(51 days)
Not Found
No
The summary describes a far infrared heating device in a back support belt and mentions skin temperature testing. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies.
Yes
The device is intended for the temporary relief of pain and stiffness, muscular relaxation, and temporary increase of local circulation, which are therapeutic claims. It also points to "therapeutic heat" in the summary of performance studies.
No
The device is indicated for temporary relief of pain and stiffness, muscular relaxation, and increased circulation. Its function as a far infrared heating device primarily suggests therapeutic rather than diagnostic use.
No
The device description explicitly states it is a "far infrared heating device that is provided in a back support belt," indicating it is a hardware device.
Based on the provided information, the Back-tek system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the temporary relief of pain, stiffness, spasms, strains, sprains, and to increase local circulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The device is described as a far infrared heating device in a back support belt. This is a physical therapy device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro methods, or providing information for diagnosis.
IVD devices are used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Back-tek system's function is to apply heat to the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
ILY
Device Description
The Back-tek device is a far infrared heating device that is provided in a back support belt.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle.
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
York Biomedical
, ,
5.0 510(k) Summary or 510(k) Statement
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Back-Tek device is provided below.
| Device Common Name: | Infrared Lamp | |
|---|---|---|
| Device Proprietary Name: | Back-Tek | JUN 23 2010 |
| Submitter: | York Biomedical Inc. | |
| 8132 Artie Kemp Rd. | ||
| Frederick, MD 21701 | ||
| Phone: 301-788-0702 | ||
| Contact: | Calley Herzog | |
| Consultant | ||
| Biologics Consulting Group, Inc. | ||
| Phone: 720-883-3633 | ||
| Email: cherzog@bcg-usa.com | ||
| Classification | ||
| Regulation: | 21 CFR 890.5500 | |
| Panel: | Physical Medicine | |
| Product Code: | ILY |
Indication for Use:
The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Device Description:
The Back-tek device is a far infrared heating device that is provided in a back support belt.
Performance Data:
Skin temperature testing is provided to show that the Back-Tek provides therapeutic heat during the treatment cycle.
Substantial Equivalence:
The Back-Tek device is a far infrared heating device that is substantially equivalent to the Thermotex Platimun Heat Therapy System cleared in K092589 based on indication for use and technological characteristics.
1
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
York Biomedical, Inc. % Biologics Consulting Group, Inc. Ms. Calley Herzog 13417 Quivas Street Westminster, Colorado 80234
Re: K101227
Trade/Device Name: Back-Tek Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: May 3, 2010 Received: May 3, 2010
Dear Ms. Herzog:
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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
JUN 2 3 2010
2
Page 2 - Ms. Calley Herzog
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/ucm1.1.5809.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 vours.
Sincererly, years,
Mark A. Milkus
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
York Biomedical
くな
4.0 Indications for Use Statement
510(k) Number (if known): __
Device Name: Back-Tek
.
Indications For Use:
The Back-tek system is indicated for the temporary relief of minor muscle and joint pain and stiffness; and the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use__X (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)
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
Number K1012
Page 10