(266 days)
No
The summary describes a standard electrosurgical device with a smoke evacuation attachment. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The "adaptive" nature of the smoke evacuation likely refers to its physical design or connection method, not an intelligent system.
Yes
This device is intended for cutting and coagulation of tissue during general surgical procedures, which are therapeutic actions.
No
The device is a monopolar RF device indicated for cutting and coagulation of tissue and for removing smoke, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly states it is a "single use, sterile, electrosurgical device with a light and adaptive smoke evacuation attachment" and includes physical components like an electrode, shaft, handle, and cable. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery." This describes a device used on the patient's body during surgery, not a device used to test samples from the body (in vitro).
- Device Description: The description details a surgical tool with an electrode, light, and smoke evacuation attachment. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PhotonBlade® with Adaptive Smoke Evacuation is a surgical instrument used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The PhotonBlade® with Adaptive Smoke Evacuation (PB2SE) is a single use, sterile, electrosurgical device with a light and adaptive smoke evacuation attachment.
The device has a monopolar electrode at the distal tip, which delivers Radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The adaptive smoke evacuation attachment connects to the telescoping shaft and the cable of the PhotonBlade. It incorporates a barb connector at the end of the tubing to allow connection to a secondary suction hose connected to a smoke evacuation system. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.
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 conducted on the PB2SE to demonstrate compliance with the product requirements, safety and effectiveness, and substantial equivalence to the predicate.
The following product performance tests were completed; biocompatibility, performance testing, and electrical safety/electromagnetic compatibility.
Biocompatibility: Per the "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," (FDA guidance, June 2016) and ISO 10993-1:2009/(R)2013, the device falls into the category external communicating device, tissue contact, less than 24- hour duration. The only new contacting material introduced with the subject device is the smoke evacuation tubing. Biocompatibility testing was performed on the material and confirmed to be biocompatible for its intended use.
Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety testing and EMC testing were conducted per IEC 60601-1:2005 + A1:2012 with US deviation, IEC 60601-2-2:2017 (6th Edition) and IEC 60601-1-2:2014 (4thEdition), and AIM 7351731 Rev 2.00 standards. The device complies with the relevant sections of the standards.
Mechanical and Functional Testing: Mechanical and functional testing were performed on conditioned samples (EtO sterilization, distribution simulation, and 24 months accelerated aging) to confirm design inputs. The results confirm the product meets the specifications and acceptance criteria.
Smoke Evacuation: No standard requirements specific to the smoke performance exist, however, tests were conducted with the device to verify the device meets the design requirements, performance specifications, and intended use. The design of the smoke evacuation attachment does not affect or change the function of the electrosurgical device. The smoke evacuation flow rate was evaluated and compared between the PB2SE and the reference device PEAK PlasmaBlade 3.0S, demonstrating equivalent or better flow rate. The intake portion of the device did not obstruct the electrosurgical function of the pencil, while removing smoke. The results demonstrate the product is safe, effective, and meets the requirements for technology, performance and intended use.
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.
March 6, 2020
INVUITY, INC. c/o Ms. Susanne Galin Stryker Instruments Principal Regulatory Affairs Specialist 444 De Haro Street San Francisco, California 94107
Re: K191583
Trade/Device Name: PhotonBlade with Adaptive Smoke Evacuation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 5, 2020 Received: February 6, 2020
Dear Susanne Galin:
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
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.
