(340 days)
Not Found
No
The device description focuses on a sensor and solenoid system for controlling gas flow based on the presence of waste anesthetic gas, with no mention of AI or ML technologies.
No
This device is for scavenging waste anesthetic gases, preventing pressure changes in the breathing circuit, and is not directly used for treating a disease or condition.
No
Explanation: The device is designed for scavenging waste anesthetic gases and regulating their flow, not for diagnosing any medical condition.
No
The device description explicitly mentions physical components like a "sensor and solenoid combination" and being "placed between the individual anesthetic workstation and the waste gas evacuation vacuum system," 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 scavenge waste anesthesia gases during surgical procedures. This is a function related to the delivery of anesthesia and the management of the operating room environment, not the testing of biological samples from the human body.
- Device Description: The device description details a system that manages gas flow and pressure in an anesthesia waste gas evacuation system. It does not describe any components or processes related to analyzing biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on biological sample analysis.
The device is clearly designed for use in a surgical setting to manage waste gases, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Dynamic Gas Scavenging System is intended to be used for the scavenging of waste anesthesia machines during the provision of general anesthesia to adults and children.
Product codes
CBN
Device Description
The Dynamic Gas Scavenging System 2 (DGSS-2) is a waste anesthetic scavenging interface placed between the individual anesthetic workstation and the waste gas evacuation vacuum system in a surgical care facility. Through a sensor and solenoid combination, it allows waste gas exhaust flow to the waste gas vacuum line only in the presence of waste anesthetic gas, and interrupts all exhaust flow when no waste gas is present. The system effectively prevents both positive and negative pressure on the patient breathing circuit, and it is usable over a wide range of anesthetic gas flows. It is designed for use in conjunction with low-flow (
§ 868.5430 Gas-scavenging apparatus.
(a)
Identification. A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.(b)
Classification. Class II (performance standards).
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December 4, 2020
Anesthetic Gas Reclamation, Inc. % Laurel Arrigona Regulatory Ceutical Laboratories, Inc. 2300 Valley View Lane Ste. 230 Farmers Branch, Texas 75234
Re: K193646
Trade/Device Name: Dynamic Gas Scavenging System 2 (DGSS - 2) Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: Class II Product Code: CBN Dated: November 6, 2020 Received: November 6, 2020
Dear Laurel Arrigona:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
ence determination does not mean that FDA
Page 2
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193646
Device Name
Dynamic Gas Scavenging System 2 (DGSS - 2)
Indications for Use (Describe)
The Dynamic Gas Scavenging System is intended to be used for the scavenging of waste anesthesia machines during the provision of general anesthesia to adults and children.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 7 – 510(k) Summary
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Email: larrigona@ceuticallabs.com Phone Number: 972-241-8374 Fax Number: 972-241-0619
| Date of Submission: | December 23, 2019 |
|---|---|
| Submission Sponsor: | James Berry, MD |
| Anesthetic Gas Reclamation, Inc. | |
| 10606 Shady Trail #22 | |
| Dallas, Texas 75220 | |
| Email: admin@gasrecycler.com | |
| Phone Number: 972-707-7321 | |
| Fax Number: 972-707-7343 | |
| Submission Completed By: | Laurel Arrigona |
| Regulatory | |
| Ceutical Laboratories, Inc. | |
| 2300 Valley View Lane, Suite 230 | |
| Farmers Branch, Texas 75234 |
Device Identification
| Trade/Proprietary Name: | Dynamic Gas Scavenging System 2 (DGSS-2) |
|---|---|
| Common/Usual Name: | Waste Anesthetic Scavenging Interface |
| Classification Name: | Apparatus, Gas-Scavenging |
| Classification Regulation: | 868.5430 |
| Product Code: | CBN |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
Predicate Device
| Trade/Proprietary Name: | Dynamic Gas Scavenging System |
|---|---|
| Common/Usual Name: | Waste Anesthetic Scavenging Interface |
| Classification Name: | Apparatus, Gas-Scavenging |
| Classification Regulation: | 868.5430 |
| Product Code: | CBN |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
| 510(k) Number: | K063519 |
| Manufacturer: | Anesthetic Gas Reclamation, Inc |
| Intended Use: | This device is intended to be used for the scavenging of |
| waste anesthetic gases from anesthesia machines during the | |
| provision of general anesthesia to adults and children. |
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Device Description
The Dynamic Gas Scavenging System 2 (DGSS-2) is a waste anesthetic scavenging interface placed between the individual anesthetic workstation and the waste gas evacuation vacuum system in a surgical care facility. Through a sensor and solenoid combination, it allows waste gas exhaust flow to the waste gas vacuum line only in the presence of waste anesthetic gas, and interrupts all exhaust flow when no waste gas is present. The system effectively prevents both positive and negative pressure on the patient breathing circuit, and it is usable over a wide range of anesthetic gas flows. It is designed for use in conjunction with low-flow ( 1,000,000 cycles), but no definitive determination has been made. The reservoir bag is now composed of silicone rubber and resists environmental degradation. It should not be a factor although semi-annual inspection is recommended.
