(659 days)
Not Found
No
The device description and intended use clearly describe a reusable surgical gown, a physical barrier device. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The Maxima Surgical Gown is intended to protect patients and healthcare workers from microorganism transfer, not to treat or diagnose a medical condition.
No
The device is a surgical gown intended to protect healthcare workers and patients from the transfer of micro-organisms, body fluids, and particulate material. It is a barrier device, not a diagnostic one.
No
The device is a physical surgical gown made of polyester fabric, 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 "operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material." This describes a barrier function for personal protection, not a diagnostic test performed on samples from the human body.
- Device Description: The description focuses on the material, construction, and barrier performance of the gown. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a surgical gown, which falls under the category of personal protective equipment (PPE) used in a healthcare setting.
N/A
Intended Use / Indications for Use
The reusable Maxima Surgical Gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
The reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Elevate Textiles Item Numbers / gown color / liquid barrier protection / gown size MAXAL3S / Royal Blue B103 / AAMI Level 3 / Small MAXAL3M / Royal Blue B103 / AAMI Level 3 / Medium MAXAL3L / Royal Blue B103 / AAMI Level 3 / Large
Product codes
FYA
Device Description
The Maxima® Surgical Gown is a reusable woven surgical gown for use in sterile conditions. It is made of 100% filament polyester that provides AAM PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone up to 75 reprocessing cycles. The back of the gown provides AAMI Level 3 Liquid Barrier Performance Barrier up to 75 reprocessing cycles. The seam in the sleeves are sealed with a permanent seam tape which seals the stitch area enabling it to perform as AAMI Level 3 up to 75 reprocessing cycles.
Maxima® Surgical Gown will be manufactured in small, medium, and larges sizes. Maxima® Surgical Gowns will be sold as non-sterile reusable surgical gowns that are to be laundered, sterilized and processed by health care facilities and or contract laundry and sterliization companies before first use and after each subsequent 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
operating room 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)
Performance testing was performed to verify that the acceptance criteria. The testing done on the Maxima® Surgical Gown was conducted to demonstrate the safety and effectiveness of the subject device with the relevant test methods cited below, including the appropriate biocompatibility test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Cytotoxicity: non-cytotoxic
- Skin Irritation: non-irritating
- Skin Sensitization: non-sensitizing
- Water Resistance (Hydrostatic Pressure): Avg. 70.3 cm (>50 cm AQL 4.0)
- Water Resistance (Impact Penetration): Mean 0.01 g (30 lbf)
- Tear Strength: Warp: 25.3 lbf, Fill: 7.4 lbf (>1.5 lbf)
- Seam Strength: Warp: 78 lbf, Fill: 65.4 lbf (>30 lbf)
- Weight: 88 gsm (Documentation Only)
- Flammability: Class 1 (Class 1)
- Lint Generation: log10 (lint count) 1.89 (Documentation Only)
- Evaporative Resistance: Ret Critical Zone 0.01193, Ret Noncritical Zone 0.01157 (Documentation Only)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 11, 2022
Elevate Textiles Nathaniel Terry Technical Director 22 American Street Mt. Holly, North Carolina 28210
Re: K201351
Trade/Device Name: Maxima Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: December 8, 2021 Received: December 13, 2021
Dear Nathaniel Terry:
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.
1
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 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 mediation-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 Clarence W. Murray III, Ph.D. 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) K201351
Device Name Maxima Surgical Gown
Indications for Use (Describe)
The reusable Maxima Surgical Gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
The reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows: * Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Elevate Textiles Item Numbers / gown color / liquid barrier protection / gown size MAXAL3S / Royal Blue B103 / AAMI Level 3 / Small MAXAL3M / Royal Blue B103 / AAMI Level 3 / Medium MAXAL3L / Royal Blue B103 / AAMI Level 3 / Large
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | |
| X Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(k) Summary (K201351)
[As required by section 807.92(c)]
Submitter:
Elevate Textiles 22 American Street Mt Holly NC, 28120
Contact Person:
Nathaniel Terry Technical Director / Regulatory Affairs Telephone: 336-684-1683 Email: Nathaniel.terry@elevatetextiles.com
Summary Preparation Date
December 1, 2021
Type of Submission Traditional 510(k)
Device Name / Classification
| Trade Name: | Maxima® Surgical Gown |
|---|---|
| Common Name: | Sterile Surgical Gown |
| Classification Name: | Surgical Gown, Class 2 |
Predicate Device - Maxima® Surgical Gown claims substantial equivalence to:
K150598 Blockade Surgical Gown manufactured by Medline Industries, Inc
Device Description
The Maxima® Surgical Gown is a reusable woven surgical gown for use in sterile conditions. It is made of 100% filament polyester that provides AAM PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone up to 75 reprocessing cycles. The back of the gown provides AAMI Level 3 Liquid Barrier Performance Barrier up to 75 reprocessing cycles. The seam in the sleeves are sealed with a permanent seam tape which seals the stitch area enabling it to perform as AAMI Level 3 up to 75 reprocessing cycles.