Long H. Chen 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K191583
Device Name
PhotonBlade® with Adaptive Smoke Evacuation
Indications for Use (Describe)
The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
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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3
5 510(k) Summary
Date Prepared: 05 March 2020
5.1 Regulatory authority
This 510(k) Summary is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92
5.2 Company name:
INVUITY, INC. 444 De Haro Street San Francisco, CA 94107
5.3 Contact person:
Susanne Galin, RAC Principal Regulatory Affairs Specialist Stryker Instruments, on behalf of: Invuity, Inc. 444 De Haro Street San Francisco, CA 94107 susanne.galin@stryker.com Phone: (269) 800-1041
5.4 Name of device
| Trade Name: | PhotonBlade® with Adaptive Smoke Evacuation |
|---|---|
| Common Name: | Electrosurgical Cutting and Coagulation Device |
| Device Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories (21 |
| CFR 878.4400) | |
| Device Panel: | General and Plastic Surgery |
| Device Classification: | Class II |
5.5 Predicate device:
- PhotonBlade® (K162053)
Reference devices:
- Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil (K160693) ●
- Medtronic PEAK PlasmaBlade 3.0S (K093695)
4
5.6 Device modifications:
Subject device modifications without change to fundamental scientific technology and intended use;
- . Changes to the internal components and external components of the telescoping shaft and electrode to improve the electrical insulation
- Update to PCBA LED driver circuit component to reduce susceptibility to RF interference, resulting in a more consistent illumination function
Device modification with change to fundamental scientific technology and intended use;
- . The proposed device incorporates an Adaptive Smoke Evacuation component
5.7 Device description
The PhotonBlade® with Adaptive Smoke Evacuation (PB2SE) is a single use, sterile, electrosurgical device with a light and adaptive smoke evacuation attachment.
The device has a monopolar electrode at the distal tip, which delivers Radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The adaptive smoke evacuation attachment connects to the telescoping shaft and the cable of the PhotonBlade. It incorporates a barb connector at the end of the tubing to allow connection to a secondary suction hose connected to a smoke evacuation system. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.
5.8 Indications for Use Statement
The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
5.9 Comparison of Technological Characteristics
The predicate for the PB2SE electrosurgical pencil portion of the device has been identified as the previously cleared PhotonBlade® (K162053). The pencils utilize monopolar RF energy for cutting and coagulation via an insulated metal electrode. Both pencils share the same technological characteristics, operating principles and performance characteristics.
The Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil (K160693) has been identified as a reference device for the smoke evacuation portion of the PB2SE. The reference ESEP pencil is used to demonstrate that the addition of a smoke evacuation function to the PB2SE electrosurgical pencil is established in a similar manner. Both electrosurgical pencils incorporate a smoke channel to remove the smoke produced from general surgical procedures utilizing electrosurgical cutting and coagulation. Both require suction from an independent smoke evacuation system to remove smoke. The devices have the same
5
K191583
intended use and similar technological characteristics. Additionally, the Medtronic PEAK PlasmaBlade 3.0S (another RF monopolar electrosurgical pencil with integrated smoke evacuation tubing) is referenced as it has similar dimensions of smoke evacuation tubing.
| Attribute | Invuity
PhotonBlade® with
Adaptive Smoke
Evacuation
(PB2SE)
Subject Device | Invuity
PhotonBlade (PB1)
(K162053)
Predicate | Stryker® Neptune® E-
SEP Smoke Evacuation
Pencil (E-SEP)
(K160693)
Reference | Medtronic PEAK
PlasmaBlade
3.0S
(K093695)
Reference |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | | |
| Indications for
Use | The PhotonBlade®
with Adaptive
Smoke Evacuation is
a monopolar RF
device coupled with
illumination that is
indicated for cutting
and coagulation of
tissue during
general surgical
procedures and for
removing smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system. | The Photonblade is
a monopolar RF
device coupled
with illumination
that is indicated for
cutting and
coagulation of
tissue during
general surgical
procedures. | The Neptune E-SEP is
an Integrated Smoke
Evacuation Pencil
(pencil) designed for
general electrosurgical
applications including
