(217 days)
The Ab Belt device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
The Ab Belt is a single channel battery operated muscle stimulation system specifically designed for improving abdominal muscle tone, for strengthening the abdominal muscles and for developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The device is supplied with a set of three identical electrodes, a tube of conductive gel, an instruction manual, a set of batteries and a fabric belt extension for fuller figures. Power is derived from three (3) 1.5V AAA batteries located on an external pop-on connector and slid into a pocket on the belt facia. The central umbilical electrode is common to each of the left and right stimulation circuits.
The electrodes connect mechanically to 'press-studs' mounted on the inner face of the abdominal belt. The studs are presented in such a way that each of the outer electrodes may be rotated about a single common stud to accommodate both inner and outer muscle groups. Only these single common studs of the outer electrodes and the central umbilical electrode are electrically connected to the stimulator unit. This prevents stimulation to the user through a stud, which is not covered by an electrode pad.
The user extends the belt and puts it in a wrapping motion from front to back, closing it at the back using Velcro patches. When the belt is in place the central electrode locates over the umbilicus and the two outer electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the rib cage. It is well known in the art that this electrode positioning is particularly useful for stimulating the abdominal muscles.
The pulsed stimulation current passes between the outer and center electrodes only. There is no current passed from outer electrode to outer electrode. The user has no access to the wiring or connectors as they are stored internally within the belt structure. As a result he or she cannot alter the current path and so the possibilities for misuse are greatly reduced.
The provided text describes a muscle stimulator called "Ab Belt" and its 510(k) submission, confirming its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on regulatory aspects rather than detailed performance study results.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and performance studies, as this information is not present in the provided text.
Specifically, the following information you requested is missing:
- A table of acceptance criteria and the reported device performance: Not present. The document only states the indications for use and compares the device's characteristics to a predicate device.
- Sample sized used for the test set and the data provenance: Not present. No performance testing data is discussed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no performance study is described.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not present. The device is a muscle stimulator, not an AI diagnostic tool that would typically involve MRMC studies with human readers.
- Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study is detailed.
- Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
The document states:
- "The Ab Belt device has the same indications for use as the predicate device."
- "The Ab Belt device has equivalent technological characteristics and instructions for use, as compared to the predicate device."
- "The device meets the mandatory performance standard identified in 21 CFR 898."
- "The biocompatibility of the electrodes has been established."
These statements indicate that the device meets regulatory requirements and is considered equivalent to a predicate, but they do not provide specific performance metrics, acceptance criteria, or study details. The "mandatory performance standard identified in 21 CFR 898" would specify certain electrical or safety performance aspects, but the text does not elaborate on these or provide test results against them.
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1.0 510(K) SUMMARY
1.1 Sponsor Information
| Sponsor | The Dezac Group54-56 Bath RoadCheltenham, Glos.GL53 7HGUnited Kingdom |
|---|---|
| Registration | in England No. 2186341 |
| Contact Person | Mr. Kevin Herbert, Project Engineer |
Phone +44 1242 702300 Fax +44 1242 702301 E-mail kherbert@dezac.co.uk
SFP 1 3 2002
1.2 Device Name
| Trade Name of Device | Ab Belt |
|---|---|
| Common Name | Muscle Stimulator |
| Classification name | Powered Muscle Stimulator |
| Product Code | NGX |
| Regulation Class | II |
| Regulation Number | 890.5850 |
1.3 Indications for Use
The Ab Belt device is indicated for use for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.
Device Description 1.4
The Ab Belt is a single channel battery operated muscle stimulation system specifically designed for improving abdominal muscle tone, for strengthening the abdominal muscles and for developing a firmer abdomen. It comprises an electronic stimulation controller module which generates the required electrical stimulation signals and an abdominally worn electrode belt
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which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. The device is supplied with a set of three identical electrodes, a tube of conductive gel, an instruction manual, a set of batteries and a fabric belt extension for fuller figures. Power is derived from three (3) 1.5V AAA batteries located on an external pop-on connector and slid into a pocket on the belt facia. The central umbilical electrode is common to each of the left and right stimulation circuits.
The electrodes connect mechanically to 'press-studs' mounted on the inner face of the abdominal belt. The studs are presented in such a way that each of the outer electrodes may be rotated about a single common stud to accommodate both inner and outer muscle groups. Only these single common studs of the outer electrodes and the central umbilical electrode are electrically connected to the stimulator unit. This prevents stimulation to the user through a stud, which is not covered by an electrode pad.
The user extends the belt and puts it in a wrapping motion from front to back, closing it at the back using Velcro patches. When the belt is in place the central electrode locates over the umbilicus and the two outer electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the rib cage. It is well known in the art that this electrode positioning is particularly useful for stimulating the abdominal muscles.
The pulsed stimulation current passes between the outer and center electrodes only. There is no current passed from outer electrode to outer electrode. The user has no access to the wiring or connectors as they are stored internally within the belt structure. As a result he or she cannot alter the current path and so the possibilities for misuse are greatly reduced.
Basis for Substantial Equivalence 1.5
Predicate Device
Slendertone™ Flex: K010335 (Class II) Bio-Medical Research Ltd c/o Mr. Robert Dormer Hyman, Phelps & McNamara, P.C. 700 13th Street NW, Suite 1200 Washington, D.C. 20005
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- The Ab Belt device has the same indications for use as the predicate device. .
- The Ab Belt device has equivalent technological characteristics and instructions for use, as . compared to the predicate device.
- The device meets the mandatory performance standard identified in 21 CFR 898. .
- The biocompatibility of the electrodes has been established. .
- . The conductive gel is a legally-marketed gel cleared through 510(k) number K983964.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three heads in profile, representing health and human services. The bird is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2002
Mr. Kevin Herbert The Dezac Group 54-56 Bath Road Cheltenham, Glos. GL53 7HG United Kingdom
Re: K020427
Trade/Device Name: Ab Belt Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 9, 2002 Received: September 10, 2002
Dear Mr. Herbert:
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
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Page 2 - Mr. Kevin Herbert
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.
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,
L. Mark N. Milken
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
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Indications for use statement
| 510(k) number (if known): | K020427 |
|---|---|
| Device Name: | AbBelt |
| Sponsor Name: | The Dezac Group |
| Indications for use: | The AbBelt is indicated for use for improvement ofabdominal muscle tone, for strengthening of theabdominal muscles, and for the development of a firmerabdomen. |
Mark N. Millerson
(Division Sign-Off) (Division Sign of General, Restorative and Neurological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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).