(262 days)
No
The 510(k) summary describes a standard electrosurgical probe with a smoke evacuation feature. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies focus on physical characteristics like aspiration flow rate and thermal spread, not algorithmic performance.
No.
The device is used to deliver energy to cut and coagulate tissue during surgical procedures, which is a surgical tool rather than a therapeutic device for treating a condition.
No
Explanation: The device is described as an electrosurgical probe intended to cut and coagulate tissue and evacuate smoke during surgical procedures. Its function is interventional (therapeutic), not diagnostic.
No
The device description clearly outlines physical components (probes, shaft, handpiece) and requires connection to external hardware (electrosurgical generator, vacuum source) for operation. It is a hardware device with a smoke evacuation feature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Epix® Electrosurgical Probes with Smoke Evacuation are used during surgical procedures to cut and coagulate tissue and evacuate smoke. They directly interact with the patient's body during surgery.
- Intended Use: The intended use clearly states it's for "delivering energy... to cut and coagulate tissue during laparoscopic... surgical procedures." This is a therapeutic and surgical function, not a diagnostic test performed on a sample outside the body.
The device is a surgical instrument used for treatment and procedural support, not for diagnosing a condition based on laboratory analysis of a sample.
N/A
Intended Use / Indications for Use
The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Product codes
GEI
Device Description
Electrosurgical probes are designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures. The device also has a smoke evacuation feature. The subject device has an angled shaft that fits through 10mm trocar cannulas and must be connected to a standard electrosurgical generator and a vacuum source in order to operate according to its intended use. The shaft can be rotated 360 degrees using a knob on the handpiece.
The probes are available in the following tip configurations:
- Spatula Tip
- L-Hook Tip
- Needle Tip
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
The Epix Electrosurgical Probes are designed/evaluated to the following safety and performance standards/tests:
- IEC 60601-1 Medical electrical equipment General requirements for safety
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- ISO 10993 Biological Evaluation of Medical Devices.
- Aspiration flow rate (smoke evacuation feature) comparison testing against a reference device: the Applied Medical Suction/Irrigator cleared in K003443. This device is also marketed by Applied Medical and contains a smoke evacuation feature when connected to the hospital vacuum source.
Thermal spread during electrosurgical cutting and coagulation was evaluated side-by-side with the predicate Microline™ Electrosurgical Cautery Probes (K981188) and also against a reference device, the Applied Medical Epix Electrosurgical S/I Probes (K132300). Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures. All applicable functions (i.e., electrosurgical cut and coagulation) were tested using high, medium, and low settings on a monopolar generator. Thermal spread was found to be similar between the subject, predicate, and reference devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three intertwined lines, representing the three branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2016
Applied Medical Resources Ms. Jessica Cho.MS Manager, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K151480
Trade/Device Name: Epix Electrosurgical Probe with Smoke Evacuation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulatory Class: Class II Product Code: GEI Dated: January 26, 2016 Received: January 27, 2016
Dear Ms. Cho:
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 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 of medical devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151480
Device Name
Epix® Electrosurgical Probes with Smoke Evacuation
Indications for Use (Describe)
The Epix® Electrosurgical Probes with Smoke Evacuation (spatula, L-hook, needle tips) are intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic (inclusive of endoscopic) surgical procedures where is introduced into the body through a cannula. The device may be used for the evacuation of smoke created by electrosurgery at the surgical site.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| 510(K) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Jessica Cho, MS
Manager, Regulatory Affairs
Applied Medical Resources
jcho@appliedmedical.com
Tel: (949) 713-7958
Fax: (949) 713-8205 |
| Date of Preparation: | January 26, 2016 |
| Trade Name: | Epix® Electrosurgical Probes with Smoke Evacuation |
| Common Name: | Electrosurgical Probes |
| Classification: | Electrosurgical cutting and coagulation device and accessories.
