(52 days)
Not Found
No
The summary describes a standard electrosurgical device with illumination and does not mention any AI or ML capabilities. The performance studies focus on electrical, mechanical, and thermal effects, not algorithmic performance.
No
The device is used for cutting and coagulation of tissue during surgical procedures, which are interventional actions, not therapeutic ones.
No
The device is indicated for "cutting and coagulation of tissue," which are treatment functions, not diagnostic ones.
No
The device description clearly states it is a physical, single-use, sterile electrosurgical device with an electrode, shaft, handle, and cable, which are all hardware components.
Based on the provided information, the PhotonBlade is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "cutting and coagulation of tissue during general surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body (in vitro).
- Device Description: The description details a surgical tool with an electrode and light, designed for direct interaction with tissue. 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.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The PhotonBlade's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Tissue
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
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 and |
| Accessories (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
:
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.
4
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 PhotonBlade
Subject Device | PEAK Surgical PlasmaBlade
(Medtronic)
K093695 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The PhotonBlade is
intended for soft tissue
dissection and coagulation
coupled with illumination
for use in General Surgical
procedures. | The Peak PlasmaBlade is
intended for soft tissue
dissection and coagulation
for use in General, Plastic,
and Orthopedic surgical
procedures. |
| Principle of
Operation | Electrosurgical cutting and
coagulation | Electrosurgical cutting and
coagulation |
| Anatomical Site(s) | Soft Tissue | Soft Tissue |
| Use | Single Use | Single Use |
| Materials | Metal electrode/enamel
insulator | Metal electrode/enamel
insulator |
| Specification | | |
| Energy Type | Radiofrequency (RF) | Radiofrequency (RF) |
| Power Modes | Monopolar | Monopolar |
| Electrode | Stainless steel blade
insulated with enamel | Stainless steel blade
insulated with enamel |
| Compliance | | |
| Sterilization | Sterile-Ethylene Oxide | Sterile-Ethylene Oxide |
| EMC & Electrical
Safety Testing | IEC 60601-1 3rd Edition
IEC 60601-2-2 | IEC 60601-1 2nd Edition |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 |
Comparison to Predicate Device(s)
5
| Attribute | Invuity PhotonBlade
Subject Device | PARE Surgical NOVA ES
(Electrosurgical) Pencil with
Light K944363 |
|------------------------------|---------------------------------------|-------------------------------------------------------------------------|
| Illuminate Surgical
Field | Yes | Yes |
| Illumination
source | LED | LED |
| Illumination
location | Shaft | Handle |
| Nominal Light
Output | 28 lumens (n=29) | 30 lumens (n=1) |
| Illumination
power source | 3V Battery | 3V Battery |
| Battery
characteristic | 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.