(104 days)
No
The device description and performance studies focus on electrosurgical technology and do not mention any AI or ML components.
No
The device is described as an electrosurgical instrument indicated for cutting and coagulation of soft tissue during surgical procedures, which are considered diagnostic or surgical interventions, not therapeutic in nature.
No
The device is used for cutting and coagulation of soft tissue during surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a single-use, disposable, electrosurgical instrument consisting of physical tips designed to be attached to a handpiece and used with electrosurgical generators. This involves significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation of soft tissue during otolaryngology (ENT) surgery" and "coagulation of tissue and suction of fluids" during surgical procedures. This describes a device used on a patient during a surgical procedure, not a device used to test samples from a patient outside the body.
- Device Description: The description details an electrosurgical instrument that applies radio-frequency energy for cutting and coagulation. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal, Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.
Product codes
GEI
Device Description
The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use, disposable, electrosurgical instrument consisting of two PlasmaBlade tips (UPPP tip and Suction Coagulator tip) designed to be attached to the Plasmablade ENT handpiece (cleared as the PEAK Plasmablade TnA handpiece via K083415). These devices are used with Pulsar I (K073057) and Pulsar II (K102029) Electrosurgical Generators. The devices provide radio-frequency energy for cutting (UPPP tip only) and coagulation of soft tissue and contain integrated suction for the evacuation of smoke and fluids from the surgical site. 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 Pulsar Generators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, 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
The design and performance of the PEAK PlasmaBlade UPPP device were verified and validated through bench testing.
Electrical Safety of the PEAK PlasmaBlade UPPP was conducted in accordance with the following FDA recognized consensus standards:
IEC 60601-1:2005 3rd Edition And A1:2012 Medical electrical equipment-Part 1: General requirements for safety and Essential Performance
IEC 60601-2-2 Edition 5.0 2009-02 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Comparative performance testing was conducted in an in-vivo animal model utilizing GLP. Performance and thermal effect of the PEAK PlasmaBlade UPPP and Suction Coagulator in the in-vivo model was equivalent to that of the predicate device.
Cadaveric testing was also conducted to further validate the devices for their intended use.
Clinical testing was not required for this product.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines suggesting movement or connection. The profiles are arranged in a way that creates a sense of depth and unity. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
Medtronic Advanced Energy Lydia Sakakeeny, Ph.D. Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K150297
Trade/Device Name: PEAK PlasmaBlade UPPP and Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 24, 2015 Received: April 28, 2015
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.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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.
Jennifer R. Stevenson -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): K150297
Device Name: PEAK PlasmaBlade UPPP
Indications for Use:
The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including, uvulopalatopharyngoplasty (UPPP) 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)
3
Indications for Use
510(k) Number (if known): K150297
Device Name: PEAK PlasmaBlade Suction Coagulator
Indications for Use:
The PEAK PlasmaBlade Suction Coagulator device is intended for use in surgical procedures such as general and otolaryngology (ENT) including, uvulopalatopharyngoplasty (UPPP), tonsillectorny, and adenoidectomy, where coagulation of tissue and suction of fluids are desired. It is not intended to be used as a dissection instrument.
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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Image /page/4/Picture/0 description: The image is the logo for Medtronic. The logo features a circular graphic on the left with three figures in different positions, suggesting movement or transformation. To the right of the graphic is the company name, "Medtronic," in a bold, blue sans-serif font. Below the name is the tagline, "Alleviating Pain • Restoring Health • Extending Life," also in blue.
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: | March 13, 2015 |
| Device Trade Name: | PEAK PlasmaBlade UPPP and Suction Coagulator
PEAK PlasmaBlade Suction Coagulator |
| 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 Tip PS300-001)
K014290 (Original) Arthrocare ENT Plasma Wands
K103775 PEAK PlasmaBlade Suction Coagulator |
| Device Description: | The PEAK PlasmaBlade® UPPP and Suction Coagulator is a single-use,
disposable, electrosurgical instrument consisting of two PlasmaBlade
tips (UPPP tip and Suction Coagulator tip) designed to be attached to the
Plasmablade ENT handpiece (cleared as the PEAK Plasmablade TnA
handpiece via K083415). These devices are used with Pulsar I
(K073057) and Pulsar II (K102029) Electrosurgical Generators. The
devices provide radio-frequency energy for cutting (UPPP tip only) and
coagulation of soft tissue and contain integrated suction for the
evacuation of smoke and fluids from the surgical site. 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 Pulsar Generators. |
| Intended Use: | The PEAK PlasmaBlade UPPP is indicated for cutting and coagulation of
soft tissue during otolaryngology (ENT) surgery including,
uvulopalatopharyngoplasty (UPPP) and tonsillectomy (Pharyngeal,
Tubal, Palatine).
The PEAK PlasmaBlade Suction Coagulator device is intended for use in
surgical procedures such as general and otolaryngology (ENT) including,
uvulopalatopharyngoplasty (UPPP), tonsillectomy, and adenoidectomy,
where coagulation of tissue and suction of fluids are desired. It is not
intended to be used as a dissection instrument. |
5
Image /page/5/Picture/0 description: The image is the logo for Medtronic. On the left is a circular graphic with three figures in different positions. To the right of the graphic is the name "Medtronic" in a large, bold, blue font. Below the name is the slogan "Alleviating Pain - Restoring Health - Extending Life" in a smaller, blue font.
Technological Characteristics:
The PEAK PlasmaBlade UPPP and Suction Coaqulator are similar to the predicate devices in that they are single use, sterile, electrosurgical instruments used to cut (UPPP only) and coagulate soft tissue utilizing RF powered distal ends. Both enable the suction of fluid and smoke from the surgical site.
Summary of Non-Clinical Testing:
The design and performance of the PEAK PlasmaBlade UPPP device were verified and validated through bench testing.
Electrical Safety of the PEAK PlasmaBlade UPPP was conducted in accordance with the following FDA recognized consensus standards:
| Recognition
| Number | Standard | Title of Standard |
|---|---|---|
| 19-4 | IEC 60601-1:2005 3rd | |
| Edition And A1:2012 | Medical electrical | |
| equipment-Part 1: General | ||
| requirements for safety and | ||
| Essential Performance | ||
| 6-228 | IEC 60601-2-2 Edition 5.0 | |
| 2009-02 | Medical electrical | |
| equipment Part 2-2: | ||
| Particular requirements for | ||
| the basic safety and | ||
| essential performance of | ||
| high frequency surgical | ||
| equipment and high | ||
| frequency surgical | ||
| accessories |
Comparative performance testing was conducted in an in-vivo animal model utilizing GLP. Performance and thermal effect of the PEAK PlasmaBlade UPPP and Suction Coagulator in the in-vivo model was equivalent to that of the predicate device.
Cadaveric testing was also conducted to further validate the devices for their intended use.
Summary of Clinical Tests: Clinical testing was not required for this product.
Conclusion: The indications for use, technology and performance characteristics of the PEAK PlasmaBlade UPPP and Suction Coagulator are equivalent to the predicate devices' and therefore Medtronic Advanced Energy claims Substantial equivalence to the predicate devices.