(138 days)
The Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.
The Surgical gowns is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
The provided text is a 510(k) summary for a medical device, specifically Surgical Gowns. It details the device's characteristics, intended use, and comparative testing against a predicate device to demonstrate substantial equivalence.
However, the request asks for information relevant to the acceptance criteria and the study that proves a device (likely an AI/ML powered device for diagnosis or similar application) meets those criteria. The provided document does not describe an AI/ML powered device, nor does it detail a study involving expert readers or AI assistance. Instead, it focuses on non-clinical performance testing of a physical product (surgical gowns) based on recognized standards.
Therefore, most of the specific points requested (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to the content of this document.
I will attempt to answer the parts that are applicable based on the provided document, interpreting "acceptance criteria" as the performance requirements for the surgical gowns and "study" as the non-clinical performance testing conducted.
Here's an adaptation based on the provided document, acknowledging the limitations:
Acceptance Criteria and Device Performance for Surgical Gowns (K212718)
This document describes the non-clinical performance testing of surgical gowns (K212718) to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI/ML device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., expert readers, MRMC studies, ground truth for training) are not applicable.
Below is a table summarizing the acceptance criteria (performance requirements based on standards) and the reported device performance for the surgical gowns.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria (Standard Requirement/Predicate Performance) | Reported Device Performance (K212718) |
|---|---|---|
| AAMI Level 3 Barrier Protection | Meets AAMI Level 3 per ANSI/AAMI PB70:2012 | Meets AAMI Level 3 per ANSI/AAMI PB70:2012 |
| Impact Penetration | Typically a low value (e.g., 0.0-0.10 g for predicate) | < 0.1g |
| Hydrostatic Resistance (Critical Zone) | Typically a minimum cmH2O (e.g., 65-92 cm for predicate) | > 50cmH2O |
| Resistance to Blood and Liquid Penetration | Level 3 per PB70 | Level 3 per PB70 |
| Tensile Strength (Machine Direction) | Predicate: 21.57 lbf (approx. 95.9 N) | 252N |
| Tensile Strength (Cross Direction) | Predicate: 13.6 lbs (approx. 60.5 N) | 121N |
| Tear Resistance (Fabric direction A) | Predicate: 3.47 lbf (approx. 15.4 N) | 91N |
| Tear Resistance (Fabric direction B) | Predicate: 5.63 lbs (approx. 25.0 N) | 34.5N |
| Flame Spread | Class 1, Non Flammable | Class 1, Non Flammable |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 |
| Shelf Life | Not identified for predicate | 2 years |
| Cytotoxicity | Noncytotoxic (Comply with ISO 10993-5) | Noncytotoxic (Pass) |
| Irritation | Nonirritating (Comply with ISO 10993-10) | Nonirritating (Pass) |
| Sensitization | Nonsensitizing (Comply with ISO 10993-10) | Nonsensitizing (Pass) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of gowns) used for each non-clinical performance test. The data provenance is implied to be from the manufacturer's testing of their product. The testing is non-clinical performance testing, not a human study, and therefore terms like "retrospective or prospective" are not directly applicable in the typical sense for clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device is a physical product (surgical gowns) and its performance is evaluated through standardized laboratory tests, not by human expert assessment of diagnostic outputs.
4. Adjudication Method for the Test Set:
Not applicable. Performance is determined by objective measurements according to recognized standards (e.g., AATCC 42, AATCC 127, ASTM D5034, ASTM D5733, 16 CFR Part 1610, AAMI PB70, ISO 10993).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not an algorithm. The reported performance relates to the gown's material properties and barrier protection.
7. The Type of Ground Truth Used:
The "ground truth" for the surgical gowns' performance is established by the results of standardized laboratory testing (e.g., measurements of impact penetration, hydrostatic resistance, tensile strength, tear resistance, flame spread, and biocompatibility assays). These tests provide objective values that are compared against predefined criteria from recognized industry standards (e.g., AAMI PB70, ASTM, AATCC, ISO standards).
8. The Sample Size for the Training Set:
Not applicable. This is a manufactured product, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved for this type of device.
