(319 days)
Not Found
No
The device description and performance studies focus on physical processes (heating, humidifying, filtering) and control circuits, with no mention of AI or ML algorithms for data analysis, decision-making, or image processing.
No.
The device is an accessory to an insufflator designed to warm, humidify, and filter a gas stream for inflation during laparoscopic surgery, making it a supportive device rather than a direct therapeutic agent.
No
This device is an accessory to an insufflator designed to warm, humidify, and filter a gas stream for insufflation during laparoscopic surgery. It is a therapy support device that conditions gas, not a diagnostic device that identifies diseases or conditions.
No
The device description clearly outlines physical components like a control module, a disposable filter heater/humidifier tubing set, and a heating element, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "heat, humidify and filter a gas stream used for inflation during laparoscopic surgery." This describes a device used during a surgical procedure to condition a gas being introduced into the body.
- Device Description: The description details how the device physically modifies a gas stream (heating, humidifying, filtering) before it is used for insufflation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. IVDs are typically used to analyze blood, urine, tissue, or other bodily fluids or substances.
- Performance Studies: The performance studies focus on the device's ability to heat, humidify, and maintain gas pressure, which are all related to its function during insufflation, not diagnostic testing.
The device is an accessory to an insufflator, which is a surgical device used to inflate a body cavity. This aligns with the description of a medical device used in a surgical setting, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85HIF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, pleural space, chest cavity, abdominal cavity or any other body cavity
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K941438, K952508, K920205, K920986
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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
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 5.
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.
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.
2
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.
3
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
4
510(k) Number (if known): K9700 St 66
Device Name: Filter Heater/Hydrator Insufflation Gas Conditioner
Indications For Use:
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.
(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)
OR
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