(212 days)
No
The summary describes a microprocessor-controlled insufflator with various operating modes and performance testing related to gas flow and pressure, but there is no mention of AI or ML capabilities.
No.
A therapeutic device is used to treat a disease or condition. The Nebulae™ I 50 LPM Insufflator is used to create space for surgical procedures, it does not directly treat a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device provides CO2 gas distention "for diagnostic and/or operative endoscopy."
No
The device description explicitly states it is a "CO2 (Carbon Dioxide) High Flow Insufflator" with "touch screen control" and is "microprocessor controlled." The performance studies also describe bench testing involving flow rates, fill time, and overpressure relief, which are physical characteristics of a hardware device.
Based on the provided information, the Nebulae™ I 50 LPM Insufflator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. This is a procedure performed in vivo (within a living organism) to facilitate visualization and manipulation during surgery.
- Device Description: The device is described as a CO2 insufflator used for surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Nebulae™ I does not perform any analysis of biological specimens.
The device is a surgical instrument used to create space within the body for surgical procedures, not to diagnose conditions by analyzing samples.
N/A
Intended Use / Indications for Use
The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting
Product codes (comma separated list FDA assigned to the subject device)
HIF, FCX, OSV
Device Description
The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.
The system includes the following major components:
- Selectable Power Supply, 100, 115 or 230 VAC + 10%, 47-63 Hz
- True Abdominal Pressure Sensing (TAP™) feature
- Variable Volume Alarm
- Recognizes Wall or Bottle CO2 Gas Source
- Touch Screen Buttons work in timed, auto increment / decrement manner
- Interfaces to control or work with data collection systems, such as a RS232
- Display indicates "Restriction"
- Supports a minimum of one (1) gas warmer
- Fifty (50) LPM at output port of the Insufflator when utilizing a standard Northgate style (#7-510-28) Tubing Set. Approximately 9 LPM at the Veress Needle, 22 LPM at most Trocars.
- Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less.
The following are cleared medical devices that may be used with this device: tubing Sets, 7-510-28 (General Use) and 7-510-31 (TAP™ set that provides continuous pressure information when connected to the insufflator) cleared under K983326 on February 5, 1999; and the 6-820-00 (In-Line Warmer) cleared under K022052 on January 24, 2003.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical cavities
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)
Performance testing was completed to demonstrate that the Nebulae™ I functions as intended and performs as intended for safety purposes.
- Device Flow Rates- Bench testing was done in a simulated use environment for all operating modes and the device performed within the specified flow rates.
- Fill Time - Bench testing was done in a simulated use environment and proved that the Nebulae I could fill an abdomen simulator within the specified time period.
- Flow Accuracy - Bench testing was done to prove that the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes and the device performed within the specified flow accuracy range.
- Overpressure Relief - Bench testing was done to prove that the Nebulae™ I would relieve over pressure conditions of 5mmHg above the preset and return to the preset within the specified time range. The device was tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all flow rates specified, the device relieved pressure within the specified time range.
- Comparative Flow Rate Testing - The predicate devices were tested along with the Nebulae™ I to compare the flow rates of the devices using an 11mm trocar with a 10mm laparoscope. The highest flow rates measured were 32 LPM.
- Pediatric Mode Comparative Testing - The Nebulae™ I was tested along with the predicate device in pediatric mode, in each of the weight modes, with a veress needle and also with a trocar. A simulated abdomen of an appropriate size for each weight mode was used. During testing in each of the weight modes, a leak was introduced and removed, and then overpressure and under pressure conditions were created. The response times were measured and compared with the predicate device and the Nebulae™ I was found to perform as well as, or better, than the predicate device.
