(199 days)
E1551X, E1450X
Not Found
No
The summary describes a coated electrosurgical blade and its performance characteristics compared to predicate devices. There is no mention of AI, ML, image processing, or any data-driven decision-making component within the device itself. The performance studies focus on physical properties and effects on tissue.
No.
The device is an electrosurgical accessory intended for cutting and coagulation during surgical procedures, which are interventional acts, not therapeutic in nature. The device itself does not provide therapy but facilitates a surgical procedure.
No
Explanation: The Surginetics AdvantageBlade is an electrosurgical accessory used for cutting and coagulation during surgical procedures. Its intended use and device description focus on its function in performing surgical interventions, not on diagnosing medical conditions. While performance tests involve measuring various parameters, these measurements are for evaluating the blade's efficacy in surgical procedures, not for diagnostic purposes related to a patient's health.
No
The device description clearly states it is a "coated blade intended for use as a monopolar electrosurgical accessory," which is a physical hardware component. The performance studies also involve testing the physical properties and performance of this blade.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in "conventional monopolar electrosurgical accessories" and "surgical procedures." This indicates it's used during a surgical procedure on a patient's tissue, not for testing samples outside the body.
- Device Description: The description reinforces its use as a "monopolar electrosurgical accessory" and its function in cutting and coagulation of tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's health status. The device's function is purely therapeutic/surgical.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Surginetics AdvantageBlade is intended as an alternative to uncoated stainless steel as well as coated electrodes for use in conventional monopolar electrosurgical accessories. The AdvantageBlade is intended for use in situations where monopolar electrosurgery is used.
The Surginetics AdvantageBlade™ coated electrodes are indicated for use in surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The coated electrodes are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
Product codes
GEI
Device Description
The Surginetics AdvantageBlade is a coated blade intended for use as a monopolar electrosurgical accessory. The blade reduces the smoke emitted into the surgical area, uses lower wattages with less tissue damage and the coating provides a surface that facilitates ease of cleaning of tissue residues that may accumulate during use. The coating provides for ease of eschar cleaning.
The blades are intended for use with monopolar electrosurgical accessories and will be packaged separately. The coated blades will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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
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 performed on prototype Surginetics AdvantageBlade electrodes. The configuration is representative of the range of electrodes that will be available in coated form.
Testing that adjusted the power from an electrosurgical generator (a Valleylab Force FX) until a particular blade cut effectively was used to obtain most of the performance data. This test, which is called a Titrated Power Test because it adjusts the power until effective cutting occurs, was used to determine the power level at which effective cutting occurred, the amount of delay and drag during cutting, the amount of smoke produced, the amount of eschar accumulated, and the amount of tissue damage. The tissue sample used was fresh beef liver (about six hours old). Beef liver is used because its consistency and size enables high quality comparisons.
Another test, the Insulation Penetration Test, carefully placed a sharp penetrator on the insulated surface of a coated blade and then periodically increased the load on the penetrator and measured the time until the penetrator pushed through the insulating coating and contacted the underlying metal blade.
Key Results:
- Electrode low power cutting: The Surginetics AdvantageBlade starts cutting effectively at lower power than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
- Initial delay/drag: The Surginetics AdvantageBlade produced less drag at startup than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
- Electrode smoke plume production: The Surginetics AdvantageBlade produced less smoke than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
- Electrode eschar accumulation: The Surginetics AdvantageBlade produced less eschar than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
- Tissue damage: The Surginetics AdvantageBlade produced less tissue damage than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
- Coating penetration: The Surginetics AdvantageBlade demonstrated better mechanical integrity when subjected to mechanical penetration forces than the predicate coated blades. This characteristic is not germane for uncoated blades. Refer to Table A3-2 for the test data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table A3-1 Test Results for Titrated Power Test (Lower numbers are better)
- Power when cutting started (WATTS)
- Delay/Drag Score
- Smoke Score
- Eschar Score
- Tissue Damage Score
Table A3-2 Test Results for Insulation Penetration Test (Larger numbers are better)
- Elapsed Time until Insulation Failed (Seconds)
- Final Weight Driving Penetrator (Grams)
Predicate Device(s)
Valleylab Uncoated E1551X, Valleylab Coated E1450X EDGE
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Surginetics™
4900 Pearl East Circle Suite 100 Boulder CO 80301 t: 303.339.9970 f:303.339.9969 www.surginetics.com
062350
Page 186
FEB 2 6 2007
October 12, 2006
510(k) SUMMARY
Contact Name:
Maneta Lollar, Director of Regulatory Affairs and Quality Assurance
Name of Device:
Surginetics AdvantageBlade™ Proprietary Name:
Classification Name: Electrosurgical Electrodes
Class II, Electrosurgical cutting and coagulation device and Classification: accessories, General and plastic surgery (21 CFR 878.4400)
GEI Product Code:
Intended Use
The Surginetics AdvantageBlade is intended as an alternative to uncoated stainless steel as well as coated electrodes for use in conventional monopolar electrosurgical accessories. The AdvantageBlade is intended for use in situations where monopolar electrosurgery is used.
