(71 days)
Not Found
No
The description focuses on standard electrosurgical technology and does not mention AI or ML.
No
The device is used for cutting and coagulation of tissue during surgery, which is an intervention rather than a therapeutic treatment itself.
No
The device is indicated for cutting and coagulation of soft tissue, which are therapeutic functions, not diagnostic ones. The device description also focuses on energy delivery for surgical procedures, not measurement or analysis for diagnosis.
No
The device description explicitly states it consists of a generator, tissue dissection devices (handpieces), and an optional foot pedal, all of which are hardware components.
Based on the provided information, the PEAK Surgery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for cutting and coagulation of soft tissue during surgical procedures on a living patient. This is an in-vivo application.
- Device Description: The device is an electrosurgical unit and handpieces designed to deliver RF energy for surgical intervention. This is a therapeutic and surgical tool, not a device for examining specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PEAK Surgery System's function is to directly interact with and modify tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The PEAK 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 surgical procedures.
Product codes
GEI
Device Description
The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin
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)
Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
082786
DEC 0 3 2008
510(k) Summary for the PEAK Surgery System
1. Submitter name and address:
PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293
Contact: Grace Carlson, MD
Date Prepared: September 22, 2008
2. Device Name:
| Trade Name: | PEAK Surgery System, consisting of:
PULSAR TM Generator and
PEAK PlasmaBlade TM Tissue Dissection Devices |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR 878.4400) |
3. Predicate Devices:
PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device (K073057) Ellman Surgi-Max Generator (K061174) ELECTROMEDICS FAS-CLEAN electrode (K073616)
4. Device description:
The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
Page 1 of 2
K08278
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5. Intended Use:
Page 2 of 2
The PEAK 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 surgical procedures.
Technological Characteristics: 6.
The PEAK Surgery System is similar to the predicate devices in that they are all electrosurgical instruments used to cut tissue and coagulate soft tissue, utilizing RF powered distal ends.
7. Performance Data:
Preclinical laboratory and performance tests were executed to ensure the devices functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate devices, and meets safety and effectiveness criteria.
8. Sterilization:
The PEAK PlasmaBlade Tissue Dissection Devices are provided sterile. The device is not intended for reuse or resterilization.
9. Conclusions:
By virtue of design, materials, function, and intended use, the PEAK Surgery System is substantially equivalent to FDA-cleared devices currently marketed in the United States. In establishing substantial equivalence to the predicate devices, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of those systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The overall design is simple and conveys a sense of official government authority.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2008
Peak Surgical, Inc. % Grace A. Carlson, MD Consultant, Regulatory and Clinical Affairs 2464 Embarcadero Way Palo Alto, California 94303
Re: K082786
Trade/Device Name: PEAK Surgery System (PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Devices
Regulation Number: 21 CFR 878.4400
Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 22, 2008
Received: September 23, 2008
Dear Dr. Carlson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Grace A. Carlson, MD
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark H. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation · Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K082 786
Device Name: PEAK Surgery System (PULSARTIA Generator and PEAK PlasmaBlade The Tissue Dissection Devices
Indications for Use:
The PEAK 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), Daily Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nithodyh for mxn
(Division Sign-Off) Division of General, Restorative,
PEAK Surgery, Inc. SIO(k) Notification for PEAK Surgery System Expanded MEHICALOgical Devices September 22, 2008
510(k) Number K082786
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