(154 days)
The PelleFirm RF device is intended to provide heating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
The device is a hand-held RF probe with integrated massaging head. The device is activated using a footswitch and is used with the Ellman radiofrequency generators. The radiofrequency generator operates at 4 mHz and is used in the pure sinewave ("CUT") mode to produce heating for the elevation of tissue temperature.
The PelleFirm System consists of the PelleFirm handpiece, RF generator, neutral plate, Gel, Footswitch, and associated cables and cords. The handpiece contains a large monopolar electrode to provide tissue heating. A massaging head surrounds the handpiece electrode and provides mechanical stimulation to the tissue to reduce the appearance of cellulite. A cable connects the handpiece to the RF generator.
The provided text is a 510(k) summary for the PelleFirm System. It details the device's technical characteristics and intended use, and states that performance data demonstrates its safety and effectiveness. However, it does not include specific acceptance criteria, sample sizes for test or training sets, details about ground truth establishment, or any information about multi-reader multi-case (MRMC) studies.
Therefore, much of the requested information cannot be extracted from the given text.
Here's what can be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | - Device heats tissues consistently for an extended period of time. - Device functioned as intended. - Tissue heating was observed as expected. - Device is in conformity with IEC 60601-1 and IEC 60601-2-2. |
2. Sample size used for the test set and the data provenance
The document states "Clinical performance testing demonstrates the device's ability to heat tissues consistently for an extended period of time." However, it does not specify the sample size used for this testing, the country of origin of the data, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.
4. Adjudication method for the test set
This information is not available in the provided text.
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
This information is not available in the provided text. The PelleFirm System is a medical device for therapeutic use, not primarily an AI-driven diagnostic or imaging analysis tool, so an MRMC study in the context of human readers and AI assistance would not be directly applicable to its function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The PelleFirm System is a physical device operated by a human user (a hand-held RF probe with integrated massaging head). The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this device as described.
7. The type of ground truth used
The document mentions "tissue heating was observed as expected," implying an objective measurement of temperature increase as a basis for assessing performance. However, it does not explicitly define a "ground truth" in terms of expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI-based devices. For the "temporary reduction in the appearance of cellulite," the method of assessing this reduction and what constitutes "ground truth" is not detailed.
8. The sample size for the training set
This information is not available in the provided text.
9. How the ground truth for the training set was established
This information is not available in the provided text.
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K132949 page 1/2
510(K) Summary
This 510(K) Summary of safety and effectiveness for the PelleFirm System is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Ellman International |
|---|---|
| Address: | Ellman International400 Karin LaneHicksville, NY 11801 |
| Contact Person: | Alison Sathe |
| Telephone/Email/Fax: | 213-658-8960asathe@ellman.com516-267-6750 |
| Preparation Date: | February 20, 2014 |
| Device Trade Name: | PelleFirm System |
| Common Name: | Massager, Vacuum, Radio Frequency Induced Heat |
| Classification Name: | Massager, Vacuum, Radio Frequency Induced Heat,PBX, 878.4400 |
| Legally Marketed PredicateDevice(s): | truSculpt (Cutera K 122389) |
Device Description:
. .
The device is a hand-held RF probe with integrated massaging head. The device is activated using a footswitch and is used with the Ellman radiofrequency generators. The radiofrequency generator operates at 4 mHz and is used in the pure sinewave ("CUT") mode to produce heating for the elevation of tissue temperature.
Intended Use:
The PelleFirm RF component is intended use is to generate deep heat within the body tissues for selected medical conditions such as the temporary relief of minor aches and pain, muscle spasms. and an increase in local circulation. The PelleFirm massage component is also intended to provide temporary reduction in the appearance of cellulite.
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The PelleFirm indications for use are:
The PelleFirm RF device is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
Technological Characteristics:
The PelleFirm System consists of the PelleFirm handpiece, RF generator, neutral plate, Gel, Footswitch, and associated cables and cords. The handpiece contains a large monopolar electrode to provide tissue heating. A massaging head surrounds the handpiece electrode and provides mechanical stimulation to the tissue to reduce the appearance of cellulite. A cable connects the handpiece to the RF generator.
Performance Data:
The system has been tested and found to be in conformity with IEC 60601-1 and IEC 60601-2-2. Clinical performance testing demonstrates the device's ability to heat tissues consistently for an extended period of time. In all testing, the device functioned as intended and tissue heating was observed as expected.
Substantial Equivalence:
The PelleFirm System is as safe and effective as the predicate device. It has the same intended uses and similar indications, technological characteristics, principles of operation as its predicate device. The technological differences between the PelleFirm and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the PelleFirm is as safe and effective as the truSculpt device. Thus, PelleFirm System is substantially equivalent to the predicate.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Ellman International, Inc. Alison Sathe, Director of Regulatory and Clinical Affairs 400 Karin Lanc Hicksville, NY, 11801
Re: K132949
Trade/Device Name: Pellefirm System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: 11 Product Code: PBX Dated: January 16, 2014 Received: January 22, 2014
Dear Ms. Alison Sathe:
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 10 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-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.
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Page 2 - Ms. Alison Sathe
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.hum.
Sincerely yours,
Felipe Aquel
for
Binita S. Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132949
Device Name PelleFirm System
Indications for Use (Describe)
The PelleFirm RF device is intended to provide heating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The PelleFirm massage device is intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.02.20 16:36:08 -05*00'
FORM FDA 3881 (1/14) For BSA
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§ 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.