(402 days)
Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.
HS AMICA devices family is a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
AMICA-GEN is available in the following different models: AMICA-GEN AGN (Microwave generator only), AMICA-GEN AGN-R (Radiofrequency generator only), and AMICA-GEN AGN-H (Hybrid Microwave and Radiofrequency generator). The MW and RF outputs can never be activated simultaneously. The actual energy source in use depends on the applied part type, RF or MW, connected to the generator.
There are several available variants of PROBE (i.e. the applied parts for direct energy delivery into the patient's body for percutaneous or intra-operative use): AMICA-PROBE (disposable device for MW energy delivery) and RF AMICA-PROBE (monopolar, straight, stainless steel electrode for RF energy delivery).
HS AMICA devices family consists of non-sterile reusable electronic parts, and sterile disposable applied parts. The sterilization method used for all the sterile components is Ethylene Oxide.
The microwave devices can be operated in continuous and PULSE mode. The PULSE mode is new operational mode with a duty cycle of 40% and a max output power of 190 Watts.
The provided text is a 510(k) Summary for a medical device (HS AMICA devices family) seeking clearance from the FDA. It primarily focuses on comparing the new device to a predicate device and demonstrating substantial equivalence through various tests and compliance with standards.
However, the document does not describe an AI/ML-based medical device. The "AI" term in the prompt implies such a device. This document describes an "Electrosurgical Cutting and Coagulation Device and Accessories," which uses microwave and radiofrequency energy for thermo-ablation of soft tissues. The software update mentioned (Rev. 1.7.1) appears to be a general software update for device control, not an AI/ML algorithm for diagnostic or prognostic purposes.
Therefore, the specific information requested about acceptance criteria and studies for an AI/ML device (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) is not present in the provided text as it pertains to an AI/ML aspect.
The document does mention "Performance Data" and "Thermal Effects performance tests" with ex-vivo bovine liver, kidney, and muscle as part of the verification and validation studies. It states that "the system passed all pre-determined acceptance criteria identified in the test plan." However, it does not explicitly list these acceptance criteria or the reported performance in a quantitative, granular way as would be expected for an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). The nearest it comes to a performance claim is that "PULSE mode ablations allowed for slightly more spherical ablations."
Based on the provided text, I cannot fulfill the request for information regarding AI/ML device acceptance criteria and study details because the device described is not an AI/ML device.
If the question were rephrased to be about the non-AI medical device described in the document, here's what could be extracted, though it would still be limited:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with EN 60601-1:2006+A11:2011+A1:2013 (Medical electrical equipment – General requirements for basic safety and essential performance) | Device complies. |
| Compliance with EN 60601-2-2:2009+A11:2011 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of high frequency surgical equipment) | Device complies. |
| Compliance with EN60601-2-6:2015+A11:2016 (Medical electrical equipment – Particular requirements for the basic safety and essential performance of microwave therapy equipment) | Device complies. |
| Compliance with EN 60601-1-2:2015 (Medical electrical equipment – Electromagnetic disturbances – Requirements and tests) | Device complies. |
| Compliance with IEC 62304:2015-06 (Medical device software – Software life cycle processes) | Device complies. |
| Compliance with ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Device complies. |
| Compliance with ISO 10993-7-2008 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals) | Device complies. |
| Compliance with ISO 11135-2014 (Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices) | Device complies. |
| Compliance with ISO 11138-1-2006 (Sterilization of health care products – Biological indicators – Part 1: General requirements) | Device complies. |
| Compliance with ISO 11737-1-2006 (Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products) | Device complies. |
| Compliance with ISO 11737-2-2009 (Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process) | Device complies. |
| Performance test-bench for Thermal Effects (as per FDA guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery) - "safely and effectively as predicate device" for soft tissue coagulation. | Demonstrated safe and effective performance in coagulation of soft tissues with microwave energy, comparable to the predicate. PULSE mode enabled "slightly more spherical ablations." |
2. Sample sized used for the test set and the data provenance:
- The document mentions "Thermal Effects tests with ex-vivo bovine liver, kidney and muscle." No specific sample sizes (number of tissue samples or experiments) are provided.
- Data provenance: Ex-vivo bovine tissues.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned, as this is a performance test on tissue, not an AI ground truth establishment.
4. Adjudication method for the test set:
- Not applicable/Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done as this is not an AI/ML device for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a standalone electrosurgical system. The performance tests were of the device's ability to ablate tissue.
