(44 days)
Not Found
No
The device description details a microprocessor-controlled electrical stimulator with pre-set programs 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 is also explicitly "Not Found".
Yes
The device description clearly states its intended use 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," all of which are therapeutic applications.
No
The device is described as an electrical neuromuscular stimulator that provides therapy (e.g., maintaining range of motion, reducing muscle spasms) rather than diagnosing conditions.
No
The device description clearly states it is a portable electrical neuromuscular stimulator with hardware components including a stimulator unit, batteries, electrodes, and splints.
Based on the provided information, the NESS Children System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device's purpose as providing electrical neuromuscular stimulation for therapeutic benefits like increasing range of motion, reducing muscle spasm, etc. This is a direct therapeutic intervention on the body.
- Device Description: The description details a portable electrical stimulator with surface electrodes and splints. This is a physical device that applies electrical current to the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The NESS Children System does not interact with or analyze such specimens.
Therefore, the NESS Children System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NESS Children System is intended for pediatric use 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.
Product codes
89 IPF, IPG
Device Description
The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries, serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these 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 NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb (hand, forearm, arm, thigh, leg)
Indicated Patient Age Range
Pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 890.3025 Prosthetic and orthotic accessory.
(a)
Identification. A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
510(K) Summary NESS Children System 510(k) Number K 024279
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:
Orly Maor Push-med Ltd. 117 Ahuzah St. Ra'anana 43373, Israel Tel: 972-9- 7718130 Fax: 972-9-7718131 orly@push-med.com
And/or
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910
Date Prepared:
December, 2002
1
Trade Name:
NESS Children System
Classification Name:
Powered Muscle Stimulators
Classification:
The FDA has classified Powered muscle stimulators devices as class II devices (product code 89 IPF, Regulation No. 890.5850) and they are reviewed by the Restorative Devices Branch .
Predicate Device:
Ness System cleared under K022776
Performance Standards:
No performance standards have been established for powered muscle stimulators under section 514 of the FDC Act. No special controls apply.
Indications:
The NESS Children System is intended for pediatric use 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.
Device Description:
The NESS Children System is a portable, one-channel electrical neuromuscular stimulator for personal use. The stimulator, which is powered by rechargeable nickel-cadmium batteries,
2
serves surface electrodes held on to the limb by a splint. A selection of four splints for the hand and forearm, the arm, the thigh, or the leg is provided in three sizes each to fit children dimensions.
A single channel of constant-voltage symmetrical biphasic Russian waveform stimulation is delivered to the muscles through surface electrodes. Microprocessor-controlled switching of the stimulation between these 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 NESS Children System to provide extension and flexion of the limb segment distal to that of the splint. The user can select from five stimulation programs by pressing the mode button on the control unit and can increase or decrease the stimulation intensity in ten discrete levels.
Substantial Equivalence:
NESS Ltd. believes that the NESS Children System is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be an abstract representation of a human form or bird-like figure, composed of three curved lines.
FEB 0 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neuromuscular Electrical Stimulation Systems, Ltd. C/O•Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, D.C.
Re: K024279
Trade/Device Name: NESS Children System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPG Dated: December 23, 2002 Received: December 23, 2002
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
4
Page 2 - Mr. Jonathan S. Kahan
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Mark M Millman
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
5
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Ness Children System
Indications for Use: The NESS Children System is intended for pediatric use 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.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
fo Mark N Milheras
510(k) Number ___ (Division Sign-Off)
Division of General, Restorative
and Neurological Devices
$10(k) Number. K024279
Prescription Use _ OR Over the Counter
(Per 21 CFR 801.109) Use _