EndoArmor™ + Surgical Gown
Device Facts
| Record ID | K203548 |
|---|---|
| Device Name | EndoArmor™ + Surgical Gown |
| Applicant | Boston Scientific Corporation |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Feb 21, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
EndoArmor™+ Surgical Gowns are single-use personal protective equipment intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. EndoArmor™+ Surgical Gowns meet the respective Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Device Story
EndoArmor™+ Surgical Gown is single-use personal protective equipment (PPE) worn by healthcare professionals in clinical/surgical settings. Device provides AAMI Level 3 liquid barrier protection in critical zones (front and sleeves) using polyethylene film laminated with nonwoven spunbond polypropylene. Back of gown is non-protective spunbond polypropylene to facilitate airflow and user comfort. Device is supplied non-sterile; end-user performs sterilization prior to use. Gown features hook-and-loop neck closure, belt ties, and knit cuffs. Primary function is to prevent transfer of microorganisms, body fluids, and particulate matter between patient and healthcare worker, thereby reducing infection risk.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing including biocompatibility (ISO 10993-5, -7, -10), flammability (16 CFR 1610), and physical performance testing (ASTM F2407-20, AATCC TM42, AATCC TM127, ASTM D5034-09, ASTM D5587-15, ASTM D1683). All tests passed.
Technological Characteristics
Materials: Polyethylene film laminated with nonwoven spunbond polypropylene (front/sleeves); nonwoven spunbond polypropylene (back). Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Flammability: Class 1 per 16 CFR 1610. Sterilization: Ethylene Oxide (EtO) per ISO 11135-1. Form factor: One-size-fits-most, non-reinforced, hook-and-loop closure, knit cuffs.
Indications for Use
Indicated for healthcare professionals as personal protective equipment to protect patients and workers from microorganisms, body fluids, and particulate matter during surgical procedures.
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
- Medline Level 3 Surgical Gown (Sirus Non-Reinforced) (K190950)
Submission Summary (Full Text)
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February 21, 2022
Boston Scientific Corporation Laura Meehan Principal Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, Massachusetts 01752
### Re: K203548
Trade/Device Name: EndoArmor™ + Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: January 20, 2022 Received: January 21, 2022
#### Dear Laura Meehan:
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 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
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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,
Clarence W. Murray, III, PhD 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) K203548
Device Name EndoArmor™ + Surgical Gown
#### Indications for Use (Describe)
EndoArmor™+ Surgical Gowns are single-use personal protective equipment intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
EndoArmor™+ Surgical Gowns meet the respective Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Type of Use (Select one or both, as applicable)
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|
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# 510(k) Summary for EndoArmor™+ Surgical Gown K203548
### 1. Submitter
Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way Marlborough, MA 01752
### Contact:
Laura Meehan Principal Regulatory Specialist Phone: (508) 382-0442 E-mail: Laura.Meehan@bsci.com
Date Prepared: January 20, 2022
### 2. Device
| Trade Name: | EndoArmor™+ Surgical Gown |
|----------------------------|----------------------------|
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Apparel |
| Product Code: | FYA |
| Device Class and Panel: | Class II, General Hospital |
| Classification Regulation: | 21 CFR §878.4040 |
#### 3. Predicate Devices
| Trade Name: | Medline Level 3 Surgical Gown (Sirus Non-Reinforced) |
|----------------------------|------------------------------------------------------|
| Manufacturer: | Medline Industries, Inc. |
| Clearance Number: | K190950 |
| Common Name: | Surgical Gown |
| Classification Name: | Surgical Apparel |
| Product Code: | FYA |
| Device Class and Panel: | Class II, General Hospital |
| Classification Regulation: | 21 CFR §878.4040 |
#### 4. Device Description
EndoArmor™+ Surgical Gowns are intended to be worn by health care professionals as personal protective equipment to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The EndoArmor™+ Surgical Gown is constructed from a polyethylene film laminated with nonwoven spunbond polypropylene that provides AAMI Level 3 liquid barrier performance in
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the critical zones. The EndoArmor™+ Surgical Gown back was designed to allow for airflow and breathability to support user comfort. The back of the gown is constructed from spunbond polypropylene and is non-protective.