Substantial Equivalence Discussion
The following table compares the Dynamic Gas Scavenging System 2 to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the bases for the determination of substantial equivalence.
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| Table 7A – Comparison of Characteristics | ||
|---|---|---|
| Manufacturer | Anesthetic Gas | |
| Reclamation LLC | Anesthetic Gas | |
| Reclamation LLC | ||
| Trade Name | New Device | |
| Dynamic Gas Scavenging | ||
| System – 2 (DGSS-2) | Dynamic Gas Scavenging | |
| System (DGSS) | ||
| 510(k) Number | Not Assigned | K063519 |
| Intended Use | The device is intended to | |
| be used for the | ||
| scavenging of waste | ||
| anesthetic gases from | ||
| anesthesia machines used | ||
| during the provision of | ||
| general anesthesia to | ||
| adults and children. | The device is intended to | |
| be used for the | ||
| scavenging of waste | ||
| anesthetic gases from | ||
| anesthesia machines | ||
| during the provision of | ||
| general anesthesia to | ||
| adults and children. | ||
| Anesthesia Machine – | ||
| Specific | No | No |
| Control Circuit | Digital | Analog |
| Pressure Sensing | Solid – State | Mechanical Diaphragm |
| Solenoid | Co – Axial High Flow | 5 mm Orifice |
| Power Requirement | 0.4 A | 0.8 A |
| Status Indicator | Green LED | Green LED |
| Positive Pressure Relief | Integrated | Integrated |
| Negative Pressure Relief | -2 cm H2O | -2 cm H2O |
| WAGD Maximum Flow Rate | 50 Ipm | 50 Ipm |
| Machine Location | External Mount | External Mount |
| Waste Anesthetic Ingress | Via 19mm Hose | Via 19mm Hose |
| Physical Attachment | GCX or Other Rail | GCX or Other Rail |
Table 7A – Comparison of Characteristics
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Non-Clinical Performance Data
The Dynamic Gas Scavenging System 2 has been thoroughly tested through verification of specifications and validation, including materials testing including volatile organic compounds, to ensure safe use of the device in its intended use environment. Verification of compliance with applicable standards has also been completed. The following quality assurance measures were applied during the development of the Dynamic Gas Scavenging System 2:
| Quality Assurance Measure | Standard(s) |
|---|---|
| Risk Analysis | ISO 80601-2-13 |
| Requirements/Specification Reviews | ISO 80601-2-13 |
| Design Reviews | ISO 80601-2-13 |
| Testing on Unit Level (Module Verification) | ISO 80601-2-13 |
| Integration Testing (System Verification) | ISO 80601-2-13 |
| Performance Testing (Verification) | IEC 60601-1-2:2014 and ISO 80601-2-13 |
| Materials Testing including Volatile Organic Compounds (VOC) | ISO 80601-2-13 |
| Verification Testing including Electrical Safety Testing and Electromagnetic Compatibility Testing | IEC 60601-1-2:2014 |
| Simulated Use/User Requirements Testing (Validation) | ISO 80601-2-13 |
Clinical Testing
There was no clinical testing required to support the Dynamic Gas Scavenging System 2 as the indications for use is equivalent to the predicate device. The safety and efficacy of the Dynamic Gas Scavenging System 2 is supported by the non-clinical testing performed. The verification and validation testing of the Dynamic Gas Scavenging System 2 was found to be acceptable and support the claims of substantial equivalence.
Statement of Substantial Equivalence
It has been shown in this 510(k) submission that the difference between the Dynamic Gas Scavenging System 2 and the predicate device does not raise any questions regarding its safety and effectiveness. The Dynamic Gas Scavenging System 2, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.
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Conclusion
The Dynamic Gas Scavenging System 2 has similar intended use and technological characteristics as the predicate device. The Dynamic Gas Scavenging System 2 is both safe and effective for the scavenging of waste anesthetic gases from anesthesia workstations during the provision of general anesthesia to adults and children.