(427 days)
The BEVER™ Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
BEVER™ Reinforced Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm10.0 mm in 0.5 mm increments7.0 mm in 0.5 mm increments
BEVER™ Reinforced Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm
BEVER " Reinforced Endotracheal tube is an Endotracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.
The BEVER™ Reinforced Endotracheal tube is sterile, single use device supplied with a standard 15 mm connector. It is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, cuff, inflating system (including inflating tube, valve and pilot balloon) and 15 mm connector. The uncuffed tube is composed of main tube and 15 mm connector. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.
The provided document is a 510(k) summary for the BEVER™ Reinforced Endotracheal Tube. It primarily demonstrates substantial equivalence to predicate devices based on design, materials, and compliance with various international standards for medical devices, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or AI-driven device.
Therefore, the requested information, particularly regarding sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/diagnostic studies, is not applicable to this type of submission. This document describes a traditional medical device (an endotracheal tube), not a software or AI/ML-based device that would typically involve such studies.
However, I can extract the "acceptance criteria" and "reported device performance" in the context of compliance with relevant standards and the conclusions drawn for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Compliance with Standards/Characteristics) | Reported Device Performance (as claimed in the 510(k) Summary) |
|---|---|
| Physical and Design Characteristics: | |
| ISO 5361:1999 (E) - Dimension | Conformed with ISO 5361:1999 (E) |
| ISO 5361:1999 (E) - Design | Conformed with ISO 5361:1999 (E) |
| ISO 5361:1999 (E) - Material | Conformed with ISO 5361:1999 (E). Made of PVC and stainless steel wire, same as predicate devices. |
| ISO 5361:1999 (E) - Packaging | Conformed with ISO 5361:1999 (E) |
| ISO 5361:1999 (E) - Labeling | Conformed with ISO 5361:1999 (E) |
| Kink-resistance | Spiral metal wire reinforcement provides kink-resistance. Allows tube to be easily bent in all directions while maintaining lumen patency. |
| Biocompatibility: | |
| ISO 10993 standards (general) | Testing performed based on ISO 10993 standards |
| AAMI / ANSI / ISO 10993-5:2009 (Cytotoxicity) | Passed |
| AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006(E) (Sensitization & Irritation) | Passed (Sensitization & Irritation) |
| AAMI / ANSI / ISO 10993-6:2007 (Implantation) | Passed |
| AAMI / ANSI / ISO 10993-3:2009 (Genotoxicity) | Passed |
| Sterility & Shelf Life: | |
| AAMI / ANSI / ISO 11135-1:2007 (EO Sterilization) | Sterilization process validated to be compliant |
| AAMI / ANSI / ISO 10993-7:2008 (EO Sterilization Residuals) | Compliant |
| Shelf life requirement | 4 years |
| Accelerated aging (183 days) | Still compliant with device specifications |
| Real-time stability study (4 years) | Validated 4-year shelf life |
| Intended Use: | |
| Airway management by oral/nasal intubation of trachea during anesthesia, where neck movement or prone position could cause kinking. | Same intended use as predicate devices. |
| Technological Characteristics: | |
| Same design and performance characteristics as predicate devices. | Claimed substantial equivalence based on same design and performance. |
For the remaining points, as explained, the context of this 510(k) summary for a reinforced endotracheal tube does not involve the type of diagnostic or AI performance studies implied by these questions. This is a traditional device submission focused on material conformity, biocompatibility, and sterilization validation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission focuses on compliance with physical, chemical, and biological standards for a manufactured medical device, not on data analysis from a "test set" of patients or images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth establishment by experts is not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring expert adjudication was described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. No MRMC or AI-assisted study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm and does not have a "standalone" performance in that sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's safety and effectiveness relies on compliance with established ISO and AAMI standards for physical properties, materials, biocompatibility, and sterility.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
{0}------------------------------------------------
Hangzhou Bever dical Devices Co., Ltd.
Add: No. 8-1, Longquan Rd., Canggian Town, Yuhang District, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515
ve 111406 510(k) Summary
JUL 19 2012
1. Submitter (Owner) of 510 (k):
Hangzhou Bever Medical Devices Co., Ltd. No. 8-1, Longquan Rd., Cangqian Town, Yuhang District 311121, Hangzhou, China Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Registration Number: 3008729910
2. Contact person:
Allyson Zhou Management Representative Tel: +86-571-8861 6630 Fax: +86-0571-8861 6515 Email: zlshio1224@sina.com
3. Device Name:
Common Name: Reinforced Endotracheal Tube. Reinforced Tracheal Tube Trade Name: BEVER 114 Reinforced Endotracheal Tube Classification name: Tracheal tube(W/Wo Connector) (21 CFR 868.5730. Product Code BTR)
4. Predicate Device:
BEVER is claiming substantial equivalence to the following medical devices: Well Lead Reinforced Endotracheal Tube - K073383 Portex Reinforced Endotracheal Tube - K032112
5. Device Description
BEVER™ Reinforced Endotracheal Tube with cuff (Oral/Nasal) is available in sizes 3.0mm~10.0 mm in 0.5 mm increments
BEVER™ Reinforced Endotracheal Tube without cuff (Oral/Nasal) is available in sizes 2.0mm~7.0 mm in 0.5 mm increments
BEVER " Reinforced Endotracheal tube is an Endotracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. This type of product is typically used during operations where a high degree of flexibility is required from the tube, for instance prone position, head and neck surgery, and oral surgery. The plastic material and the spring allow the tube to be easily bent in all directions. The steel reinforcement maintains the patency of the lumen.
