(111 days)
Not Found
No
The device description focuses on modifications to internal electrical components and increased power output of an existing RF electrosurgical generator. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is explicitly described for various surgical procedures involving the cutting, coagulation, and ablation of soft tissues to treat medical conditions.
No
The device description clearly states its purpose is for "resection, ablation, and coagulation of soft tissues and hemostasis" using radiofrequency energy, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly states it is a radiofrequency (RF) electrosurgical generator, which is a hardware device that produces energy for surgical procedures. It also mentions modifications to internal electrical components and an increase in power output, further 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 clearly describes surgical procedures involving the resection, ablation, and coagulation of soft tissues and hemostasis. These are direct interventions on the patient's body during surgery.
- Device Description: The device is described as a radiofrequency (RF) electrosurgical generator used for cutting and coagulation of soft tissue. This is a surgical tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a surgical instrument used in vivo (within the living body) during various surgical procedures.
N/A
Intended Use / Indications for Use
Orthopedic, arthroscopic, spinal, and neurological
For resection, ablation, and coagulation of soft tissues and hemostasis in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma. Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.
The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.
The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, Knee, shoulder, ankle, elbow, hip and wrist, skin, palatal, ear, turbinage
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)
Non-Clinical Testing:
- Electrical safety and EMC testing in accordance with AAMI ANSI ES60601-1, IEC 60601-1-2. and IEC 60601-2-2
- Usability assessment in accordance with IEC 62366
- Software verification and validation in accordance with IEC 62304 and the FDA Final Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Energy output verification of each of the five modes and comparison to predicate
- Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue
Clinical Testing:
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
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.
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
§ 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.
0
Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
May 3, 2017
Elliquence, LLC Mr. Paul Buhrke IV QA/RA Manager 2455 Grand Avenue Baldwin, New York 11510
Re: K170107
Trade/Device Name: Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 03, 2017 Received: April 04, 2017
Dear Mr. Buhrke:
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 Actinclude 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 device
1
related 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.
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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170107
Device Name
Surgi-Max Ultra (IEC6-SU170, IEC6-SV170, IEC6-SP170)
Indications for Use (Describe)
Orthopedic, arthroscopic, spinal, and neurological
For resection, ablation, and coagulation of soft tissues and hemostasis in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma. Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
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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510 (k) Summary
(As required by 21 CFR 807.92(a))
Date Prepared
May 1, 2017
Submitter's Information (807.92(a)(1))
Company Name and Address:
Elliquence, LLC 2455 Grand Avenue Baldwin, NY 11510 Phone: (516) 277-9000 Fax: (516) 277-9001 www.elliquence.com
Establishment Registration for Elliquence, LLC is 3007024186.
Contact Information:
Daniel Connell - Requlatory Affairs Associate Phone: (516) 277-9036 Fax: (516) 277-9011 Email: dconnell@elliquence.com
Paul D. Buhrke IV- QA/RA Manager Phone: (516) 277-9010 Fax: (516) 277-9011 Email: pbuhrke@elliquence.com
Device Information (807.92(a)(2))
Trade Name Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170)
Common/Usual Name Electrosurgical unit and accessories, electrosurgical cutting and coagulation device and accessories
elliquence, LLC. 2455 Grand Avenue · Baldwin, New York 11510 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com
4
Classification Name and Regulation Electrosurgical Cutting and Coagulation Device and Accessories; 21 CFR 878.4400
K170107 Page 2 of 5
Class FDA Classification: Class II FDA Product Code: GEI
Predicate Devices (807.92(a)(3))
Device Description (807.92(a)(4))
The elliquence Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is a modification to the existing Surgi-Max® / Surgi-Max® Plus (K100390) line of radiofrequency (RF) electrosurgical generators. It is a compact source of high-frequency RF energy employed for cutting and coagulation of soft tissue in a variety of surgical procedures. It is designed to enable the performance of monopolar and bipolar functions in conjunction with separatelymarketed electrosurgical accessories and ancillary equipment which have been developed by elliquence for mutually-exclusive use with the Surgi-Max® line of generators.
The Surgi-Max® Ultra (IEC6-SP170, IEC6-SU170, & IEC6-SV170) is the result of an update to internal electrical components of the Surgi-Max® / Surgi-Max® Plus. As a result of this equipment update, device design as it relates to internal electrical system framework was simplified in many respects and overall efficiency was greatly improved upon. This increase in efficiency enabled an increase in the maximum power output of the device from 120W to 170W. Aside from this increase in maximum power output, all other operational aspects of the device were conserved. The only other modifications made to the device were aesthetic in nature.
The modifications enacted do not affect the device's intended use or alter its fundamental scientific technology.
