Not Found
No
The device description details a microprocessor-controlled electrical stimulator with pre-programmed modes and user-adjustable intensity. There is no mention of learning, adaptation, or data-driven decision-making that would indicate AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is intended for various therapeutic indications such as maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation, as well as providing hand active range of motion and hand function for patients with upper limb paralysis or hemiplegia. It uses electrical neuromuscular stimulation to achieve these effects.
No
The device is an electrical neuromuscular stimulator intended for therapeutic purposes such as increasing range of motion, reducing muscle spasm, and preventing disuse atrophy, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components including a control unit, splint, electrodes, cable, and batteries, in addition to the software controlling the stimulation programs.
Based on the provided information, the Handmaster is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the Handmaster is for therapeutic purposes related to neuromuscular stimulation for rehabilitation and functional improvement of the hand and upper limb. This involves direct interaction with the patient's body to achieve a physical effect.
- Device Description: The device is an electrical neuromuscular stimulator that applies electrical currents to the muscles through surface electrodes. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition based on sample analysis
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Handmaster does not perform any of these functions. It is a therapeutic device used for physical rehabilitation.
N/A
Intended Use / Indications for Use
The Handmaster is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.
Product codes
IPF, GZI
Device Description
The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.
The electrode locations allow the Handmaster to give finger and thumb extension and flexion. By pressing the Mode button on the Control Unit, the user can select from seven stimulation programs that comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. In addition to the former light glowing presentation of the active mode, the new LCD screen enables also the presentation of the name of active mode and sub-mode. A continuously changing three and two-bar combination indicates that the stimulation phase is active. A "seventh like" object indicates the stimulation intensity or the battery condition.
The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment like display.
During the initial system set-up, the clinician opens a screw secured clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.
The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device.
The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal mesh. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge is provided to facilitate wetting of the electrode pads.
Rechargeable nickel-metal-hydride (NiMH) batteries power the device. Battery status can be displayed both during device operation and while recharging the batteries. Both visual and audio battery-low warnings are provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper limb, hand, forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personal use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro, biocompatibility, electrical and electromagnetic testing and verification and validation testing of the software were performed to ensure that the modified HANDMASTER does not raise any new questions of safety and efficacy. Based on these tests results, N.E.S.S Ltd. believes that the modified HANDMASTER is substantially equivalent to the cleared HANDMASTER devices, without raising new safety and/or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
AUG - 8 2003
510(K) SUMMARY
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page 1 of 4
N.E.S.S. NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEM
HANDMASTER
Applicant's Name:
N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. 19 Ha-Haroshet Street Kiedar Center, Suite 207 P.O. Box 2500, Industrial Zone Ra'anana 43465 ISRAEL Tel: 011-972-9-7485738 Fax: 011-972-9-7485740
Contact Person:
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5791 Fax: (202) 637-5910
And/or
Dorit Winitz, Ph. D Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131 dorit@push-med.com
Date Prepared:
June, 2003
Trade Name:
HANDMASTER
1
Classification Name:
Powered muscle stimulators
031900
page 2 of 4
Classification:
Class II: Product Code 89IPF: Regulation No. 890.5850.
Predicate Devices
Neuromuscular Electrical Stimulation Systems Handmaster N.E.S.S. (K952273, K982482, and K010837).
Device Description:
The Handmaster is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator serves five surface electrodes held on to the upper limb by a splint. The control unit housing the stimulator may be worn using the shoulder strap provided, or it may be placed on any stable surface. The splint is worn on the hand and forearm. The splint is connected to the control unit by a light cable.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through five surface electrodes. Microprocessor-controlled switching of the stimulation between these five electrodes allows the muscles to be activated in combinations either cyclically or continuously. The stimulation is ramped up at the beginning and down at the end of each cycle.
The electrode locations allow the Handmaster to give finger and thumb extension and flexion. By pressing the Mode button on the Control Unit, the user can select from seven stimulation programs that comprise either cyclic or continuous activation of the finger and thumb extensors and flexors. In addition to the former light glowing presentation of the active mode, the new LCD screen enables also the presentation of the name of active mode and sub-mode. A continuously changing three and two-bar combination indicates that the stimulation phase is active. A "seventh like" object indicates the stimulation intensity or the battery condition.
The user can increase or decrease the stimulation intensity in ten discrete levels by pressing on buttons labeled "+" or "-" on the control unit. This alters the duration of the stimulation pulse. The intensity is displayed as a number (0 to 9) on a seven-segment like display.
2
KO 31900
page 3 of 4
During the initial system set-up, the clinician opens a screw secured clinical panel within the control unit. Adjustments are provided for limiting the maximum current to the extensor muscles and to the flexor muscles, along with a global timing factor which increases or decreases the duration of the stimulation cycles, effectively speeding or slowing the cyclic hand motion.
The user starts or stops the stimulation program by pressing a "trigger" button. If required, the user may also stop all stimulation immediately by switching OFF the device.
The Handmaster splint is used to hold the wrist joint at a comfortable extension angle (20°), and also to hold the electrodes on the forearm and hand segments. It is constructed from fiber-reinforced plastic with soft polyurethane cushion sections to distribute stress over bony regions. The electrodes are made from metal mesh. Replaceable water-soaked cloth pads are arranged over the electrodes to provide a conductive interface with the skin. A sponge is provided to facilitate wetting of the electrode pads.
Rechargeable nickel-metal-hydride (NiMH) batteries power the device. Battery status can be displayed both during device operation and while recharging the batteries. Both visual and audio battery-low warnings are provided.
Intended Use:
The Handmaster is intended to be used for the following indications: Maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegia due to stroke, it is also intended to provide hand active range of motion and hand function.
Performance Data & Substantial Equivalence
The Handmaster device is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available Handmaster devices. The principle changes between the devices include:
- Change of the User Control display from 7-Segment display to a ■ graphic display (LCD) and related changes in hardware and software
- 내 Change of the mechanical ON/OFF switch
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031900
page 4 of 4
- Change in power supply 의
- Limited changes in the external closure 이
- Change of the battery 확
- Change in operating mode combinations 이
- Change in part of the splint materials 미
In vitro, biocompatibility, electrical and electromagnetic testing and verification and validation testing of the software were performed to ensure that the modified HANDMASTER does not raise any new questions of safety and efficacy. Based on these tests results, N.E.S.S Ltd. believes that the modified HANDMASTER is substantially equivalent to the cleared HANDMASTER devices, without raising new safety and/or effectiveness issues.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines representing the head, body, and tail.
Public Health Service
AUG - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
N.E.S.S. Neuromuscular Electrical Stimulation Systems Ltd. c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K031900
Trade/Device Name: HANDMASTER Regulation Numbers: 21 CFR 882.5810, 890.5850 Regulation Names: External functional neurolmuscular stimulator, Powered muscle stimulator Regulatory Class: II Product Codes: GZI, IPF, Dated: June 18, 2003 Received: July 9, 2003
Dear Mr. Kahan:
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 such 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); good manufacturing practice requirements as set
5
Page 2 - Mr. Jonathan S. Kahan, Esq.
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known):_ KO 3 /900
N.E.S.S. Neuromuscular Electrical Stimulation System Device Name: HANDMASTER
Indications for Use:
The Handmaster is intended to be used for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation. In patients suffering from upper limb paralysis due to C5 spinal cord injury or hemiplegic patients due to stroke, it is also intended to provide hand active range of motion and hand function.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number __
Prescription Use (Per 21 CFR 801.109) OR
Over Use
KO31900
the
Counter
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
\\PH - 64270/0001 - 12604 v1 510(k) Number