(216 days)
No
The document describes a radiofrequency and ultrasound system for dermatological and general surgical procedures. There is no mention of AI or ML in the intended use, device description, or performance studies. The device appears to be based on established energy-based technologies.
Yes.
The device is intended for the "non-invasive treatment of wrinkles and rhytids," "temporary reduction in the appearance of cellulite," and "relief of pain, muscle spasms, and joint contractures," all of which are therapeutic applications. Additionally, the device description explicitly states the presence of a "therapeutic ultrasound hand piece."
No.
The device is intended for therapeutic and aesthetic procedures such as wrinkle treatment, cellulite reduction, and pain relief, not for diagnosing conditions.
No
The device description explicitly states it is a "console with three previously cleared RF hand pieces and one ultrasound hand piece" and mentions "therapeutic ultrasound hand piece" and "touch screen on the console". This indicates significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are focused on dermatological and general surgical procedures, non-invasive treatment of wrinkles and rhytids, temporary reduction of cellulite, skin ablation and resurfacing, and therapeutic ultrasound for pain relief, muscle spasms, and joint contractures. None of these involve testing samples from the human body (like blood, urine, tissue) to diagnose or monitor a medical condition.
- Device Description: The device is described as a console with RF and ultrasound hand pieces used for applying energy to the body. This is consistent with a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device operates in vivo (on the body) for therapeutic and cosmetic purposes.
N/A
Intended Use / Indications for Use
The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for:
- Relief of pain
- Muscle spasms
- · Joint contractures
- · NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
Product codes (comma separated list FDA assigned to the subject device)
IMI, GEI, ISA, NUV
Device Description
The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Bench Testing was conducted.
Key results:
- the ultrasound device must raise the skin temperature to 40-45°C in less than 15 minutes
- the ultrasound device must be capable of maintaining the skin temperature at 40-45°C for a minimum of 10 minutes
- the ultrasound device can treat for 30 minutes with no adverse effects.
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.
K952536, K121150, K101147, K082622
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
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Alma Lasers Inc. % Kathy Maynor Consultant Kathy Maynor 26 Rebecca Ct Homosassa, Florida 34446
Re: K160075
Trade/Device Name: Accent XL Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: IMI, GEI; ISA; NUV Dated: July 15, 2016 Received: July 20, 2016
Dear Ms. Maynor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
Sincerely yours,
Michael J.Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160075
Device Name Accent XL
Indications for Use (Describe)
The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for:
- Relief of pain
- Muscle spasms
- · Joint contractures
- · NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
| 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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3
K160075 510(k) Summary
I. General Information
II.
| 510(k) Holder: | Alma Lasers Inc.
485 Half Day Rd. Suite 100
Buffalo Grove, IL 60089 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kathy Maynor
Regulatory Consultant
352-586-3113 |
| Summary Preparation Date: | August 16, 2016 |
| Names | |
| Trade Name: | Accent XL |
| Classification Names: | Diathermy, Ultrasonic,
For Use in Applying
Deep
Therapeutic Heat
Electrosurgical Cutting Devices and Accessories
Therapeutic Massager |
| Product Codes: | IMI (Primary) – Diathermy, Ultrasonic, For Use in
Applying Deep Therapeutic Heat
GEI- Electrosurgical, Cutting & Coagulation &
Accessories
ISA - Massager, Therapeutic, Electric
NUV - Massager, Vacuum, Light Induced Heating |
| Classification Panels: | Physical Medicine for ultrasound hand piece
General and Plastic Surgery for other hand pieces |
| Regulations: | 21 CFR Part 890.5300 Ultrasonic Diathermy
21 CFR Part 878.4400 Electrosurgical Cutting Devices
21 CFR 890.5660 Therapeutic Massager
21 CFR 878.4810 Laser Surgical Instrument For Use In
General and Plastic Surgery and in Dermatology |
| Common Name: | Ultrasound, Surgical Devices, Radiofrequency |
4
III. Predicate Devices
| K091615 | General Project MC1 (primary) |
|---|---|
| K952536 | Zimmer Sono 5 (reference) |
| K121150 | Alma Lasers Family of Pixel RF Tips |
| K101147 | Modified Alma Lasers Family of Accent Radiofrequency (RF) System |
| K082622 | Alma Lasers Accent B-Shape Massager Hand piece/Module |
IV. Product Description
The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.
