |||
| Isolation Gown (AAMI | ||||
| Level 3), Non-sterile | Predicate: MICROCOOL | |||
| Isolation Gown, Non-sterile | Reference Predicate: | |||
| Surgical Gown, Level 3, | ||||
| Sterile | ||||
| Tearing | ||||
| Strength | Tested to ASTM D5587. | |||
| Met acceptance criteria | Unknown | Met Acceptance Criteria to | ||
| ASTM D5733 | ||||
| Resistance to | ||||
| Linting | Tested to NWSP | |||
| 160.1.R0. Met acceptance | ||||
| criteria | Unknown | Unknown | ||
| Heat Loss | Tested to ASTM F1868 | |||
| PART C. Met acceptance | ||||
| criteria | Unknown | Unknown | ||
| Seam Strength | Tested to ASTM D5035. | |||
| Met acceptance criteria | Unknown | Met Acceptance Criteria to | ||
| ASTM D1683 | ||||
| Water Vapor | ||||
| Transmission | Tested to ASTM E96. Met | |||
| acceptance criteria | Unknown | Unknown | ||
| Air Permeability | Tested to ASTM D737. | |||
| Met acceptance criteria | Unknown | Unknown | ||
| Bio- | ||||
| compatibility | Irritation | |||
| ISO 10993-10 | Under the conditions of the | |||
| study, not an irritant | No evidence of dermal | |||
| irritation | Under the conditions of the | |||
| study, not an irritant | ||||
| Sensitization | ||||
| ISO 10993-10 | Under the conditions of the | |||
| study, not a sensitizer | No evidence of component | |||
| sensitizer | Under conditions of the | |||
| study, not a sensitizer | ||||
| Cytotoxicity | ||||
| ISO 10993-5 | Under the conditions of the | |||
| study the device is non- | ||||
| cytotoxic | No evidence of component | |||
| sensitizer (met USP XXIII | ||||
| requirements) | Under the conditions of the | |||
| study the device is non- | ||||
| cytotoxic |
6
Note: "unknown" above indicates performance values were not available in predicate 510(k) submissions
The PRIMAGARD AAMI PB70 Level 3 Isolation Gowns (non sterile, single use) are substantially equivalent with the MicroCool Isolation gowns (Non-Sterile). PRIMAGARD isolation gowns have been tested for biocompatibility, flammability, and other physical performance as documented above and meet or exceed the applicable requirements of the recognized and other related standards and therefore the proposed product is as safe and as effective for its intended use. The predicate isolation gown references testing to ASTM F1671 (and ASTM F1670) and therefore would be considered a level 4 barrier protection gown (moderate/high barrier protection category as per guidance). The proposed priMED gown follows AAMI PB70 and is a level 3 barrier protection (also considered in the moderate/high barrier protection category).
To additionally support the safety and effectiveness of barrier performance characteristics of the PRIMAGARD Level 3 isolation gowns, the proposed gown has been compared to a reference AAMI Level 3 surgical gown, as described in the above table. The reference surgical gown also falls under 21 CFR 878.4040 but has different indication for use (i.e., the isolation gowns are devices to be worn by health care personnel in isolations and shall provide full coverage, whereas the surgical gowns are devices to be worn by operating room personnel during surgical procedures and have distinct critical zones).
7
As described in detail in the comparison table, both proposed and reference devices provide moderate barrier protection (AAMI PB70 level 3) with the exception that the PRIMAGARD Level 3 Isolation Gown provides full barrier coverage compared to the reference surgical gown as the whole entire isolation gown is considered the critical zone. Therefore the proposed PRIMAGARD level 3 isolation gowns are as safe and effective as the predicate for their intended use.
Conclusion:
Based on the test results and comparison of PRIMAGARD isolation gowns with the predicate isolation gown and reference surgical gown, PRIMAGARD isolation gowns are as safe and as effective for their intended use as the legally marketed devices identified in this submission. PRIMAGARD isolation gowns are substantially equivalent to the legally marketed devices identified in this submission.