(150 days)
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.
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 provided text describes a 510(k) submission for the PEAK Surgery System, specifically the PULSAR II Generator, which is a modification of a previously cleared device. The submission focuses on demonstrating substantial equivalence to the predicate device, not on meeting specific performance acceptance criteria through a clinical study with a defined dataset.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document does not provide specific acceptance criteria (e.g., a certain sensitivity, specificity, accuracy, or performance metric) for the device. Instead, it states that "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications." It then concludes that "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria." This is a regulatory statement of equivalence, not a report of specific performance against predefined acceptance criteria from a study.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This was not a study evaluating performance against a test set with human data. The "tests" mentioned were likely engineering and functional performance tests for the device's hardware, circuitry, and output energy, comparing them to the predicate device. The context implies these were laboratory tests rather than tests on a dataset of clinical cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No. This device is an electrosurgical unit, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's performance was evaluated independently. However, this was not an "algorithm only" evaluation as understood in AI/software. Rather, it refers to the engineering and functional performance of the electrosurgical unit. The "Laboratory and performance tests" assessed the device itself (PULSAR II Generator and PlasmaBlade Tissue Dissection Devices) to ensure it functioned as intended and met design specifications, and that its output energy and delivery system were similar to the predicate.
7. The Type of Ground Truth Used
Not applicable in the context of clinical ground truth (e.g., pathology, outcomes data, expert consensus). For electrosurgical devices, "ground truth" would typically refer to established engineering specifications, safety standards, and performance benchmarks for electrosurgical energy output, tissue cutting, and coagulation characteristics. The "performance data" likely referred to measurements and observations against these engineering standards.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware electrosurgical unit, not a machine learning model. There is no concept of a "training set" for such a device in the context of this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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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)
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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.
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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.
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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
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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
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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)
§ 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.