(395 days)
K11093, K150134
K11093, K150134
No
The device description and performance studies focus on the mechanical and electrical aspects of a vacuum pump, with no mention of AI or ML capabilities.
No
The device is described as a waste gas evacuation apparatus intended to remove exhaled waste gases, rather than to administer therapy or directly treat a patient's condition.
No
The device is described as a "waste gas evacuation apparatus" whose purpose is to remove exhaled waste gases. It is a vacuum pump that is used with nitrous oxide/oxygen delivery equipment. There is no indication that it diagnoses any medical condition.
No
The device description clearly states it is a "small, portable, vacuum pump" and describes its physical components and function, indicating it is a hardware 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 remove exhaled waste gases from patients during procedures involving nitrous oxide/oxygen analgesia. This is a function related to patient care and environmental safety within a healthcare setting, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a vacuum pump designed to connect to nitrous oxide/oxygen delivery equipment to scavenge waste gases. This mechanical function is not related to analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on sample analysis
The device's function is purely related to managing waste gases generated during a medical procedure. This falls under the category of general medical devices used in patient care environments.
N/A
Intended Use / Indications for Use
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
Product codes
CBN, BTA
Device Description
The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.
The MINISCAVTM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use only in healthcare facilities, clinics, and physician and dentist offices.
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)
Non-Clinical Testing Summary:
- AAMI/ANSI/ES60601-1 for electrical safety
- IEC 60601-1-2 for EMC
- Durability:
- Continuous running demonstrated that the vacuum pump stays within its specifications for at least 10,000 hours
- Real-time testing of the complete unit supports that the device meets its performance specifications after 2 years use
- Vacuum and Flow testing:
- Testing demonstrates that the device provides a constant vacuum of
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Sedation Systems LLC % Paul Dryden Consultant, Promedic LLC 2471 McMullen Booth Rd., Ste. 316 Clearwater, Florida 33759
Re: K160950
Trade/Device Name: MINISCAVTM Regulation Number: 21 CFR 868.5430 Regulation Name: Gas-Scavenging Apparatus Regulatory Class: Class II Product Code: CBN, BTA Dated: April 27, 2017 Received: May 1, 2017
Dear Paul Dryden:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K160950
Device Name
MINISCAVTM
Indications for Use (Describe)
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (8/14)
Page 1 of 1
EF PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
Sedation Systems LLC 2471 McMullen Booth Rd., Suite 316 Clearwater, FL 33759
Tel – 888-959-5288
| Official Contact: | S. Michael Bender, Managing Member |
|---|---|
| Proprietary or Trade Name: | MINISCAV™ |
| Common/Usual Name: | Apparatus, Gas Scavenging |
| Classification Name / | |
| Product Classification | Apparatus, Gas Scavenging |
| CBN, 21CFR 868.5430, Class II | |
| Predicate Devices: | G. Dundas, Active Waste Gas Scavenger System, K11093 |
| Medela, Dominant Flex Suction Pumps, K150134 |
Device Description:
The MINISCAV™ is a small, portable, vacuum pump that generates a constant vacuum that can be connected via a standard flexible vacuum hose to nitrous oxide / oxygen delivery equipment. The vacuum hose is connected to the "vacuum / suction" nipple on exemplary equipment.
Indications for Use:
The MINISCAV™ waste gas evacuation apparatus is intended to remove patients' exhaled waste gases during procedures where analgesia is administered to a patient via inspiration of mixtures of nitrous oxide and oxygen from a nitrous oxide / oxygen delivery device. Not intended for use with flammable anesthetic gases.
This device is intended for professional use only in healthcare facilities, clinics, and physician and dentist offices.
