(339 days)
Not Found
No
The device is a disposable isolation gown, and the description focuses on material properties and barrier performance, with no mention of AI or ML.
No
The device is an isolation gown intended to protect wearers and patients from microorganisms and fluids, not to treat a medical condition or disease.
No
The device description clearly states it is an "isolation gown" intended to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It is a barrier device, not designed to diagnose any condition or disease.
No
The device description clearly states it is a physical isolation gown constructed of materials like polypropylene and polyethylene, and performance studies involve physical properties like liquid barrier performance and flammability. This indicates it is a hardware device, 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 gown is for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical construction and barrier properties of the gown.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical properties like barrier performance, strength, and flammability, which are relevant to a protective garment, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This gown does not perform any such function.
N/A
Intended Use / Indications for Use
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and X-large sizes.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
AMD Ritmed AssureWear™ VersaGown isolation gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown ger ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).
AMD Ritmed AssureWear™ VersaGown is a single use, disposable medical device provided nonsterile and non-intended for use in operating rooms and is constructed of polypropylene Spunbond--Meltblown-Spunbond Nonwovens (SMS), non-woven and coated with polyethylene. The isolation gown consists of one critical zone throughout the entire gown including the seams and belt attachments but excluding cuffs, hems and bindings.
AMD Ritmed AssureWear™ VersaGown is available with the following variations:
Wrist
- Elastic cuffs- Thumb loop
- Elastic cuffs- Extended cuff (Thumb loop)
- Elastic cuffs
Sleeves - Straight
- Inclined
Color - Blue
Neck Closure - Flexneck™
- Flexneck™ Plus
- Tie
Sizes - Large
- X-large
The Flexneck™ is comprised of unique and flexible, latex-free, double elastic closure that creates the wildest head opening.
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
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)
Non-Clinical Performance: The device was tested against the following standards:
- AAMI PB70 (AAMI PB70 Liquid Barrier Performance Classification of Protective Apparel)
- AATCC TM 127 (Water Resistance: Hydrostatic Pressure Test) (Chest: 109.34 +/- 0.34 cmH2O, Sleeve seams: 110.67+/- 3.84 cmH2O, Belt attachments: 104 +/- 5.19 cmH2O, Body/sleeve/belt mean: 108 +/- 3.1 cm H2O)
- AATCC TM 42 (Water Resistance: Impact Penetration Test) (Chest: 0.3: 2.07; >0.5: 1.97, Index for Particulate Matter (IPM): 1.50; Inside: Total linting >0.3: 2.16; >0.5: 2.00, Index for Particulate Matter (IPM): 1.35)
- ISO 10993-1 (ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and)
- ISO 10993-5 (Biological Evaluation of Medical Devices- Part 5: Tests for In-Vitro Cytotoxicity) (non-cytotoxic)
- ISO 10993-10 (Biological Evaluation of Medical Devices- Part 10: Tests for irritation and delayed-type hypersensitivity) (not an irritant, not a sensitizer)
Clinical Performance: Not applicable
Key results: The nonclinical test results demonstrate that the AMD Ritmed AssureWear™ VersaGown is as safe, as effective, and performs as well as or better than the legally marketed device, Cardinal Health™ Isolation Gowns (K160339).
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.
Cardinal Health™ Isolation Gowns (K160339)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2020
AMD Medicom Inc. Nektaria Markoglou Director, Product Innovation and Development 2555 Chemin de l'Aviation Pointe-Claire, Montreal, H9P2Z2 Ca
Re: K190306
Trade/Device Name: AMD Ritmed AssureWear VersaGown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: December 16, 2019 Received: December 17, 2019
Dear Nektaria Markoglou:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190306
Device Name
AMD Ritmed AssureWear™ VersaGown
Indications for Use (Describe)
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and Xlarge sizes.
| Flexneck Models | Flexneck Plus Models | Tie Models |
|---|---|---|
| A69964 | A69933 | A8300 |
| A69965 | A69934 | A8301 |
| A69966 | A69935 | A8302 |
| A69967 | A69936 | A8303 |
| A69968 | A69937 | A8304 |
| A69969 | A69938 | A8305 |
| 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
510(k) Summary
| 510(k) Number: | K190306 |
|---|---|
| Manufacturer: | AMD Medicom, Inc. |
| 2555 Chemin de l'Aviation, Pointe-Claire, | |
| Quebec, H9P 2Z2, Canada | |
| Phone Number: | 514-636-6262 |
| Contact Person: | Nektaria Markoglou |
| Date Prepared: | January 14, 2020 |
| Trade Name: | AMD Ritmed AssureWear™ VersaGown |
| Regulation Number: | 21CFR878.4040 |
| Regulation Name: | Surgical Apparel |
| Device Class: | Class II |
| Product Code: | FYC |
| Device Classification Name | Gown, Isolation, Surgical |
| Predicate Device | Cardinal Health™ Isolation Gowns (K160339) |
Device Description
AMD Ritmed AssureWear™ VersaGown isolation gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown ger ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).
AMD Ritmed AssureWear™ VersaGown is a single use, disposable medical device provided nonsterile and non-intended for use in operating rooms and is constructed of polypropylene Spunbond--Meltblown-Spunbond Nonwovens (SMS), non-woven and coated with polyethylene. The isolation gown consists of one critical zone throughout the entire gown including the seams and belt attachments but excluding cuffs, hems and bindings.
