Relaxation of muscle spasms; .
Prevention or retardation of disuse atrophy; ●
Increasing local blood circulation; .
Muscle re-education; .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
Maintaining or increasing range of motion. .

Device Description

The Revitive IX consists of foot pads and/or electrode pads that deliver electrical stimulation to the muscles; an optional feature that allows for ankle movement during stimulation (IsoRocker); a remote control; and a user interface.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the supporting study:

The provided 510(k) summary for the Actegy's Revitive IX does not contain specific acceptance criteria or a dedicated study explicitly designed to prove the device meets pre-defined performance acceptance criteria in the way typically found for novel diagnostic algorithms or complex medical devices requiring clinical efficacy studies.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics, intended uses, and safety standards. The performance data mentioned refer to general safety and functional testing, not to specific clinical performance metrics with pre-defined acceptance thresholds.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address what information is available and indicate where information is absent.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily centered around safety, electromagnetic compatibility, biocompatibility, and functional equivalence to the predicate device. There are no specific quantitative clinical performance metrics (like sensitivity, specificity, accuracy, etc.) provided in relation to the stated indications for use.

Acceptance Criterion (Implied)	Reported Device Performance
Safety and Functionality	"In all instances, the Revitive IX functioned as intended and the results observed were as expected." (General statement)
Biocompatibility	"Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted." (General statement that testing was done, implying compliance)
Electromagnetic Compatibility (EMC) & Electrical Safety	"EMDD (93/42EEC), EN60601-1-2:2007" (Compliance with relevant standards is stated).Patient Leakage Current (Normal condition): 6.21 µA max (vs. <0.1 µA for predicate)Patient Leakage Current (Single fault condition): 8.36 µA max (vs. 2.4 µA for predicate)Enclosure Leakage: 5.99 µA max (normal), 7.95 µA max (single fault)
Technological Equivalence to Predicate Device (Compex IF 3Wave - NMES mode)	Output Parameters:- Mid-frequency (20-80Hz) muscle stimulator- Biphasic pulses- Regulated voltage up to 150V."While there are minor differences in the values for certain of the technological features, the key parameters of the Revitive IX and Compex IF 3Wave are within the same range."Functional Features:- Number of Output Modes: 1 (vs. 3+Combo for predicate)- Number of Output Channels: 2 (1 for sole, 1 for body pads) (vs. 2 for predicate)- Synchronous or Alternating: Alternating- Software/Firmware/Microprocessor Control: Yes- Automatic Shut Off: Yes- Patient Override Control: Yes
Adherence to Regulatory Standards	"Complies" with 21 CFR 898

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not specified. This was not a study involving a "test set" of patients or data in the context of diagnostic or clinical performance. The "performance data" refers to engineering and safety verification.
- Data Provenance: Not applicable/Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no "ground truth" to establish for a test set in a clinical performance context. The assessment was against engineering specifications and regulatory standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set for clinical performance was evaluated this way.
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. This device is a muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a physical medical device for muscle stimulation, not an AI algorithm. Its performance is measured directly by its electrical output and safety, not as an algorithm's classification accuracy.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the clinical sense. The "ground truth" for the performance data mentioned would be the relevant engineering standards (e.g., EN60601-1-2 for EMC) and the device's design specifications for electrical output and safety characteristics.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable.

Summary of the Study:

The "study" or "performance data" referred to in the 510(k) submission for the Revitive IX comprises standard engineering and regulatory compliance testing. This includes:

Biocompatibility testing: To ensure the materials in contact with the patient are safe.
Electromagnetic compatibility (EMC) testing (EN60601-1-2:2007): To ensure the device operates correctly in its electromagnetic environment and does not interfere with other devices.
Electrical Safety testing (EMDD (93/42EEC), UL 60601-1, CSA C22.2 No.601-1-M90): This covers aspects like patient leakage current, enclosure leakage current, and insulation.
Functional performance verification: Confirming that the device's electrical output parameters (frequency, pulse type, voltage range) and operational features (channels, modes, controls) align with its design specifications and are comparable to the predicate device.

The overarching goal of these tests was to demonstrate that the Revitive IX is as safe and effective as its predicate devices and that its minor technological differences do not raise new issues of safety or effectiveness, thus justifying a finding of substantial equivalence. There was no clinical trial or algorithm performance study described in the provided document.