The EndoArmor™+ Surgical Gown is single-use, one-size fits most personal protective equipment supplied non-sterile with sterilization instructions and validated sterilization parameters to enable the end-user to sterilize the gown prior to being used in sterile surgical procedures.
## 5. Indications for Use
EndoArmor™+ Surgical Gowns are single-use personal protective equipment intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
EndoArmor™+ Surgical Gowns meet the respective Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
#### Technological Characteristics Comparison of the proposed device and predicate device 6.
| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | EndoArmor™ + Surgical<br>Gown | Medline Level 3 Surgical<br>Gown (Sirus Non-<br>Reinforced) | N/A |
| 510(k) Reference | K203548 | K190950 | N/A |
| Product Owner | Boston Scientific<br>Corporation | Medline Industries, Inc. | N/A |
| Regulation<br>Number | 21 CFR §878.4040 | 21 CFR §878.4040 | Identical |
| Product Code | FYA | FYA | Identical |
| Device<br>Characteristic | Proposed Device | Predicate Device | Comparison<br>Analysis |
| Intended Use | EndoArmorTM+ Surgical<br>Gowns are single-use<br>personal protective<br>equipment intended to be<br>worn by healthcare<br>professionals to help<br>protect both the patient and<br>the healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br><br>EndoArmorTM+ Surgical<br>Gowns meet the respective<br>Level 3 requirements of<br>ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use in<br>health care facilities. | Medline Level 3 Surgical<br>Gowns (Sirus Non-<br>Reinforced) are sterile,<br>single use surgical apparel<br>intended to be worn by<br>healthcare professionals to<br>help protect both the<br>patient and the healthcare<br>worker<br>from the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br><br>Medline Level 3 Surgical<br>Gowns (Sirus Non-<br>Reinforced) meet the<br>respective Level 3<br>requirements of<br>ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use in<br>health care facilities. | Similar |
| Color | Blue | Blue | Identical |
| Design Features | Fabric Non-Reinforced<br>Hook and Loop Closure at<br>neck<br>Belt Ties<br>Knit Cuffs<br>Standard Sleeves | Fabric Non-Reinforced<br>Hook and Loop Closure at<br>neck<br>Belt Ties<br>Knit Cuffs<br>Standard Sleeves | Identical |
| Sizes | One-size fits most | Small to XXXX-Large | Similar |
| Materials | Front/Sleeves:<br>Polyethylene Film<br>Laminated with Nonwoven<br>Spunbond Polypropylene<br><br>Back: Nonwoven<br>Spunbond Polypropylene | Nonwoven SMS<br>Polypropylene/Polyolefin | Similar |
| Critical Zone<br>Performance<br>Specifications | AAMI Level 3 Barrier<br>Protection | AAMI Level 3 Barrier<br>Protection | Identical |
| Device | Proposed Device | Predicate Device | Comparison |
| Characteristic | | | Analysis |
| Prescription vs.<br>OTC | OTC | OTC | Identical |
| Contact<br>Duration | Surface, Intact, < 24 hours | Surface, Intact, < 24 hours | Identical |
| Sterile vs.<br>Non-Sterile | Sold as single-use, non-<br>sterile to end user with<br>sterilization instructions<br>and validated EtO<br>sterilization method | Sterile (Ethylene Oxide) or<br>sold as bulk single-use,<br>non-sterile to re-<br>packager/re-labeler<br>establishments for further<br>packaging and sterilization<br>using the validated EtO<br>sterilization method<br>according to ISO 11135-1<br>prior to being provided to<br>the end user | Identical |
| Single Use vs.<br>Reusable | Single Use | Single Use | Identical |
| Biocompatibility | Under the test conditions,<br>the subject device was<br>shown to be non-cytotoxic,<br>non-irritating and non-<br>sensitizing per ISO 10993-<br>5 & ISO 10993-10. | Under the test conditions,<br>the subject device was<br>shown to be non-cytotoxic,<br>non-irritating and non-<br>sensitizing per ISO 10993-<br>5 & ISO 10993-10. | Identical |
| Flammability | Meets requirements of<br>Flame Resistant CPSC<br>1610 Class 1 | Meets requirements of<br>Flame Resistant CPSC<br>1610 Class 1 | Identical |
### Table 5-1: Comparison of Proposed and Predicate Devices
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## 7. Performance Data
