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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the "PhotonBlade® with Adaptive Smoke Evacuation" device. This is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a novel AI/software as a medical device (SaMD) cleared through a de novo or PMA pathway.

Therefore, the document does not contain the information typically sought for a study proving device performance against acceptance criteria for an AI/SaMD. Specifically:

No acceptance criteria table for AI performance: The document focuses on performance testing for an electrosurgical device (e.g., electrical safety, mechanical/functional testing, biocompatibility, smoke evacuation flow rate).
No mention of AI/algorithm: The device is described as a monopolar RF device with illumination and adaptive smoke evacuation. There is no indication of an AI component.
No data provenance, expert ground truth, adjudication, MRMC studies: These elements are characteristic of studies evaluating AI performance in interpreting medical images or other data, which is not applicable here.
No standalone algorithm performance or training set information: Again, these are specific to AI/machine learning models.

Based on the provided text, the device is an electrosurgical tool, and the "study" described is a set of engineering and bench tests, not a clinical study to prove AI performance.

Therefore, it is not possible to describe the acceptance criteria and study as requested, because the provided input does not pertain to an AI/SaMD.

However, I can extract the acceptance criteria and performance data for the electrosurgical device itself as described in the 510(k) summary:

Acceptance Criteria and Device Performance (for the electrosurgical device, not AI/SaMD)

The document frames the "acceptance criteria" and "performance" in terms of confirming the device meets design specifications, safety, and effectiveness compared to predicates, rather than statistical performance metrics for an AI system.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

Acceptance Criteria / Performance Aspect	Reported Device Performance
Biocompatibility	Tested per ISO 10993-1:2009/(R)2013 and FDA guidance (June 2016). The only new contacting material (smoke evacuation tubing) was tested and confirmed to be biocompatible for its intended use. Classification: external communicating device, tissue contact, less than 24-hour duration.
Electrical Safety & EMC	Tested per IEC 60601-1:2005 + A1:2012 (US deviation), IEC 60601-2-2:2017 (6th Ed), IEC 60601-1-2:2014 (4th Ed), and AIM 7351731 Rev 2.00 standards. The device complies with relevant sections of the standards.
Mechanical & Functional Testing	Performed on conditioned samples (EtO sterilization, distribution simulation, 24 months accelerated aging). Results confirm the product meets the specifications and acceptance criteria. (Specific metrics not provided, but general compliance stated).
Illumination Function	Nominal Light Output: 29 Lumens (compared to 28 Lumens for predicate). Light Color: White. Updates to PCBA LED driver circuit component to reduce susceptibility to RF interference, resulting in a more consistent illumination function.
Smoke Evacuation	No specific standards exist, but tests were conducted to verify design requirements, performance specs, and intended use. The design does not affect or change electrosurgical function. Smoke evacuation flow rate was evaluated and compared to reference device (PEAK PlasmaBlade 3.0S), demonstrating equivalent or better flow rate. The intake portion did not obstruct electrosurgical function while removing smoke. Results demonstrate the product is safe, effective, and meets requirements for technology, performance, and intended use.
Sterility Assurance Level (SAL)	1 x 10^-6 (consistent with predicate and reference devices).
Electrical Insulation Improvement	Changes to internal and external components of telescoping shaft and electrode were made to improve electrical insulation. This indicates an improved safety feature compared to the predicate, implicitly meeting an internal acceptance criteria for improved insulation. (No specific numerical acceptance criteria provided, but the improvement is noted as a device modification).
Substantial Equivalence	The overall conclusion is that the data demonstrates the device is "at least as safe and effective as the predicates," and any differences do not raise new safety/effectiveness issues, thus supporting a determination of substantial equivalence. This is the overarching "acceptance criterion" for a 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in numerical terms for each test. The text mentions "conditioned samples" for mechanical and functional testing, and "the material" for biocompatibility. This suggests standard engineering test samples, not patient cohorts.
Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The studies are bench/engineering tests conducted by the manufacturer. No country of origin for "data" in the sense of patient data is relevant here. The studies are retrospective in the sense that they are performed on manufactured devices to support the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. This is an electrosurgical device, not an AI system that interprets medical data. Ground truth in this context refers to engineering specifications and performance standards established through generally accepted methods in medical device testing. There are no human "experts" establishing a clinical ground truth for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set:

Not Applicable. As there are no human experts classifying or interpreting data for decision-making (as in AI/SaMD evaluations), there is no adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. MRMC studies are specific to evaluating the clinical performance of diagnostic or screening devices, often involving human readers with and without AI assistance. This device is an electrosurgical tool, and such a study is not relevant to its function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This device does not have a standalone algorithm for diagnostic or interpretative purposes. "Standalone performance" in this context would refer to the device's electrosurgical and smoke evacuation functions on their own, which are indeed what the performance tests cover (e.g., flow rate, electrical safety).

