(266 days)
Not Found
No
The description focuses on standard electrosurgical technology (RF energy for cutting and coagulation) and does not mention any AI/ML components or functionalities. The "Not Found" entries for AI/ML mentions and training/test data descriptions further support this.
No
The device is used for cutting and coagulation of soft tissue during surgical procedures, which are interventional actions rather than therapeutic.
No
The device is described as an electrosurgical unit used for cutting and coagulation of soft tissue during surgical procedures, which are therapeutic functions, not diagnostic.
No
The device description clearly outlines hardware components including a generator, handpiece with electrode, shaft, handle, cable, and optional footswitch.
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 surgical procedures." This describes a surgical tool used directly on the patient's body, not a device used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description details an electrosurgical unit and a handpiece for delivering energy for cutting and coagulation. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically alter tissue during surgery.
N/A
Intended Use / Indications for Use
The PULSAR Electrosurgical Generator with the PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
Product codes
GEI
Device Description
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 Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device 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 handpiece.
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)
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)
K981724, K013255, K791639, K962044, K960255
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
Ko73057
a. 1.6 2
JUL 2 2 2008
510(k) Summary for the PULSARTM Generator and PEAK PlasmaBlade™ Tissue Dissection Device
1. Submitter name and address:
PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3022 Fax: 650-331-3293
Contact: Grace Carlson, MD
Date Prepared: October 29, 2007
2. Device Name:
| Trade Name: | PULSART™ Generator and
PEAK PlasmaBlade™ Tissue Dissection Device |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR 878.4400) |
3. Predicate Devices:
Medtrex OR Pro 300 Electrosurgical Generator (K981724) Ellman Surgitron 120 IEC (K013255) Valleylab E2515 Electrosurgical Accessory (K791639) Valleylab Coated Electrode (K962044) Utah Medical Ceramic Blade Electrode (K960255)
4. Device description:
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 Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device 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 handpiece.
1
న. Intended Use:
The PULSAR Electrosurgical Generator with the PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
6. Technological Characteristics
The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device 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 Device is provided sterile. The device is not intended for reuse or resterilization.
9. Conclusions
By virtue of design, materials, function, and intended use, the PULSAR Generator and PEAK PlasmaBlade Tissue Dissection Device 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2008
PEAK Surgical, Inc. % Grace A. Carlson, MD 2464 Embarcadero Way Palo Alto, California 94303
Re: K073057
Trade/Device Name: PULSAR™ Generator and PEAK PlasmaBlade™ Tissue Dissection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2008 Received: June 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 rectassified 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 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.
3
Page 2 - Grace A. Carlson, MD
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 M. Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
16073057 P. 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: PULSARIM Generator and PEAK PlasmaBlade 10 Tissue Dissection Device
Indications for Use:
The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
PEAK Surgical, Inc.
October 29, 2007
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)
(Division Sign-Off) Division of General, Restorative, PULSAR Generator and PEAK PlasmaBlade Premailed Nemendogical Devices
510(k) Number
20