(90 days)
Not Found
No
The device description and performance studies focus on the mechanical delivery and diffusion of CO2 gas, with no mention of AI or ML technologies.
Yes
The device is described as "intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism," which treats a medical condition.
No
The device is described as a surgical tool for insufflation of carbon dioxide to reduce the risk of air embolism, not for identifying or diagnosing a condition.
No
The device description clearly outlines physical components like tubing, a filter, and a diffusing tip, indicating it is a hardware device, not software-only.
Based on the provided information, the TEMED Gas Diffuser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The TEMED Gas Diffuser is used to insufflate carbon dioxide gas directly into the thoracic cavity during surgery. It does not analyze or test any biological samples.
- The intended use is for a surgical procedure. The device is used during open heart surgery to reduce the risk of air embolism, not to diagnose a condition or monitor a patient's health through laboratory testing.
- The device description focuses on gas delivery and displacement. The components and function are related to delivering CO2 gas into a surgical space, not to processing or analyzing biological specimens.
Therefore, the TEMED Gas Diffuser falls under the category of a surgical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TEMED Gas Diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
Product codes
HIF
Device Description
The TEMED Gas Diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound, which will increase the level of CO2 in the local atmosphere and reduce the risk of air embolism. Air will enter the heart and great vessels during conventional open-heart surgery and can be difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and may result in embolism to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is 25 times more soluble in blood and tissue than air is. Arterial CO2 emboli will thus be fewer and dissolve more quickly, decreasing the risk of organ injury. Carbon dioxide is 50% heavier than air and will therefore sink to the bottom of the chest cavity, displacing the air as it does so. Air displacement in this way will result in a local atmosphere surrounding the wound of up to 100% CO2.
The TEMED device is formed of the following components; a section of ¼" tubing which can be connected to a regulated, medical grade, CO₂gas source. This piece of tubing features an in-line 0.2μ microbial filter placed 0.50m from the end. This tubing is connected to a further piece of tubing which is smaller in diameter and length. This last section of tubing is malleable, allowing surgeons to place the tip of the diffuser as per the instructions for use. The final component of the TEMED Gas Diffuser is the hydrophobic diffusing tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiovascular surgeons in open heart surgery
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
Performance testing has found that the TEMED Gas Diffuser is capable of delivering carbon dioxide into the thoracic cavity as intended. The testing looked at the device performance of both the TEMED Gas Diffuser and the predicate device. The Gas Delivery Study found that the TEMED Gas Diffuser is capable of delivering medical grade CO2 into the thoracic cavity. The Air Displacement Efficiency Test shows that the local atmosphere of CO2 increases sufficiently, displacing air to the same degree as the predicate device.
The shelf life validation programme proves that the device's structural integrity and functionality remain during the shelf life of the product.
Biocompatibility testing has been performed to ensure that this device and its component parts and materials are biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
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.
February 14, 2018
TEMED
Katie Evans Quality Manager Unit 3, Keynor Farm, Keynor Lane, Sidlesham, West Sussex PO20 7LL United Kingdom
Re: K173545
Trade/Device Name: TEMED Gas Diffuser Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF Dated: October 30, 2017 Received: November 16, 2017
Dear Katie Evans:
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.
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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173545
Device Name TEMED Gas Diffuser
Indications for Use (Describe)
The TEMED Gas Diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
| 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) application for P2514: TEMED Gas Diffuser
Image /page/3/Picture/2 description: The image shows the word "TEMED" in a bold, sans-serif font. The letters are all capitalized and green. The background is white.
Unit 3. Keynor Farm. Sidlesham. West Sussex. PO20 7LL.