V. Indications for Use
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.
The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.
The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-
. Temporary reduction in the appearance of cellulite.
Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL. Accent Elite] to provide: -
Temporary reduction in the appearance of cellulite.
The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.
The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Ultrasound Module provides ultrasonic diathermy intended for: · Relief of pain
Premarket Notification, Traditional 510(k)
5
- Muscle spasms
- Joint contractures
- NOT for the treatment of malignancies
The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].
6
Summary of Technical Characteristics VI.
Ultrasound
| Parameter | K160075
Accent XL with the Alma Ultra
handpiece | K091615
MC1 General Project | K952536
Zimmer Sono 5 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Product Code & Regulation No. | IMI
21 CFR 890.5300 | IMI
21 CFR 890.5300 | IMI
21 CFR 890.5300 |
| Cooling | Thermoelectric | Unk, | Unk. |
| Ultrasounds Frequency | 1MHz (± 20%) | 1MHz (± 20%) | 0.8MHz |
| Pulse Modulation Frequency | Continuous | Pulsed 20-60kHz | Continuous |
| Effective Radiating Area (ERA) | 1.2 cm2 | 4.9cm2 | 5.0cm2 |
| BNR (Maximum Beam Non-
uniformity Ratio) | 6:1 | 4:1 | 6:1 |
| Ultrasonic Intensity | 3W/cm2 | 3W/cm2 | 3W/cm2 |
| Max treatment time | 30 minutes | 30 minutes | 30 minutes |
| User Interface | LCD touch screen | LCD touch screen | Unk. |
| Electrical Requirements | 100-240VAC,
50-60 Hz,
6.3 A, | 100-240VAC
50-60 Hz | Unk. |
| Indications for Use | Ultrasonic Diathermy:
- Relief of pain;
- Muscle spasms;
- Joint contractures;
- NOT for the treatment of malignancies. | Ultrasonic Diathermy:
- Relief of pain;
- Muscle spasms;
- Joint contractures;
- NOT for the treatment of
malignancies. | Not available in FDA
website database |
7
RF and Massage
| Device Name | K160075 | K121150 | K101147 |
|---|---|---|---|
| Characteristics | Accent XL with the Alma Ultra Hand piece | Alma Lasers, Ltd. | |
| Family of Accent RF Pixel Tips with PixelRF | |||
| Module/ Hand piece | Alma Lasers Family of Accent RF Systems | ||
| [Accent, Accent XL, Accent Elite] (w/ UniPolar & | |||
| BiPolar Hand pieces] | |||
| Product Code | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery |
| Regulation | • GEI, OUH, NUV, ISA - 21 CFR 878.4400 | • GEI, OUH - 21 CFR 878.4400 | • NUV, GEI, ISA - 21 CFR 878.4810 |
| Intended Use | Intended for use in dermatologic and general | Intended for use in dermatologic and general | Intended for use in dermatologic and general |
| surgical procedures | surgical procedures | surgical procedures | |
| Indications for Use | The Unipolar and Bipolar hand pieces, when | ||
| used as a combined treatment, are indicated for | |||
| the non-invasive treatment of wrinkles and | |||
| rhytids. | |||
| The Pixel RF Tips (stationary and rolling), when | |||
| used with the unipolar hand piece, are indicated | |||
| for dermatological procedures requiring | |||
| ablation and resurfacing of the skin. | The Alma Lasers family of Accent RF Systems | ||
| (Accent, Accent XL, Accent Elite) with Unipolar | |||
| and Bipolar Hand pieces are intended for use in | |||
| dermatologic and general surgical procedures. | |||
| The Unipolar and Bipolar hand pieces, when used | |||
| as a combined treatment, are indicated for the | |||