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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2022
Xiantao Dingcheng Non-Woven Product Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K212718
Trade/Device Name: Surgical gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: August 20, 2021 Received: August 27, 2021
Dear Boyle Wang:
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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212718
Device Name Surgical Gowns
Indications for Use (Describe)
The Surgical gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K212718 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: XIANTAO DINGCHENG NONWOVEN PRODUCTS CO.,LTD Address: LIUKOU INDUSTRIAL PARK,XIANTAO CITY,HUBEI PROVINCE,CHINA 433000 Contact: Mr. Cheng Qin Phone Number: 86-18007229722 Date of Preparation: 02/08/2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Surgical gowns Common name: Surgical gown Classification name: Gown, Surgical Model(s): M, L, XL, XXL.
3.0 Classification
Production code: FYA Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Cardinal Health 200, LLC Device: Cardinal Health™ Non-Reinforced Surgical Gown 510(k) number: K170762
5.0 Indication for Use Statement
The Surgical gowns are intended to be worn by operating room personnel during
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surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use, disposable medical devices, provided sterile.
6.0 Device description
The Surgical gowns is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.
| Table 3 - General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated device | Remark |
| Product Code | FYA | FYA | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Surgical gowns | Cardinal HealthTMNon-Reinforced SurgicalGown | - |
| 510(k) No. | Pending | K170762 | - |
| Models | M, L, XL, XXL. | M-S, M, L, XL, XXL | Similar |
| Intended Use | The Surgical gowns is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical gowns are single use. | Cardinal HealthTM Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI | Same |
| disposable medical devices,provided sterile. | PB70). The Cardinal Health ™Non-Reinforced SurgicalGowns are single use,disposable medical devices;provided sterile and non-sterile. | ||
| Composite | Neck Closure: LoopBelt TiesKnit CuffsTransfer Tab | Neck Closure: Hook and LoopBelt TiesKnit CuffsTransfer Tab | Same |
| Material | Polyolefin (Polypropylene)SMS nonwovenCotton | Polyolefin (Polypropylene)SMS nonwoven | Similar |
| Color | Blue | Blue | Same |
| Sterility | Sterile | Non-Sterile and sterile | * Gap 1 |
| Sterilization method | EO | EO | Same |
| Shelf life | 2 years | No identified | * Gap 2 |
| Single Use | Yes | Yes | Same |
| Impact Penetration | <0.1g | 0.0-0.10 g | Same |
| HydrostaticResistance | >50cmH2O for critical zone | 65-92 cm | * Gap 3 |
| Tensile strength | Machine direction mean:252N;Cross direction mean: 121N | MD mean: 21.57 lbf;CD mean: 13.6 lbs | * Gap 4 |
| Tear resistance | Fabric direction A mean: 91N;Fabric direction B mean:34.5N; | MD mean: 3.47 lbf;CD mean: 5.63 lbs | * Gap 5 |
| Flame spread | Class 1, Non Flammable | Class 1, Non Flammable | Same |
| Resistance to bloodand liquid penetration | Level 3 per PB70 | Level 3 per PB70 | Same |
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | Same |
| Irritation | Comply with ISO 10993-10 | Comply with ISO 10993-10 | Same |
| Sensitization |
7.0 Technological Characteristic Comparison Table
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- Gap analysis:
Gap 1: the proposed device is provided sterile, the predicate device has two types sterile and non sterile, this difference does not create additional risks to the device. Gap 2-4, the two devices have some small deviations in product performance, but the differences in the performance test results do not raise additional questions for safety and effectiveness.
8.0 _Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the "Guidance on Premarket Notification [510(k)]
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Submissions for Surgical Gowns and Surgical Drapes" dated on August, 1993.
| Items | Performance | Test methods |
|---|---|---|
| Impact Penetration | <0.1g | AATCC 42 |
| Hydrostatic Resistance | >50cmH2O for critical zone | AATCC 127 |
| Resistance to blood and liquid penetration | Level 3 | AAMI PB70 |
| Tensile strength | Machine direction mean: 252N;Cross direction mean: 121N | ASTM D5034 |
| Tear resistance | Farbic direction A mean: 91N;Farbic direction B mean: 34.5N; | ASTM D5733 |
| Flame spread | Class 1, Non Flammable | 16 CFR Pat 1610 |
| SAL | 10-6 | |
| Shelf life | 2 years |
Table 1 - Performance Testing
| Table 2 - Biocompatibility Testing | ||
|---|---|---|
| Item | Proposed Device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device isnoncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device isnonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device isnonsensitizing | Pass |
9.0 _Clinical Test Conclusion
No clinical study implemented for the Surgical gowns.
10.0 Conclusion
The conclusions drawn from the comparison and analysis above demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness.
§ 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.