The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.

Device Description

The PhotonBlade is a single use, sterile, electrosurgical device with a light. The PhotonBlade has an electrode at the distal tip, which delivers RF energy for cutting and coagulation of soft tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. 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 the PhotonBlade device, an electrosurgical device with illumination, and its comparison to predicate devices for FDA 510(k) clearance. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for AI devices.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering and bench testing, rather than clinical trials or AI performance evaluations.

Given the information provided in the text, I can only report what is included:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various performance tests conducted to demonstrate compliance with product requirements, safety, efficacy, and substantial equivalence to the predicate devices. These tests generally assess the device's capability to perform its stated functions.

Test Category	Description / Performance Demonstrated
Mechanical Testing	Conducted on PhotonBlade devices exposed to EO sterilization and simulated transportation to demonstrate compliance with product requirements.
Electrical Safety / EMC Testing	Demonstrated compliance with: - IEC 60601-1 3rd Edition - IEC 60601-2-2
Operational Testing	Conducted on PhotonBlade devices exposed to EO sterilization and simulated transportation to demonstrate compliance with product requirements. (Specific operational metrics are not detailed, but it implies the device functions as intended for cutting and coagulation, and illumination.)
Ex-vivo Thermal Effects on Tissue Comparisons	Conducted to demonstrate safety and efficacy. (Specific results or comparisons are not detailed, but the aim is to show comparable or acceptable thermal effects to predicate devices. The document states: "PhotonBlade and PlasmaBlade both have insulated electrodes that extend and rotate. Both devices utilize blade electrodes where only the edge of the blade is exposed or active. As such, the principles of operation involved in cutting and coagulation of tissue are the same on either device.")
Biocompatibility	Demonstrated compliance with ISO 10993-1.
Packaging Evaluation	Conducted to demonstrate compliance with product requirements.
Sterilization	Sterile-Ethylene Oxide.
Illumination Output	PhotonBlade: 28 lumens (n=29) PARE Surgical NOVA ES: 30 lumens (n=1) (This is a comparison point, not an acceptance criterion, but it shows the measured output for the illumination feature).
Shelf Life Studies	Product Shelf Life studies for 7 months and 37 months will be conducted. (This indicates ongoing or planned studies, not necessarily completed ones with reported performance for final acceptance in this document.)
Overall Conclusion	The data submitted support the substantial equivalence claim for the proposed indications for use; the PhotonBlade is as safe and effective as the predicate device(s). Invuity Inc. considers the PhotonBlade device to be substantially equivalent to the legally marketed predicate device(s) with respect to the device function, intended use, and patient population. Any differences in technological characteristics between the PhotonBlade device and the predicate device(s) do not raise any new issues of safety and effectiveness.

Missing Information (Not found in the provided text):

2. Sample size used for the test set and the data provenance:
* Not specified in the provided text. The document refers to "Performance testing was conducted on PhotonBlade devices" but does not detail sample sizes for specific tests or the origin of any data (e.g., country of origin, retrospective/prospective). The illumination output mentioned "n=29" for the PhotonBlade, which refers to the number of devices measured for that specific attribute.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This document is for a traditional surgical device, not an AI device requiring expert ground truth for classification/diagnosis.

4. Adjudication method for the test set:
* Not applicable. This document is for a traditional surgical device, not an AI device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This document is for a traditional surgical device, not an AI device. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This document is for a traditional surgical device, not an AI device.

7. The type of ground truth used:
* Not applicable in the context of AI algorithms. The "ground truth" for the device's performance relies on engineering specifications, physical measurements, and comparison to the established performance of predicate devices, as demonstrated through bench testing and ex-vivo studies.

8. The sample size for the training set:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set is mentioned.

9. How the ground truth for the training set was established:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set or ground truth establishment method for it is mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 15, 2016

Invuity, Inc. Mr. John Kang Senior Director, Quality Assurance and Regulatory Affairs 444 De Haro Street San Francisco, California 94107

Re: K162053

Trade/Device Name: PhotonBlade Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 20, 2016 Received: July 25, 2016

Dear Mr. Kang:

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. 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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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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 Parts 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,

Christopher J. Ronk -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

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Indications for Use

510(k) Number (if known) K162053

Device Name PhotonBlade™

Indications for Use (Describe)

The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "INVUITY intelligent photonics". The logo consists of a circular graphic to the left of the word "INVUITY" in bold, black letters. Below the word "INVUITY" is the phrase "intelligent photonics" in a smaller, thinner font. The circular graphic is made up of several smaller circles in different shades of blue and green.

5 510(K) SUMMARY

Date Summary Prepared July 20, 2016.

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:

John Kang Senior Director RA/QA INVUITY, INC. 444 De Haro Street San Francisco, CA 94107

5.4 Name of device

Trade Name:	PhotonBlade™
Common Name:	Electrosurgical Accessory
Device Product Code:	GEI
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)
Device Panel:	General and Plastic Surgery
Device Classification:	Class II

5.5 Predicate device(s):

0 PEAK Surgical PlasmaBlade 3.0S (K093695)
0 PARE NOVA ES Pencil with Surgical Light Source (K944363)

5.6 Device description

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Image /page/4/Picture/0 description: The image shows the logo for Invuity, a company that specializes in intelligent photonics. The logo features a circular icon with a gradient of blue and green colors, followed by the company name in bold, black letters. Below the company name, the words "intelligent photonics" are written in a smaller, lighter font.