Class II, Product Code: GEI, Regulation: 21 CFR 878.4400 |
| Primary Predicate
Device: | Microline™ Pentax Inc Electrosurgical Cautery Probes
510(k): K981188
Product Code: GEI |
| Reference Device: | Applied Medical Suction/Irrigator
510(k): K003443
Product Code: FHF
Applied Medical Epix Electrosurgical S/I Probes
510(k): K132300
Product Code: GEI |
| Intended Use: | The Epix® Electrosurgical Probes with Smoke Evacuation (spatula,
L-hook, needle tips) are intended to deliver energy from an
independent monopolar electrosurgical generator to cut and
coagulate tissue during laparoscopic (inclusive of endoscopic)
surgical procedures where the device is introduced into the body
through a cannula. The device may be used for the evacuation of
smoke created by electrosurgery at the surgical site. |
| Device Description: | Electrosurgical probes are designed for electrosurgical cutting and
coagulation of tissue during general laparoscopic procedures. The
device also has a smoke evacuation feature. The subject device has
an angled shaft that fits through 10mm trocar cannulas and must be
connected to a standard electrosurgical generator and a vacuum
source in order to operate according to its intended use. The shaft |
4
can be rotated 360 degrees using a knob on the handpiece.
The probes are available in the following tip configurations:
- Spatula Tip
- L-Hook Tip ●
- Needle Tip
Summary of Technological Characteristics:
The subject electrosurgical probes feature a monopolar connector post at the base of the pistol grip handle, which may be connected to the monopolar port of an electrosurgical generator (ESG), via a standard 4mm cable, to perform electrosurgery.
When the ESG is activated by its footswitch(es), RF energy is conducted from the connector, along the shaft, and delivered at the tip. Cutting and coagulation using the subject device is fully dependent on the output waveform from the connected ESG.
A long flexible tube extends from the handpiece and connects the device to a vacuum source available in most operating suites. The smoke aspiration rate is fully dependent on the pressure of the vacuum source.
The subject and the predicate Microline™ Electrosurgical Cautery Probes (K981188) devices are similar in tip-configuration, size, materials, technology, and performance. Both are devices designed for electrosurgical cutting and coagulation during general laparoscopic procedures and function when connected to a standard electrosurgical generator.
The main difference between subject and predicate is that the subject device has a smoke evacuation capability.
Discussion of Performance Testing:
The Epix Electrosurgical Probes are designed/evaluated to the following safety and performance standards/tests:
- IEC 60601-1 Medical electrical equipment General requirements for safety ●
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for safety -● Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-2-2 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- ISO 10993 Biological Evaluation of Medical Devices.
- Aspiration flow rate (smoke evacuation feature) comparison testing against a reference device: the Applied Medical Suction/Irrigator cleared in K003443. This device is also marketed by Applied Medical and contains a smoke evacuation feature when connected to the hospital vacuum source.
Thermal spread during electrosurgical cutting and coagulation was evaluated side-by-side
5
with the predicate Microline™ Electrosurgical Cautery Probes (K981188) and also against a reference device, the Applied Medical Epix Electrosurgical S/I Probes (K132300). Testing was performed in vitro using tissue that is representative of what the device may encounter during general laparoscopic procedures. All applicable functions (i.e., electrosurgical cut and coagulation) were tested using high, medium, and low settings on a monopolar generator. Thermal spread was found to be similar between the subject, predicate, and reference devices.
Conclusions Drawn from Testing:
The subject Epix Electrosurgical Probes with Smoke Evacuation are substantially equivalent to the predicate Microline™ Electrosurgical Cautery Probes (K981188) with the additional capability of removing smoke from the operative site. Thermal spread was found to be substantially equivalent to the predicate Microline device. The smoke evacuation feature was found to be comparable to a separate reference device, the Applied Medical Suction/Irrigator cleared in K003443.
The Epix® Electrosurgical Probes with Smoke Evacuation are substantially equivalent in safety and effectiveness to the Microline™ Electrosurgical Cautery Probes (K981188).