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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance is based on substantial equivalence to a predicate device, the CarbonAid CO2 Diffuser. Therefore, the acceptance criteria are largely implied by demonstrating equivalent performance to the predicate device.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported TEMED Gas Diffuser Performance
Functional Equivalence: Capable of insufflating CO2 into the thoracic cavity.	"The TEMED Gas Diffuser is capable of delivering carbon dioxide into the thoracic cavity as intended."
Air Displacement Efficiency: Displaces air sufficiently.	"The Air Displacement Efficiency Test shows that the local atmosphere of CO2 increases sufficiently, displacing air to the same degree as the predicate device."
CO2 Delivery Rate: Delivers CO2 at a rate up to 10 l/min.	"Up to 10 l/min" (matching the recommended flow rate of the predicate device).
Biocompatibility: Device and components are biocompatible.	"Biocompatibility testing has been performed to ensure that this device and its component parts and materials are biocompatible."
Shelf-life Stability: Maintains structural integrity and functionality over shelf life.	"The shelf life validation programme proves that the device's structural integrity and functionality remain during the shelf life of the product."
Sterilization Method: Compatible with Ethylene Oxide sterilization.	"Ethylene Oxide" (matching the predicate device).
Storage Temperature: Stable within a defined storage temperature range.	"1 — 40°C" (Predicate: 10 - 30°C, implying the TEMED device is stable over a broader range).
Safety and Effectiveness: No new questions of safety or effectiveness.	"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."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Performance testing" and a "Gas Delivery Study" and an "Air Displacement Efficiency Test," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The performance evaluation focuses on direct measurement of device characteristics rather than expert-derived ground truth for complex clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (measuring gas delivery and displacement), an adjudication method for human interpretation of results is unlikely to have been employed in the traditional sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

This is not applicable as the device is a physical medical device (gas diffuser) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human improvement with AI assistance was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is a physical medical device and does not involve an algorithm working in a standalone capacity.

7. The Type of Ground Truth Used

For the performance tests described ("Gas Delivery Study" and "Air Displacement Efficiency Test"), the ground truth would be objective, quantitative measurements of CO2 delivery rates, CO2 concentration in the local atmosphere, and potentially air displacement metrics. It does not appear to rely on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.

8. The Sample Size for the Training Set

This is not applicable as the device is a physical medical device and does not involve a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a machine learning model.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K173545

Device Name TEMED Gas Diffuser

Indications for Use (Describe)

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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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:	TEMEDUnit 3Keynor FarmKeynor LaneSidleshamPO20 7LLUnited Kingdom
CONTACT PERSON:	Katie EvansQuality ManagerPhone: 0044 1243 572255Fax: 0044 1243 210079Email: katie@temed.net
MANUFACTURER:	HMT Medizintechnik GmbHFrauenstrasse 30Maisach82216Germany
Registration Number:	This establishment is yet to be registered with the FDA.

Section 5: 510(k) Summary

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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

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Device Description:

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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) DocumentNumber	Date Cleared	Indications for use
Cardia Innovation ABCarbonAid CO2Diffuser	K112975	22/06/2012	Intended for use bycardiovascular surgeons inopen heart surgeryprocedures for theinsufflation of carbondioxide gas into thethoracic cavity to reducethe risk of air embolismwhich can result in organdamage.

Table 4.1: Predicate Device

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Intended Use

Indications:

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.

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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.

Regulation Number and Section

§ 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.