4
AMD Ritmed AssureWear™ VersaGown is available with the following variations:
Wrist
- Elastic cuffs- Thumb loop ●
- Elastic cuffs- Extended cuff (Thumb ● loop)
- Elastic cuffs
Sleeves
- . Straight
- Inclined ●
Color
-
Blue
Neck Closure -
Flexneck™
-
Flexneck™ Plus ●
-
Tie
Sizes
- Large ●
- X-large ●
The Flexneck™ is comprised of unique and flexible, latex-free, double elastic closure that creates the widest head opening.
Indication for Use
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and X-large sizes.
| Flexneck Models | Flexneck Plus Models | Tie Models |
|---|---|---|
| A69964 | A69933 | A8300 |
| A69965 | A69934 | A8301 |
| A69966 | A69935 | A8302 |
| A69967 | A69936 | A8303 |
| A69968 | A69937 | A8304 |
| A69969 | A69938 | A8305 |
Predicate Device
Cardinal HealthTM Isolation Gown, K160339
5
Technological Characteristics Comparison Table
The table below compares the construction, technology, design, claims and intended use of AMD Ritmed AssureWear™ VersaGown and the predicate device.
| Comparison Component | AMD Ritmed AssureWear™ VersaGown (subject device) | Cardinal Health™ Isolation Gown (predicate device) | Comparison | |
|---|---|---|---|---|
| Manufacturer | AMD Medicom Inc. | Cardinal Health LLC | ||
| 510 K number | K190306 | K160339 | ||
| Intended use | AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown is a single use, disposable medical device provided non-sterile and non-intended for use in operating rooms. | Cardinal Health isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operation room. The Cardinal Health Isolation Gown is a single use, disposable medical device provided non-sterile. | Same | |
| Level of barrier protection AAMI PB70 | Level 3 | Level 3 | Same | |
| Technology | N/A | N/A | Same | |
| Material composition | PP SMS non-woven + PE | PE SMS non-woven | Similar | |
| Design | Thumb loop | |||
| Elastic cuffs | ||||
| Extended cuff (Thumb loop) | ||||
| Flexneck™ | ||||
| Tie (neck) | ||||
| Straight sleeve | ||||
| Inclined sleeve | ||||
| Blue belt tie | ||||
| Reinforced seams | Medical tape Neck closure | |||
| White belt tie | ||||
| Elastic cuffs | Similar for all designs except for the Flexneck patented design | |||
| Color | Blue | Blue and yellow | Similar | |
| Sterility | Non- Sterile | Non- Sterile | Same | |
| Use | Single use; disposable | Single use; disposable | Same | |
| Non-clinical Performance | ||||
| Basic weight ASTM D3776 | $39.97 \pm 1.61 g/m^2$ | |||
| (1.17 oz/yd²±0.05) | 41 g/m² (1.21 oz/yd²) | Similar | ||
| Liquid barrier performance | Hydrostatic Pressure AATCC 127 | |||
| Chest: $109.34 \pm 0.34$ cmH2O | ||||
| Sleeve seams: $110.67\pm 3.84$ cmH2O | ||||
| Belt attachments: $104 \pm 5.19$ cmH2O | ||||
| Body/sleeve/belt mean: $108 \pm 3.1$ cm H₂O |
Impact penetration AATCC 42
Chest: 0.3 :
2.07; >0.5 : 1.97
Index for Particulate Matter
(IPM): 1.50
Inside: Total linting >0.3 :
2.16; >0.5 : 2.00
Index for Particulate Matter
(IPM): 1.35 | N/A | NA | |
| Biocompatibility | Irritation ISO 10993-10 | Under the condition of the study, not an irritant | Under the condition of each study is non-cytotoxic, non-irritating, and non-sensitizing | Same |
| | Sensitization ISO 10993-10 | Under the condition of the study, not a sensitizer | | Same |
| | Cytotoxicity ISO 10993-5 | Under the condition of the study, non- cytotoxic | | Same |
6
Non-Clinical Performance
The following standards were utilized in performance and biocompatibility testing of the AMD Ritmed AssureWear™ VersaGown.
| | Standards
Organization | Standards Title |
|-----------|---------------------------|------------------------------------------------------------------------------------------------|
| PB70 | AAMI | AAMI PB70 Liquid Barrier Performance
Classification of Protective Apparel |
| TM 127 | AATCC | Water Resistance: Hydrostatic Pressure
Test |
| TM 42 | AATCC | Water Resistance: Impact Penetration Test |
| D3776 | ASTM | Test Methods for Mass Per Unit Area
Weight of Woven Fabric |
| D5034 | ASTM | Standard Test Method for Breaking
Strength and Elongation of Textile
Fabrics (Grab Test) |
| D5587 | ASTM | Standard Test Method for Tearing
Strength of Fabrics by Trapezoid
Procedure |
| Part 1610 | CPSC | Standard for the Flammability of Clothing
Textiles |
7
| 9073-10 | ISO | ISO 9073-10 Textiles-Test methods for
nonwovens-Part 10: Lint and other
particles generation in the dry state. |
|----------|-----|----------------------------------------------------------------------------------------------------------------------|
| 10993-1 | ISO | ISO 10993-1 Biological Evaluation of
Medical Devices- Part 1: Evaluation and |
| 10993-5 | ISO | Biological Evaluation of Medical
Devices- Part 5: Tests for In-Vitro
Cytotoxicity |
| 10993-10 | ISO | Biological Evaluation of Medical
Devices- Part 10: Tests for irritation and
delayed-type hypersensitivity |
Clinical Performance
Not applicable
Conclusion
The conclusions drawn from the nonclinical test demonstrate that the AMD Ritmed AssureWear™ VersaGown is as safe, as effective, and performs as well as or better than the legally marketed device, Cardinal Health™ Isolation Gowns (K160339).