510(K) SUMMARY: TEMED Gas Diffuser
General Information
| SUBMITTER: | TEMED
Unit 3
Keynor Farm
Keynor Lane
Sidlesham
PO20 7LL
United Kingdom |
|----------------------|--------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Katie Evans
Quality Manager
Phone: 0044 1243 572255
Fax: 0044 1243 210079
Email: katie@temed.net |
| MANUFACTURER: | HMT Medizintechnik GmbH
Frauenstrasse 30
Maisach
82216
Germany |
| Registration Number: | This establishment is yet to be registered with the FDA. |
Section 5: 510(k) Summary
4
Device Identification:
| DEVICE TRADE NAME: | TEMED Gas Diffuser |
|---|---|
| DEVICE PRODUCT CODE: | HIF |
| REGULATORY CLASS: | II |
| REGULATION NUMBER: | 21 CFR 884.1730 |
| REGULATION NAME: | Insufflator, laparoscopic |
5
Device Description:
The TEMED Gas Diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound, which will increase the level of CO2 in the local atmosphere and reduce the risk of air embolism. Air will enter the heart and great vessels during conventional open-heart surgery and can be difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and may result in embolism to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is 25 times more soluble in blood and tissue than air is. Arterial CO2 emboli will thus be fewer and dissolve more quickly, decreasing the risk of organ injury. Carbon dioxide is 50% heavier than air and will therefore sink to the bottom of the chest cavity, displacing the air as it does so. Air displacement in this way will result in a local atmosphere surrounding the wound of up to 100% CO2.
The TEMED device is formed of the following components; a section of ¼" tubing which can be connected to a regulated, medical grade, CO₂gas source. This piece of tubing features an in-line 0.2μ microbial filter placed 0.50m from the end. This tubing is connected to a further piece of tubing which is smaller in diameter and length. This last section of tubing is malleable, allowing surgeons to place the tip of the diffuser as per the instructions for use. The final component of the TEMED Gas Diffuser is the hydrophobic diffusing tip.
6
510(K) application for P2514: TEMED Gas Diffuser
Image /page/6/Figure/1 description: The image shows a diagram of a CO2 delivery system. The system includes a CO2 tank, a flowmeter, a bacterial filter, and a hydrophobic tip. The CO2 flows from the tank, through the flowmeter and filter, and out of the hydrophobic tip. The arrows indicate the direction of the CO2 flow.
Figure 4.1: How the TEMED Gas Diffuser might be used. The device is connected to regulated carbon dioxide gas source, the gas flows through the bacterial filter, through a further length of malleable tubing and then out through the hydrophobic tip.
Predicate Device Information:
A device previously cleared by the FDA in the following 510(K) Notification intended for use by cardiovascular surgeons during open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.
| Device Name: | CarbonAid CO2 Diffuser |
|---|---|
| Manufacturer: | Cardia Innovation AB |
510(k) No: K112975
| Device | 510(K) Document
Number | Date Cleared | Indications for use |
|---------------------------------------------------|---------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardia Innovation AB
CarbonAid CO2
Diffuser | K112975 | 22/06/2012 | Intended for use by
cardiovascular surgeons in
open heart surgery
procedures for the
insufflation of carbon
dioxide gas into the
thoracic cavity to reduce
the risk of air embolism
which can result in organ
damage. |
Table 4.1: Predicate Device
7
Intended Use
Indications:
The TEMED Gas Diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
The device will be used during open heart surgery procedures whereby the chest is cut open to allow surgery to be performed on the muscles, valves or arteries of the heart.
The device is a means of flooding the thoracic cavity with carbon dioxide to reduce the risk of air emboli entering the heart and great vessels.
| | Predicate Device
(CarbonAidCO2 Diffuser) | TEMED Gas Diffuser |
|--------------------------|---------------------------------------------|--------------------|
| Gas Flow Rate | 10 l/min (recommended) | Up to 10 l/min |
| Storage Temperature (°C) | 10 - 30°C | 1 — 40°C |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
Technological Characteristics:
Table 4.2: The technological characteristics of the predicate device and the TEMED Gas Diffuser.
Technologically, both the subject device and the predicate device are the same. Both devices are intended for the insufflation of carbon dioxide gas during open heart surgery. Any difference between the devices do not raise any questions of safety or effectiveness.
8
Performance Data:
Performance testing has found that the TEMED Gas Diffuser is capable of delivering carbon dioxide into the thoracic cavity as intended. The testing looked at the device performance of both the TEMED Gas Diffuser and the predicate device. The Gas Delivery Study (see substantial equivalence discussion) found that the TEMED Gas Diffuser is capable of delivering medical grade CO2 into the thoracic cavity. The Air Displacement Efficiency Test shows that the local atmosphere of CO2 increases sufficiently, displacing air to the same degree as the predicate device.
There is no difference in the safety or effectiveness between the device that TEMED intends to market and the predicate device with respect to the performance of the device.
The shelf life validation programme proves that the device's structural integrity and functionality remain during the shelf life of the product.
Biocompatibility testing has been performed to ensure that this device and its component parts and materials are biocompatible.