5
Intended Use (807.92(a)(5))
Orthopedic, arthroscopic, spinal, and neurological
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, sub-mucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Substantial Equivalence Comparison (807.92(a)(6))
The Surgi-Max® Ultra is substantially equivalent in both intended use and technological characteristics to the Surgi-Max® / Surgi-Max® Plus (K100390) as well as the Bovie® IDS-310 Electrosurgical Generator (K134054). An extensive comparison chart concerning key characteristics is provided on the following pages (Table 5.1).
6
Table 5.1 Substantial Equivalence Comparison Chart
| | Surgi-Max® Ultra
(K170107) - SUBJECT
DEVICE | Surgi-Max® / Surgi-Max
Plus (K100390) –
PREDICATE | Bovie® IDS-310
Electrosurgical Generator
(K134054) - PREDICATE |
|-----------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | elliquence, LLC | elliquence, LLC | Bovie Medical Corp. |
| Product code | GEI | GEI | GEI |
| Regulation
number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation
name | Electrosurgical Cutting and
Coagulation Device and
accessories | Electrosurgical Cutting and
Coagulation Device and
accessories | Electrosurgical Cutting and
Coagulation Device and
accessories |
| Indications for
use | See previous page | See previous page | The IDS-310 High
Frequency Electrosurgical
Generator is used to deliver
RF energy via an assortment
of surgical devices to cut and
coagulate different kinds of
tissue. |
| Prescription
device
(21 CFR
801.109) | Yes | Yes | Yes |
| Principle of
Operation | Conversion of electrical
energy to high-frequency RF
energy
(monopolar and bipolar) | Conversion of electrical
energy to high-frequency RF
energy
(monopolar and bipolar) | Conversion of electrical
energy to high-frequency RF
energy
(monopolar and bipolar) |
| Modes of
operation | Cut
Blend
Hemo
Bipolar
Bipolar Turbo | Cut
Blend
Hemo
Bipolar
Bipolar Turbo | 9 Monopolar and 4 bipolar
modes |
| Output
frequency | 4 MHz (monopolar)
1.7 MHz (bipolar) | 4 MHz (monopolar)
1.7 MHz (bipolar) | 350 - 490 kHz (monopolar)
490 kHz (bipolar) |
| Maximum power
output | 170W | 120W | 300W |
| Voltage
(peak-to-peak) | 1,200V | 1,600V | 8,000V |
| Duty Cycle | 10 sec On / 30 sec OFF | 10 sec On / 30 sec OFF | 10 sec On / 30 sec OFF |
| Supply input
power | 100 V AC – 240 V AC, 50/60
Hz | 100 V AC – 240 V AC, 50/60
Hz | 100 V AC – 240 V AC, 50/60
Hz |
elliquence, LLC. 2455 Grand Avenue • Baldwin, New York 11510 (516) 277.9000 • Fax: (516) 277.9001 • www.elliquence.com
7
| | Surgi-Max® Ultra
(K170107) – SUBJECT
DEVICE | Surgi-Max® / Surgi-Max
Plus (K100390) –
PREDICATE | Bovie® IDS-310
Electrosurgical Generator
(K134054) - PREDICATE |
|---------------------------------------------------|-------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------|
| Power
activation
control | Footswitch and/or
fingerswitch | Footswitch and/or
fingerswitch | Footswitch and/or
fingerswitch |
| Electrical safety
and EMC testing
standards | AAMI ANSI ES60601-1
IEC 60601-1-2
IEC 60601-2-2 | AAMI ANSI ES60601-1
IEC 60601-1-2
IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 |
| Applied part
type | CF | BF | CF |
Non-Clinical Testing (807.92(b)(1))
The modifications enacted for the Surgi-Max® Ultra were made in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation activities were planned and conducted in order to address identified risks and ensure the safety and effectiveness of the device with the modifications enacted. This testing included:
- . Electrical safety and EMC testing in accordance with AAMI ANSI ES60601-1, IEC 60601-1-2. and IEC 60601-2-2
- Usability assessment in accordance with IEC 62366
- Software verification and validation in accordance with IEC 62304 and the FDA Final . Guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Energy output verification of each of the five modes and comparison to predicate ●
- . Thermal effect comparison for representative modes of the subject device and predicate on ex-vivo bovine tissue
Clinical Testing (807.92(b)(2))
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Conclusion (807.92(b)(3))
Based upon a comparison of the intended uses, technological characteristics, and performance testing, we have concluded that the subject device is substantially equivalent to the selected predicate devices.
elliquence, LLC. 2455 Grand Avenue · Baldwin, New York 11510 (516) 277.9000 · Fax: (516) 277.9001 · www.elliquence.com