(151 days)
No
The device description focuses on the physical structure and lumens of the endotracheal tube, and there is no mention of AI, ML, or related concepts in the provided text.
No
This device is primarily used for airway management and secretion evacuation, which are supportive functions rather than direct treatment or therapy.
No
This device is an endotracheal tube designed for airway management and evacuation/drainage, not for diagnosing medical conditions. While it has a lumen for "air sampling above the cuff to detect leakage of air from the lungs past the cuff," its primary function is therapeutic management and not diagnostic.
No
The device description clearly outlines a physical endotracheal tube with multiple lumens, a cuff, and various components made of materials like PVC, Silicone, and Polyurethane. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for airway management by intubation and evacuation/drainage of the subglottic space. This is a direct medical intervention on the patient's body.
- Device Description: The device is a physical tube with lumens for inflation, suction, and venting/sampling. It is designed to be inserted into the trachea.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The "air sampling above the cuff to detect leakage of air from the lungs past the cuff" is a functional check of the device's seal, not a diagnostic test on a bodily fluid or tissue.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic and management purpose.
N/A
Intended Use / Indications for Use
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
Product codes
BTR
Device Description
The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff. A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff. The AnapnoGuard ETT is comprised of the following components: - Main lumen (PVC or Silicone) - . Cuff (Polyurethane for PVC tube and Silicone for Silicon tube) - Cuff inflate/deflate lumen . - . Two suction lumens combined into one outside of the tube sealed with a cap - Venting/air and CO2 sampling lumen sealed with a cap. ● - Murphy eye (with or without) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Preclinical study was designed in order to evaluate the safety and effectiveness of using the AnapnoGuard ETT device as an endotracheal tube intended for airway management by oral or nasal intubation. Altogether 6 goats were intubated for 4 to 6 hours. No occlusion or any adverse events occurred during the study, airway stay open throughout study procedure. Study has demonstrated that the AnapnoGuard ETT device is safe and effective for its intended use (pre-clinical study summary is provided in attachment No. 10). Due to the pre-clinical study performed with the AnapnoGuard ETT device, the thorough performance tests and comprehensive clinical study performed by the cleared predicate device (Attachment No. 9), Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5420 Ether hook.
(a)
Identification. An ether hook is a device that fits inside a patient's mouth and that is intended to deliver vaporized ether.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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MAR - 2 2010
こ
510(K) SUMMARY
AnapnoGuard™ Endotracheal Tube
510(k) Number K Ω93 | 2 b
Applicant's Name: Hospitech Respiration Ltd. 20 Hamagshimim St. Kiryat Matalon, POB. 7970 Petach-Tikva, 49250 Israel TEL: (972)3-919-1648, FAX: (972)3-919-1649
- Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@qsitemed.com
- Preparation Date: September 21, 2009
Trade Name: AnapnoGuard™ ETT
Device Type Tracheal Tube
Classification: Regulatory Name: tube, tracheal
Product Code: BTR
Regulation No: 21 CFR 868.5730
Class: II
Classification Panel: Anesthesiology
Device Description:
The AnapnoGuard™ Endotracheal Tube is a sterile, single-use device supplied with main lumen with a standard 15mm connector. Four lumens are embedded within tube walls. One is a standard lumen used for the inflation/deflation of the cuff. Two suction lumens are embedded in the dorsal side of the tube having spatially unified into one success above the cuff. The two suction lumens are unified into one external lumen. These lumens are used to evacuate secretions that accumulate above the cuff.
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Hospitech AnapnoGuard ETT K093126 510k Response
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Image /page/1/Picture/0 description: The image shows a logo for Hospitech Respiration. The logo features a globe-like design with horizontal and vertical lines, resembling a grid. In the center of the globe, there is a large letter 'H' in a bold, serif font. Below the globe and the letter 'H', the words 'Hospitech Respiration' are written in a serif font.
A forth lumen is embedded on the ventral side of the tube having an inlet port above the cuff. It is used for a) venting the subglottis space during suction to avoid vacuum b) for saline (or other fluid) rinsing above the cuff to dilute the secretions and ease the suction c) for air sampling above the cuff to detect leakage of air from the lungs past the cuff.
The AnapnoGuard ETT is comprised of the following components:
- Main lumen (PVC or Silicone) ●
- . Cuff (Polyurethane for PVC tube and Silicone for Silicon tube)
- Cuff inflate/deflate lumen .
- . Two suction lumens combined into one outside of the tube sealed with a cap
- Venting/air and CO2 sampling lumen sealed with a cap. ●
- Murphy eye (with or without) .