Product Description
The Surginetics AdvantageBlade is a coated blade intended for use as a monopolar electrosurgical accessory. The blade reduces the smoke emitted into the surgical area, uses lower wattages with less tissue damage and the coating provides a surface that facilitates ease of cleaning of tissue residues that may accumulate during use. The coating provides for ease of eschar cleaning.
The blades are intended for use with monopolar electrosurgical accessories and will be packaged separately. The coated blades will also fit in currently marketed electrosurgical pencils offered by other manufacturers.
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Page 2 of 86
Statement of Substantial Equivalence
Surginetics AdvantageBlade is substantially equivalent in function and intended use to the following legally marketed devices:
- Valleylab Uncoated E1551X 1.
- Valleylab Coated E1450X EDGE 2.
For additional information see the information in Tables 1, A3-1, and A3-2.
Safety and Performance
1. Biocompatibility Testing
The biological safety of the Surginetics AdvantageBlade has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. The components of the blades have incidental short term contact with patient tissues at the surgical site.
Performance Testing 2.
Performance testing was performed on prototype Surginetics AdvantageBlade electrodes. The configuration is representative of the range of electrodes that will be available in coated form.
Testing that adjusted the power from an electrosurgical generator (a Valleylab Force FX) until a particular blade cut effectively was used to obtain most of the performance data. This test, which is called a Titrated Power Test because it adjusts the power until effective cutting occurs, was used to determine the power level at which effective cutting occurred, the amount of delay and drag during cutting, the amount of smoke produced, the amount of eschar accumulated, and the amount of tissue damage. The tissue sample used was fresh beef liver (about six hours old). Beef liver is used because its consistency and size enables high quality comparisons.
Another test, the Insulation Penetration Test, carefully placed a sharp penetrator on the insulated surface of a coated blade and then periodically increased the load on the penetrator and measured the time until the penetrator pushed through the insulating coating and contacted the underlying metal blade.
- Electrode low power cutting �
The Surginetics AdvantageBlade starts cutting effectively at lower power than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data.
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Ko62350
Page 3 of 6
-
Initial delay/drag .
The Surginetics AdvantageBlade produced less drag at startup than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data. -
Electrode smoke plume production ●
The Surginetics AdvantageBlade produced less smoke than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data. -
Electrode eschar accumulation ●
The Surginetics AdvantageBlade produced less eschar than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data. -
Tissue damage ●
The Surginetics AdvantageBlade produced less tissue damage than the predicate uncoated and coated blades. Refer to Table A3-1 for the test data. -
Coating penetration ●
The Surginetics AdvantageBlade demonstrated better mechanical integrity when subjected to mechanical penetration forces than the predicate coated blades. This characteristic is not germane for uncoated blades. Refer to Table A3-2 for the test data.
