(402 days)
Not Found
No
The summary describes a soft tissue ablation system using microwave and radiofrequency energy. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The new PULSE mode is a fixed operational mode with a defined duty cycle, not an adaptive or learning algorithm.
Yes
The device is described as "a fully featured soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues," which means it treats a medical condition.
No
Explanation: The device is described as a "soft tissue ablation system that is intended for coagulation (thermo-ablation) of soft tissues," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly details hardware components including generators (microwave, radiofrequency, and hybrid), probes (applied parts for energy delivery), and mentions reusable electronic parts and sterile disposable applied parts. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Coagulation (thermo-ablation) of soft tissue." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a "soft tissue ablation system" that delivers energy (microwave or radiofrequency) directly into the patient's body via probes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is clearly intended for a therapeutic intervention (ablation) performed in vivo (within the living body), not for in vitro (in glass/outside the body) diagnostic testing.
N/A
Intended Use / Indications for Use
Coagulation (thermo-ablation) of soft tissue. Not for use in cardiac procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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)
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line. The logo is simple and professional, reflecting the organization's role in regulating food and drugs.
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.
1
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
2
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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"An aqency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, 23/25
04011 Aprilia (LT) – Italy
Tel.: +39 06 9201961
Fax: +39 06 92727871 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration Number: | 810312 |
| Contact Person in Italy: | Silvia Scarpellini
ISEMED srl
Via P.Togliatti, 19/X
40026 Imola (BO) Italy
phone: (+39) 0542 683803 ext 212
Fax: +39 0542 698456
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:
4
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
5
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.
6
| | | | | PREDICATE
DEVICE | |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | H.S. HOSPITAL SERVICE | | | H.S.
HOSPITAL
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-
ablation) of soft tissues.
Not for use in cardiac
procedures | | Coagulation (thermo-
ablation) of soft tissues.
Not for use in cardiac
procedures | |
| Mechanism of action | Interstitial
thermoablation of
soft tissues through
controlled emission
of MW energy at the
tip of a microwave
coaxial antenna
lodged into a needle | Interstitial
thermoablation of soft
tissues through
controlled emission of
MW energy or RF
energy (non-
simultaneous),
respectively at the tip of a microwave coaxial | Interstitial
thermoablation of soft
tissues through
controlled emission of
RF energy at the tip of
RF electrodes | Interstitial
thermoablation of soft
tissues through
controlled emission of
MW energy or RF
energy (non-
simultaneous),
respectively at the tip
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
needle or at the tip of
RF electrodes | | antenna lodged into a
needle or at the tip of
RF electrodes | | |
| Technical features | | | | | |
| Design structure | • Generator
• Applicator (coaxial
microwave
applicator)
• Cooling system
(peristaltic pump,
coolant tank and
tubing for applicator
cooling)
• Footswitch | • Generator
• Applicators (coaxial
microwave applicator,
RF applicator)
• Return pad
• Cooling system
(peristaltic pump,
coolant tank and tubing
for applicator cooling)
• Footswitch | • Generator
• Applicator (RF
applicator)
• Return pad
• Cooling system
(peristaltic pump,
coolant tank and tubing
for applicator cooling)
• Footswitch | • Generator
• Applicators (coaxial
microwave applicator,
RF applicator)
• Return pad
• Cooling system
(peristaltic pump,
coolant tank and tubing
for applicator cooling)
• Footswitch | |
| Microwave
applicator
Connection | Yes | Yes | No | Yes | |
| Radiofrequency
applicator connection | No | Yes | Yes | Yes | |
| Return pad connection | No | Yes | Yes | Yes | |
| | | | | PREDICATE
DEVICE | |
| | | | | H.S. HOSPITAL
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
management | Automatic | Automatic | Automatic | Automatic | |
| Coolant | Sterile Disposable
saline solution | Sterile Disposable
saline solution | Sterile Disposable
saline solution | Sterile Disposable
saline solution | |
| Needle temperature
range (°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 (for
continuous mode)
Up to 190 (for pulsed
mode) | Up to 140 (for
continuous mode)
Up to 190 (for pulsed
mode) | - | Up to 140 (only
continuous mode
available) | |
| Microwave power
delivered control | Manual | Manual | - | Manual | |
| Microwave applicators features | | | | | |
| Microwave applicator | 11-14-16 | 11-14-16 | - | 11-14-16 | |
| | 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 | |
| needle diameters
(Gauge) | | | | | |
| Microwave applicator
needle lengths (cm) | 15-20-27 | 15-20-27 | - | 15-20-27 | |
| Microwave applicator
terminal lengths (mm) | 19 | 19 | - | 19 | |
| Radiofrequency emission features | | | | | |
| Radiofrequency
frequency (kHz) | - | 450 | 450 | 450 | |
| Radiofrequency power
(W) | - | Up to 200 | Up to 200 | Up to 200 | |
| Radiofrequency power
delivery control | - | Manual or Automatic | Manual or Automatic | Manual or Automatic | |
| Radiofrequency power
output mode | - | Monopolar | Monopolar | Monopolar | |
| Operative impedance
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
DEVICE | |
| | H.S. HOSPITAL SERVICE | | | H.S.
HOSPITAL
SERVICE | |
| | HS AMICA DEVICES FAMILY | | | | |
| | AMICA GEN AGN | AMICA GEN AGN-H | AMICA GEN AGN-R | AMICA GEN AGN-H | |
| applicator typologies | - | - | - | - | |
| Radiofrequency
applicator needle
Diameters (Gauge) | - | 17-18 | 17-18 | 17-18 | |
| Radiofrequency
applicator needle
lengths (cm) | - | 7-10-15-20-25-27 | 7-10-15-20-25-27 | 7-10-15-20-25-27 | |
| Radiofrequency
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
applicator typologies | - | Single | Single | - | |
| Radiofrequency
applicator needle
Diameters (Gauge) | - | 17-18 | 17-18 | - | |
| Radiofrequency
applicator needle
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
DEVICE | |
| H.S. HOSPITAL SERVICE | | | | H.S. HOSPITAL
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
probe variants
featuring local fluid
delivery | - | 1 or 2 | 1 or 2 | - | |
| Local fluid delivery
(Yes/No) | - | Yes | Yes | No | |
| Safety features | | | | | |
| Condition of use of
applicators | Sterile - disposable | Sterile - disposable | Sterile - disposable | Sterile - disposable | |
7
8
9
10
11
12
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
13
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).