{1}------------------------------------------------
The BEVER™ Reinforced Endotracheal tube is sterile, single use device supplied with a standard 15 mm connector. It is available in cuffed and uncuffed variants and is for oral or nasal use. The cuffed tube is composed of main tube, cuff, inflating system (including inflating tube, valve and pilot balloon) and 15 mm connector. The uncuffed tube is composed of main tube and 15 mm connector. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway, thus preventing loss of ventilation / anaesthetic and nebulised drugs, and reducing the likelihood of any aspirated stomach contents from entering the lungs. Uncuffed tubes are used mainly for paediatric patients or when patients require less protection from loss of ventilation / anaesthetic and nebulised drugs and or stomach aspiration.
6. Indications for Use
The BEVER " Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
7. Substantial Equivalence
The BEVER™ Reinforced Endotracheal Tube maintains the same intended use as the predicate devices. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved or flexed or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
The BEVER™ Reinforced Endotracheal Tube is composed essentially of the same materials as the predicate devices. The material for both devices is PVC and stainless steel wire.
The BEVERTM Reinforced Endotracheal tube has the same design and performance characteristic as the predicate devices.
8. Device Performance
The dimension, design, material, sterility, packaging and labeling of BEVER™ Reinforced Endotracheal tubes are conformed with ISO 5361:1999 (E).
9. Summary of Testing
Biocompatibility testing was performed based on ISO 10993 standards. The subject device passed the following biocompatibility testings:
- Cytotoxicity �
- Sensitization .
Section 2, Page 2 of 3 Pages
{2}------------------------------------------------
- . Irritation
- Genotoxicity .
- Implantation .
And the subject device is compliance with the following Biocompatibility standards:
- AAMI / ANSI / ISO 10993-5:2009 Biological evaluation of medical devices --. Part 5: Tests for In Vitro cytotoxicity
- AAMI / ANSI / ISO 10993-10: 2002/Amd. 1:2006(E) Biological evaluation of . medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1
- AAMI / ANSI / ISO 10993-6:2007 Biological evaluation of medical devices --� Part 6: Tests for local effects after implantation
- AAMI / ANSI / ISO 10993-3:2009 Biological evaluation of medical devices -. Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
10. Sterility and shelf life
The device is sterilized by ethylene oxide. The sterilization process has been validated to be compliance with
- AAMI / ANSI / ISO ISO11135-1: 2007 Sterilization of health care products . - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
- AAMI / ANSI / ISO 10993-7: 2008 Biological Evaluation of Medical . Devices - Part 7: Ethylene Oxide Sterilization Residuals
Regarding the accelerated aging testing result, after 183 days accelerated aging, BEVER™ Reinforced Endotracheal Tubes are still compliance the requirements of device specification. The shelf life of device could be considered as 4 years. And, according to the real time stability study, the 4 years shelf life of device has been validated. So the shelf life of subject device is 4 years.
11. Conclusions
These proposed devices have the same intended use and technological characteristics to the currently-marketed predicate devices. No new issues of safety or effectiveness are introduced by using these devices. Therefore we believe the proposed devices are substantially equivalent to the currently-marketed predicate devices.
12. Date of submission
January 13, 2012
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Allyson Zhou Management Representative Hangzhou Bever Medical Devices Company, Limited No. 8-1 Longquan Road Cangqian Town, Yuhang District Hangzhou, Zhejiang China 311121
JUL 1 9 2012
Re: K111406
Trade/Device Name: BEVER™ Reinforced Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: July 12, 2012 Received: July 12, 2012
Dear Ms. Zhou:
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. 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.
{4}------------------------------------------------
Page 2- Ms. Zhou
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): Device Name: BEVER™ Reinforced Endotracheal Tube Indications For Use:
The BEVER™ Reinforced Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea during anesthesia. The product may be used where the patient's neck is likely to be moved or the patient is in the prone position so that a non-reinforced tracheal tube might become kinked.
Over-The-Counter Use No AND/OR . Prescription Use _ Yes (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y Schutts
(Division Sign-Off) Division of Anasthesiology, General Hospital Intection Control. Dental Devices
510(k) Number よう
Section 1, Page 1 of 1 Page
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).