AMD Ritmed AssureWear VersaGown

K190306 · Amd Medicom, Inc. · FYC · Jan 17, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K190306
• Device Name: AMD Ritmed AssureWear VersaGown
• Applicant: Amd Medicom, Inc.
• Product Code: FYC · General, Plastic Surgery
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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. 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.

Device Story

Disposable isolation gown; provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Constructed from polypropylene Spunbond-Meltblown-Spunbond (SMS) non-woven fabric coated with polyethylene. Features include various wrist configurations (elastic, thumb loop, extended cuff), neck closures (Flexneck, Flexneck Plus, tie), and sleeve styles. Used by healthcare personnel in clinical settings; not for operating room use. Protects wearer and patient by acting as a physical barrier. Non-sterile, single-use.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Polypropylene SMS non-woven coated with polyethylene. Barrier: AAMI Level 3. Standards: AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ASTM D3776 (mass/area), ASTM D5034 (breaking strength), ASTM D5587 (tearing strength), 16 CFR 1610 (flammability), ISO 9073-10 (linting), ISO 10993-5/10 (biocompatibility). Form factor: 18 models, large/X-large sizes, various cuff/neck/sleeve configurations.

Indications for Use

Indicated for healthcare personnel to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material. Not for use in operating rooms. Single-use, non-sterile disposable device.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cardinal Health™ Isolation Gowns (K160339)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

| 510(k) Number: | K190306 |
|----------------------------|-------------------------------------------------------------------------------------------|
| Manufacturer: | AMD Medicom, Inc.<br>2555 Chemin de l'Aviation, Pointe-Claire,<br>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<br>Elastic cuffs<br>Extended cuff (Thumb loop)<br>Flexneck™<br>Tie (neck)<br>Straight sleeve<br>Inclined sleeve<br>Blue belt tie<br>Reinforced seams | Medical tape Neck closure<br>White belt tie<br>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 | $39.97 \pm 1.61 g/m^2$<br>(1.17 oz/yd²±0.05) | 41 g/m² (1.21 oz/yd²) | Similar | |
| Liquid barrier performance | Hydrostatic Pressure AATCC 127<br>Chest: $109.34 \pm 0.34$ cmH2O<br>Sleeve seams: $110.67\pm 3.84$ cmH2O<br>Belt attachments: $104 \pm 5.19$ cmH2O<br>Body/sleeve/belt mean: $108 \pm 3.1$ cm H₂O<br><br>Impact penetration AATCC 42<br>Chest: <0.1 g<br>Sleeve seams: <0.1 g<br>Belt attachments: < 0.1 g<br>Body/sleeve/belt mean: < 0.1 g | Body/sleeve mean: 69<br><br>Body/ sleeve mean: 0.08 | Similar | |
| Comparison Component | AMD Ritmed<br>AssureWear™ VersaGown<br>(subject device) | Cardinal Health™<br>Isolation Gown<br>(predicate device) | Comparison of<br>Technological<br>Characteristics | |
| Flammability<br>16 CFR Part 1610.7 | Class I | Class I | Same | |
| Breaking strength (MD) ASTM D5034 | $18.17 \pm 0.31$ lbf | 22.23 lb | Similar | |
| Breaking strength (CD) ASTM D5034 | $11.78 \pm 0.33$ lbf | 14.18 lb | Similar | |
| Tearing strength (MD) ASTM D5587 | $11.01 \pm 0.64$ lbf | 4.40 lb | Similar | |
| Tearing strength (CD) ASTM D5587 | $5.30 \pm 0.35$ lbf | 7.99 lb | Similar | |
| Linting (ISO 9073-10) | Particulate size range(µm):<br>1 to 25<br>Outside: Total linting >0.3 :<br>2.07; >0.5 : 1.97<br>Index for Particulate Matter<br>(IPM): 1.50<br>Inside: Total linting >0.3 :<br>2.16; >0.5 : 2.00<br>Index for Particulate Matter<br>(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<br>Organization | Standards Title |
|-----------|---------------------------|------------------------------------------------------------------------------------------------|
| PB70 | AAMI | AAMI PB70 Liquid Barrier Performance<br>Classification of Protective Apparel |
| TM 127 | AATCC | Water Resistance: Hydrostatic Pressure<br>Test |
| TM 42 | AATCC | Water Resistance: Impact Penetration Test |
| D3776 | ASTM | Test Methods for Mass Per Unit Area<br>Weight of Woven Fabric |
| D5034 | ASTM | Standard Test Method for Breaking<br>Strength and Elongation of Textile<br>Fabrics (Grab Test) |
| D5587 | ASTM | Standard Test Method for Tearing<br>Strength of Fabrics by Trapezoid<br>Procedure |
| Part 1610 | CPSC | Standard for the Flammability of Clothing<br>Textiles |

{7}------------------------------------------------

| 9073-10 | ISO | ISO 9073-10 Textiles-Test methods for<br>nonwovens-Part 10: Lint and other<br>particles generation in the dry state. |
|----------|-----|----------------------------------------------------------------------------------------------------------------------|
| 10993-1 | ISO | ISO 10993-1 Biological Evaluation of<br>Medical Devices- Part 1: Evaluation and |
| 10993-5 | ISO | Biological Evaluation of Medical<br>Devices- Part 5: Tests for In-Vitro<br>Cytotoxicity |
| 10993-10 | ISO | Biological Evaluation of Medical<br>Devices- Part 10: Tests for irritation and<br>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).