(61 days)
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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.
The Epix Electrosurgical Probe with Smoke Evacuation is a sterile, single-use monopolar instrument equipped with a smoke evacuation feature. The proposed device uses RF energy provided by a generator to electrosurgically cut and/or coagulate tissue during general laparoscopic procedures. The electrosurgical probes are available in three different tip geometries with probe lengths ranging between 20cm - 45cm. All models are constructed of the same materials and by similar manufacturing assembly processes.
This document from the FDA describes the substantial equivalence determination for the "Epix Electrosurgical Probe with Smoke Evacuation" (K171684) compared to a predicate device, the "Epix Electrosurgical Probes" (K132300).
The provided text does not contain the detailed acceptance criteria or the specific study results in the format requested. It states that certain performance tests were conducted and that the device "Met Acceptance Criteria" or was "Substantially Equivalent," but it does not specify what those criteria were (e.g., a numerical threshold or a specific characteristic being achieved) or the quantitative results of the tests.
Therefore, I cannot fulfill all parts of your request with the given information. However, I can extract the available information regarding performance data.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Reported Device Performance |
|---|---|
| Electrosurgical Performance | Substantially Equivalent |
| Smoke Evacuation Performance | Substantially Equivalent |
| Biocompatibility | Met Acceptance Criteria |
| Mechanical Testing | Met Acceptance Criteria |
| Electrical Safety Testing | Met Acceptance Criteria |
| Electromagnetic Compatibility (EMC) Testing | Met Acceptance Criteria |
Missing Information: The document does not specify the actual acceptance criteria (e.g., "electrical impedance within X ohms," "smoke evacuation rate of Y L/min") for each test, only that they were met or that the device was substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It can be inferred that the testing was conducted by Applied Medical Resources Corporation for this FDA submission, likely within the US, but this is not explicitly stated.
- Retrospective or Prospective: Not specified. These were likely laboratory-based performance and safety tests rather than clinical studies.
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 and not provided. The performance tests described (Electrosurgical, Smoke Evacuation, Biocompatibility, Mechanical, Electrical Safety, EMC) are engineering and laboratory-based tests, not clinical evaluations requiring expert interpretation of results for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of subjective findings. The tests performed are objective performance measurements.
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 MRMC comparative effectiveness study was done. The device is a physical electrosurgical probe, not an AI-assisted diagnostic tool.
- The document explicitly states: "No animal or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical electrosurgical probe, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance tests listed, the "ground truth" would be established by validated test methodologies and engineering specifications, rather than clinical ground truth types like pathology or expert consensus. For example, for electrical safety, the ground truth is adherence to IEC standards. For biocompatibility, it's compliance with ISO 10993 series.
8. The sample size for the training set
- This information is not applicable as the device is a physical electrosurgical probe, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2017
Applied Medical Resources Corporation Aditi Iyengar Regulatory Affairs Analyst 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K171684
Trade/Device Name: Epix Electrosurgical Probe with Smoke Evacuation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 6, 2017 Received: June 7, 2017
Dear Aditi Iyengar:
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
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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 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. Jennifer R. Stevenson -S3
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Device Name
Epix® Electrosurgical Probe with Smoke Evacuation
Indications for Use (Describe)
The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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.
| 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) |
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510(k) Summary
| 510(K) Submitter: | Applied Medical Resources Corporation22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000 | ||
|---|---|---|---|
| Contact Person: | Aditi IyengarRegulatory Affairs AnalystApplied Medical Resourcesaiyengar@appliedmedical.comTel: (949) 713-8007Fax: (949) 713-8205 | ||
| Date of Preparation: | June 6, 2017 | ||
| Trade Name: | Epix® Electrosurgical Probes with Smoke Evacuation | ||
| Common Name: | Smoke Evacuation Electrosurgery Probes | ||
| Classification: | Electrosurgical cutting and coagulation device and accessories.Regulation: 21 CFR 878.4400Device Class: Class IIProduct Code: GEI | ||
| Predicate Device: | Epix® Electrosurgical Probes510(k)#: K132300Product Code: GEI | ||
| Device Description: | The Epix Electrosurgical Probe with Smoke Evacuation is a sterile,single-use monopolar instrument equipped with a smokeevacuation feature. The proposed device uses RF energy providedby a generator to electrosurgically cut and/or coagulate tissueduring general laparoscopic procedures. The electrosurgicalprobes are available in three different tip geometries with probelengths ranging between 20cm - 45cm. All models are constructedof the same materials and by similar manufacturing assemblyprocesses. The following configurations will be available: | ||
| Probe Length | Probe Configuration | Model Number | |
| 20 cm | Spatula TipL-Hook TipNeedle Tip | CW011CW012CW013 | |
| Probe Length | Probe Configuration | Model Number | |
| 35 cm | Spatula Tip | CW031 | |
| L-Hook Tip | CW032 | ||
| Needle Tip | CW033 | ||
| 42cm | Spatula Tip | CW001 | |
| L-Hook Tip | CW002 | ||
| Needle Tip | CW003 | ||
| 45cm | Spatula Tip | CW041 | |
| L-Hook Tip | CW042 | ||
| Needle Tip | CW043 |
27 cm
Spatula Tip
L-Hook Tip Needle Tip
CW021
CW022
CW023
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Intended Use: The Epix Electrosurgical Probe with Smoke Evacuation is intended to deliver energy from an independent monopolar electrosurgical generator to cut and coagulate tissue during laparoscopic 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.