Intended Use Statement:
The AnapnoGuard™ Endotracheal Tube is indicated for airway management by oral or nasal intubation of the trachea and for evacuation or drainage of the subglottic space.
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | Manufacturer | 510k No | Date of approval |
|---|---|---|---|
| SealGuard Endotracheal | |||
| Tube | Covidien | K082520 | Oct 2, 2008 |
| Well Lead Endotracheal | |||
| tube | Well Lead | K042683 | Feb 18, 2005 |
Performance Standards
AnapnoGuard™ Endotracheal Tube was tested and complies with the following standards:
- ISO 5361:1999 Anaesthetic and respiratory equipment --. Tracheal tubes and connectors
- · ANSIIAAMIIISO 11135-1:2007 Sterilization of health care products - Ethylene oxide
Hospitech AnapnoGuard ETT K093126 510k Response
ટર્
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- AAMI TIR28:2001 Product adoption and process equivalency . for ethylene oxide sterilization
- ISO 14971-1:2007 Risk management for medical devices ●
- ISO 10993-1:2003(E), Biological evaluation of medical ● devices -- Part 1: Evaluation and testing
A detailed description appears in Section 14.
Bench Tests
AnapnoGuard™ Bench testing demonstrated that the Endotracheal Tube is as safe and effective as the cleared predicate devices.
The following bench tests were conducted:
- Determination of Cuff Resting Diameter ●
- Resistance to Cuff Herniation ●
- Cuff Symmetry ●
- Suction Safety Test .
- . Resistance to tube collapse
Summary of Pre-Clinical and clinical study
Preclinical study was designed in order to evaluate the safety and effectiveness of using the AnapnoGuard ETT device as an endotracheal tube intended for airway management by oral or nasal intubation. Altogether 6 goats were intubated for 4 to 6 hours. No occlusion or any adverse events occurred during the study, airway stay open throughout study procedure. Study has demonstrated that the AnapnoGuard ETT device is safe and effective for its intended use (pre-clinical study summary is provided in attachment No. 10).
Due to the pre-clinical study performed with the AnapnoGuard ETT device, the thorough performance tests and comprehensive clinical study performed by the cleared predicate device (Attachment No. 9), Hospitech believes that clinical studies are not required to determine the safety and efficacy of the device.
Comparison to the Predicate Device
The AnapnoGuard™ Endotracheal Tube has the same intended use, general and specific indications and principles of operation as the cleared Covidien's SealGuard Endotracheal Tube (K082520). The material composition of both is the same; the lumens are made of PVC and the cuff of PU (polyurethane).
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The minor differences between the AnapnoGuard and the SealGuard Endotracheal Tube do not raise any new questions of safety or efficacy. Moreover, bench and preclinical testing of the AnapnoGuard™ Endotracheal Tube (bench testing are provided in Attachments 7) demonstrated that the AnapnoGuard™ Endotracheal Tube is as safe and effective as the predicate devices. Thus, the AnapnoGuardTM Endotracheal Tube is substantially equivalent to the already cleared SealGuard Evac Endotracheal Tube.
The PVC of the AnapnoGuard™ Endotracheal Tube PVC model is identical to the PVC of the Well Lead Endotracheal Tube cleared in K042683 and the Silicone of the AnapnoGuard™ Endotracheal Tube Silicone model is identical to the silicone of the All-Silicone 2-Way and 3-Way Hematuria Catheter cleared in K021142
Hospitech AnapnoGuard ETT K093126 510k Response
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 1 1 2010
Mr. Yoram Levy Regulatory Consultant Hospitech Respiration Limited 20 Hamagshimim Street Kiryat Matalon Petach Tikva 49348 ISRAEL
Re: K093126
Trade/Device Name: AnapnoGuard Endotracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: February 14, 2010 Received: March 2, 2010
Dear Mr. Levy:
This letter corrects our substantially equivalent letter of March 2, 2010 .
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 (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.
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.
5
Page 2 - Mr. Levy
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
h for
Susan Runner, DDS Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices. Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
| Device Name: | AnapnoGuard™ Endotracheal Tube |
|---|---|
| Indications for Use: | The AnapnoGuard™ Endotracheal Tube is indicated for airway |
| management by oral or nasal intubation of the trachea and for | |
| evacuation or drainage of the subglottic space. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF
NEEDED NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Anesthesiology, 510(k) Number
Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093126
1-2 AnapnoGuard™ Endotracheal Tube - 510k Notification