The Cellfina™ System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation.

Device Description

The Cellfina System is intended to provide precise focal release of subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1).

AI/ML Overview

The provided text is related to a 510(k) summary for the Cellfina System and discusses an extension of shelf life and labeling changes. It repeatedly refers to the predicate device (K150505) for clinical trial data and other non-clinical tests. Therefore, the details regarding acceptance criteria and the study proving the device meets those criteria are primarily found by referencing the K150505 submission, which is not fully included in this document.

However, based on the information provided in the current document (K153677) and the references within it, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

The provided document (K153677) is a Special 510(k) for a shelf-life extension and labeling changes. It states that the clinical effectiveness and safety data from the predicate device (K150505) are applicable. Thus, the acceptance criteria for the effectiveness of the device are derived from the clinical data demonstrating "long term improvement in the appearance of cellulite... up to 2 years of observation" as stated in the Indications for Use.

For the specific changes submitted in K153677 (shelf-life extension), the acceptance criteria are related to the stability and performance of the device after aging. The document states:

Acceptance Criteria (for K153677, focusing on shelf-life)	Reported Device Performance (from K153677)
CK1 disposable kit shelf life stability	"ship testing, simulated use, structural integrity, verification of physical characteristics and primary functionality on 12 month aged product demonstrates that the CK1 disposable kit is stable out to 12 months of shelf life."
Compliance with electrical safety standards	"The subject device... was tested to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) and was found to be in compliance with the requirements of this standard."

Note on Clinical Performance from Predicate Device (K150505) as inferred from Indications for Use:

Acceptance Criteria (for device effectiveness as per K150505)	Reported Device Performance (Inferred from Indications for Use)
Long term improvement in the appearance of cellulite	"long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 years of observation."

2. Sample size used for the test set and the data provenance

The current document (K153677) does not provide this information directly as it refers to the predicate device (K150505) for "in-vivo evaluation (clinical trial data)". For the shelf-life extension, the "test set" for performance evaluation consists of "12 month aged product" for the CK1 disposable kit. The sample size for this testing is not specified. The data provenance for the clinical trial would be available in the K150505 submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the K153677 document, as it defers to the predicate device (K150505) for clinical data. The clinical trial data for the original device approval would have involved assessments by qualified medical professionals (e.g., dermatologists, plastic surgeons) to determine the improvement in cellulite appearance.

4. Adjudication method for the test set

This information is not explicitly provided in the K153677 document. The adjudication method for assessing clinical outcomes (e.g., improvement in cellulite appearance) would have been specified in the clinical trial protocol referenced in the K150505 submission.

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 is not applicable. The Cellfina System is a powered surgical instrument for treating cellulite, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, a MRMC study involving "human readers" and "AI assistance" would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The Cellfina System is a physical device used by a physician (human-in-the-loop) to perform a surgical procedure. It is not an algorithm performing a task without human intervention.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the clinical effectiveness of the device (as inferred from K150505 via the Indications for Use), the ground truth for "improvement in the appearance of cellulite" would likely be based on:

Expert assessment: Clinical evaluators (e.g., physicians) making subjective and/or objective assessments of cellulite severity before and after treatment.
Patient outcomes data: Patient satisfaction and self-assessment of their cellulite appearance.
Possibly photographic evidence: Standardized photographs evaluated by blinded experts.

For the shelf-life extension (K153677), the ground truth is based on engineering and performance testing to ensure the device components meet specifications after aging.

8. The sample size for the training set

This is not applicable in the context of an algorithm training set, as the Cellfina System is a medical device for direct treatment, not an AI/ML model being trained. If "training set" refers to the subjects in the original clinical study (K150505), that information is not provided here.

9. How the ground truth for the training set was established

Not applicable for the same reasons as point 8.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2016

Ulthera, Inc. Suzon Lommel Vice President, Regulatory & Ouality Affairs 1840 S Stapley Dr. Suite 200 Mesa, Arizona 85204

Re: K153677

Trade/Device Name: The Cellfina System Regulation Number: 21 CFR 878.4790 Regulation Name: Powered Surgical Instrument for Improvement in the Appearance of Cellulite Regulatory Class: Class II Product Code: OUP Dated: January 29, 2016 Received: February 1, 2016

Dear Suzon Lommel:

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 vours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K153677

Device Name Cellfina™ System

Indications for Use (Describe)

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)

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 of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency 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."

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10. 510(k) Summary

This 510(k) Summary for the Cellfina System is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

Applicant:	Ulthera, Inc.
Address:	1840 South Stapley DriveSuite 200Mesa, AZ 85204
Contact Person:	Suzon Lommel, Vice President Regulatory and Quality Affairs
Telephone:	(408) 336-1761
Fax:	(480) 619-4071
Submission Date:	December 17, 2015
Device Trade Name:	The Cellfina System
Common Name:	Powered surgical instrument for improvement in the appearance ofcellulite.
Classification:	Regulatory Class II
Classification Name:	Powered surgical instrument for improvement in the appearance ofcellulite.
Regulation Number:	21CFR 878.4790
Product Code:	OUP
Legally Marketed Predicate:	The Cellfina System, 510(k): K150505
Applicable Guidance:	The following guidance special controls are applicable to the CellfinaSystem:

Class II (special controls). The special controls for this device are:

(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.

