(150 days)
Not Found
No
The description focuses on the electrosurgical unit's hardware and energy delivery, with no mention of AI/ML terms or functionalities.
Yes
The device is used for cutting and coagulation of soft tissue during various surgical procedures, which is a direct therapeutic intervention.
No
Explanation: The device is indicated for cutting and coagulation of soft tissue during surgical procedures, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines hardware components including a generator, tissue dissection devices (handpieces with electrodes, shafts, handles, and cables), and an optional footswitch. This is not a software-only device.
Based on the provided information, the PEAK Surgery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "cutting and coagulation of soft tissue during General, Plastic and Reconstructive... surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body.
- Device Description: The description details an electrosurgical unit and handpieces for delivering RF energy for cutting and coagulation. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, 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 is a surgical tool used for therapeutic purposes (cutting and coagulating tissue).
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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating 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
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)
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
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
DEC 1 6 2010
510(k) Summary:
PEAK Surgery System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
1. Submitter Name and Address:
PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293
| Contact: | Lois Nakayama |
|---|---|
| Sr. Manager, Regulatory Affairs |
Date prepared: July 15, 2010
2. Device Name:
Trade Name: PEAK Surgery System: PULSAR Generators and PlasmaBlade Tissue Dissection Devices
Common Name: Electrosurgical Device and Accessories
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number: 21 CFR § 878.4400
Product Code: GEI
Regulatory Class: Class II
-
- Predicate Devices:
PEAK Surgery System:
- Predicate Devices:
PULSAR Generator and PlasmaBlade Tissue Dissection Devices (K082786)
1
Device Description: 4.
The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating 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.
The PULSAR II Generator is a modification of the PULSAR Generator
5. Intended 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.
6. Technological Characteristics
The PEAK PULSAR II Generator is similar to the predicate device in design specifications, output energy, and delivery system. They are both electrosureical instruments designed to produce monopolar RF energy for cutting and coagulation during surgery. The modifications to the hardware, circuitry and operating frequency do not significantly affect the safety or effectiveness of the device.
7. Performance Data:
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
8. Sterilization
The PULSAR II Generator is not supplied sterile and is not intended to be sterilized.
2
9. Conclusion:
By virtue of design, materials function and intended use, the PEAK PULSAR II is as safe, as effective and performs as well as or better than the predicate device. In establishing substantial equivalence to the predicate device, PEAK Surgical evaluated the indications for use, product specifications and energy requirements of the device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 6 2010
PEAK Surgical, Inc. % Ms. Lois Nakayama 2464 Embarcadero Way Palo Alto, California 94303
Re: K102029
Trade/Device Name: PEAK Surgery System (PULSAR® Generators and PEAK PlasmaBlade® Tissue Dissection Devices) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 12, 2010 Received: November 15, 2010
Dear Ms. Nakayama:
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
4
Page 2 - Ms. Lois Nakayama
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Az. B. N.ta
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: PEAK Surgery System (PULSAR® Generators and PEAK PlasmaBlade® 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), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102029
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)