(216 days)
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].
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.
The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.
| Acceptance Criterion | Reported Device Performance (K160075 Accent XL with Alma Ultra handpiece) |
|---|---|
| Ultrasonic Performance (Compared to Predicate K091615 MC1 General Project) | - |
| Ultrasound Frequency | 1MHz (± 20%) |
| Ultrasonic Intensity | 3W/cm² |
| Max treatment time | 30 minutes |
| BNR (Maximum Beam Non-uniformity Ratio) | 6:1 (within range of predicate K952536 Zimmer Sono 5 which is 6:1, and K091615 MC1 General Project which is 4:1) |
| ERA (Effective Radiating Area) | 1.2 cm² (different from predicates (4.9cm² and 5.0cm²), but deemed not to present new safety/effectiveness concerns as parameters are within ranges used by predicate devices) |
| Electrical Safety & EMC | - |
| IEC 60601-1:05+CORR.1(2006)+CORR.2(2007)+A1:12 | Testing performed in accordance with this standard. |
| IEC 60601-1-2:2007 (edition 3.0) | Testing performed in accordance with this standard. |
| IEC 60601-2-5:2009 | Testing performed in accordance with this standard. |
| Biocompatibility | - |
| ISO 10993-5:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| ISO 10993-10:1999 | Testing performed in accordance with this standard. Patient contacting material previously cleared in K042000 and K141237. |
| Performance Bench Testing (Temperature) | - |
| Raise skin temperature to 40-45°C | Achieved in less than 15 minutes. |
| Maintain skin temperature at 40-45°C | Maintained for a minimum of 10 minutes. |
| Treat for 30 minutes with no adverse effects | Device capable of this. |
2. Sample size used for the test set and data provenance
The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
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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
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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
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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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K160075 510(k) Summary
I. General Information
II.
| 510(k) Holder: | Alma Lasers Inc.485 Half Day Rd. Suite 100Buffalo Grove, IL 60089 |
|---|---|
| Contact Person: | Kathy MaynorRegulatory Consultant352-586-3113 |
| Summary Preparation Date: | August 16, 2016 |
| Names | |
| Trade Name: | Accent XL |
| Classification Names: | Diathermy, Ultrasonic,For Use in ApplyingDeepTherapeutic HeatElectrosurgical Cutting Devices and AccessoriesTherapeutic Massager |
| Product Codes: | IMI (Primary) – Diathermy, Ultrasonic, For Use inApplying Deep Therapeutic HeatGEI- Electrosurgical, Cutting & Coagulation &AccessoriesISA - Massager, Therapeutic, ElectricNUV - Massager, Vacuum, Light Induced Heating |
| Classification Panels: | Physical Medicine for ultrasound hand pieceGeneral and Plastic Surgery for other hand pieces |
| Regulations: | 21 CFR Part 890.5300 Ultrasonic Diathermy21 CFR Part 878.4400 Electrosurgical Cutting Devices21 CFR 890.5660 Therapeutic Massager21 CFR 878.4810 Laser Surgical Instrument For Use InGeneral and Plastic Surgery and in Dermatology |
| Common Name: | Ultrasound, Surgical Devices, Radiofrequency |
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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)
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- 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].
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Summary of Technical Characteristics VI.
Ultrasound
| Parameter | K160075Accent XL with the Alma Ultrahandpiece | K091615MC1 General Project | K952536Zimmer Sono 5 |
|---|---|---|---|
| Product Code & Regulation No. | IMI21 CFR 890.5300 | IMI21 CFR 890.5300 | IMI21 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, | 100-240VAC50-60 Hz | Unk. |
| Indications for Use | Ultrasonic Diathermy:1. Relief of pain;2. Muscle spasms;3. Joint contractures;4. NOT for the treatment of malignancies. | Ultrasonic Diathermy:1. Relief of pain;2. Muscle spasms;3. Joint contractures;4. NOT for the treatment ofmalignancies. | Not available in FDAwebsite database |
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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 PixelRFModule/ 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, whenused as a combined treatment, are indicated forthe non-invasive treatment of wrinkles andrhytids.The Pixel RF Tips (stationary and rolling), whenused with the unipolar hand piece, are indicatedfor dermatological procedures requiringablation and resurfacing of the skin. | The Alma Lasers family of Accent RF Systems(Accent, Accent XL, Accent Elite) with Unipolarand Bipolar Hand pieces are intended for use indermatologic and general surgical procedures.The Unipolar and Bipolar hand pieces, when usedas a combined treatment, are indicated for thenon-invasive treatment of wrinkles and rhytids.The Pixel RF Tips (stationary and rolling), whenused with the unipolar hand piece, are indicatedfor dermatological procedures requiring ablationand resurfacing of the skin. | Indicated for: The non-invasive treatment ofwrinkles and rhytids using a combined treatmentwith Unipolar and Bipolar hand pieces |
| RF Power(or Energy) | • UniPolar & UniLargeUp to 200 W (1.51 W/mm2)• BiPolar & BiPolarSUp to 420 W (1.51 W/mm2) | • UniPolarUp to 200 W (2.08 W/mm2) | • UniPolar & UniLargeUp to 200 W (1.51 W/mm2)• BiPolar & BiPolarSUp 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 NameCharacteristics | K160075Accent XL with the Alma Ultra Hand piece | K121150Alma Lasers, Ltd.Family of Accent RF PixelRF Tips with PixelRFModule/ Hand piece | K101147Alma Lasers Family of Accent RF Systems[Accent, Accent XL, Accent Elite] (w/ UniPolar &BiPolar Hand pieces] |
| Pulse modulationfrequency | RF Pixel:65KHzUniPolar & BiPolar Hand pieces:15KHz | RF Pixel:65KHz | UniPolar & BiPolar Hand pieces:15KHz |
| Pulse modulationcontrol | PWM | PWM | PWM |
| Standing Wave Ratio | 1:2 | 1:2 | 1:2 |
| RF massage ringrotation speed | 150 turns/min (tpm) | Not applicable | 150 turns/min (tpm) |
| Handpiece-Patientcontact interface area | • UniPolar & UniLarge13 to 19 mm dia.• BiPolarS & BiPolar8.95 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 & UniLarge13 to 19 mm dia.• BiPolarS & BiPolar8.95 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 NameCharacteristics | K160075Accent XL with the Alma Ultra Hand piece | K121150Alma Lasers, Ltd.Family of Accent RF Pixel Tips with PixelRFModule/ Hand piece | K101147Alma Lasers Family of Accent RF Systems[Accent, Accent XL, Accent Elite] (w/ UniPolar &BiPolar Hand pieces] |
| HandpieceSize/WeightDimensions | Size:• UniPolar - 169 x 205 mm• BiPolar - 167 x 203 mm• PixelRF Hand piece - 160 x 155 mmWeight: | Size:PixelRF Hand piece - 160 x 155 mmWeight: | Size:• UniPolar - 169 x 205 mm• BiPolar - 167 x 203 mmWeight: |
| Patient ContactMaterials | Hand pieces:• Anodized aluminum and Delrin plasticTip:• 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 & RollerPixelRF Tips:Reusable, cleanable, serializable Tips anddisposable tips also available | Disposable and Reusable Stationary & RollerPixelRF Tips:• Reusable, cleanable, serializable Tips anddisposable tips also available | Not applicable |
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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
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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.
§ 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.