(117 days)
No
The summary describes a standard electrosurgical generator with integrated smoke evacuation and does not mention any AI or ML capabilities.
Yes
The device is described as an electrosurgical generator intended for cutting and coagulating tissues, which are therapeutic actions. It also integrates smoke evacuation for surgical procedures.
No
The device is an electrosurgical generator used for cutting and coagulating tissues and for smoke evacuation during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is an "electrosurgical generator containing an integrated surgical smoke evacuator" and describes hardware components like output modes, power ranges, and a dedicated footswitch.
Based on the provided information, the SafeAir Combi is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering high frequency energy for cutting and/or coagulating tissues and removing surgical smoke during surgical procedures. This is a direct interaction with the patient's body for therapeutic and procedural purposes.
- Device Description: The description reinforces its use in operating theatres for general surgical procedures, involving electrosurgical modes and smoke evacuation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SafeAir Combi does not perform any such analysis of biological specimens.
The SafeAir Combi is an electrosurgical generator with integrated smoke evacuation, which is a type of surgical device used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI, FYD
Device Description
SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories.
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
Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.
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 performance testing:
- Electrical Safety: Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
- Bench / Performance Testing: Comparative performance testing included: Human factors testing, Transportation simulation, Smoke evacuation functionality, Testing in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" (Thermal effects on tissue, ESU performance, COM functionality, Accessories compatibility). The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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April 26, 2023
LiNA Medical ApS % Scott Blood Director of Regulatory Services MEDIcept. Inc. 200 Homer Ave Ashland, Massachusetts 01721
Re: K223932
Trade/Device Name: SafeAir combi (SFR-combi-US) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, FYD Dated: December 28, 2022 Received: March 30, 2022
Dear Scott Blood:
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.
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
1
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 medical devices and radiation-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,
Digitally signed by Mark Mark Trumbore -S Date: 2023.04.26 14:06:27 Trumbore -S -04'00 Mark Trumbore, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
SafeAir combi (SFR-combi-US)
Indications for Use (Describe)
The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "LINA" in red, with a black dot above the "i". To the right of the word is a red target symbol. The target symbol is made up of two concentric circles, with a vertical and horizontal line intersecting at the center. The overall design is simple and modern.
Date:
Company:
April 26, 2023
LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Jarosław Mrówczyński Regulatory Affairs Manager Email: imr@lina-medical.com Office number: +48 61 222 21 21
Official Contact:
Scott Blood Director of Regulatory Services MEDIcept Inc. 200 Homer Avenue Ashland, MA 01721 Email: SBlood@medicept.com Office number: +1 978-729-5978
Proprietary or Trade Name: SafeAir combi
| Common/Usual Name: | Electrosurgical cutting and coagulation device and accessories |
|---|---|
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | 21 CFR 878.4400, Class II |
| Classification Product Code: GEI, FYD | |
| Predicate Device: | |
| Reference Predicate: | K143161: Covidien Force FX Generators |
| K182224: LiNA Medical Smoke Evacuator compact |
Device Description:
SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.
Formervangen 5
4
Image /page/4/Picture/0 description: The image shows the word "LiNA" in red, with the "i" in "LiNA" having a black dot above it. To the right of the word "LiNA" is a red target symbol. The target symbol has a dot in the center, and two curved lines around the dot.
Indications for Use:
The SafeAir Combi generator is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.
Substantial Equivalence:
| | Subject Device
LiNA Medical | Predicate Device
Covidien | Reference device
LiNA Medical | Comparison |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| | SafeAir Combi | Force FX Generators | SafeAir Smoke
Evacuator compact | |
| | This Submission | K143161 | K182224 | |
| Indications for
Use | The SafeAir Combi generator
is an electrosurgical generator
containing an integrated
surgical smoke evacuator. The
unit is intended to deliver high
frequency energy for cutting
and/or coagulating tissues
using monopolar and bipolar
tools in surgical procedures.