| non-invasive treatment of wrinkles and rhytids. | |||
| The Pixel RF Tips (stationary and rolling), when | |||
| used with the unipolar hand piece, are indicated | |||
| for dermatological procedures requiring ablation | |||
| and resurfacing of the skin. | Indicated for: The non-invasive treatment of | ||
| wrinkles and rhytids using a combined treatment | |||
| with Unipolar and Bipolar hand pieces | |||
| RF Power | |||
| (or Energy) | • UniPolar & UniLarge | ||
| Up to 200 W (1.51 W/mm2) | |||
| • BiPolar & BiPolarS | |||
| Up to 420 W (1.51 W/mm2) | • UniPolar | ||
| Up to 200 W (2.08 W/mm2) | • UniPolar & UniLarge | ||
| Up to 200 W (1.51 W/mm2) | |||
| • BiPolar & BiPolarS | |||
| Up to 420 W (1.51 W/mm2) | |||
| Peak Output | 300W | 300W | 300W |
| RF Frequency | $40.68 MHz \pm 20 kHz$ | 40.680MHz | 40.680MHz |
| Device Name | |||
| Characteristics | K160075 | ||
| Accent XL with the Alma Ultra Hand piece | K121150 | ||
| Alma Lasers, Ltd. | |||
| Family of Accent RF PixelRF Tips with PixelRF | |||
| Module/ Hand piece | K101147 | ||
| Alma Lasers Family of Accent RF Systems | |||
| [Accent, Accent XL, Accent Elite] (w/ UniPolar & | |||
| BiPolar Hand pieces] | |||
| Pulse modulation | |||
| frequency | RF Pixel: | ||
| 65KHz | |||
| UniPolar & BiPolar Hand pieces: | |||
| 15KHz | RF Pixel: | ||
| 65KHz | UniPolar & BiPolar Hand pieces: | ||
| 15KHz | |||
| Pulse modulation | |||
| control | PWM | PWM | PWM |
| Standing Wave Ratio | 1:2 | 1:2 | 1:2 |
| RF massage ring | |||
| rotation speed | 150 turns/min (tpm) | Not applicable | 150 turns/min (tpm) |
| Handpiece-Patient | |||
| contact interface area | • UniPolar & UniLarge | ||
| 13 to 19 mm dia. | |||
| • BiPolarS & BiPolar | |||
| 8.95 to 13 mm dia. | |||
| • Stationary PixelRF Tips (Unipolar) | |||
| 12 mm dia. | |||
| • Roller PixelRF Tips (Unipolar) | |||
| 10 x 22.7 mm circumference 'roller' | • Stationary PixelRF Tips (Unipolar) | ||
| 12 mm dia. | |||
| • Roller PixelRF Tips (Unipolar) | |||
| 10 x 22.7 mm circumference 'roller' | • UniPolar & UniLarge | ||
| 13 to 19 mm dia. | |||
| • BiPolarS & BiPolar | |||
| 8.95 to 13 mm dia. | |||
| Tip Matrix | Stationary PixelRF Tips | ||
| • ~ 110 Pixel points (1.0 pixels/mm2) | |||
| Roller PixelRF Tips | |||
| • ~132 Pixel points per cm (1.3 pixels/mm2) | Stationary PixelRF Tips | ||
| • ~ 110 Pixel points (1.0 pixels/mm2) | |||
| Roller PixelRF Tips | |||
| • ~132 Pixel points per cm (1.3 pixels/mm2) | Not applicable | ||
| Tip Matrix type | Electrodes | Electrodes | Not applicable |
| Cooling | Thermo-electric cooling | Not applicable | Thermo-electric cooling |
| Device Name | |||
| Characteristics | K160075 | ||
| Accent XL with the Alma Ultra Hand piece | K121150 | ||
| Alma Lasers, Ltd. | |||
| Family of Accent RF Pixel Tips with PixelRF | |||
| Module/ Hand piece | K101147 | ||
| Alma Lasers Family of Accent RF Systems | |||
| [Accent, Accent XL, Accent Elite] (w/ UniPolar & | |||
| BiPolar Hand pieces] | |||
| Handpiece | |||
| Size/Weight | |||
| Dimensions | Size: | ||
| • UniPolar - 169 x 205 mm | |||
| • BiPolar - 167 x 203 mm | |||
| • PixelRF Hand piece - 160 x 155 mm | |||
| Weight: | Size: | ||
| PixelRF Hand piece - 160 x 155 mm | |||
| Weight: | Size: | ||
| • UniPolar - 169 x 205 mm | |||
| • BiPolar - 167 x 203 mm | |||
| Weight: | |||
| Patient Contact | |||
| Materials | Hand pieces: | ||
| • Anodized aluminum and Delrin plastic | |||
