(81 days)
PlasmaBlade X3.0S Light (K193579)
No
The summary describes a standard electrosurgical device with illumination and smoke evacuation features. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on standard electrical, mechanical, and thermal characteristics.
Yes
The device is used for cutting and coagulation of soft tissue during various medical procedures, which falls under therapeutic intervention.
No
The device is described as an electrosurgical device for cutting and coagulation of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a physical electrosurgical device with a monopolar electrode, shaft, LED illumination, and in one model, smoke evacuation tubing. It delivers RF energy and is used for cutting and coagulation of tissue. This is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices are described as electrosurgical devices that use radiofrequency energy for cutting and coagulation of soft tissue during surgical procedures. They are used directly on the patient's tissue, not on specimens taken from the patient.
- Intended Use: The intended use clearly states the devices are for surgical procedures across various anatomical sites.
- Device Description: The description focuses on the physical components and how they deliver energy for surgical purposes.
- Performance Studies: The performance studies described are related to the surgical function of the device (cutting, coagulation, smoke evacuation, thermal spread on tissue), not diagnostic testing of specimens.
Therefore, the PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that 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, avnecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).
The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coaqulation 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, neurological, and breast procedures (including mastectorny and lumpectomy), 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 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, avnecologic, orthopaedic, arthroscopic, spinal, neurological, and breast
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)
A suite of performance testing was conducted to demonstrate substantial equivalence with the predicate device. Testing requirements were determined by relevant standards and FDA Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, issued March 9, 2020.
Sterilization, Biocompatibility, Electrical Safety and EMC Testing were conducted to the following standards: ISO 11135:2014, ISO 10993-7:2008, ISO 11737-1: 2018, ISO 11737-2: 2019, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-11:2017, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], ANSI AAMI IEC 60601-2-2: 2017, AIM Standard 7351731 Rev. 3.00 2021-06-04.
Performance Testing included: Simulated Use Life Testing, Coag Verification Test, Telescope Locking Force Test, Telescope Bending Test, Light (Lumen) Test, Blade Bending Test, Smoke Evacuation Test (for PhotonBlade 3 Smoke Evacuation only), Thermal Spread Testing (ex vivo across three porcine tissue types: muscle, skin and liver tissue).
All pre-defined acceptance criteria for the above tests were met. Results from the the subject devices perform as intended and support a determination of substantial equivalence to the predicate.
Usability/Human Factors testing demonstrated safe and effective use for the intended use, and use environments in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016.
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.
PlasmaBlade X3.0S Light (K193579)
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.
PhotonBlade with Adaptive Smoke Evacuation (K191583)
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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October 21, 2024
Stryker Instruments Miriam Giltinan Senior Staff Regulatory Affairs Specialist 1941 Stryker Way Portage, Michigan 49002
Re: K242266
Trade/Device Name: PhotonBlade 3; PhotonBlade 3 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: August 1, 2024 Received: August 1, 2024
Dear Miriam Giltinan:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Long H. Chen--> Digitally signed by Long H.Chen-S
Date: 2024.10.21 12:58:00 -04'00'
Long Chen, Ph.D. 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
3
Indications for Use
Submission Number (if known)
K242266
Device Name
PhotonBlade 3;
PhotonBlade 3 Smoke Evacuation
Indications for Use (Describe)
The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that 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, avnecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).
The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coaqulation 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, neurological, and breast procedures (including mastectorny and lumpectomy), 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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510(k) Summary
Submitter Information
| 510(k) Owner/Submitter: | Stryker Instruments
1941 Stryker Way
Portage, MI 49002
USA |
|-------------------------|-------------------------------------------------------------------------------------|
| Contact Person: | Miriam Giltinan
Senior Staff RA Specialist
Email: miriam.giltinan@stryker.com |
| Registration Number: | 3015967359 |
| Date Summary Prepared: | August 01, 2024 |
Device Name
| Trade Name(s)/Model number(s): | PhotonBlade 3/0730-101-000 |
|---|---|
| PhotonBlade 3 Smoke Evacuation/0730-102-000 | |
| Classification Name: | Electrosurgical cutting and coagulation device and |
| accessories (21 CFR 878.4400) | |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class 2 |
| Product Code: | GEI |
Predicate Device
Predicate: PlasmaBlade X3.0S Light (K193579)
Reference: PhotonBlade with Adaptive Smoke Evacuation (K191583)
Device Description
The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.