Comparison of Technological Characteristics with the Predicate Device
The subject and predicate electrosurgical probes are similar in technological characteristics, materials, performance, and method of operation. They are designed to deliver RF energy via connection to an independent monopolar generator to electrosurgically cut and coagulate tissue during general laparoscopic procedures. The subject and predicate probes are both compatible with standard monopolar electrosurgical generators such as the Medtronic® ForceTriad® generator (K110268), ConMed® System 5000™ generator (K020186), or Karl Storz ® AUTOCON ® II 400 SCB generator (K062464), using a standard 4mm monopolar female connector. Additionally, both subject and predicate probes are also equipped with a suction feature to aid in visualization of the surgical site.
The following technological differences exist between the subject and predicate electrosurgical probes:
- The suction feature on the subject device is intended to evacuate smoke while the ● suction feature on the predicate device is intended to aspirate fluid.
- . The subiect product line is available in an additional tip configuration, needle tip, and the shaft length of the subject probe is available in the range of 20cm - 45cm where the predicate probe was cleared with a 33cm length.
Table 1 below provides a more detailed comparison of the subject and predicate electrosurgical probes.
| PredicateEpix Electrosurgical Probes | SubjectEpix Electrosurgical Probeswith Smoke Evacuation | |
|---|---|---|
| Trade Name | Epix Electrosurgical Probes | Epix Electrosurgical Probe withSmoke Evacuation |
| PredicateEpix Electrosurgical Probes | SubjectEpix Electrosurgical Probeswith Smoke Evacuation | |
| Probe TipConfigurations | • Spatula Tip• L-Hook Tip• J-Hook Tip | • Spatula Tip• L-Hook Tip• Needle Tip |
| 510(k) Holder | Applied Medical ResourcesCorporation | Same as predicate |
| 510(k) Number | K132300 | K171684 |
| Regulation | 21 CFR §878.4400 | Same as predicate |
| FDA Product Code | GEI | Same as predicate |
| DeviceClassification | FDA Class II | Same as predicate |
| Type of Use | Prescription Use Only | Same as predicate |
| Energy Type | Monopolar | Same as predicate |
| Energy source | Electrosurgical generatorprovided by user | Same as predicate |
| Cablecompatibility | Standard 4mm monopolarcables | Same as predicate |
| Materials | Stainless Steel, polymers | Same as predicate |
| Shaft Properties | • 33cm working length• 360 ° rotation• Straight | • 20cm - 45cm working lengths• 360 ° rotation• Angled at distal end |
| Single Use | No | Yes |
| Standards | Conforms to:• ISO 10993-series• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-2• IEC 60601-2-18• AAMI TIR 17 | Conforms to:• ISO 10993-series• IEC 60601-1• IEC 60601-1-2• IEC 60601-2-2• IEC 60601-2-18• ISO 11137-2• AAMI TIR 33 |
Table 1: Comparison of Characteristics
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Performance Data
The performance data in Table 2 is provided in support of the substantial equivalence determination.
Table 2: Substantial Equivalence Tests
| Test | Result |
|---|---|
| Electrosurgical Performance | Substantially Equivalent |
| Smoke Evacuation Performance | Substantially Equivalent |
The performance data in Table 3 is provided to demonstrate safety and efficacy of the subject devices.
Table 3: Performance Tests
| Test | Result |
|---|---|
| Biocompatibility | Met Acceptance Criteria |
| Mechanical Testing | Met Acceptance Criteria |
| Electrical Safety Testing | Met Acceptance Criteria |
| Electromagnetic Compatibility (EMC) Testing | Met Acceptance Criteria |
No animal or clinical studies were required to demonstrate the safety and efficacy of the subject device in support of this application for premarket clearance. The non-clinical performance data detailed in this submission supports the substantial equivalence of the subject device.
Conclusion
Based on the intended use, technological characteristics, and performance testing results, the subject Epix Electrosurgical Probes with Smoke Evacuation are substantially equivalent to the predicate Epix Electrosurgical Probes and do not raise any new issues of safety and efficacy.
§ 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.