7. The type of ground truth used:
- The "ground truth" for the performance tests was the observable thermal ablation effects on ex-vivo bovine tissues (e.g., size and shape of ablation zone).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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October 28, 2019
HS Hospital Service SPA % Silvia Scarpellini Regulatory Affairs Consultant ISEMED srl Via P. Togliatti 19/X Imola. 40026 Italy
Re: K182605
Trade/Device Name: HS AMICA devices family Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 17, 2018 Received: September 21, 2018
Dear Silvia Scarpellini:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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) K182605
Device Name HS AMICA DEVICES FAMIL Y
Indications for Use (Describe) Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.
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
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HS AMICA devices family
510(K) SUMMARY
HS AMICA devices family
This 510(k) Summary is being submitted in accordance with the requirements of 21CFR 807.92.
1. General Information
| Submitter: | H.S. Hospital Service S.p.A.Via A. Vacchi, 23/2504011 Aprilia (LT) – ItalyTel.: +39 06 9201961Fax: +39 06 92727871 |
|---|---|
| Establishment Registration Number: | 810312 |
| Contact Person in Italy: | Silvia ScarpelliniISEMED srlVia P.Togliatti, 19/X40026 Imola (BO) Italyphone: (+39) 0542 683803 ext 212Fax: +39 0542 698456Email: regulatory@isemed.eu |
| Summary Preparation Date: | October 24, 2019 |
2. Device
| Device Name | HS AMICA devices family |
|---|---|
| Classification name | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI |
| Regulation number | 878.4400 |
| Class | II |
3. Predicate Device
HS AMICA devices family is substantially equivalent to the following device legally marketed in US:
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HS AMICA devices family
| Applicant | Device name | 510(k) Number |
|---|---|---|
| H.S. HOSPITAL SERVICE S.P.A. | HS AMICA devices family | K150112 |
4. Device Description
HS AMICA devices family is the advance version of the design of the legally marketed HS AMICA devices family Ablation System (K150112).
AMICA-GEN is available in the following different models (same as in K150112):
- AMICA-GEN AGN: Microwave generator only .
- AMICA-GEN AGN-R: Radiofrequency generator only .
- AMICA-GEN AGN-H: Hybrid Microwave and Radiofrequency generator (NB: the . MW and RF outputs can never be activated simultaneously. The actual energy source in use depends on the applied part type, RF or MW, connected to the generator)
HS AMICA devices family is a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
There are several available variants of PROBE (i.e. the applied parts for direct energy delivery into the patient's body for percutaneous or intra-operative use):
- AMICA-PROBE's design is identical to that already cleared in K150112: disposable device for MW energy delivery into tissues through an embedded coaxial antenna of asymmetric dipole type. The antenna is lodged into a stainless steel needle serving as introducer. AMICA-PROBE is internally cooled all along the introducer length. The distal emitting tip (uncooled) -terminated by a sharp pyramidal metallic tip for facilitating tissue penetration- is endowed with a patented miniaturized choke for reflected waves confinement, so as to ensure a more spherical ablation shape;
- RF AMICA-PROBE 's design is identical to that already cleared in K150112. ● RF AMICA-PROBE is a monopolar (i.e. single terminal), straight, stainless steel electrode, covered with an insulating sheath throughout its length, but for a few millimeters or centimeters at its distal tip (therefore referred to as "exposed tip"), which is terminated by a sharp pyramidal point for facilitating tissue penetration. RF AMICA-PROBE is internally cooled down to the exposed tip. When using RF AMICA-PROBE the current output to the patient's body delivered through the probe exposed tip must return to the generator through one or more "return
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electrodes" (also referred to as "grounding pads" or "dispersion plates" or "neutral electrodes"), in the form of metallic foils attached to the patient's skin and directly connected to the current generator.
HS AMICA devices family consists of non-sterile reusable electronic parts, and sterile disposable applied parts, identically to the predicate device HS AMICA devices family (K150112). The sterilization method used for all the sterile components is Ethylene Oxide. The method is exactly the same used and validated for the predicate device cleared in HS AMICA devices family.
The microwave devices can be operated in continuous and PULSE mode. The PULSE mode is new operational mode with a duty cycle of 40% and a max output power of 190 Watts.
5. Indications for use
Coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
6. Comparison of technological characteristics with the predicate devices
This subject device is the advance version of the previous HS AMICA devices family (K150112), that has been included in the present submission as predicate device. They have identical indications for use and same technology features, with the following different technical features in the subject device:
- a) new option of Microwave power delivery algorithms; namely, the "PULSED" mode, which provides for intermittent energy delivery according to a given working cycle.
- b) software version updated to Rev. 1.7.1
The comparison of the subject and predicate devices based on indications for use, technology and performance characteristics, is summarized in the following table and discussed below.