7. The Type of Ground Truth Used:

For this device, the "ground truth" is defined by:
- Engineering Specifications: Defined by the manufacturer's design inputs.
- International Standards: e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility.
- Predicate Device Performance: Benchmarking against the previously cleared PhotonBlade® and reference devices for function (e.g., smoke evacuation flow rate).
- Intended Use/Design Requirements: Verification that the device performs as intended (cutting, coagulation, smoke removal) without affecting electrosurgical function.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As there is no training set for an AI model, there is no ground truth establishment process for it.

Summary

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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.

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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)

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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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 (21CFR 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)

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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

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

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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	InvuityPhotonBlade® withAdaptive SmokeEvacuation(PB2SE)Subject Device	InvuityPhotonBlade (PB1)(K162053)Predicate	Stryker® Neptune® E-SEP Smoke EvacuationPencil (E-SEP)(K160693)Reference	Medtronic PEAKPlasmaBlade3.0S(K093695)Reference
General Characteristics
Indications forUse	The PhotonBlade®with AdaptiveSmoke Evacuation isa monopolar RFdevice coupled withillumination that isindicated for cuttingand coagulation oftissue duringgeneral surgicalprocedures and forremoving smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem.	The Photonblade isa monopolar RFdevice coupledwith illuminationthat is indicated forcutting andcoagulation oftissue duringgeneral surgicalprocedures.	The Neptune E-SEP isan Integrated SmokeEvacuation Pencil(pencil) designed forgeneral electrosurgicalapplications includingcutting andcoagulation, and forremoving smokegenerated byelectrosurgery whenused in conjunctionwith an effectivesmoke evacuationsystem. The pencilenables the operatorto remotely conduct anelectrosurgical currentfrom theoutput connector of anelectrosurgical unit(generator) to theoperative site for thedesired surgical effect.	The PEAKPlasmaBlade isindicated forcutting andcoagulation ofsoft tissue duringgeneral, plastic,andreconstructive(including butnot limited toskin incisionsanddevelopment ofskin flaps), ENT,gynecologic,orthopaedic,arthroscopic,spinal, andneurologicalprocedures.
Principal ofOperation	RF Monopolarelectrosurgicalcutting andcoagulation	RF Monopolarelectrosurgicalcutting andcoagulation	N/A - comparing toPB1 predicate	N/A - comparingto PB1 predicate
Method ofOperation	Push-Buttonactivation ofelectrosurgicalenergy.	Push-Buttonactivation ofelectrosurgicalenergy, smokeevacuationcontrolled by asmoke evacuationunit.
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 mmLength - 0.762 m		Inner Diameter – 10 mmLength - 3 m	Inner Diameter - 2.54 mmLength – 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 2458Polycarbonate	Makrolon 2458Polycarbonate	N/A - comparing to PB1 predicate	N/A - comparing to PB1 predicate
buttons, SmokeTubing ClipMaterial		(does not haveclips)
TelescopingShaft Material	PolyethyleneTerephthalate (PET)	PolyethyleneTerephthalate(PET)	N/A – comparing toPB1 predicate	N/A – comparingto PB1 predicate
Waveguide	Zeon Zeonex 690RCOP	Zeon Zeonex 690RCOP	N/A – comparing toPB1 predicate	N/A – comparingto PB1 predicate
SterilizationMethod	EtO	EtO	EtO	EtO
SterilityAssurance Level	1 × 10-6	1 × 10-6	1 × 10-6	1 × 10-6
Duration andtype of patientcontact	Limited contact withtissue	Limited contactwith tissue	Limited contact withtissue	Limited contactwith tissue

Table 5.9-1 Comparison to Predicate and Reference Devices

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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.

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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.

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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.

Regulation Number and Section

§ 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.