Summary

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K 123354

510(k) SUMMARY Actegy's Revitive IX

JUN 2 8 2013

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE വന

Phone:	+44(0) 1344 636 940
Facsimile:	+44(0) 8452 255 612
Contact Person:	Josh Penny
Date Prepared:	June 27, 2013

Name of Device and Name/Address of Sponsor

Revitive IX

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE UK

Common or Usual Name

Muscle Stimulator, Neuromuscular electrical stimulation (NMES) device

Classification Name

Powered muscle stimulator, 21 C.F.R. § 890.5850, Product code IPF

Predicate Devices

IF 3Wave Interferential Stimulator System, Model 711 OS, Compex Technologies, Inc. (K050046) Lifecare Garment Electrodes, Everyway Medical Instruments Co. Ltd. (K103719)

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Intended Use / Indications for Use

The Revitive IX is indicated for:

Relaxation of muscle spasms; .
Prevention or retardation of disuse atrophy; ●
Increasing local blood circulation; .
Muscle re-education; .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and .
Maintaining or increasing range of motion. .

Technological Characteristics

Both Revitive IX and Compex IF 3Wave are mid-frequency (20-80Hz) muscle stimulator devices with biphasic pulses, and both operate in a range which balances between comfort and effective contractions. While there are minor differences in the values for certain of the technological features, the key parameters of the Revitive IX and Compex IF 3Wave are within the same range.

Performance Data

Biocompatibility and electromagnetic compatibility and safety testing, and other performance testing were conducted. In all instances, the Revitive IX functioned as intended and the results observed were as expected.

Substantial Equivalence

The Revitive IX is as safe and effective as the IF 3Wave Interferential Stimulator System and the Lifecare Garment Electrodes. The Revitive IX has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Revitive IX and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Revitive IX is as safe and effective as the predicate devices. Thus, the Revitive IX is substantially equivalent.

Basic Unit Characteristics
	Compex IF 3Wave -NMES mode	Revitive IX
510(k) Number	K050046
Device Name, Model	IF 3Wave Model 7110S	REVITIVE IX, RIX
Manufacturer	Compex Technologies, Inc	Actegy Ltd
Power Source(s)	3.6Vdc Lithium IonPolymer rechargeablebattery, 3000mAh	Power adaptorInput: 100-240V, 50/60Hz,0.18A.Output: 5.0Vdc, 1.0A
Method of Line Current Isolation	Transformers isolation	Transformers isolation
Basic Unit Characteristics
	Compex IF 3Wave -NMES mode	Revitive IX
Patient Leakage Current2
Normal condition ( $\mu$ A)	<0.1 $\mu$ A (*)	Patient leakage: 6.21 $\mu$ A maxEnclosure leakage: 5.99 $\mu$ A max
Single fault condition ( $\mu$ A)	2.4 $\mu$ A (*)	Patient leakage: 8.36 $\mu$ A maxEnclosure leakage: 7.95 $\mu$ A max
Number of Output Modes	3 + Combo (IF/NMES)	1
Number of Output Channels	2	2 (1 for sole, 1 for body pads)
Synchronous or Alternating?	Alternating	Alternating
Method of Channel Isolation	Transformer	Transformer
Regulated Current or Regulated Voltage?	Regulated voltage up to 150V	Regulated voltage up to 150V
Software/Firmware/Microprocessor Control?	Yes	Yes
Automatic Overload Trip?	No	No
Automatic No-Load Trip?	Yes	No
Automatic Shut Off?	Yes	Yes
Patient Override Control?	Yes	Yes
Indicator Display:
On/Off Status?	Yes	Yes
Low Battery	Yes	n/a
Voltage/Current Level?	Yes (0 to 100V)	Yes (0V to 150V )
Timer Range (minutes)	15 to 30 mins (NMES pre-set modes)	1 to 60 mins
Compliance with Voluntary Standards?	UL 60601-1, CSA C22.2No.601-1-M90	EMDD(93/42EEC),EN60601-1-2:2007
Compliance* with 21 CFR 898?(*Becomes mandatory beginning May 9, 2000)	21 CFR Part 898 (*)	Complies
Weight	323g with battery	1725g (not including PSU)
Dimensions (mm) [W x H x D]	98.5mm x 160mm x33.5mm	Ø360mm x 75mm overallheight
Housing Materials and Construction	Unknown	Casing/body ABS,footpads NBR

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(*) Refer to Compex 510(k) application K050046

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

June 28, 2013

Actegy Ltd. c/o John J. Smith, M.D., J.D. Hogan Lovells US LLP 553 13th Street NW Washington, DC 20004

Re: K123354

Trade/Device Name: Revitive IX Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: May 28, 2013 Received: May 28, 2013

Dear Dr. John Smith:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. John Smith

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

hup://www.fda.gov/MedicalDevices/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for

Victor Krauthamer, Ph.D. Acting 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): K123354

Device Name: _ Revitive IX_

Indications For Use:

The Revitive IX device is indicated for:

· Relaxation of muscle spasms
Prevention or retardation of disuse atrophy �
Increasing local blood circulation ●
Muscle re-education .
Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis

AND/OR

Maintaining or increasing range of motion .
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 ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number _ K123354

Page 1 of 1

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).