(444 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and barrier performance of a surgical gown. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a surgical gown, which is personal protective equipment intended to protect healthcare workers and patients from microorganisms and body fluids, not to treat a disease or condition.
No
Explanation: The device is a surgical gown intended for protective purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical gown constructed from materials like polyethylene film and polypropylene, which are hardware components.
Based on the provided text, the EndoArmor™+ Surgical Gown is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the gown is "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." This describes a barrier device for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical construction and barrier properties of the gown. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Use in a laboratory setting for testing
The device is clearly described as personal protective equipment (PPE) designed to prevent the transfer of substances between individuals.
N/A
Intended Use / 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 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.
Product codes
FYA
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 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.
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 professionals
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)
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: ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. Purpose: The purpose of this test methodology is to evaluate the cytotoxicity endpoint. Acceptance Criteria: Under the test conditions, the subject device must be non-cytotoxic per ISO 10993-5. Results: Pass.
Test Method: ISO 10993-7, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals. Purpose: The purpose of this test methodology is to evaluate the EO/ECH residuals. Acceptance Criteria: Under the test conditions, the EO/ECH residual levels of the subject device must be below the maximum allowable limits for adult patient populations based on body mass per ISO 10993-7. Results: Pass.
Test Method: ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. Purpose: The purpose of this test methodology is to evaluate the irritation and skin sensitization endpoint. Acceptance Criteria: Under the test conditions, the subject device must be non-irritating and non-sensitizing per ISO 10993-10. Results: Pass.
Test Method: ASTM F2407-20, Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities. Purpose: The purpose of this test methodology is to evaluate the standard specification for surgical gown. Acceptance Criteria: Under the test conditions, the subject device must meet the required tensile strength, tear resistance, and seam strength per ASTM F2407-20. Results: Pass.
Test Method: AATCC TM42, Test Method for Water Resistance: Impact Penetration. Purpose: The purpose of this test methodology is to evaluate the impact penetration endpoint. Acceptance Criteria: Under the test conditions, the subject device must meet the required resistance to the penetration of water per ANSI/AAMI PB70. Results: Pass.
Test Method: AATCC TM127, Test Method for Water Resistance: Hydrostatic Pressure Test. Purpose: The purpose of this test methodology is to evaluate the Hydrostatic Pressure Test endpoint. Acceptance Criteria: Under the test conditions, the subject device must meet the required resistance to the penetration of water under hydrostatic pressure per ANSI/AAMI PB70. Results: Pass.
Test Method: ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test). Purpose: The purpose of this test methodology is to evaluate the Grab Test endpoint. Acceptance Criteria: Under the test conditions, the subject device must meet the required tensile strength per ASTM F2407-20. Results: Pass.
Test Method: ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure. Purpose: The purpose of this test methodology is to evaluate the Tearing Strength of Fabrics by Trapezoid Procedure. Acceptance Criteria: Under the test conditions, the subject device must meet the required tear resistance per ASTM F2407-20. Results: Pass.
Test Method: ASTM D1683 / D1683M-17, Standard Test Method for Failure in Sewn Seams of Woven Fabrics. Purpose: The purpose of this test methodology is to evaluate the Standard Test Method for Failure in Sewn Seams of Woven Fabrics. Acceptance Criteria: Under the test conditions, the subject device must meet the required seam strength per ASTM F2407-20. Results: Pass.
Test Method: 16 CFR Part 1610, Standard for the Flammability of Clothing Textiles. Purpose: The purpose of this test methodology is to evaluate the Flammability of Clothing Textiles. Acceptance Criteria: Under the test conditions, the subject device must meet the Class I flammability standard per 16 CFR Part 1610. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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)
| 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 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
4
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
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | EndoArmor™ + Surgical
Gown | Medline Level 3 Surgical
Gown (Sirus Non-
Reinforced) | N/A |
| 510(k) Reference | K203548 | K190950 | N/A |
| Product Owner | Boston Scientific
Corporation | Medline Industries, Inc. | N/A |
| Regulation
Number | 21 CFR §878.4040 | 21 CFR §878.4040 | Identical |
| Product Code | FYA | FYA | Identical |
| Device
Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Intended Use | EndoArmorTM+ 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.
EndoArmorTM+ 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. | Medline Level 3 Surgical
Gowns (Sirus Non-
Reinforced) are sterile,
single use surgical apparel
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.
Medline Level 3 Surgical
Gowns (Sirus Non-
Reinforced) 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. | Similar |
| Color | Blue | Blue | Identical |
| Design Features | Fabric Non-Reinforced
Hook and Loop Closure at
neck
Belt Ties
Knit Cuffs
Standard Sleeves | Fabric Non-Reinforced
Hook and Loop Closure at
neck
Belt Ties
Knit Cuffs
Standard Sleeves | Identical |
| Sizes | One-size fits most | Small to XXXX-Large | Similar |
| Materials | Front/Sleeves:
Polyethylene Film
Laminated with Nonwoven
Spunbond Polypropylene
Back: Nonwoven
Spunbond Polypropylene | Nonwoven SMS
Polypropylene/Polyolefin | Similar |
| Critical Zone
Performance
Specifications | AAMI Level 3 Barrier
Protection | AAMI Level 3 Barrier
Protection | Identical |
| Device | Proposed Device | Predicate Device | Comparison |
| Characteristic | | | Analysis |
| Prescription vs.
OTC | OTC | OTC | Identical |
| Contact
Duration | Surface, Intact,