When used with an
electrosurgical pencil capable
of surgical smoke evacuation,
the console is also intended to
remove and filtrate smoke
generated during
electrosurgical procedures | The Force FX™
Electrosurgical
Generator is an
electrosurgical
generator containing
monopolar and bipolar
technology. It is
intended for use with
accessories during
surgical procedures
where the surgeon
requires electrosurgical
cutting (resecting,
dividing, or separating)
and coagulating
(hemostasis). | SafeAir Smoke Evacuator
compact is designed to
remove and filter smoke
generated during
electrosurgical and laser
procedures. | Same with
predicate device,
reference device |
| | Subject Device
LiNA Medical
SafeAir Combi
This Submission | Predicate Device
Covidien
Force FX Generators
K143161 | Reference device
LiNA Medical
SafeAir Smoke
Evacuator compact
K182224 | Comparison |
| Input power | 110 - 230 V, 50-60 Hz | 100 - 240 V, 50-60 Hz | 100-120V/220-240V,
50Hz/60Hz | Similar |
| Energy output | HF energy for electrosurgery | HF energy for
electrosurgery | Not applicable | Identical |
| Dimensions and
weight | 17 x 40 x 40 cm, 22 kg | 11 x 35.6 x 35.6 cm, 8.2
kg | 14 x 30 x 38, 13.5 kg | Different |
| Working
conditions | Temperature: 10 to 35 °C
Relative Humidity: 15-75%,
non-condensing
Atmospheric Pressure: 800 to
1060 hPa | Temperature: 10 to 40
°C
Relative Humidity: 30-
75%
Atmospheric Pressure:
700 to 1060 hPa | Temperature: 10 to 35 °C
Relative Humidity: 30%-
75%, non-condensing
Atmospheric Pressure: n/a | Similar |
| Transport and
storage | Circumstance Temperature: -
10°C to +60°C
Relative Humidity: 10% to
90%
Atmospheric Pressure: 500 to
1060 hPa | Circumstance
Temperature: -40 to +70
°C
Relative Humidity: 25-
85 %
Atmospheric Pressure:
500 to 1060 hPa | Circumstance
Temperature: -10 to 60 oC
Relative Humidity: 25-
85% non-condensing
Atmospheric Pressure: n/a | Similar |
| Display | One LCD touchscreen min. 7
inch diagonal | No touchscreen, buttons
for power settings | No touchscreen, buttons
for power settings | Different |
| Electrical
protective class | Class I | Class I | Class I | Identical |
| Duty cycle | 25% on max power (10s
activation and 30s off) | 25% on max power (10s
activation and 30s off) | Not applicable | Identical |
| CQM | Acceptable resistance range
(for monopolar activation):
- 10 to 130 Ohms
- or up to a 30% increase in the
initial measured contact
resistance
(whichever is less) | Acceptable resistance
range (for monopolar
activation): - 5 to 135 Ohms
- or up to a 40%
increase in the initial
measured contact
resistance
(whichever is less) | Not applicable | Different |
| Monopolar | ESU generator connects its
electrosurgical accessories and
a neutral ESU pad to form a
cyclic circuit, the HF current
generated from the generator
and through the accessory to
achieve CUT or COAG, and
then return to generator by the
neutral pad. | ESU generator connects
its electrosurgical
accessories and a
neutral ESU pad to
form a cyclic circuit, the
HF current generated
from the generator and
through the accessory to
achieve CUT or COAG,
and then return to
generator by the neutral
pad. | Not applicable | Identical |
| Bipolar | HF current generated from the
generator and the cyclic circuit
formed between the two tips of
the bipolar forceps, the HF
power through the two tips to
work on patient obtaining
COAG, no need extra ESU
pad. | HF current generated
from the generator and
the cyclic circuit formed
between the two tips of
the bipolar forceps, the
HF power through the
two tips to work on
patient obtaining
COAG, no need extra
ESU pad. | Not applicable | Identical |
| Subject Device
LiNA Medical
SafeAir Combi
This Submission | Predicate Device
Covidien
Force FX Generators
K143161 | Reference device
LiNA Medical
SafeAir Smoke
Evacuator compact
K182224 | Comparison | |
| Output mode
MONOPOLAR | 2 Different CUT modes
CUT Pure: - Power: 200 W max,
- Rated load (max): 400 Ω,
- Crest factor: 1.5
- Frequency: 472 kHz
CUT Blend: - Power: 200 W max,
- Rated load (max): 400 Ω,
- Crest factor: 2.1
- Frequency: 472 kHz | 3 Different CUT modes
including
CUT Pure with
following parameters: - Power: 300W max
- Rated load: 300 Ohm
- Crest Factor: 1.5
- Frequency: 390 kHz
and CUT Blend with
following parameters: - Power: 200W max
- Rated load: 300 Ohm
- Crest Factor: 2.5
- Frequency: 390 kHz | Not applicable | Different |
| | 2 Different COAG modes
COAG Fulg: - Power: 120 W max,
- Rated load (max): 400 Ω,
- Crest factor: 6.6
- Frequency: 472 kHz
COAG Spray: - Power: 120 W max,
- Rated load (max): 400 Ω,
- Crest factor: 7.5
