(184 days)
Not Found
No
The summary describes a standard electrosurgical probe for cutting and coagulation, with no mention of AI/ML features or data processing that would typically involve such technologies. The performance studies focus on functional equivalence of suction and irrigation.
Yes
The device is used for electrosurgical cutting and coagulation of tissue during laparoscopic procedures, which are medical interventions aimed at treating conditions.
No.
The device's stated intended use is for electrosurgical cutting and coagulation, and irrigation/evacuation, which are therapeutic and procedural functions, not diagnostic ones. There is no mention of identifying or diagnosing a disease or condition.
No
The device description explicitly states it is a reusable suction and irrigation device, which are hardware components, and the performance studies focus on the functional performance of these hardware features.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures." This describes a surgical tool used directly on the patient's tissue, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description reinforces this, stating it's a "reusable suction and irrigation device designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures." Again, this points to a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on surgical intervention in vivo.
N/A
Intended Use / Indications for Use
The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Electrosurgical probes are reusable suction and irrigation devices designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures.
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)
The Epix Electrosurgical Probes are designed to the following safety and performance standards: 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, and ISO 10993 Biological Evaluation of Medical Devices.
Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence of performance in a laboratory setting. The bench top tests were designed to focus on the functional performance of the suction and irrigation features.
Testing demonstrates that the subject Epix Electrosurgical Probes are substantially equivalent to the predicate Modulap Reusable Unipolar Electrosurgical Probes.
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
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(K) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jessica Cho
Regulatory Affairs Specialist
Applied Medical Resources
jcho@appliedmedical.com
Tel: (949) 713-8470 ext. 6697
Fax: (949) 713-8205 |
| Date of Preparation: | July 22, 2013 |
| Trade Name: | Epix® Electrosurgical Probes |
| Common Name: | Electrosurgical Probes |
| Classification: | Class II
Product Code: GEI
Regulation: 21 CFR 878.4400 |
| Predicate Device: | Modulap™ Reusable Unipolar Electrosurgical Probes
510(k)#: K983623
Product Code: GCJ |
| Device Description: | Electrosurgical probes are reusable suction and irrigation devices
designed for electrosurgical cutting and coagulation of tissue during
general laparoscopic procedures. |
| Intended Use: | The Epix® electrosurgical probes are indicated for irrigation,
evacuation of fluids, and electrosurgical cutting and coagulation during
general laparoscopic procedures. |
Summary of Technological Characteristics:
The Epix® Electrosurgical Probes are substantially equivalent in safety and effectiveness to the Modulap™ Reusable Unipolar Electrosurgical Probes (K983623).
The subject and predicate device are similar in tip-configuration, size, materials, technology, and Priveres They are reusable, suction and irrigation devices designed for electrosurgical cutting and coagulation during general laparoscopic procedures. The subject and predicate electrosurgical probes are each designed to interface and function when connected to a suction irrigation tubing set and electrosurgical generator.
1
Discussion of Performance Testing:
The Epix Electrosurgical Probes are designed to the following safety and performance standards: 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, and ISO 10993 Biological Evaluation of Medical Devices.
Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence of performance in a laboratory setting. The bench top tests were designed to focus on the functional performance of the suction and irrigation features.
Conclusions Drawn from Testing:
Testing demonstrates that the subject Epix Electrosurgical Probes are substantially equivalent to the predicate Modulap Reusable Unipolar Electrosurgical Probes.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
January 24, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Applied Medical Resources Corporation Ms. Jessica Cho Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K132300
Trade/Device Name: Epix® Electrosurgical Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 14, 2014 Received: January 16, 2014
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 (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.
3
Page 2 - Ms. Jessica Cho
Status (1) The States (1) The States (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshuaj@JWipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510 (K) Number: K132300
Device Name: Epix® Electrosurgical Probes
Indications for Use: The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
Long H. Chen -A
2.19200300.100.1.1=130038 4:24:42 -05-00
for BSA
(Division Sign-Off)
Division of Surgical Devices
510(k) Number: K132300