(184 days)
The Epix® Electrosurgical Probes are indicated for irrigation, evacuation of fluids, and electrosurgical cutting and coagulation during general laparoscopic procedures.
Electrosurgical probes are reusable suction and irrigation devices designed for electrosurgical cutting and coagulation of tissue during general laparoscopic procedures.
The provided text describes the 510(k) summary for the Epix® Electrosurgical Probes, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a device using AI, or complex performance metrics such as sensitivity, specificity, or reader studies.
Therefore, many of the requested categories, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not applicable to this type of regulatory submission. This submission is for a traditional surgical device, not an AI/ML software device.
Here's a breakdown of the relevant information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance (Conclusions from Testing) |
|---|---|
| IEC 60601-1 (General requirements for safety) | "Testing demonstrates that the subject Epix Electrosurgical Probes are substantially equivalent to the predicate Modulap Reusable Unipolar Electrosurgical Probes." |
| IEC 60601-1-2 (Electromagnetic compatibility) | Performance was evaluated "side-by-side to evaluate substantial equivalence of performance in a laboratory setting." |
| IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories) | Bench top tests focused "on the functional performance of the suction and irrigation features." |
| ISO 10993 (Biological Evaluation of Medical Devices) | This indicates biological safety was addressed as per the standard. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable for this type of device submission. The performance testing described is benchtop testing comparing the subject device to a predicate device, not a clinical study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. Ground truth, in the context of clinical expert review, is not relevant for a benchtop performance comparison of physical medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data (e.g., images), which is not the case here.
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:
This information is not applicable. This is a traditional electrosurgical probe, not an AI/ML-driven device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission is based on the performance of the legally marketed predicate device and compliance with recognized international safety and performance standards for electrosurgical equipment (IEC 60601 series, ISO 10993). The performance of the subject device was compared to the predicate device in a laboratory setting.
8. The sample size for the training set:
This information is not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" for this device.
{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 Corporation22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000 |
|---|---|
| Contact Person: | Jessica ChoRegulatory Affairs SpecialistApplied Medical Resourcesjcho@appliedmedical.comTel: (949) 713-8470 ext. 6697Fax: (949) 713-8205 |
| Date of Preparation: | July 22, 2013 |
| Trade Name: | Epix® Electrosurgical Probes |
| Common Name: | Electrosurgical Probes |
| Classification: | Class IIProduct Code: GEIRegulation: 21 CFR 878.4400 |
| Predicate Device: | Modulap™ Reusable Unipolar Electrosurgical Probes510(k)#: K983623Product Code: GCJ |
| Device Description: | Electrosurgical probes are reusable suction and irrigation devicesdesigned for electrosurgical cutting and coagulation of tissue duringgeneral laparoscopic procedures. |
| Intended Use: | The Epix® electrosurgical probes are indicated for irrigation,evacuation of fluids, and electrosurgical cutting and coagulation duringgeneral 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
§ 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.