(103 days)
No
The device description and performance studies focus on material properties and barrier performance, with no mention of AI or ML.
No
The device is a surgical gown intended for protective purposes for both patients and personnel, not for treating or diagnosing a disease or condition.
No
This device is a surgical gown intended to protect patients and personnel from microorganisms and fluids during surgical procedures, not to diagnose a medical condition.
No
The device description clearly states it is a physical surgical gown made of poly-reinforced material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical construction and materials of the gown, designed for barrier protection.
- Performance Studies and Key Metrics: The performance studies and metrics listed (break strength, tear strength, hydrostatic pressure, etc.) are related to the physical properties and barrier performance of the gown, not to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
The Medical Surgical Gowns is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.
Product codes
FYA
Device Description
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
- AATCC 42:2017 Water Resistance: Impact Penetration Test;
- ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
- ASTM D1683/D1683M-17:2017/(R) 2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D 5587-15:2015 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- ASTM D 5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
- ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics;
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
- ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
- ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
January 6, 2021
Beijing Biosis Healing Biological Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, Shanghai 200120 China
Re: K202844
Trade/Device Name: Medical Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 10, 2020 Received: December 9, 2020
Dear Diana Hong:
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 and Part 809); 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: CAPT 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
2
Indications for Use
510(k) Number (if known) K202844
Device Name Medical Surgical Gowns
Indications for Use (Describe)
The Medical Surgical Gowns is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.
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) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K202844
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K202844
-
- Date of Preparation: 1/5/2021
-
- Sponsor Identification
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD
No.6 plant west, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600 Beijing, China.
Establishment Registration Number: 3016668451
Contact Person: Ting Jiang Position: RA Director Tel: +86-10-6125 2660-816 Fax: +86-10-6125 2030 Email: jiangting@biosishealing.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
-
- Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
- Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
4
510(k) Summary
Identification of Proposed Device న.
Trade Name: Medical Surgical Gowns Common Name: Surgical Gown;
Regulatory Information
Classification Name: Surgical Gown; Classification: II; Product Code: FYA; Regulation Number: 21CFR 878.4040 Review Panel: General & Plastic Surgery;
Indication for Use:
The Medical Surgical Gowns is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Medical Surgical Gowns met the requirements for Level 3 classification.
Device Description:
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.
Identification of Predicate Device 6.
510(k) Number: K172987 Product Name: Surgical Gown (AG1001, AG2001, AG3001)
5
Technological Characteristic Comparison Tables 7.
| ITEM | Proposed Device K202844 | Predicate Device K172987 | Remark |
|---|---|---|---|
| Product Code | FYA | FYA | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for use | The Medical Surgical Gowns is | ||
| intended to be worn by operating | |||
| room personnel during surgical | |||
| procedure to protect both the | |||
| surgical patient and the operating | |||
| room personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | |||
| Per ANSI/AAMI PB70:2012 | |||
| Liquid barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| health care facilities, the Medical | |||
| Surgical Gowns met the | |||
| requirements for Level 3 | |||
| classification. | Surgical gown is intended to be | ||
| worn by operating room personnel | |||
| during surgical procedure to | |||
| protect both the surgical patient | |||
| and the operating room personnel | |||
| from transfer of microorganisms, | |||
| body fluids, and particulate | |||
| material. | |||
| Per ANSI/AAMI PB70:2012 | |||
| Liquid barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| health care facilities, the AG series | |||
| surgical gowns met the | |||
| requirements for Level 3 | |||
| classification. | Same | ||
| Style | Poly-reinforced | Non-reinforced | |
| Fabric-reinforced | |||
| Poly-reinforced | Similar | ||
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
6
| ITEM | Proposed Device | Predicate Device | Remark | ||
|---|---|---|---|---|---|
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL | Similar | ||
| Break strength | >20N | >20N | Same | ||
| Tear strength | >20N | >30N | Similar | ||
| Air permeability | >15 cm3/s/cm2 (29 ft3/min/ft2) | >30 ft3/min/ft2 | Similar | ||
| Lint | Log1050 cm | >50 cm | Same | ||
| Water impact | ≤1.0 g | ≤1.0 g | Same | ||
| Material | SMS nonwoven, polyethylene, | ||||
| polyester | SMMMS, polypropylene, | ||||
| polyethylene, polyester | Similar | ||||
| Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same | ||
| Biocompatibility | |||||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same | ||
| Skin Irritation | No Irritation | No Irritation | Same | ||
| Sensitization | No Sensitization | No Sensitization | Same | ||
| Sterile | Ethylene Oxide (EO), SAL=10-6 | Ethylene Oxide (EO), SAL=10-6 | Same |
Table 2 Technological Characteristic Comparison
8. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
- A AATCC 42:2017 Water Resistance: Impact Penetration Test;
- A ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
-
ASTM D1683/D1683M-17:2017/(R) 2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- A ASTM D 5587-15:2015 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
-
ASTM D 5034-09:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
- A ASTM D737-18:2018 Standard Test Method for Air Permeability of Textile Fabrics;
- A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
Page 4 of 5
7
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and perform as well as or better than the legally marketed predicate device.
- Conclusion