- Tissue Desiccation Effect Testing - The Nebulae™ I and the 40L Abdominal Insufflators were used in a cross comparison test to demonstrate the tissue desiccation or drying effect at their maximum flow rates while connected to a standard 5mm trocar. A typical 5mm laparoscopic instrument was inserted into the trocar sleeve to simulate an actual usage scenario. Moist bovine liver was used to show the drying effect. Both Insufflators were set to allow their maximum achievable flow rates of CO2 to come in contact with the moist liver tissue samples. The gas flow was to remain on for 30 seconds and 60 seconds. The 5mm trocar sleeve distal opening was set in close proximity to the surface of the tissue sample. Results in both cases showed a negligible change to the tissue surface with no perceivable depth of desiccation. This was clearly evident in the crosssectional tissue samples. It was concluded that the 50LPM and the 40LPM insufflators described above were identical relative to tissue desiccation and drying.
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.
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.
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.
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K120151
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August 15, 2012
High Flow Insufflation Unit Nebulae™ I
AUG 1 7 2012
General Information
Applicant Name:
Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 Telephone: 224-856-2222 Fax: 847-608-9405
ontact Person
Casey Kurek Regulatory Manager Telephone: 224-856-2222 Fax: 847-608-9405 E-Mail: ckurek@northgate-tech.com
Manufacturer:
Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · Telephone: 224-856-2222 Fax: 847-608-9405 :
Registration #:
1450997
2. Device Identification
Device Trade Name: Common Name:
Classification Name:
Nebulae TM I 50 LPM Insufflator / REF# 7-650-00 Carbon Dioxide Insufflator for Laparoscopy and Endoscopic Vessel Harvesting
Insufflator, Laparoscopic 21 CFR 884.1730, Insufflator, Carbon Dioxide for Endoscope 21 CFR 876.1500
Regulatory Class:
Product Code:
HIF. FCX. OSV
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3. Predicate Device Information
1
| Device Name: | 45L CORE Insufflator F114 | |
|---|---|---|
| Common Name: | Carbon Dioxide Insufflator for Laparoscopy and | |
| Endoscopic Vessel Harvesting | ||
| Manufacturer: | W.O.M. World of Medicine | |
| 510(k) No. | K063367 |
| 2. | INSUFFLATOR, | Device Name: | 40LPM ABDOMINA |
|---|---|---|---|
| CATALOG # | 72-00203-0 | ||
| Common Name: | Insufflator | ||
| Manufacturer: | Northgate Technologies Inc. | ||
| 510(k) No. | K022052 |
4. Device Description
The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.
The system includes the following major components:
- · Selectable Power Supply, 100, 115 or 230 VAC + 10%, 47-63 Hz
- · True Abdominal Pressure Sensing (TAP™) feature
- · Variable Volume Alarm
- · Recognizes Wall or Bottle CO2 Gas Source
- · Touch Screen Buttons work in timed, auto increment / decrement manner
- · Interfaces to control or work with data collection systems, such as a RS232
- · Display indicates "Restriction"
- · Supports a minimum of one (1) gas warmer
- · Fifty (50) LPM at output port of the Insufflator when utilizing a standard Northgate style (#7-510-28) Tubing Set. Approximately 9 LPM at the Veress Needle, 22 LPM at most Trocars.
2
Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a document identifier and page number. The text "K120157" is at the top, likely serving as a document or project number. Below that, the text "pg. 2 of 5" indicates that this is page 2 of a 5-page document.
- · Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less.
The following are cleared medical devices that may be used with this device: tubing Sets, 7-510-28 (General Use) and 7-510-31 (TAP™ set that provides continuous pressure information when connected to the insufflator) cleared under K983326 on February 5, 1999; and the 6-820-00 (In-Line Warmer) cleared under K022052 on January 24, 2003.