Maxima® Surgical Gown will be manufactured in small, medium, and larges sizes. Maxima® Surgical Gowns will be sold as non-sterile reusable surgical gowns that are to be laundered, sterilized and processed by health care facilities and or contract laundry and sterliization companies before first use and after each subsequent use.
Indications for Use
The Maxima Surgical Gown is a reusable surgical gown intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker of micro-organisms, body fluids, and particulate material.
The Maxima Surgical Gown is provided non-sterilization parameters are as follows:
- Prevac Steam Sterilization - 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Elevate Textiles Item Numbers / Gown Color / Liquid Barrier Protection / Gown Size
MAXAL3S / Royal B103 / AAMI Level 3 / Small MAXAL3M MAXAL3L
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Summary of Technological Characteristics
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Maxima® Surgical Gown | Blockade Surgical Gown | N/A |
| 510(k) Reference | K201351 | K150598 | N/A |
| Product Owner | Elevate Textiles | Medline Industries Inc. | N/A |
| Product Code | FYA | FYA | same |
| Intended Use | Intended to be used by
operating room personnel
during surgical procedures to
help protect both the patient
and the health care worker
from transfer of micro-
organisms, body fluids, and
particulate material. | Intended to be used by
operating room personnel
during surgical procedures
to help protect both the
patient and the health care
worker from transfer of
micro-organisms, body
fluids, and particulate
material. | same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | same |
| Color | Royal B103 | Ceil, Jade | different |
| Design Features | belt ties
knit cuffs
neck closure: metal snaps | belt ties
knit cuffs
neck closure: metal snaps | same |
| Sizes | Small, Medium, Large | Large, X-Large XX-Large | similar |
| Materials | Woven polyester | Woven polyester | same |
| Performance
Specifications | Level 3 ANSI/AAMI PB70
Barrier protection | Level 3 ANSI/AAMI PB70
Barrier protection | same |
| Prescription vs. OTC | ОТС | OTC | same |
| Contact Durations | Surface, Breached or
Compromised, 50 cm AQL 4.0 | Avg. 70.3 cm |
| Water Resistance | AATCC 42: Test Method for Water Resistance: Impact
Penetration | 30 lbf | Warp: 138.9 lbf
Fill: 82.01 lbf |
| Tear Strength | ASTM D 5587: Standard Test Method for Tearing Strength of
Fabrics by Trapezoid Procedure | >1.5 lbf | Warp: 25.3 lbf
Fill: 7.4 lbf |
| Seam Strength | ASTM D1683: Standard Test Method For Failure In Sewn
Seams Of Woven Fabrics | >30 lbf | Warp: 78 lbf
Fill: 65.4 lbf |
| Weight | ASTM D3776/D3776M-09a: Standard Test Methods For Mass
Per Unit Area (Weight) Of Fabric | Documentation Only | 88 gsm |
| Flammability | 16 CFR 1610: Standard for the Flammability of Clothing
Textiles | Class 1 | Class 1 |
| Lint Generation | EN ISO 9073-10: Textiles - Test methods for nonwovens -
Part 10: Lint and other particles generation in the dry state | Documentation Only | log10 (lint count) 1.89 |
| Evaporative Resistance | ASTM F1868: Standard Test Method for Thermal and
Evaporative Resistance of Clothing Materials Using a Sweating
Hot Plate | Documentation Only | Ret Critical Zone 0.01193
Ret Noncritical Zone 0.01157 |
Summary of Clinical Testing
Not applicable
Conclusion
Based on the information provided in this premarket notification, Elevate Textiles concludes that the Maxima® Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device K150598 Medline Blockade Surgical gown.