5.7 Indications for Use statement

The PhotonBlade™ is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general surgical procedures.

5.8 Substantial equivalence comparison

Two predicates have been identified for the PhotonBlade, PlasmaBlade 3.0S and NOVA ES Pencil. In terms of the indications for use, the PlasmaBlade 3.0S and the NOVA ES Pencil are predicates for soft tissue cutting and coagulation and the NOVA ES Pencil is a predicate for surgical light (illumination).

Attribute	Invuity PhotonBladeSubject Device	PEAK Surgical PlasmaBlade(Medtronic)K093695
Intended Use	The PhotonBlade isintended for soft tissuedissection and coagulationcoupled with illuminationfor use in General Surgicalprocedures.	The Peak PlasmaBlade isintended for soft tissuedissection and coagulationfor use in General, Plastic,and Orthopedic surgicalprocedures.
Principle ofOperation	Electrosurgical cutting andcoagulation	Electrosurgical cutting andcoagulation
Anatomical Site(s)	Soft Tissue	Soft Tissue
Use	Single Use	Single Use
Materials	Metal electrode/enamelinsulator	Metal electrode/enamelinsulator
Specification
Energy Type	Radiofrequency (RF)	Radiofrequency (RF)
Power Modes	Monopolar	Monopolar
Electrode	Stainless steel bladeinsulated with enamel	Stainless steel bladeinsulated with enamel
Compliance
Sterilization	Sterile-Ethylene Oxide	Sterile-Ethylene Oxide
EMC & ElectricalSafety Testing	IEC 60601-1 3rd EditionIEC 60601-2-2	IEC 60601-1 2nd Edition
Biocompatibility	ISO 10993-1	ISO 10993-1

Comparison to Predicate Device(s)

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Attribute	Invuity PhotonBladeSubject Device	PARE Surgical NOVA ES(Electrosurgical) Pencil withLight K944363
Illuminate SurgicalField	Yes	Yes
Illuminationsource	LED	LED
Illuminationlocation	Shaft	Handle
Nominal LightOutput	28 lumens (n=29)	30 lumens (n=1)
Illuminationpower source	3V Battery	3V Battery
Batterycharacteristic	Replaceable	Non-replaceable
Light Color	White	White

Comparison to Predicate Device(s)-Illumination (Lighted ES Pencil)

Technological Characteristics 5.9

The PhotonBlade device is similar to both predicate devices in that they are electrosurgical instruments used to cut and coagulate soft tissue utilizing RF energy.

PhotonBlade and PlasmaBlade both have insulated electrodes that extend and rotate. Both devices utilize blade electrodes where only the edge of the blade is exposed or active. As such, the principles of operation involved in cutting and coagulation of tissue are the same on either device. The differences between the PhotonBlade and PlasmaBlade are:

0 The PlasmaBlade device has aspiration and the PhotonBlade does not.
. The PlasmaBlade is compatible with a dedicated electrosurgical unit (ESU) or generator and the PhotonBlade is intended for use with general purpose FDA-cleared RF generators with the standard or traditional (Bovie) three plug receptacle, such as the Valleylab (Medtronic) Force FX c and Conmed S5000 for example.
The PhotonBlade has a light and the PlasmaBlade does not. 0

The PhotonBlade and NOVA ES Pencil lights both provide illumination using LED technology. In both devices, the illumination is powered by a battery; however, the PhotonBlade battery is replaceable, while the NOVA ES Pencil battery is not. The NOVA ES Pencil electrode tip is not insulated, and the device is provided with two tip configurations (one long and one short). The

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Image /page/6/Picture/0 description: The image shows the logo for Invuity, a company that specializes in intelligent photonics. The logo consists of a circular icon with a blue and green color scheme, followed by the company name in bold, black letters. Below the company name, the words "intelligent photonics" are written in a smaller, lighter font.

PhotonBlade has an insulated tip with only one configuration that can be adjusted via an extendable shaft. The NOVA ES Pencil has three LEDs that are located in the handle of the device; the distance from the electrode tip to the LEDs varies depending on the tip configuration. The PhotonBlade has one LED that is located in the shaft of the device; the distance from the electrode tip to the LED is constant (approx. 2cm).

The differences identified between the PhotonBlade and its two predicates (PlasmaBlade and NOVA ES Pencil Surgical Light Source) do not present any new concerns of safety and effectiveness.

5.10 Summary of Performance Data

Performance testing was conducted on PhotonBlade devices that were exposed to EO sterilization and simulated transportation to demonstrate compliance with the product requirements and to demonstrate safety, efficacy, and substantial equivalence to the predicate. The following product performance tests are included: mechanical, electrical safety/electromagnetic compatibility, operational, ex-vivo thermal effects on tissue comparisons, biocompatibility, and packaging evaluation. Product Shelf Life studies for 7 months and 37 months will be conducted.

Like the predicate device(s), no clinical testing was necessary to support substantial equivalence. The data submitted support the substantial equivalence claim for the proposed indications for use; the PhotonBlade is as safe and effective as the predicate device(s).

5.11 Conclusion

Invuity Inc. considers the PhotonBlade device to be substantially equivalent to the legally marketed predicate device(s) with respect to the device function, intended use, and patient population. Any differences in technological characteristics between the PhotonBlade device and the predicate device(s) do not raise any new issues of safety and effectiveness. The Invuity PhotonBlade is substantially equivalent to the proposed predicate devices.

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.