The Georgia BioMedical Filter Heater/Hydrator Insufflation Gas Conditioner is an accessory to an insufflator intended to heat, humidify and filter a gas stream used for inflation during laparoscopic surgery.

Device Description

The Filter Heater/Hydrator Insufflation Gas Conditioner is a single use device which attaches to the outlet port of an insufflator and is designed to warm and humidify the gas stream prior to insufflation. The device consists of a universal gas connector, a control module which houses the control and safety circuits for the system and a disposable filter heater/humidifier (FHH) tubing set.

Gas from the insufflator is routed into the FHH tubing set via the control module. Within the filter heater/humidifier tubing set particles >0.3 um in size are filtered from the gas, the gas is heated to 35°C and the gas is hydrated to >80% relative humidity. The distal end of the filter heater/humidifier tubing set terminates in a Luer lock connection for attachment to a gas entrance port for the abdomen, pleural space, chest cavity, abdominal cavity or any other body cavity.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Georgia BioMedical, Inc. Filter Heater/Hydrator Insufflation Gas Conditioner, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Heating Time	Device reaches 35°C (body temperature) rapidly after activation.	Operates at 36°C within 100 seconds of activation.
Humidity (Flow Rate)	Maintains >80% relative humidity at varying flow rates.	>80% relative humidity maintained at flow rates up to 8 liters/minute.
Pressure Drop	Insignificant reduction in gas pressure.	Only a very slight reduction in gas pressure, which increases with flow rate; humidification of FHH cassette does not increase pressure drop.
Sustained Humidity	Capacity adequate to humidify 180 liters of gas over usage conditions.	Under worst-case conditions (high flow rate, under-humidification), results suggest adequate capacity with 8cc water charge and moderate flow rates.

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

The document does not explicitly state a "sample size" in terms of number of devices or experimental replicates for the performance tests. The descriptions are general (e.g., "Testing was performed").

Test Set Sample Size: Not explicitly stated. The descriptions imply multiple measurements were taken for each test condition (e.g., "This procedure was repeated for flow rates of 3,5,6 and 8 liters/minute").
Data Provenance: The studies were conducted by Georgia BioMedical, Inc. or their consultants for regulatory submission. The origin (e.g., country) is the USA, based on the submission to the FDA. The nature of the studies is prospective as they are performance tests conducted to demonstrate the device meets design specifications.

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

This information is not applicable as the described tests are laboratory performance evaluations of physical parameters (temperature, humidity, pressure), not diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance testing of the device's physical functions (heating, humidification, pressure), not a study comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical accessory with no AI algorithms. The performance testing described is "standalone" in the sense that it measures the device's inherent physical performance, but it's not applicable to the context of "algorithm only" performance.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria was established by measurement against engineering specifications and industry standards/expectations for medical gas conditioning. For example:

Temperature: Measured by a thermometer/sensor.
Relative Humidity: Measured by a hygrometer/sensor.
Gas Pressure: Measured by a pressure gauge/sensor.

These measurements were then compared against the target performance values (e.g., 35°C, >80% relative humidity, slight pressure reduction).

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical hardware product, not a software algorithm that requires a "training set" in the context of machine learning.

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

This information is not applicable for the same reason as point 8.

Summary

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K9708566

P193

510(k) Summary Georgia BioMedical, Inc. Filter Heater/Hydrator Insufflation Gas Conditioner

JAN 2 3 1998

Georgia BioMedical, Inc. 250 Charter Lane Macon, Georgia 31210

CONTACT PERSON

SUBMITTED BY

Douglas E. Ott, M.D. Georgia BioMedical, Inc. 250 Charter Lane Macon, Georgia 31210

DATE PREPARED

July 1, 1997

2. DEVICE NAME

Filter Heater/Hydrator Insufflation Gas Conditioner

CLASSIFICATION NAME

Laparoscopic Insufflator

CLASSIFICATION STATUS

The Filter Heater/Hydrator Insufflation Gas conditioner (21 CFR 884.1730, Product Code 85HIF) has been classified under Section 513 of the Act as Class II by the Obstetrical and Gynecological Devices Panel.

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K970866
PL093

3. PREDICATE DEVICES

WISAP Op-Pneu subject of K941438, the WISAP Flow-Therme subject of K952508, the CO,Guard™ Insufflator Filter Tubing, Georgia BioMedical, Inc. subject of K920205 and the Snowden-Pencer Insufflator subject of K920986.

4. INTENDED USE

DEVICE DESCRIPTION 5.

PERFORMANCE TESTING 7.

Testing was performed to evaluate the time required for the Filter Heater/Hydrator Insufflation Gas Conditioner to heat the gas after the device is first activated. The data shows a temperature of 36°C is reached within 100 seconds of activation, demonstrating that the heating element in the Filter Heater/Hydrator Insufflation Gas Conditioner rapidly warms the insufflation gas to body temperature after activation.

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11970866 12013

Testing was performed to determine the effect of flow rate on the relative humidity of the conditioned gas. Gas was allowed to flow at a rate of 1 liter per minute for 2-5 minutes, at which time the humidity at the outlet port of the FHH tubing set was recorded. This procedure was repeated for flow rates of 3,5,6 and 8 liters/minute. The data shows that a relative humidity of >80% can be maintained with flow rates of at least 8 liters/minute.

Testing was performed to determine the effect of the FHH tubing set, with and without the presence of humidification fluid, on gas pressure. The results of this testing indicate only a very slight reduction in gas pressure produced by the proposed Filter Heater/Hydrator Insufflation Gas Conditioner. This reduction in gas pressure increases with flow rate. Humidification of the FHH cassette does not increase the pressure drop observed, even at high rates of gas flow.

Testing was performed to demonstrate the maintenance of humidity of the conditioned gas. The testing was performed under worst case conditions, at a high flow rate and under-humidification. The results suggest that at use conditions of an 8 cc water charge and moderate flow rates, the capacity of the system is adequate to humidify the 180 liter volume of gas specified by the manufacturer.

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Georgia Biomedical, Inc. c/o Cynthia J. M. Nolte, Ph.D. Associate Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760 Re: K970866

JAN 2 3 1998

Laparoscopic Filter Heater/Hydrator Insufflation Gas Conditioner (Georgia Biomedical, Inc.) Dated: October 24, 1997 Received: October 27, 1997 Regulatory class: II 21 CFR $884.1730/Product code: 85 HIF

Dear Dr. Nolte:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified inaccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K9700 St 66

Device Name: Filter Heater/Hydrator Insufflation Gas Conditioner

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use

Robert R. Rathbun/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

(970866 510(k) Number

Georgia BioMedical, Inc. Additional Information for Filter Heater/Hydrator

7/1/97

Page A-1

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.