5. Indications for Use
The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures:
- General Laparoscopic Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting
Typical Endoscopic Surgical Procedures requiring the need for CO2 Insufflation:
Categories
General Laparoscopy Cholecystectomy Hernia Repair Appendectomy Hysterectomy Bowel Resection
Pediatric Laparoscopy Cholecystectomy Appendectomy Gastric Surgery Bowel Resection Splenectomy
Bariatric Laparoscopy Gastric Banding Gastric Bypass
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Endoscopic Vessel Harvesting Saphenous Vein Harvesting for arterial bypass procedures
6. Technological Differences
The Nebulae™ I device is like the 40L Abdominal Insufflator (K022052) except it flows 50LPM out of a single output port, has a touchscreen, and has one warmer port.
The Nebulae™ I device is like the 45L CORE Insufflator F114 (K063367) except it flows 5LPM more, has Custom Mode, and does not contain a proprietary connection for a tubing set.
7. Performance Data
Both Design Verification and Design Validation have been completed.
Performance testing was completed to demonstrate that the Nebulae™ I functions as intended and performs as intended for safety purposes.
Device Flow Rates- Bench testing was done in a simulated use environment for all operating modes and the device performed within the specified flow rates.
Fill Time - Bench testing was done in a simulated use environment and proved that the Nebulae I could fill an abdomen simulator within the specified time period.
Flow Accuracy - Bench testing was done to prove that the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes and the device performed within the specified flow accuracy range.
Overpressure Relief - Bench testing was done to prove that the Nebulae™ I would relieve over pressure conditions of 5mmHg above the preset and return to the preset within the specified time range. The device was tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all flow rates specified, the device relieved pressure within the specified time range.
Comparative Flow Rate Testing - The predicate devices were tested along with the Nebulae ™ I to compare the flow rates of the devices using an 11mm trocar with a 10mm laparoscope. The highest flow rates measured were 32 LPM.
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Pediatric Mode Comparative Testing - The Nebulae™ I was tested along with the predicate device in pediatric mode, in each of the weight modes, with a veress needle and also with a trocar. A simulated abdomen of an appropriate size for each weight mode was used. During testing in each of the weight modes, a leak was introduced and removed, and then overpressure and under pressure conditions were created. The response times were measured and compared with the predicate device and the Nebulae™ I was found to perform as well as, or better, than the predicate device.
Tissue Desiccation Effect Testing - The Nebulae™ I and the 40L Abdominal Insufflators were used in a cross comparison test to demonstrate the tissue desiccation or drying effect at their maximum flow rates while connected to a standard 5mm trocar. A typical 5mm laparoscopic instrument was inserted into the trocar sleeve to simulate an actual usage scenario. Moist bovine liver was used to show the drying effect.
Both Insufflators were set to allow their maximum achievable flow rates of CO2 to come in contact with the moist liver tissue samples. The gas flow was to remain on for 30 seconds and 60 seconds. The 5mm trocar sleeve distal opening was set in close proximity to the surface of the tissue sample. Results in both cases showed a negligible change to the tissue surface with no perceivable depth of desiccation. This was clearly evident in the crosssectional tissue samples. It was concluded that the 50LPM and the 40LPM insufflators described above were identical relative to tissue desiccation and drying.
The Nebulae™ I was tested and shown to conform to the following standards: Electrical Safety - IEC 60601-1:2005
EMC - EN 60601-1-2:2007
8. Conclusion
The different technological characteristics and information submitted to the FDA do not raise new questions of safety and efficacy. Testing has shown that the device is at least as safe and effective as the legally marked predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 17 2012
Ms. Casey Kurek Regulatory Manager Northgate Technologies Inc. 1591 Scottsdale Court ELGIN IL 60123
Re: K120151
Trade Name: Nebulae™ I 50 LPM Insufflator Regulation Number: 21 CFR § 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, OSX, FCX Dated: August 2, 2012 Received: August 3, 2012
Dear Ms. Kurek:
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 801); medical device reporting (reporting of medical
6
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Nebulae™ | 50 LPM Insufflator/ REF #7-650-00 Device Name:
Indications For Use:
The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures:
General Laparoscopic
Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting
Prescription Use × (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Airns 222
(Division Sign-Oit)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K120151
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