(63 days)
The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.
The RS Medical Conductive Garments consist of the RS-LB™ Low Back Conductive Garment and RS-FBG" Full Back Conductive Garment. The RS-LB" Low Back Conductive Garment is a wrap designed for the low back that uses Velcro® closures to affix the garment around the waist and lower back. The garment contains eight conductive metal snaps onto which a snap cable can be connected to the outside of the garment. These snaps extend through the garment and an adhesive backed electrode pad is affixed to the snap surface on the inner surface of the garment. The garment allows for easy electrode placement and stabilization of electrode locations on the back for repeated electrostimulation treatments to facilitate treatment compliance. The RS-FBG" Full Back Conductive Garment is a similar vest type compliance accessory that has sixteen metal snaps spaced from the lower back on either side of the spinal column to the middle and upper back. The RS Medical Conductive Garments utilize the identical UltraStim® Electrode pads used with the predicate device.
The provided document describes a 510(k) submission for RS Medical Conductive Garments (RS-LB™ Low Back Conductive Garment, RS-FBG™ Full Back Conductive Garment). This is a premarket notification for a Class II medical device, indicating that its review focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on extensive clinical trials for effectiveness.
Therefore, the study did not involve human subjects, and many of the requested fields related to clinical study design and human reader performance are not applicable. The assessment primarily relied on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Continuity | Met applicable specifications | Met applicable specifications (specific values not provided) |
| Attachment/Removal Force of Cable Sets & Safety Snap Covers | Met applicable specifications | Met applicable specifications (specific values not provided) |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified for the non-clinical tests. Typically, for such tests, a small number of representative units would be tested (e.g., 3-5 units).
- Data Provenance: Not applicable. The tests were non-clinical, likely conducted in a lab setting by the manufacturer, RS Medical, or a contracted testing facility (e.g., Underwriters Laboratories, Inc. is mentioned in the FDA letter).
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
N/A - This was a non-clinical performance study; therefore, no human experts were involved in establishing ground truth for clinical outcomes. The "ground truth" here would be the physical and electrical properties of the materials and design, evaluated against engineering specifications.
4. Adjudication Method for the Test Set
N/A - No human adjudication was involved. The tests were objective measurements against predefined engineering specifications.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
N/A - No MRMC study was conducted. The device is a conductive garment, not an imaging or diagnostic device requiring human interpretation of results. The study was focused on the device's physical and electrical performance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
N/A - This device is a conductive garment, not an algorithm or AI system. Its performance is assessed based on its physical and electrical properties.
7. Type of Ground Truth Used
For the non-clinical performance tests, the ground truth was established by engineering specifications for electrical continuity and mechanical forces (attachment/removal). These are objective, measurable parameters relevant to the device's function as a conductive garment.
8. Sample Size for the Training Set
N/A - This refers to a manufactured product; there is no "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set Was Established
N/A - Not applicable as there is no training set. The design and manufacturing processes for the garments would be guided by industry standards, material specifications, and internal engineering design documents.
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510(k) Summary
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k) premarket notification was in accordance with 21 CFR 807.92.
Date prepared: May 20, 2009
1. Applicant, Official Correspondent and Owner of 510(k)
RS Medical 14001 S.E. First Street Vancouver, WA 98684 Attn: Timothy J. Johnson, Director of Regulatory Affairs Telephone: 360-823-4940 Fax: 866-210-6928
Official Correspondent: William Carroll
2. Name of Device
Trade/Proprietary Name: RS-LB™ Low Back Conductive Garment, RS-FBG™ Full Back Conductive Garment Common/Usual Name: Conductive garments Classification Name: Cutaneous electrode, 21 CFR 882.1320, product code GXY
3. Legally Market Predicate Devices
The RS-LB™ Low Back Conductive Garment and RS-FBG™ Full Back Conductive Garment are substantially equivalent to the Axelgaard Manufacturing Company, Ltd. UltraStim® Kit (K013532) which include UltraStim® Electrodes (K000947).
4. Indications for Use
The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.
5. Device Description and Substantial Equivalence
The RS Medical Conductive Garments consist of the RS-LB™ Low Back Conductive Garment and RS-FBG" Full Back Conductive Garment. The RS-LB" Low Back Conductive Garment is a wrap designed for the low back that uses Velcro® closures to affix the garment around the waist and lower back. The garment contains eight conductive metal snaps onto which a snap cable can be connected to the outside of the garment. These snaps extend through the garment and an adhesive backed
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electrode pad is affixed to the snap surface on the inner surface of the garment. The garment allows for easy electrode placement and stabilization of electrode locations on the back for repeated electrostimulation treatments to facilitate treatment compliance. The RS-FBG" Full Back Conductive Garment is a similar vest type compliance accessory that has sixteen metal snaps spaced from the lower back on either side of the spinal column to the middle and upper back. The RS Medical Conductive Garments utilize the identical UltraStim® Electrode pads used with the predicate device. The RS Medical Conductive Garments share the same principle of operation and intended use with the predicate device, the design features of the conductive metal snaps are the same and the products utilize the identical UltraStim® Electrode pads (private labeled under RS Medical's name) used with the predicate device.
Based on the similarities, the RS Medical Conductive Garments and accessories are deemed to be substantially equivalent to the predicate device, the Axelgaard Manufacturing Company Ltd, UltraStim® Kit.
6. Non-Clinical Performance
The RS Medical Conductive Garments were tested for electrical continuity from stimulator through cable sets through the garments' metal snaps to the double sided cutaneous electrode. The results of continuity testing met applicable specifications. The garments metal snaps were tested for attachment and removal force of the associated cable sets and safety snap covers and met applicable specifications.
7. Conclusions
The non-clinical performance test results demonstrate that the RS Medical Conductive Garments are safe and effective in delivering electrical stimulation to the attached cutaneous electrodes. The devices perform in an equivalent manner as does the predicate device, the Axelgaard Manufacturing Company Ltd, UltraStim® Kit.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and leg. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2009
RS Medical c/o Marc M. Mouser CAS Manager, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607-8542
Re: K090951
Trade/Device Name: RS-LBTM Low Back Conductive Garment, Rs-FGB™ Full Back
Conductive Garment
Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II
Product Code: GXY
Dated: May 22, 2009 Received: May 26, 2009
Dear Mr. Mouser:
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.
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 - Mr. Marc M. Mouser
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Offs of of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofree number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mahing B. Eggleton, MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K090951
Device Name: RS Medical Conductive Garments
Indication for Use:
The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.
Prescription Use_ X (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 Evaluation (ODE)
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(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K090951
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).