| Tip: | |||
| • Stationary PixelRF Tips – Aluminum | |||
| • Roller PixelRF Tips – Aluminum, Sapphire | • Stationary PixelRF Tips – Aluminum | ||
| • Roller PixelRF Tips – Aluminum, Sapphire | Hand pieces: | ||
| • Anodized aluminum and Delrin plastic | |||
| How provided | Disposable and Reusable Stationary & Roller | ||
| PixelRF Tips: | |||
| Reusable, cleanable, serializable Tips and | |||
| disposable tips also available | Disposable and Reusable Stationary & Roller | ||
| PixelRF Tips: | |||
| • Reusable, cleanable, serializable Tips and | |||
| disposable tips also available | Not applicable |
8
9
10
VII. Substantial Equivalence Information and Performance Testing
The review of the indications for use and technical characteristics provided above, demonstrates that the Accent XL with the Alma Ultra hand piece, is substantially equivalent to the predicate devices.
Testing was performed in accordance with the following IEC tests:
IEC 60601-1:05+CORR.1(2006)+CORR.2(2007)+A1:12 The general standard IEC 60601-1 - Medical Equipment / medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.
IEC 60601-1-2:2007 (edition 3.0): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-2:2009: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 60601-2-5:2009: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment.
Biocompatibility testing was performed in accordance with the following standards and the patient contacting material for the ultrasound hand piece has been previously cleared in K042000 and K141237:
ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:1999 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Performance Bench Testing
Additionally, temperature testing was conducted to ensure that (1) the ultrasound device must raise the skin temperature to 40-45°C in less than 15 minutes, (2) the ultrasound device must be capable of maintaining the skin temperature at 40-45°C for a minimum of 10 minutes and (3) the ultrasound device can treat for 30 minutes with no adverse effects.
Conclusion VIII.
The Accent XL with the Alma Ultra hand piece has the same intended use as the predicate devices with similar indications for use. It presents similar technological
11
characteristics as the predicate device including design features, ultrasonic intensity, ultrasound frequency etc.
Although there are some differences between the Accent XL with the Alma Ultrasound hand piece, and its predicate devices in terms of Effective Radiating Area (ERA), BNR (Maximum Beam Non-uniformity Ratio) etc., the differences do not present any new concerns of safety and effectiveness, since the Accent XL with the Alma Ultra hand piece parameters are within the range used by the predicate devices for treatment of temporary relief of pain, muscle spasms and joint contractures.
The Accent XL with the Alma Ultra hand piece and its predicate devices operate with the same mechanism of action, based on converting electromagnetic energy in ultrasonic oscillations and delivering ultrasonic waves to the treated area.
The RF hand pieces and the massager hand piece that can also be attached to the Accent XL console were previously cleared via K121150 and K101147.
Therefore, the Accent XL with the Alma Ultra hand piece has the same intended use, technological characteristics, and principles of operation as the predicate devices. Thus, the Accent XL with the Alma Ultra hand piece is substantially equivalent to the predicate device.