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Rayfe 4 ofb
| Table A3-1
Test Results for Titrated Power Test
| (Lower numbers are better) | |||||
|---|---|---|---|---|---|
| Power when | |||||
| cutting | |||||
| started | |||||
| (WATTS) | Delay/Drag | ||||
| Score | Smoke Score | Eschar Score | Tissue | ||
| Damage | |||||
| Score | |||||
| Valleylab | |||||
| E1551X | |||||
| (uncoated) | |||||
| Blade #1 | 15 | 60 | 48 | 48 | 46 |
| Blade #2 | 15 | 10 | 45 | 42 | 46 |
| Blade #3 | 15 | 10 | 45 | 42 | 46 |
| Mean | 15 | 27 | 46 | 44 | 46 |
| Valleylab | |||||
| E1450X | |||||
| EDGE | |||||
| (coated) | |||||
| Blade #1 | 25 | 200 | 49 | 52 | 46 |
| Blade #2 | 20 | 50 | 40 | 30 | 46 |
| Blade #3 | 20 | 70 | 35 | 25 | 46 |
| Mean | 21.7 | 107 | 41 | 36 | 46 |
| Surginetics | |||||
| Advantage | |||||
| Blade | |||||
| Blade #1 | 10 | 5 | 0 | 1 | 0 |
| Blade #2 | 5 | 7 | 0 | 0 | 0 |
| Blade #3 | 5 | 12 | 0 | 0 | 0 |
| Mean | 6.667 | 8 | 0 | 0 | 0 |
Some of the differences in the test results are large enough that it may appear that errors exist. That is not the case. Noticeable differences exist in the results. For example, the Delay/Drag score for Valleylab E1450X EDGE Blade #1 is 200 because that blade had more drag during both of the cuts made with it. Similarly, both Valleylab blades
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Page 5 of 6
produced clouds of smoke and caused tissue damage (dark brown cooked tissue appearance) and the AdvantageBlade devices did not produce any smoke and left the tissue looking as if it had been cut with a sharp steel scalpel. Similar differences were noted in the Eschar scores.
The Delay/Drag scores for the AdvantageBlade electrodes are low because the blades gave the distinct impression of gliding through the tissue. The other blades produced delays at the start of cutting or dragged, or both.
| Table A3-2
Test Results for Insulation Penetration Test
| (Larger numbers are better) | |||
|---|---|---|---|
| Elapsed Time until | |||
| Insulation Failed | |||
| (Seconds) | Final Weight Driving | ||
| Penetrator | |||
| (Grams) | Comments | ||
| Valleylab | |||
| E1450X | |||
| EDGE | |||
| (coated) | |||
| Blade #1 | 0.1 | 7.33 | Failed immediately |
| Blade #2 | 0.1 | 7.33 | Failed immediately |
| Blade #3 | 0.1 | 7.33 | Failed immediately |
| Mean | 0.1 | 7.33 | |
| Std. | |||
| Dev. | 0 | 0 | |
| Surginetics | |||
| Advantage | |||
| Blade | |||
| Blade #1 | 200-stopped test | 83 | Never failed |
| Blade #2 | 200-stopped test | 83 | Never failed |
| Blade #3 | 200-stopped test | 83 | Never failed |
| Mean | 200-stopped test | 83 | |
| Std. | |||
| Dev. | 0 | 0 |
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Page 686
The insulation penetration tests were carried out with meticulous care when the penetrator (an 18 gauge x 1.5 inch Monoject needle) was placed on the surface of the insulation of each blade. For example, the test fixture was configured so that it was never moved after the needle was positioned on the blade. This technique was used to prevent vibrating or otherwise causing motions that would induce the tip of the needle to work its way into the insulation and toward the metal portion of the blade. In spite of this great care, all of the Valleylab E1450X EDGE blades failed as soon as the tests started. The test results show the time being 0.1 seconds. That is the shortest time interval that the apparatus can measure. The weight of the needle and container above it that accumulates weight during the test run is 7.3 grams. Therefore, a time to failure of 0.1 seconds and a weight of 7.3 grams means that the needle's tip with no added weight penetrated the insulation within the few seconds it took to place the penetrator on the blade's surface and start the timer.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surginetics % Ms. Maneta Lollar Director, Regulatory Affairs and Quality Assurance 4900 Pearl East Circle Suite 100 Boulder, Colorado 80301
FEB 2 6 2007
Re: K062350
Trade/Device Name: Surginetics AdvantageBlade™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 9, 2007 Received: February 12, 2007
Dear Ms. Lollar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
7
Page 2 - Ms. Maneta Lollar
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Melkan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Kob 2350
Indications for Use
510(k) Number (if known): Not assigned at this time.
Device Name: Surginetics AdvantageBlade™
Indications For Use:
The Surginetics AdvantageBlade™ coated electrodes are indicated for use in surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The coated electrodes are an alternative to conventional monopolar electrosurgical electrodes used for these indications.
Prescription Use X (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)
Mark A. Milken
(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative,
Division of General, Devices Division of General Devices
and Neurological Devices V ( 510(k) Number_
510(k) Num