HS AMICA devices family
Device Facts
| Record ID | K182605 |
|---|---|
| Device Name | HS AMICA devices family |
| Applicant | H.S Hospital Service S.P.A |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Oct 28, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
Device Story
HS AMICA devices family is a soft tissue ablation system for percutaneous or intra-operative use. It utilizes microwave (MW) energy via a coaxial antenna or radiofrequency (RF) energy via monopolar electrodes. The system includes a generator, cooling system (peristaltic pump/coolant), and disposable probes. The generator controls energy delivery; the new 'PULSED' mode provides intermittent MW energy (40% duty cycle, 190W max). Probes feature internal cooling and sharp tips for tissue penetration. Used by physicians in clinical settings to achieve thermo-ablation. The output (thermal energy) is controlled by the physician to coagulate soft tissue. Benefits include tailored ablation shapes and sizes for individual clinical cases.
Clinical Evidence
Bench testing only. Thermal effects performance tests were conducted on ex-vivo bovine liver, kidney, and muscle. Results demonstrated that the PULSED mode performs as safely and effectively as the continuous mode of the predicate device, providing more spherical ablation shapes.
Technological Characteristics
System includes microwave/RF generator, disposable cooled probes (stainless steel), and peristaltic cooling system. MW frequency: 2450 MHz; RF frequency: 450 kHz. Connectivity: footswitch. Sterilization: Ethylene Oxide. Software: Rev. 1.7.1. Standards: EN 60601-1, EN 60601-2-2, EN 60601-2-6, EN 60601-1-2, IEC 62304, ISO 10993-1, ISO 11135.
Indications for Use
Indicated for coagulation (thermo-ablation) of soft tissues. Not for use in cardiac procedures.
Regulatory Classification
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.
Predicate Devices
- HS AMICA devices family (K150112)
Submission Summary (Full Text)
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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.
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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.<br>Via A. Vacchi, 23/25<br>04011 Aprilia (LT) – Italy<br>Tel.: +39 06 9201961<br>Fax: +39 06 92727871 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 810312 |
| Contact Person in Italy: | Silvia Scarpellini<br>ISEMED srl<br>Via P.Togliatti, 19/X<br>40026 Imola (BO) Italy<br>phone: (+39) 0542 683803 ext 212<br>Fax: +39 0542 698456<br>Email: 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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| | | | | PREDICATE<br>DEVICE | |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | H.S. HOSPITAL SERVICE | | | H.S.<br>HOSPITAL<br>SERVICE | |
| | 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-<br>ablation) of soft tissues.<br>Not for use in cardiac<br>procedures | | Coagulation (thermo-<br>ablation) of soft tissues.<br>Not for use in cardiac<br>procedures | |
| Mechanism of action | Interstitial<br>thermoablation of<br>soft tissues through<br>controlled emission<br>of MW energy at the<br>tip of a microwave<br>coaxial antenna<br>lodged into a needle | Interstitial<br>thermoablation of soft<br>tissues through<br>controlled emission of<br>MW energy or RF<br>energy (non-<br>simultaneous),<br>respectively at the tip of a microwave coaxial | Interstitial<br>thermoablation of soft<br>tissues through<br>controlled emission of<br>RF energy at the tip of<br>RF electrodes | Interstitial<br>thermoablation of soft<br>tissues through<br>controlled emission of<br>MW energy or RF<br>energy (non-<br>simultaneous),<br>respectively at the tip<br>of 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 a<br>needle or at the tip of<br>RF electrodes | | antenna lodged into a<br>needle or at the tip of<br>RF electrodes | | |
| Technical features | | | | | |
