(291 days)
Not Found
No
The description focuses on electrosurgical technology for cutting and coagulation, with no mention of AI or ML capabilities.
No.
The device is used for cutting and coagulation of soft tissue during surgery, which are surgical procedures, not therapeutic treatments.
No
The device is described as an "electrosurgical instrument" indicated for "cutting and coagulation of soft tissue" during surgery. It is a therapeutic device used for treatment, not diagnosis.
No
The device description clearly outlines a physical, single-use, disposable electrosurgical instrument with tips, a handpiece, and a wire cleaning brush. It also mentions its use with electrosurgical generators, all of which are hardware components.
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 soft tissue during otolaryngology (ENT) surgery". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an electrosurgical instrument used to physically cut and coagulate tissue. It does not involve testing samples of biological material in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's tissue during surgery.
N/A
Intended Use / Indications for Use
The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The PEAK PlasmaBlade® TnA is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip and Adenoid tip) designed to be attached to the PlasmaBlade ENT handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via K083415). The device also includes a wire cleaning brush designed to remove eschar build up and maintain a clear channel for suction.
The Adenoid Tip consists of a wire electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids, and smoke. It connects to the suction shaft of the handpiece.
These device is used with PULSAR I (K073057), PULSAR II (K102029) and AEX (K143175) Electrosurgical Generators. It provides radio-frequency energy for cutting and coagulation of soft tissue. The PEAK PlasmaBlade ENT handpiece has integrated buttons for Cut and Coag, which may be used to operate the device, or it may be activated with an optional footswitch supplied with the Generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
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)
The design and performance of the modified Adenoid Tip were verified and validated through bench testing.
Comparative performance testing was conducted in an in-vivo animal model. Thermal effect of the PEAK PlasmaBlade Adenoid Tip in the in-vivo model was substantially equivalent to that of the predicate device.
All bench and pre-clinical testing that testing confirmed that the different technological characteristics of the subject device and the respective predicates do not raise any new issues of safety or effectiveness.
Clinical testing was not required for this product.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be formed by a continuous line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8. 2016
Medtronic Advanced Energy Lydia Sakakeeny, Ph.D. Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, NH 03801
Re: K152703
Trade/Device Name: PlasmaBlade TnA Tonsil and Adenoid Dissection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 7, 2016 Received: June 8, 2016
Dear Dr. Sakakeeny:
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.
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Page 2 - Lydia Sakakeeny, Ph.D.
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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 yours.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the Medtronic logo. The logo consists of a blue circle with three figures inside, and the word "Medtronic" in blue, bold letters. The figures inside the circle are arranged in a circular pattern, with one figure standing upright and the other two lying down.
PEAK PlasmaBlade TnA (Adenoid Tip)
Indications for Use
510(k) Number (if known): K152703
Device Name: PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device
Indications for Use:
The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Medtronic
510(k) Summary
| Submitter: | Medtronic Advanced Energy
180 International Drive
Portsmouth, NH 03801 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lydia Sakakeeny, PhD
Principal Regulatory Affairs Specialist
Phone: (603) 294-5482
Fax: (603) 742-1488
E-mail:lydia.sakakeeny@medtronic.com |
| Date Summary Prepared: | September 10, 2015 |
| Device Trade Name: | PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories
(21 CFR 878.4400) |
| Product Code: | GEI |
| Predicate Device: | K083415 PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection
Device
K014290 (Original) Arthrocare ENT Plasma Wands |
| Device Description: | The PEAK PlasmaBlade® TnA is a single-use, disposable,
electrosurgical instrument consisting of two PlasmaBlade tips (Tonsil tip
and Adenoid tip) designed to be attached to the PlasmaBlade ENT
handpiece (cleared as the PEAK PlasmaBlade TnA handpiece via
K083415). The device also includes a wire cleaning brush designed to
remove eschar build up and maintain a clear channel for suction. |
| | The Adenoid Tip consists of a wire electrode housed in a plastic tip with
a bendable suction lumen that allows for the evacuation of tissue, fluids,
and smoke. It connects to the suction shaft of the handpiece. |
| | These device is used with PULSAR I (K073057), PULSAR II (K102029)
and AEX (K143175) Electrosurgical Generators. It provides radio-
frequency energy for cutting and coagulation of soft tissue. The PEAK
PlasmaBlade ENT handpiece has integrated buttons for Cut and Coag,
which may be used to operate the device, or it may be activated with an
optional footswitch supplied with the Generators. |
| Intended Use: | The PEAK PlasmaBlade TnA device is only indicated for cutting and
coagulation of soft tissue during otolaryngology (ENT) surgery including
adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine). |
| Technological Characteristics: | The PEAK PlasmaBlade TnA, Adenoid Tip is similar to the predicate
devices in that they are single use, sterile, electrosurgical instruments
used to cut and coagulate soft tissue utilizing RF powered distal ends. A
enable the suction of fluid and smoke from the surgical site. |
| Summary of Non-Clinical Testing: | The design and performance of the modified Adenoid Tip were verified
and validated through bench testing. |
| | Comparative performance testing was conducted in an in-vivo animal
model. Thermal effect of the PEAK PlasmaBlade Adenoid Tip in the in-
vivo model was substantially equivalent to that of the predicate device. |
| | All bench and pre-clinical testing that testing confirmed that the different
technological characteristics of the subject device and the respective
predicates do not raise any new issues of safety or effectiveness. |
| Summary of Clinical Tests: | Clinical testing was not required for this product. |
| Conclusion: | The indications for use, technology and performance characteristics of
the modified PEAK PlasmaBlade TnA (specifically the Adenoid Tip) are
equivalent to the predicate devices' and therefore Medtronic Advanced
Energy claims substantial equivalence to the predicate devices. |
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Technological differences between the modified adenoid tip and its predicates exist however they do not adversely impact the safety or efficacy of the devices.
For example, the modified adenoid tip and the original PEAK PlasmaBlade Adenoid tip are monopolar electrosurgical instruments with same operating principle, the modified tip utilizes a wire electrode while the predicate utilizes a blade electrode.
Similarly, while ENT Plasma Wands provide bipolar RF energy coupled with saline to the operatvie site and the PEAK PlasmaBlade adenoid tip delivers monopolar RF energy to the operative site, in vivo pre-clinical testing has confirmed that the thermal damage imparted by the two technologies are equivalent and does not raise concerns over safety or efficacy.