(339 days)
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.
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.
The provided document is a 510(k) Premarket Notification for the AMD Ritmed AssureWear™ VersaGown. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/human-in-the-loop diagnostic device.
Therefore, many of the requested criteria regarding AI device performance, clinical studies, expert consensus, and ground truth establishment are not applicable to this document. The document describes the acceptance criteria and performance of a physical medical device (isolation gown) based on non-clinical performance testing against established industry standards.
Here's the information as it can be extracted from the document:
Acceptance Criteria and Device Performance for AMD Ritmed AssureWear™ VersaGown
The device is an isolation gown intended to provide barrier protection. The "acceptance criteria" are essentially the performance requirements for an AAMI Level 3 barrier protection gown, as defined by ANSI/AAMI PB70:2012, along with other physical and biological safety standards. The "reported device performance" is the result of the tests conducted on the VersaGown.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Parameter | Acceptance Criteria (for AAMI Level 3 Gown, where applicable & standards listed) | Reported Device Performance (AMD Ritmed AssureWear™ VersaGown) |
|---|---|---|
| Level of barrier protection (AAMI PB70) | Level 3 | Level 3 |
| Basic weight (ASTM D3776) | Predicate: 41 g/m² (1.21 oz/yd²) | 39.97 ± 1.61 g/m² (1.17 oz/yd²±0.05) |
| Liquid barrier performance | ||
| - Hydrostatic Pressure (AATCC 127) | Predicate: Body/sleeve mean: 69 cmH2O | Chest: 109.34 ± 0.34 cmH2OSleeve seams: 110.67 ± 3.84 cmH2OBelt attachments: 104 ± 5.19 cmH2OBody/sleeve/belt mean: 108 ± 3.1 cm H₂O |
| - Impact penetration (AATCC 42) | Predicate: Body/sleeve mean: 0.08 g | Chest: <0.1 gSleeve seams: <0.1 gBelt attachments: < 0.1 gBody/sleeve/belt mean: < 0.1 g |
| Flammability (16 CFR Part 1610.7) | Class I | Class I |
| Breaking strength (ASTM D5034) | Predicate MD: 22.23 lbf; Predicate CD: 14.18 lbf | MD: 18.17 ± 0.31 lbfCD: 11.78 ± 0.33 lbf |
| Tearing strength (ASTM D5587) | Predicate MD: 4.40 lbf; Predicate CD: 7.99 lbf | MD: 11.01 ± 0.64 lbfCD: 5.30 ± 0.35 lbf |
| Linting (ISO 9073-10) | No predicate data provided for comparison | Particulate size range (µm): 1 to 25Outside: Total linting >0.3: 2.07; >0.5: 1.97Index for Particulate Matter (IPM): 1.50Inside: Total linting >0.3: 2.16; >0.5: 2.00Index for Particulate Matter (IPM): 1.35 |
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizing | Irritation (ISO 10993-10): Under the condition of the study, not an irritant.Sensitization (ISO 10993-10): Under the condition of the study, not a sensitizer.Cytotoxicity (ISO 10993-5): Under the condition of the study, non-cytotoxic. |
Note: For several physical properties (e.g., basic weight, breaking strength, tearing strength), the "acceptance criteria" are implicitly set by comparing to the performance of the legally marketed predicate device. The values for the predicate device are listed in the table if available for comparison.
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical performance test. The results are presented as means and standard deviations, which implies multiple measurements were taken for each test. Data provenance is not described in terms of country of origin or retrospective/prospective, as this is laboratory testing of a manufactured product, not human-subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (isolation gown), not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is determined by the results of standardized physical and biological tests.
4. Adjudication method for the test set
Not applicable. No human adjudication is involved in the performance testing of a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This type of study is typically done for diagnostic imaging AI devices, not for physical medical devices like isolation gowns.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance stated is intrinsic to the physical device.
7. The type of ground truth used
The ground truth for this device's performance is established by standardized laboratory testing protocols (e.g., AATCC 127, AATCC 42, ASTM D3776, ISO 9073-10, ISO 10993 series) against the requirements for AAMI Level 3 barrier protection. It is a physical/chemical ground truth rather than an expert consensus, pathology, or outcomes data ground truth in the context of diagnostic AI.
8. The sample size for the training set
Not applicable. This is not an AI device that involves training data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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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
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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
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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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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.
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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
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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 loopElastic cuffsExtended cuff (Thumb loop)Flexneck™Tie (neck)Straight sleeveInclined sleeveBlue belt tieReinforced seams | Medical tape Neck closureWhite belt tieElastic 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 127Chest: $109.34 \pm 0.34$ cmH2OSleeve seams: $110.67\pm 3.84$ cmH2OBelt attachments: $104 \pm 5.19$ cmH2OBody/sleeve/belt mean: $108 \pm 3.1$ cm H₂OImpact penetration AATCC 42Chest: <0.1 gSleeve seams: <0.1 gBelt attachments: < 0.1 gBody/sleeve/belt mean: < 0.1 g | Body/sleeve mean: 69Body/ sleeve mean: 0.08 | Similar | |
| Comparison Component | AMD RitmedAssureWear™ VersaGown(subject device) | Cardinal Health™Isolation Gown(predicate device) | Comparison ofTechnologicalCharacteristics | |
| Flammability16 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):1 to 25Outside: Total linting >0.3 :2.07; >0.5 : 1.97Index for Particulate Matter(IPM): 1.50Inside: Total linting >0.3 :2.16; >0.5 : 2.00Index 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 |
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Non-Clinical Performance
The following standards were utilized in performance and biocompatibility testing of the AMD Ritmed AssureWear™ VersaGown.
| StandardsOrganization | Standards Title | |
|---|---|---|
| PB70 | AAMI | AAMI PB70 Liquid Barrier PerformanceClassification of Protective Apparel |
| TM 127 | AATCC | Water Resistance: Hydrostatic PressureTest |
| TM 42 | AATCC | Water Resistance: Impact Penetration Test |
| D3776 | ASTM | Test Methods for Mass Per Unit AreaWeight of Woven Fabric |
| D5034 | ASTM | Standard Test Method for BreakingStrength and Elongation of TextileFabrics (Grab Test) |
| D5587 | ASTM | Standard Test Method for TearingStrength of Fabrics by TrapezoidProcedure |
| Part 1610 | CPSC | Standard for the Flammability of ClothingTextiles |
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| 9073-10 | ISO | ISO 9073-10 Textiles-Test methods fornonwovens-Part 10: Lint and otherparticles generation in the dry state. |
|---|---|---|
| 10993-1 | ISO | ISO 10993-1 Biological Evaluation ofMedical Devices- Part 1: Evaluation and |
| 10993-5 | ISO | Biological Evaluation of MedicalDevices- Part 5: Tests for In-VitroCytotoxicity |
| 10993-10 | ISO | Biological Evaluation of MedicalDevices- Part 10: Tests for irritation anddelayed-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).
§ 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.