| Feature | Predicate
G. Dundas
Active Waste Gas
Scavenger System
K110930 | Predicate
Medela
Dominant Flex
Suction Pumps
K150134 | Proposed
MINISCAVTM |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | CBN
CFR 868.5430
Gas scavenging
apparatus
Class II | BTA
CFR 878.4780
Powered suction pump
Class II | CBN
CFR 868.5430
Gas scavenging apparatus
Class II |
| Indications for Use | The Waste Gas
Scavenger is designed
for use with vacuum
(suction) waste gas
disposal systems with
anesthesia machines
and heart/lung bypass | The Dominant Flex
Suction Pump is
indicated for vacuum
extraction, aesthetic
body contouring,
aspiration during
flexible endoscopy, and | The MINISCAVTM waste
gas evacuation apparatus
is intended to remove
patients' exhaled waste
gases during procedures
where analgesia is
administered to a patient |
Table 1 Substantial equivalence Comparison to Predicates
4
510(k) Summary 5-May-17
Page 2 of 4
| Page 2 of 4 | |||
|---|---|---|---|
| machines. | aspiration and removal | ||
| of surgical fluids, tissue | |||
| (including bone), gases, | |||
| bodily fluids or | |||
| infectious materials | |||
| from wounds or from a | |||
| patient's airway or | |||
| respiratory support | |||
| system either during | |||
| surgery or at the beside. | via inspiration of | ||
| mixtures of nitrous oxide | |||
| and oxygen from a | |||
| nitrous oxide / oxygen | |||
| delivery device. Not | |||
| intended for use with | |||
| flammable anesthetic | |||
| gases. | |||
| This device is intended | |||
| for professional use only | |||
| in healthcare facilities, | |||
| clinics, and physician and | |||
| dentist offices. | |||
| Environment of Use | Healthcare facilities, | ||
| clinics and physician | |||
| and dentist offices. | Healthcare facilities | ||
| and clinics | |||
| Used with flammable | |||
| anesthetic gases | No | No | No |
| Requires a vacuum | |||
| source | Yes, connects to any | ||
| vacuum source | |||
| Central supply / wall / | |||
| Portable pump | Portable vacuum source | Portable vacuum source | |
| to connect to a waste gas | |||
| scavenging apparatus to | |||
| supply the vacuum source | |||
| Means of connection | A flexible vacuum hose | ||
| from the device to the | |||
| vacuum source | Connects a flexible | ||
| hose from this pump to | |||
| any device requiring a | |||
| vacuum source, i.e., gas | |||
| scavenging apparatus | Connects a flexible hose | ||
| from this pump to a gas | |||
| scavenging apparatus | |||
| Fittings | 19 mm | ||
| Hose barb for vacuum | Hose barb for vacuum | 19 mm | |
| Hose barb for vacuum | |||
| Vacuum pressures | |||
| Flow rate | Can accept a range of | ||
| applied vacuum as it no | |||
| range limit specified | Up to -700 mmHg | 90 mmHg | |
| 42 Lpm +/- 5 Lpm | |||
| Connects to a nitrous | |||
| oxide/ oxygen flowmeter | |||
| exhaust port | |||
| Technology | Passive device which | ||
| requires connection to a | |||
| vacuum source | Piston / cylinder design | ||
| Portable | Diaphragm design | ||
| Portable |
Substantial Equivalence Discussion -
Table 1 above compares the key features of the proposed MINISCA V™ with the identified predicate and reference to demonstrate that the proposed device can be found to be substantially equivalent.
Indications for Use -
While the indications for use are not identical to that of the predicate device (K110930), the subject device and Dundas predicate are intended to remove waste gases from anesthesia gas machine system..
Discussion - The MINISCAV™ is one part of a waste gas scavenging system. The parts include: (1) a scavenger to titrate exhaust gas flow from the patient circuit, which is connected to (2) a vacuum source. This device is intended to scavenge gas, which the same as the intended use of the predicate Dundas scavenger.
Technology, Construction, Performance -
5
The MINISCAVIM is a diaphragm hermetically sealed pump with a fixed vacuum flow rate. The inlet line is connected to a flowmeter exhaust port of the nitrous oxide / oxygen delivery equipment which has an exhaust port for scavenging gases. The Dundas scavenger (K110930) is a flowmeter that titrates exhaust flow with wall-supplied vacuum sources. While the Dundas scavenger does not supply the vacuum, both the MINISCAV and Dundas devices validate the ability to expel gases at specified vacuum pressures, mitigating risks associated with failure to vacuum. Therefore, the MINISCAV™ does not raise different concerns of safety or effectiveness for substantial equivalence.
The Medela Dominant Flex Suction Pump (K150134) is pump with an adjustable vacuum flow as high as -700 mmHg. The Medela includes indications to remove gases from respiratory support svstems, which the MINISCAV also performs by providing vacuum via a separate gas scavenger, Therefore, both devices are validated for vacuum specifications. Although different technologies (vacuum range -700mmHg compared to -90mmHg) exist, these differences do not raise different questions of safety and effectiveness.
Environment of Use -
The environments of use are similar to the predicate Medela Dominant Flex Suction Pump (K150134) and the Dundas Active Waste Gas Scavenger System (K110930).
Discussion - As the environments of use are similar to the predicate they should be considered substantially equivalent.
Non-Clinical Testing Summary -
We performed testing which evaluated:
- AAMI/ANSI/ES60601-1 for electrical safety ●
- IEC 60601-1-2 for EMC ●
- Durability ●
- o Continuous running demonstrated that the vacuum pump stays within its specifications for at least 10,000 hours
- Real-time testing of the complete unit supports that the device meets its O performance specifications after 2 years use
- . Vacuum and Flow testing
- Testing demonstrates that the device provides a constant vacuum of