(151 days)
Not Found
No
The summary describes a standard electrosurgical device with suction capabilities and does not mention any AI/ML components or functionalities.
No
The device is described as an "electrode attachment" intended for "coagulation of tissue and suction of fluids" during surgical procedures, which are functions during a procedure rather than therapeutic in themselves.
No.
The device is a surgical tool designed for coagulation of tissue and suction of fluids during electrosurgical procedures, not for diagnosis.
No
The device description clearly outlines physical components (suction lumen, bendable shaft, finger grip) and its function as an electrode attachment for a handpiece, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures to coagulate tissue and suction fluids. This is a direct intervention on the patient's body during surgery.
- Device Description: The device is a surgical tool that attaches to a handpiece for electrosurgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body during a surgical procedure.
N/A
Intended Use / Indications for Use
The PEAK Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils or adenoids.
The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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. Data demonstrated that the PEAK Suction Coagulator complies with the following standards:
- IEC 60601-1; Medical Electrical Equipment Part 1: General Requirements for . ● Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- . IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements for Safety: Electromagnetic Compatibility, 2001, Amendment 1: 2004.
- . IEC 60601-2-2; Medical Electrical Equipment -- Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Fourth Edition, 2006)
- ISO 11135-1; Sterilization of Healthcare Products - Ethylene Oxide - Part1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices (First Edition, 2007)
- . ISO 10993-1; Biological evaluation of medical devices - Part I: Guidance on selection of tests (2009)
- . ISO 10993-7; Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals (2008)
Histological studies comparing thermal effects of the device to the predicate device demonstrated that the PEAK Suction Coagulator 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
K103775 Pg 1 of 3
510(k) Summary: PEAK Suction Coagulator
MAY 2 7 2011
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: April 29, 2011
2. Device Name:
| Trade Name: | PEAK Suction Coagulator |
|---|---|
| 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 |
3. Predicate Devices:
Valleylab Suction Coagulator (K091223) PEAK PlasmaBlade® TnA (K083415)
1
Device Description: 4.
The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.
2.4 2