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| PREDICATEDEVICE | |||||
|---|---|---|---|---|---|
| H.S. HOSPITAL SERVICE | H.S.HOSPITALSERVICE | ||||
| HS AMICA DEVICES FAMILY | AMICA GEN AGN-H | ||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | |||
| 510(k) Number | K150112 | ||||
| General features | |||||
| Classification | II | II | |||
| Regulation number | 878.4400 | 878.4400 | |||
| Product Code | GEI | GEI | |||
| Indication statements | |||||
| Intended use | Coagulation (thermo-ablation) of soft tissues.Not for use in cardiacprocedures | Coagulation (thermo-ablation) of soft tissues.Not for use in cardiacprocedures | |||
| Mechanism of action | Interstitialthermoablation ofsoft tissues throughcontrolled emissionof MW energy at thetip of a microwavecoaxial antennalodged into a needle | Interstitialthermoablation of softtissues throughcontrolled emission ofMW energy or RFenergy (non-simultaneous),respectively at the tip of a microwave coaxial | Interstitialthermoablation of softtissues throughcontrolled emission ofRF energy at the tip ofRF electrodes | Interstitialthermoablation of softtissues throughcontrolled emission ofMW energy or RFenergy (non-simultaneous),respectively at the tipof a microwave coaxial | |
| H.S. HOSPITAL SERVICE | PREDICATE DEVICE | ||||
| HS AMICA DEVICES FAMILY | H.S. HOSPITAL SERVICE | ||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | ||
| antenna lodged into aneedle or at the tip ofRF electrodes | antenna lodged into aneedle or at the tip ofRF electrodes | ||||
| Technical features | |||||
| Design structure | • Generator• Applicator (coaxialmicrowaveapplicator)• Cooling system(peristaltic pump,coolant tank andtubing for applicatorcooling)• Footswitch | • Generator• Applicators (coaxialmicrowave applicator,RF applicator)• Return pad• Cooling system(peristaltic pump,coolant tank and tubingfor applicator cooling)• Footswitch | • Generator• Applicator (RFapplicator)• Return pad• Cooling system(peristaltic pump,coolant tank and tubingfor applicator cooling)• Footswitch | • Generator• Applicators (coaxialmicrowave applicator,RF applicator)• Return pad• Cooling system(peristaltic pump,coolant tank and tubingfor applicator cooling)• Footswitch | |
| MicrowaveapplicatorConnection | Yes | Yes | No | Yes | |
| Radiofrequencyapplicator connection | No | Yes | Yes | Yes | |
| Return pad connection | No | Yes | Yes | Yes | |
| PREDICATEDEVICE | |||||
| H.S. HOSPITALSERVICE | |||||
| H.S. HOSPITAL SERVICE | AMICA GEN AGN-H | ||||
| HS AMICA DEVICES FAMILY | |||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | |||
| Cooling systemmanagement | Automatic | Automatic | Automatic | Automatic | |
| Coolant | Sterile Disposablesaline solution | Sterile Disposablesaline solution | Sterile Disposablesaline solution | Sterile Disposablesaline solution | |
| Needle temperaturerange (°C) | From 16 to 100 | From 16 to 100 | From 16 to 100 | From 16 to 100 | |
| Treatment time range(min) | Up to 30 | Up to 30 | Up to 30 | Up to 30 | |
| Microwave emission features | |||||
| Microwave frequency(MHz) | 2450 | 2450 | - | 2450 | |
| Output power (W) | Up to 140 (forcontinuous mode)Up to 190 (for pulsedmode) | Up to 140 (forcontinuous mode)Up to 190 (for pulsedmode) | - | Up to 140 (onlycontinuous modeavailable) | |
| Microwave powerdelivered control | Manual | Manual | - | Manual | |
| Microwave applicators features | |||||
| Microwave applicator | 11-14-16 | 11-14-16 | - | 11-14-16 | |
| H.S. HOSPITAL SERVICE | PREDICATEDEVICE | ||||
| HS AMICA DEVICES FAMILY | H.S. HOSPITALSERVICE | ||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | ||
| needle diameters(Gauge) | |||||
| Microwave applicatorneedle lengths (cm) | 15-20-27 | 15-20-27 | - | 15-20-27 | |
| Microwave applicatorterminal lengths (mm) | 19 | 19 | - | 19 | |
| Radiofrequency emission features | |||||
| Radiofrequencyfrequency (kHz) | - | 450 | 450 | 450 | |
| Radiofrequency power(W) | - | Up to 200 | Up to 200 | Up to 200 | |
| Radiofrequency powerdelivery control | - | Manual or Automatic | Manual or Automatic | Manual or Automatic | |
| Radiofrequency poweroutput mode | - | Monopolar | Monopolar | Monopolar | |
| Operative impedancerange (Ω) | - | From 25 to 1000 | From 25 to 1000 | From 25 to 1000 | |
| Radiofrequency applicators features without local fluid delivery | |||||
| Radiofrequency | - | Single - Cluster | Single - Cluster | Single - Cluster | |
| PREDICATEDEVICE | |||||
| H.S. HOSPITAL SERVICE | H.S.HOSPITALSERVICE | ||||