- Frequency: 472 kHz | 4 Different COAG
Modes, including
COAG Fulgurate with
following parameters: - Power: 120W max
- Rated load: 500 Ohm
- Crest Factor: 7.0
- Frequency: 470 kHz
COAG Spray with
following parameters: - Power: 120W max
- Rated load: 500 Ohm
- Crest Factor: 8.0
- Frequency: 470 kHz | Not applicable | |
| Output mode –
Bipolar | BIPOLAR: - Power: 100 W max,
- Rated load (max): 100 Ω,
- Crest factor: 1.6
- Frequency: 472 kHz | 3 Different BiPolar
modes, including
BIPOLAR Standard
with following
parameters: - Power: 70W max
- Rated load: 100 Ohms
- Crest factor: 1.5
- Frequency: 470 kHz | Not applicable | Different |
| Instant response
technology | Automatically senses resistance
and adjusts the output voltage
to maintain a consistent effect
across different tissue density | Automatically senses
resistance and adjusts
the output voltage to
maintain a consistent
effect across different
tissue density | Not applicable | Similar |
| Power ON self
diagnostics | After pressing ON/OFF button,
device initiates self testing
procedure, which verifies
correct functioning of the
device. If problems occur, then
alarm condition is highlighted
on screen, and generator cannot
be activated. | When the generator
senses a system alarm
conditions, an alarm
sounds and an alarm
number is displayed on
the front panel. A
system alarm condition
deactivates the | Not applicable | Similar |
| | Subject Device
LiNA Medical
SafeAir Combi
This Submission | Predicate Device
Covidien
Force FX Generators
K143161 | Reference device
LiNA Medical
SafeAir Smoke
Evacuator compact
K182224 | Comparison |
| Filtration rate | The ULPA filter is 99.999%
with efficiency at 0.1 microns
particle size, SFR-FIL-C filter | Not applicable | The ULPA filter is
99.999% with efficiency
at 0.1 microns particle
size, SFR-FIL-C filter | Identical to
reference device |
| Filter Life | 5 hours | Not applicable | 5 hours | Identical to
reference device |
| Levels of smoke
evacuation | 10 levels | Not applicable | 10 levels | Identical to
reference device |
| Levels of smoke
evacuation stop
delay | 10 levels | Not applicable | 10 levels | Identical to
reference device |
| Maximum flow
rate at filter
(claimed in IFU) | 110 l/min | Not applicable | 110 l/min | Identical to
reference device |
| Maximum flow
rate measured on
pencil tip | 94,2 l/min | Not applicable | 97,8 l/min | Similar to
reference device |
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ಿ ಸ
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Image /page/7/Picture/0 description: The image shows the logo for LINA, which is written in red letters. The "i" in LINA has a black dot above it. To the right of the word LINA is a red target symbol. The target symbol has a vertical line going through the center of it.
From the comparison above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle. The differences in the devices have been assessed and do not raise new questions of safety or effectiveness.
Non-clinical performance testing:
Electrical Safety:
Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Bench / Performance Testing:
Comparative performance testing included:
- Human factors testing
- Transportation simulation
- Smoke evacuation functionality
- Testing in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions ● for Electrosurgical Devices for General Surgery"
- Thermal effects on tissue 0
- ESU performance O
- COM functionality ol
- Accessories compatibility O
The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.
Substantial Equivalence Conclusion
LiNA Medical AnS
· Formervangen 5
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The subject device and predicate device are intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. The smoke evacuation function is not a novel feature and there are several cleared devices already used in the US today. Smoke evacuation is recommended to be used in clinical procedures such as electrosurgery in which tissue smoke plume and aerosols can be generated due to concerns about potential carcinogenic effects.
The technological characteristics between the subject and predicate devices are in most cases identical, for those cases where they are similar or different, those differences have been properly tested and evaluated. Design Verification and Validation activities carried out on the SafeAir combi device confirms that device meets specification and performs as intended.
Based on above comparison and discussion, the SafeAir Combi is deemed as safe and effective as and substantially equivalent to the predicate device.