5
Indications for Use
The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that 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, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).
The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that 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, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy), and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Substantial Equivalence Comparison
The predicate device has been identified as the PlasmaBlade X3.0S Light (K193579). Both subject and predicate devices share the same intended use, and similar indications for use and technological characteristics.
Intended Use Comparison
| | PhotonBlade 3 | PhotonBlade 3 Smoke
Evacuation | PlasmaBlade
Light | X3.0S |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| | Subject Device | Subject Device | Predicate Device | |
| Classification | Class 2 | | Class 2 | |
| Product Code | GEI | | GEI | |
| Regulation | 21 CFR 878.4400 | | 21 CFR 878.4400 | |
| Regulation Name | Electrosurgical cutting and coagulation device and accessories | | Electrosurgical cutting and coagulation device and accessories | |
| Indications for Use | The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that 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, neurological, and breast procedures | The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that 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, neurological, and breast procedures | The surgery system 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. | |
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| PhotonBlade 3 | PhotonBlade 3 Smoke Evacuation | PlasmaBlade Light | |
|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | |
| (including mastectomy | |||
| and lumpectomy). | (including mastectomy | ||
| and lumpectomy), and for | |||
| removing smoke | |||
| generated by | |||
| electrosurgery when used | |||
| in conjunction with an | |||
| effective smoke | |||
| evacuation system. | |||
| Type of Use | Rx only | Rx only | |
| Conditions of Use | Single Use | Single Use |
The subject and predicate devices share identication regulation and intended use. The subject devices add an indication for "breast procedures (including mastectomy and lumpectomy)" which falls within the intended use of the predicate device. The indication is supported by a systematic literature review.
The purpose of the systematic literature review was to demonstrate the safety and efficacy of monopolar RF devices for the indication "breast procedures (including mastectomy and lumpectomy)". A thorough review of the literature explored 1) the medical field and targeted treated populations applicable for the subject devices as well as those of the predicate and other relevant monopolar RF devices; 2) clinical data for predicate and other relevant monopolar RF devices; and 3) vigilance databases to assess safety. Performance was assessed using reported outcomes including drain output, flap perfusion, thermal tissue injury, length of hospital stay, and procedural success. Safety was assessed by reviewing adverse events/complications reported in both peer-reviewed publications and vigilance databases and sought to identify events that were specifically related to the device or procedure.
Stryker identified a total of 63 unique publications utilizing search criteria specific to predefined indications. These were screened for inclusion using predetermined criteria and a weighted appraisal scoring system. In addition to vigilance databases, a thorough full-text review of 10 manuscripts was performed providing supportive clinical efficacy and safety data that covered the stated indication. An additional 34 publications describing relevant safety information (not specific to the breast indication) were included for a comprehensive product safety assessment.
Results from the systematic literature review concluded that monopolar RF devices are safe and effective for use in the breast surgery indications. No new or unexpected risks were identified.
The data supports the assertion that the indication for "breast procedures (including mastectomy and lumpectorny)" falls within the intended use (cutting and coagulation of soft tissue) of the predicate and does not introduce new questions of safety and effectiveness.
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K242266
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Technological Characteristics Comparison
| PhotonBlade 3 | PhotonBlade 3 Smoke Evacuation | PlasmaBlade Light | X3.0S | |
|---|---|---|---|---|
| Subject Device | Subject Device | Predicate Device | ||
| Mechanism of action/Principle of operation | RF Monopolar Energy | RF Monopolar Energy | ||
| Compatibility with Electrosurgical Unit (ESU) | Standard ESU complying to IEC 60601 standards | Dedicated ESU | ||
| Illumination Source | LED | LED | ||
| Illumination Location | Distal Shaft | Main handpiece body | ||
| Illumination Power Source | 2x3V battery | USB plug straight to generator | ||
| Light Color | White | White | ||
| Smoke Evacuation Design | N/A | Integrated | Integrated | |
| Smoke Evacuation Mode of Operation | N/A | Connect to commercially available smoke evacuation unit or suction/vacuum source | Connect to commercially available smoke evacuation unit or suction/vacuum source | |
| Sterilization | Sterile, single use (EtO) | Sterile, single use (EtO) | ||
| Type of Patient Contact | External Communicating Device |