(100 days)
The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
Powered Inflatable Tube Massager
This is a 510(k) clearance letter for the DJS Massager (Powered Inflatable Tube Massager). It does not contain the detailed information about acceptance criteria and study results typically found in a clinical study report or a detailed 510(k) summary. The provided document is essentially a regulatory approval letter based on substantial equivalence.
Therefore, many of the requested details cannot be extracted from this document. However, I can infer some information based on the nature of a 510(k) submission for a massager.
Here's what can be stated based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided: This document does not contain specific performance data or acceptance criteria for a clinical study comparing the DJS Massager to a benchmark. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical performance data with predefined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided: This information is not present in the regulatory clearance letter. For a massager, a "test set" in the context of clinical performance might not even be a required component if substantial equivalence can be demonstrated through other means (e.g., design, materials, intended use, energy output comparison to a predicate).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided: This document does not describe the establishment of ground truth by experts for a test set. This type of detail is typical for AI/CAD device submissions where diagnostic accuracy is assessed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided: Not applicable or not included in this type of regulatory letter.
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:
- Cannot be provided: This is highly unlikely for a powered inflatable tube massager. MRMC studies are typically for diagnostic imaging devices where AI assists in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided: Not applicable, as this device does not contain an "algorithm" in the sense of an AI or diagnostic software. It's a physical massager.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided: There is no mention of ground truth establishment in this document.
8. The sample size for the training set:
- Cannot be provided: This device does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Cannot be provided: Not applicable.
Summary of what can be extracted from the document:
- Device Name: DJS Massager (Powered Inflatable Tube Massager)
- Regulatory Status: 510(k) clearance, deemed substantially equivalent to a legally marketed predicate device.
- Regulatory Class: Class II
- Product Code: IRP
- Indications for Use: The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
- Use Environment: Over-The-Counter Use (21 CFR Subpart C)
- Date of Clearance: December 7, 2011
This document is a formal notification of FDA clearance, not a detailed technical report or clinical study summary. For a medical device like a massager, the detailed performance data and acceptance criteria would typically be found in the 510(k) summary (a public document) or the full 510(k) submission (confidential). However, for a device of this classification and type, the "study" demonstrating performance is often a comparison of technical specifications, safety data, and intended use against a predicate device, rather than a clinical trial with specific performance endpoints and ground truth.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of a staff with two snakes coiled around it, and a pair of wings at the top.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mego Afek AC Ltd. % Arent Fox LLP Mr. James R. Ravitz Suite 400 1050 Connecticut Avenue, NW Washington DC 20036
DEC - 7 2011
Re: K112479
Trade/Device Name: DJS Massager (Powered Inflatable Tube Massager) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: II Product Code: IRP Dated: November 14, 2011 Received: November 14, 2011
Dear Mr. Ravitz:
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. Isting 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
{1}------------------------------------------------
Page 2 - Mr. James R. Ravitz
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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,
FOR
Mark N. Melkerson
Peter Dm
Der
Llin Din
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
I. Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(K) NUMBER (If known): _ K 112479
DEVICE NAME:
DJS Massager (Powered Inflatable Tube Massager)
INDICATIONS FOR USE:
The DJS Massager is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in people who are in good health. The DJS Massager simulates kneading and stroking of tissues by using an inflatable garment.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112479
M 0004
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).