cutting and
coagulation, and for
removing smoke
generated by
electrosurgery when
used in conjunction
with an effective
smoke evacuation
system. The pencil
enables the operator
to remotely conduct an
electrosurgical current
from the
output connector of an
electrosurgical unit
(generator) to the
operative site for the
desired surgical effect. | The PEAK
PlasmaBlade is
indicated for
cutting and
coagulation of
soft tissue during
general, plastic,
and
reconstructive
(including but
not limited to
skin incisions
and
development of
skin flaps), ENT,
gynecologic,
orthopaedic,
arthroscopic,
spinal, and
neurological
procedures. |
| Principal of
Operation | RF Monopolar
electrosurgical
cutting and
coagulation | RF Monopolar
electrosurgical
cutting and
coagulation | N/A - comparing to
PB1 predicate | N/A - comparing
to PB1 predicate |
| Method of
Operation | Push-Button
activation of
electrosurgical
energy. | Push-Button
activation of
electrosurgical
energy, smoke
evacuation
controlled by a
smoke evacuation
unit. | | |
| Electrode | Stainless steel with insulating enamel | Stainless steel with insulating enamel | | |
| Illumination Function | | | | |
| Illumination Source | LED | LED | N/A - comparing to PB1 predicate | N/A - comparing to PB1 predicate |
| Nominal Light Output | 29 Lumens | 28 Lumens | | |
| Light Color | White | White | | |
| Smoke Evacuation Function | | | | |
| Mode of Operation | Commercially available smoke evacuation unit or suction/vacuum source | N/A - comparing to E-SEP reference | Commercially available smoke evacuation unit or suction/vacuum source | Commercially available smoke evacuation unit or suction/vacuum source |
| Smoke Evacuation Design | Adaptive - tubing can be adjusted proximally or distally and is attached alongside the telescoping shaft, handpiece, and cord. Barb connector at the proximal end of the adaptive smoke tubing mates to a tube or hose connected to a suction source | | Integrated - smoke evacuation channel integrated into the shaft of the pencil, extending off proximal end of pencil and to the suction source | Integrated - smoke evacuation channel integrated into the shaft of the pencil. Barb connector at the proximal end of the adaptive smoke tubing mates to a tube or hose connected to a suction source |
| Tube Dimensions | Inner Diameter - 3 mm
Length - 0.762 m | | Inner Diameter – 10 mm
Length - 3 m | Inner Diameter - 2.54 mm
Length – approximately 0.76 m |
| Method for occlusion | Mechanical occlusion with a pinch clamp | | No method for occlusion | Mechanical occlusion with a pinch clamp |
| Biological Characteristics | | | | |
| Electrode Material | 400-series stainless steel with enamel (porcelain) insulation and outer fluorinated ethylene propylene (FEP) insulation | 400-series stainless steel with enamel (porcelain) insulation and outer fluorinated ethylene propylene (FEP) insulation | N/A - comparing to PB1 predicate | N/A - comparing to PB1 predicate |
| Smoke Tubing Material | Polyvinyl chloride (DEHP-free) | N/A - comparing to E-SEP reference | Ethylene vinyl acetate | N/A - comparing to E-SEP reference |
| Housing Material including | Makrolon 2458
Polycarbonate | Makrolon 2458
Polycarbonate | N/A - comparing to PB1 predicate | N/A - comparing to PB1 predicate |
| buttons, Smoke
Tubing Clip
Material | | (does not have
clips) | | |
| Telescoping
Shaft Material | Polyethylene
Terephthalate (PET) | Polyethylene
Terephthalate
(PET) | N/A – comparing to
PB1 predicate | N/A – comparing
to PB1 predicate |
| Waveguide | Zeon Zeonex 690R
COP | Zeon Zeonex 690R
COP | N/A – comparing to
PB1 predicate | N/A – comparing
to PB1 predicate |
| Sterilization
Method | EtO | EtO | EtO | EtO |
| Sterility
Assurance Level | 1 × 10-6 | 1 × 10-6 | 1 × 10-6 | 1 × 10-6 |
| Duration and
type of patient
contact | Limited contact with
tissue | Limited contact
with tissue | Limited contact with
tissue | Limited contact
with tissue |
Table 5.9-1 Comparison to Predicate and Reference Devices
6
7
Technological Similarities
PhotonBlade® vs. PhotonBlade® with Adaptive Smoke Evacuation
Fundamentally, the PB1 and PB2SE surgical pencils are based on the same intended use and technological elements.
- Energy Monopolar, Radiofrequency energy ●
- Electrode Insulated metal electrode ●
- Principle of Operation - Electrosurgical cutting and coagulation of tissue
- Illumination
- Configuration (sterile, single-use)
Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil vs. PhotonBlade® with Adaptive Smoke Evacuation
The PB2SE and E-SEP have the same principle of operation as it relates to smoke evacuation. Both devices are designed to incorporate a smoke channel. Both devices require vacuum or suction from an independent source for smoke removal capability.