The final proposed finished device was tested in accordance with Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes, August 1993, Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA on December 9, 2015 and ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
| Test Method | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ISO 10993-5, Biological<br>evaluation of medical<br>devices - Part 5: Tests for<br>in vitro cytotoxicity | The purpose of this test<br>methodology is to<br>evaluate the cytotoxicity<br>endpoint. | Under the test conditions,<br>the subject device must be<br>non-cytotoxic per ISO<br>10993-5. | Pass. |
| ISO 10993-7, Biological<br>Evaluation of Medical<br>Devices-Part 7: Ethylene<br>Oxide Sterilization<br>Residuals | The purpose of this test<br>methodology is to<br>evaluate the EO/ECH<br>residuals. | Under the test conditions,<br>the EO/ECH residual<br>levels of the subject<br>device must be below the<br>maximum allowable limits<br>for adult patient<br>populations based on body<br>mass per ISO 10993-7. | Pass. |
| Test Method | Purpose | Acceptance Criteria | Results |
| ISO 10993-10, Biological<br>evaluation of medical<br>devices- Part 10: Tests for<br>irritation and skin<br>sensitization | The purpose of this test<br>methodology is to<br>evaluate the irritation and<br>skin sensitization<br>endpoint. | Under the test conditions,<br>the subject device must be<br>non-irritating and non-<br>sensitizing per ISO 10993-<br>10. | Pass. |
| ASTM F2407-20,<br>Standard Specification for<br>Surgical Gowns Intended<br>for Use in Healthcare<br>Facilities | The purpose of this test<br>methodology is to<br>evaluate the standard<br>specification for surgical<br>gown. | Under the test conditions,<br>the subject device must<br>meet the required tensile<br>strength, tear resistance,<br>and seam strength per<br>ASTM F2407-20. | Pass. |
| AATCC TM42, Test<br>Method for Water<br>Resistance: Impact<br>Penetration | The purpose of this test<br>methodology is to<br>evaluate the impact<br>penetration endpoint. | Under the test conditions,<br>the subject device must<br>meet the required<br>resistance to the<br>penetration of water per<br>ANSI/AAMI PB70. | Pass. |
| AATCC TM127, Test<br>Method for Water<br>Resistance: Hydrostatic<br>Pressure Test | The purpose of this test<br>methodology is to<br>evaluate the Hydrostatic<br>Pressure Test endpoint. | Under the test conditions,<br>the subject device must<br>meet the required<br>resistance to the<br>penetration of water under<br>hydrostatic pressure per<br>ANSI/AAMI PB70. | Pass. |
| ASTM D5034-09,<br>Standard Test Method for<br>Breaking Strength and<br>Elongation of Textile<br>Fabrics (Grab Test) | The purpose of this test<br>methodology is to<br>evaluate the Grab Test<br>endpoint. | Under the test conditions,<br>the subject device must<br>meet the required tensile<br>strength per ASTM<br>F2407-20. | Pass. |
| ASTM D5587-15,<br>Standard Test Method for<br>Tearing Strength of<br>Fabrics by Trapezoid<br>Procedure | The purpose of this test<br>methodology is to<br>evaluate the Tearing<br>Strength of Fabrics by<br>Trapezoid Procedure. | Under the test conditions,<br>the subject device must<br>meet the required tear<br>resistance per ASTM<br>F2407-20. | Pass. |
| ASTM D1683 / D1683M-<br>17, Standard Test Method<br>for Failure in Sewn Seams<br>of Woven Fabrics | The purpose of this test<br>methodology is to<br>evaluate the Standard Test<br>Method for Failure in<br>Sewn Seams of Woven<br>Fabrics | Under the test conditions,<br>the subject device must<br>meet the required seam<br>strength per ASTM<br>F2407-20. | Pass. |
| 16 CFR Part 1610,<br>Standard for the<br>Flammability of Clothing<br>Textiles | The purpose of this test<br>methodology is to<br>evaluate the Flammability<br>of Clothing Textiles. | Under the test conditions,<br>the subject device must<br>meet the Class I<br>flammability standard per<br>16 CFR Part 1610. | Pass. |
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#### 8. Conclusion
The conclusions drawn from the nonclinical tests that demonstrate that the EndoArmor™+ Surgical Gown is as safe, as effective, and performs as well as or better than the legally marketed device.