| HS AMICA DEVICES FAMILY | |||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | ||
| applicator typologies | - | - | - | - | |
| Radiofrequencyapplicator needleDiameters (Gauge) | - | 17-18 | 17-18 | 17-18 | |
| Radiofrequencyapplicator needlelengths (cm) | - | 7-10-15-20-25-27 | 7-10-15-20-25-27 | 7-10-15-20-25-27 | |
| Radiofrequencyelectrode lengths (mm) | - | 5-7-10-15-20-25-30-35 | 5-7-10-15-20-25-30-35 | 5-7-10-15-20-25-30-35 | |
| Radiofrequency applicators features with local fluid delivery | |||||
| Radiofrequencyapplicator typologies | - | Single | Single | - | |
| Radiofrequencyapplicator needleDiameters (Gauge) | - | 17-18 | 17-18 | - | |
| Radiofrequencyapplicator needlelengths (Cm) | - | 7-10-15-20-25-27 | 7-10-15-20-25-27 | - | |
| Radiofrequency active | - | 5-7-10-15-20-25-30-35 | 5-7-10-15-20-25-30-35 | ||
| PREDICATEDEVICE | |||||
| H.S. HOSPITAL SERVICE | H.S. HOSPITALSERVICE | ||||
| HS AMICA DEVICES FAMILY | AMICA GEN AGN-H | ||||
| AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | |||
| tip lengths (mm) | |||||
| Dispensing holes inprobe variantsfeaturing local fluiddelivery | - | 1 or 2 | 1 or 2 | - | |
| Local fluid delivery(Yes/No) | - | Yes | Yes | No | |
| Safety features | |||||
| Condition of use ofapplicators | Sterile - disposable | Sterile - disposable | Sterile - disposable | Sterile - disposable |
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HS AMICA devices family
The list of the differences:
-
New option of Microwave power delivery algorithms: namely, the "PULSED" a) mode, which provides for intermittent energy delivery according to a given working cycle
The difference does not raise new effectiveness or safety issues for the following reasons: -
HS AMICA devices family does not establish the power delivery mode to be . used. This is set by physician.
-
. The total maximum output power of the PULSE mode within the ablation period is 190x40%=76W, which is less than the maximum output power 140W of the continuous mode in the predicate device.
- · Thermal Effects tests with ex-vivo bovine liver, kidney and muscle demonstrated the ablation can be done with the PULSE mode as safely and effectively as the continuous mode.
b) Software version updated to Rev. 1.7.1
HS AMICA medical devices family has been developed and validated according to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices requirements FDA-May 2005 and IEC 62304.
In conclusion, the different technological features of HS AMICA devices family will not affect its classification, working principle, intended use, indications for use and target population and will not rise up new safety and effectiveness questions making HS AMICA devices family equivalent to predicate device (K150112).
7. Performance Data
The HS AMICA medical devices family and accessories and the predicate device are substantially equivalent in design concepts, technologies and materials. HS AMICA medical devices family has been verified through rigorous testing that, in part, supports the compliance of Ablation System and Accessories to the standards listed below. The system passed all pre-determined acceptance criteria identified in the test plan. HS AMICA devices family complies with:
S AMICA devices family complies with:
- EN 60601-1:2006+A11:2011+A1:2013
- EN 60601-2-2:2009+A11:2011
- EN60601-2-6:2015+A11:2016
- EN 60601-1-2:2015
- IEC 62304:2015-06
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510(k) Summary for K182605
H.S. Hospital Service S.p.A.
HS AMICA devices family
- ISO 10993-1:2009
- ISO 10993-7-2008
- ISO 11135-2014
- ISO 11138-1-2006
- ISO 11737-1-2006
- ISO 11737-2-2009
- . Performance test-bench
Thermal Effects performance tests, as suggested in FDA guidance Premarket Notification (510(K)) Submissions for Electrosurgical Devices for General Surgery, were conducted with the proposed device. Testing results with Ex-Vivo bovine liver, kidney and muscle demonstrated that HS AMICA devices family can perform as safely and effectively as the predicate device K150112 in coagulation of soft tissues with microwave energy. Results indicated that PULSE mode ablations allowed for slightly more spherical ablations, and thus offers physicians a wider range of options for tailoring the ablation shape and size to each individual clinical case.
8. Conclusions
Based on the results of Verification and Validation Studies, H.S. Hospital Service S.p.A. concludes that the advance devices HS AMICA devices family are as safe and effective as the predicate device (K150112).
§ 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.