Relax muscle spasms .
Prevent or retard disuse atrophy
Maintain or increase range of motion ●
. Increase local blood circulation
Re-educate muscle .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Device Description

The RS-4i Plus is 4 channel electrical stimulator that incorporate traditional muscle stimulation and interferential current stimulation modalities into a single unit. It has the capability to program the device's output by the care giver to match the patient's condition through the use of pre-set selections. The RS-4i Plus is hand held with an electronic display, digital single processor, software/firmware controlled functions, user keypad, cable leads and electrode pads, multiple output channels, removable, rechargeable battery, and patient data files and retrieval capability.

AI/ML Overview

The provided text describes a 510(k) summary for the RS-4i Plus Sequential Stimulator. It outlines the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study that specifically proves the device meets such criteria in terms of clinical performance metrics like accuracy, sensitivity, or specificity.

Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and compliance with safety and performance standards. The "study" mentioned is primarily a series of tests to confirm the device's basic unit characteristics and output specifications, ensuring it performs equivalently to the predicate and meets relevant electrical, mechanical, and software safety standards.

Here's an attempt to answer your questions based on the provided text, recognizing the limitations:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Technological Equivalence to Predicate Device (RS-4i)	RS-4i Plus is "equivalent to the RS-4i" in basic unit characteristics and output specifications.
Compliance with Electrical Safety Standards	Conforms to: ANSI/AAMI ES60601-1:2005, IEC 60601-1-2, IEC 601-2-10, IEC 60601-1-11
Compliance with Software Life Cycle Standards	Conforms to: ANSI/AAMI/IEC 62304:2006
Compliance with Electromagnetic Compatibility (EMC)	Conforms to: IEC 60601-1-2 Edition 3:2007-03
Compliance with Mechanical/Environmental Standards	Conforms to: IEC 60529 (IP code), ASTM E171, D4332, D5276, D4728
Functional Equivalence of Intended Use/Indications for Use	"Both devices [RS-4i Plus and RS-4i] have the same intended use/indications for use and the same fundamental scientific technology."

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

The document does not mention a "test set" in the context of clinical or diagnostic performance data. The testing described pertains to engineering and safety standards, likely performed on a limited number of devices during development and verification. There is no mention of human subject data, country of origin, or retrospective/prospective study design for performance.

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

Not applicable. The "ground truth" here is compliance with engineering and safety standards, which would be assessed by qualified engineers and testers, not clinical experts establishing a diagnosis.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) summary.

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

Not applicable. This device is a sequential stimulator, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is an electrical stimulator, not an algorithm. Its performance is inherent to its physical and functional output.

7. The type of ground truth used

The "ground truth" implied for this submission is adherence to recognized international and national standards for medical electrical equipment safety, electromagnetic compatibility, software life cycle, and physical/environmental resilience, as well as demonstrating that its output specifications match those of the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and does not have a "training set" in that context.

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

Not applicable.

Summary

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RS Medical RS-4i Plus - Response 510(k) Summary rev1 9/27/11

510(k) Summary of Safety and Effectiveness (21 CFR 807.92)

Date prepared: September 28, 2011

Submitter:

RS Medical 14001 SE First St. Vancouver, WA 98684

Contact Person:

Patrick Cougill Vice President - Legal. Ouality & Regulatory Affairs Ph: 866-849-6157 Fax: 866-886-4097

Proprietary name:

RS-4i Plus Sequential Stimulator

Common name:

Powered Muscle Stimulator

Classified name:

Powered muscle stimulator for rehabilitation CFR 890.5850 Product code: IPF, LIH

Intended use:

Interferential stimulation indications

Relieve acute pain .
Relieve and manage chronic pain .

Muscle stimulation indications

Relax muscle spasms .
Prevent or retard disuse atrophy �
Maintain or increase range of motion ●
. Increase local blood circulation
Re-educate muscle .
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis .

Substantial equivalence:

The RS-4i Plus is substantially equivalent to the RS-4i Muscle Stimulator Family (K032652). Both devices have the same intended use/indications for use and the same fundamental scientific technology.

Description of device:

The RS-4i Plus is 4 channel electrical stimulator that incorporate traditional muscle stimulation and interferential current stimulation modalities into a single unit. It has the

112348 PAGE 1 OF 3

JAN 1 9 2012

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capability to program the device's output by the care giver to match the patient's condition through the use of pre-set selections. The RS-4i Plus is hand held with an electronic display, digital single processor, software/firmware controlled functions, user keypad, cable leads and electrode pads, multiple output channels, removable, rechargeable battery, and patient data files and retrieval capability.

Technological characteristics:

Several technological characteristics of the device were modified from the predicate. These include physical characteristics to enhance the usability of the device such as more information on display and additional function keys. The processor was changed from a DSP to a MCU component. The battery was changed from a NiMH type with charger to a removable Lithium-Ion smart battery type with charging dock. Patient leads were changed from 4 pairs that are bundled to 4 individual cables with 2 leads each. For patient data, both devices include a NVRAM adapter and the RS-4i Plus also includes a USB adapter.

The RS-4i Plus was assessed and tested for its basic unit characteristics and output specifications. The results show that the RS-4i Plus is equivalent to the RS-4i.

In support of the modifications in the RS-4i Plus, the device was tested and shown to conform to the following standards:

ANSI/AAMI ES60601-1:2005 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
ANSI/AAMI ES60601-1:2005/C1:2009 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance, Amendment 1
IEC 60601-1-2 Edition 3:2007-03 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
ANSI/A AMI/IEC 62304:2006 Medical device software, Software life cycle processes .
CEI IEC 601-2-10; 1987 Medical electrical equipment Part 2-10: Particular . requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10 Amendment 1 Edition 1.0 en:2001 Medical electrical equipment Part . 2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-2-10 Amendment 1 Corrigendum 1 Technical Corrigendum: Medical . electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
IEC 60601-1-11 Edition 1.0 2010-04 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
IEC 60529 Edition 2.1 Consol. With Amendment 1:2001 Degrees of protection . provided by enclosures (IP code)
IEC 60601-1-8 Ed. 2.0 2006-10 General Requirements for Tests and Guidance for . Alarm Systems used in Medical Devices
ASTM E171 Standard Specification for Standard Atmospheres for Conditioning and . Testing Flexible Barrier Materials
ASTM D4332 Standard Practice for Conditioning Containers, Packages, Packing .

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RS Medica! RS-4i Plus - Response 510(k) Summary rev1 9/27/11

. .

ASTM D5276 Standard Test Method for Drop Test of Loaded Conatiners .
ASTM D4728 Standard Test Method for Random Vibration Testing .

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.

Food and Drug Administration 10903 New Hamoshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

RS Medical % Mr. Patrick Cougill Vice President, Legal, Quality and Regulatory Affairs 14001 SE First Street Vancouver, Washington 98684

JAN 1 9 2012

Re: K112348

Trade/Device Name: RS-4i Plus Sequential Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II - Product Code: IPF, LIH Dated: December 22, 2011 Received: December 23, 2011

Dear Mr. Cougill:

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 - Mr. Patrick Cougill

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 go to for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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,

erson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K112348

Device Name: RS-4i Plus Sequential Stimulator

Indications For Use:

Interferential Stimulation Indications:

Relieve acute pain .
Relieve and manage chronic pain .

Muscle Stimulation Indications:

Relax muscle spasm .
Prevention or retardation of disuse atrophy .
Maintain or increase range of motion .
Increase local blood circulation .
Re-educate muscle .
Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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 ExPalation (ODE)

(Divis (Division Sign-On Surgical, Orthopedic, Division of Surfaces

510(k) Number _

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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).