(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.

(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.

(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.

(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.

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(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.

The Cellfina System is intended to provide precise focal release of Device Description: subcutaneous tissue for improvement in the appearance of cellulite. The system consists of a sterile, single-use, disposable kit (CK1) and an electromechanical, non-sterile, 15-use motor module (CM1).
Current Indications for Use: The Cellfina System is intended for long term improvement in the appearance of cellulite in the buttocks and thigh areas of adult females as supported by clinical data demonstrating no significant reduction in treatment benefits up to 2 year of observation.

Substantial Equivalence Comparison:

Predicate Device(K150505)	Subject Device	EquivalenceDiscussion
Cellfina System	Cellfina System
Regulation	878.4790	878.4790	Same
Product Code	OUP	OUP	Same
Intended Use/Indications for Use	The Cellfina System isintended for long termimprovement in theappearance of cellulite inthe buttocks and thighareas of adult females assupported by clinical datademonstrating nosignificant reduction intreatment benefits up to 2years of observation.	The Cellfina System isintended for long termimprovement in theappearance of cellulite inthe buttocks and thighareas of adult females assupported by clinical datademonstrating nosignificant reduction intreatment benefits up to 2years of observation.	Same
Where Used	Clinic/doctor's office	Clinic/doctor's office	Same
Anatomical Site	Buttocks and thighs	Buttocks and thighs	Same
Type ofEnergy/Mechanismof Action	Mechanical movementdriven by battery operatedmotor module	Mechanical movementdriven by battery operatedmotor module	Same
Biological Effect	Controlled mechanicalcutting of the fibrous tissue(septae) which contributesto the appearance ofcellulite.The Cellfina Systemcontrols and stabilizes thecutting motion used byphysicians with the needlebased release procedure.	Controlled mechanicalcutting of the fibrous tissue(septae) which contributesto the appearance ofcellulite.The Cellfina Systemcontrols and stabilizes thecutting motion used byphysicians with the needlebased release procedure.	Same

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	Predicate Device(K150505)Cellfina System	Subject DeviceCellfina System	Equivalence Discussion
Patient Contact Material	Biocompatible	Biocompatible	Same
EMC/Safety Standards	Compliant60601-160601-1-2	Compliant60601-160601-1-2	Compliance toIEC 60601-1 andIEC 60601-1-2
Sterile Barrier/Packaging - CK1	• Single thermoformed tray with a Tyvek sealed outer tray.• Foam insert within outer corrugated shipper• Outer corrugated shipper	• Single thermoformed tray with a Tyvek sealed outer tray.• Foam insert within outer corrugated shipper• Outer corrugated shipper	Same
Shelf Life - CK1	6 months	12 months	CK1 shelf life extension from 6 months to 12 months; shelf life and packaging testing demonstrates stability of CK1 out to 12 months of shelf life
Motor Module Device Design	2 piece plastic enclosure to eliminate seams and remove possibly difficult to disinfect areas around the toggle switch. A single LED push button on/off switch located on as switch PCB underneath: 15 uses	2 piece plastic enclosure to eliminate seams and remove possibly difficult to disinfect areas around the toggle switch. A single LED push button on/off switch located on as switch PCB underneath: 15 uses	Same

Non-clinical Performance Data:

The subject device of this Special 510(k) submission was tested to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and was found to be in compliance with the requirements of this standard. Additionally, ship testing, simulated use, structural integrity, verification of physical characteristics and primary functionality on 12 month aged product demonstrates that the CK1 disposable kit is stable out to 12 months of shelf life. All other non-clinical tests required per the Special Controls (biocompatibility, sterility, EMC, bench testing, etc.), are provided within the predicate device under K150505 and remain applicable to this Special 510(k) submission; see the 510(k) summary for K150505 for additional information.

In-vivo Testing:

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The in-vivo evaluation (clinical trial data) information provided within the predicate device under K150505 is applicable to this Special 510(k) submission; see the 510(k) summary for K150505 for additional information.

Conclusion:

This Special 510(k) Premarket Notification is for an extension of shelf life (from 6 months to 12 months) for the sterile, single-use, disposable kit (CK1), and for labeling changes required for compliance to IEC 60601-1, 3td Edition. These changes do not alter the device design and do not pose any new questions of safety, product output or efficacy. As demonstrated through bench testing, the subject device Cellfina System is as safe, as effective, and performs as well as the legally marketed predicate device (K150505), and as such, is substantially equivalent.

Regulation Number and Section

§ 878.4790 Powered surgical instrument for improvement in the appearance of cellulite.

(a)
Identification. A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
(2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
(3) All elements of the device that may contact the patient must be demonstrated to be biocompatible.
(4) Electrical safety and electromagnetic compatibility of the device must be demonstrated.
(5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
(6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.