Medtronic PEAK PlasmaBlade 3.0S vs. PhotonBlade® with Adaptive Smoke Evacuation
The PEAK PlasmaBlade 3.0S and the PB2SE also have the same principle of operation as it relates to smoke evacuation. Both devices are designed to incorporate a smoke evacuation channel, and both devices require vacuum or suction from an independent source for smoke removal capability. Comparatively, the size of the smoke evacuation tubing is very similar in both length and inner diameter. Additionally, the PEAK PlasmaBlade 3.0S is also aligned to the PB2SE in that it also requires an intermediate suction tube to connect to a vacuum source, and features a pinch clamp to occlude the smoke evacuation tubing should it be required.
8
Technological Differences
PhotonBlade® vs. PhotonBlade® with Adaptive Smoke Evacuation
Two changes made to the predicate PB1 are subjects of this submission. One change (difference) involved improvements to electrical insulation components in the electrode and telescoping shaft (internal and external components). A second change (difference) involved an update to the PCBA LED driver circuit component.
Stryker® Neptune® E-SEP™ Smoke Evacuation Pencil vs. PhotonBlade® with Adaptive Smoke Evacuation
The following technological differences exist between the subject and reference device:
- . The smoke evacuation tubing material – The E-SEP uses Ethylene Vinyl Acetate (EVA) and the PB2SE uses DEHP-free polyvinyl chloride.
- . The smoke tube dimension – The E-SEP uses a longer tube with a larger lumen diameter than the PB2SE (Medtronic PEAK PlasmaBlade reference device is similar in smoke evacuation tube dimensions).
- . The subject device requires an intermediate suction hose while the reference connects directly to the smoke evacuation system (Medtronic PEAK PlasmaBlade reference device is the same in that it requires an intermediate suction hose).
- . The subject device has an occlusion feature to shut off the suction in case the tube becomes blocked and the reference does not (Medtronic PEAK PlasmaBlade reference device is the same in that it has an occlusion feature in the form of a pinch clamp).
5.10 Performance Data
The PB2SE features the same operating principle and manufacturing processes, and similar technology as compared to the PB1. Testing has been performed on the device materials, components, sub-assemblies, and final assemblies to confirm the safety and effectiveness of the device.
Performance testing was conducted on the PB2SE to demonstrate compliance with the product requirements, safety and effectiveness, and substantial equivalence to the predicate.
The following product performance tests were completed; biocompatibility, performance testing, and electrical safety/electromagnetic compatibility.
Biocompatibility
Per the "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," (FDA guidance, June 2016) and ISO 10993-1:2009/(R)2013, the device falls into the category external communicating device, tissue contact, less than 24- hour duration.
9
The only new contacting material introduced with the subject device is the smoke evacuation tubing. Biocompatibility testing was performed on the material and confirmed to be biocompatible for its intended use.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety testing and EMC testing were conducted per IEC 60601-1:2005 + A1:2012 with US deviation, IEC 60601-2-2:2017 (6th Edition) and IEC 60601-1-2:2014 (4thEdition), and AIM 7351731 Rev 2.00 standards. The device complies with the relevant sections of the standards.
Mechanical and Functional Testing
Mechanical and functional testing were performed on conditioned samples (EtO sterilization, distribution simulation, and 24 months accelerated aging) to confirm design inputs. The results confirm the product meets the specifications and acceptance criteria.
Smoke Evacuation
No standard requirements specific to the smoke performance exist, however, tests were conducted with the device to verify the device meets the design requirements, performance specifications, and intended use. The design of the smoke evacuation attachment does not affect or change the function of the electrosurgical device. The smoke evacuation flow rate was evaluated and compared between the PB2SE and the reference device PEAK PlasmaBlade 3.0S, demonstrating equivalent or better flow rate. The intake portion of the device did not obstruct the electrosurgical function of the pencil, while removing smoke. The results demonstrate the product is safe, effective, and meets the requirements for technology, performance and intended use.
5.11 Conclusion
The data presented for the PhotonBlade® with Adaptive Smoke Evacuation with respect to the device function, intended use, technological, and biological characteristics demonstrate that it is as least as safe and effective as the predicates. Any differences between the subject device and the predicate/reference devices do not raise any different issues of safety and effectiveness. A determination of substantial equivalence is supported.