| Design structure | • Generator<br>• Applicator (coaxial<br>microwave<br>applicator)<br>• Cooling system<br>(peristaltic pump,<br>coolant tank and<br>tubing for applicator<br>cooling)<br>• Footswitch | • Generator<br>• Applicators (coaxial<br>microwave applicator,<br>RF applicator)<br>• Return pad<br>• Cooling system<br>(peristaltic pump,<br>coolant tank and tubing<br>for applicator cooling)<br>• Footswitch | • Generator<br>• Applicator (RF<br>applicator)<br>• Return pad<br>• Cooling system<br>(peristaltic pump,<br>coolant tank and tubing<br>for applicator cooling)<br>• Footswitch | • Generator<br>• Applicators (coaxial<br>microwave applicator,<br>RF applicator)<br>• Return pad<br>• Cooling system<br>(peristaltic pump,<br>coolant tank and tubing<br>for applicator cooling)<br>• Footswitch | |
| Microwave<br>applicator<br>Connection | Yes | Yes | No | Yes | |
| Radiofrequency<br>applicator connection | No | Yes | Yes | Yes | |
| Return pad connection | No | Yes | Yes | Yes | |
| | | | | PREDICATE<br>DEVICE | |
| | | | | H.S. HOSPITAL<br>SERVICE | |
| H.S. HOSPITAL SERVICE | | | | AMICA GEN AGN-H | |
| HS AMICA DEVICES FAMILY | | | | | |
| | AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | | |
| Cooling system<br>management | Automatic | Automatic | Automatic | Automatic | |
| Coolant | Sterile Disposable<br>saline solution | Sterile Disposable<br>saline solution | Sterile Disposable<br>saline solution | Sterile Disposable<br>saline solution | |
| Needle temperature<br>range (°C) | From 16 to 100 | From 16 to 100 | From 16 to 100 | From 16 to 100 | |
| Treatment time range<br>(min) | Up to 30 | Up to 30 | Up to 30 | Up to 30 | |
| Microwave emission features | | | | | |
| Microwave frequency<br>(MHz) | 2450 | 2450 | - | 2450 | |
| Output power (W) | Up to 140 (for<br>continuous mode)<br>Up to 190 (for pulsed<br>mode) | Up to 140 (for<br>continuous mode)<br>Up to 190 (for pulsed<br>mode) | - | Up to 140 (only<br>continuous mode<br>available) | |
| Microwave power<br>delivered control | Manual | Manual | - | Manual | |
| Microwave applicators features | | | | | |
| Microwave applicator | 11-14-16 | 11-14-16 | - | 11-14-16 | |
| | H.S. HOSPITAL SERVICE | | | PREDICATE<br>DEVICE | |
| | HS AMICA DEVICES FAMILY | | | H.S. HOSPITAL<br>SERVICE | |
| | AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | |
| needle diameters<br>(Gauge) | | | | | |
| Microwave applicator<br>needle lengths (cm) | 15-20-27 | 15-20-27 | - | 15-20-27 | |
| Microwave applicator<br>terminal lengths (mm) | 19 | 19 | - | 19 | |
| Radiofrequency emission features | | | | | |
| Radiofrequency<br>frequency (kHz) | - | 450 | 450 | 450 | |
| Radiofrequency power<br>(W) | - | Up to 200 | Up to 200 | Up to 200 | |
| Radiofrequency power<br>delivery control | - | Manual or Automatic | Manual or Automatic | Manual or Automatic | |
| Radiofrequency power<br>output mode | - | Monopolar | Monopolar | Monopolar | |
| Operative impedance<br>range (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 | |
| | | | | PREDICATE<br>DEVICE | |
| | H.S. HOSPITAL SERVICE | | | H.S.<br>HOSPITAL<br>SERVICE | |
| | HS AMICA DEVICES FAMILY | | | | |
| | AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | |
| applicator typologies | - | - | - | - | |
| Radiofrequency<br>applicator needle<br>Diameters (Gauge) | - | 17-18 | 17-18 | 17-18 | |
| Radiofrequency<br>applicator needle<br>lengths (cm) | - | 7-10-15-20-25-27 | 7-10-15-20-25-27 | 7-10-15-20-25-27 | |
| Radiofrequency<br>electrode 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 | | | | | |
| Radiofrequency<br>applicator typologies | - | Single | Single | - | |
| Radiofrequency<br>applicator needle<br>Diameters (Gauge) | - | 17-18 | 17-18 | - | |
| Radiofrequency<br>applicator needle<br>lengths (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 | | |
| | | | | PREDICATE<br>DEVICE | |
| H.S. HOSPITAL SERVICE | | | | H.S. HOSPITAL<br>SERVICE | |
| HS AMICA DEVICES FAMILY | | | | AMICA GEN AGN-H | |
| | AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | | |
| tip lengths (mm) | | | | | |
| Dispensing holes in<br>probe variants<br>featuring local fluid<br>delivery | - | 1 or 2 | 1 or 2 | - | |
| Local fluid delivery<br>(Yes/No) | - | Yes | Yes | No | |
| Safety features | | | | | |
| Condition of use of<br>applicators | 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).
