(198 days)
Not Found
No
The summary describes a light therapy device with different pads and controllers, focusing on heat therapy and increased blood circulation. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is intended to provide heat therapy, relieve minor pain, stiffness, muscle spasm, and temporarily increase local blood circulation, which are all therapeutic uses.
No
The intended use of the device is to provide heat therapy for temporary relief of minor pain, stiffness, and muscle spasm, and to temporarily increase local blood circulation. These are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of "seven different shaped/sized pads holding LEDs" and "three controllers," indicating physical hardware components are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for providing heat therapy, relieving pain, stiffness, muscle spasm, and increasing local blood circulation. These are therapeutic applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a system of LED pads and controllers used for applying light therapy. This aligns with a physical therapy or pain management device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
Therefore, the HealthLight™ system is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioRemedi HealthLight™ System is indicated for the following prescription uses: Provides heat therapy, i.e., temporarily relieves minor pain, stiffness, and muscle spasm. Temporarily increases local blood circulation. It is indicated for Rx Only use.
HealthLight™ MicroController, MiniPro, ProNeurolLght, and Pro Unit are intended for the following indications for use: 1. Provides heat therapy, i.e., temporarily relieves minor pain, stiffness and muscle spasm. 2. Temporarily increases local blood circulation. It is an Rx Only medical device.
Product codes
ILY
Device Description
The BioRemedi HealthLight™ is a scalable system consisting of seven different shaped/sized pads holding LEDs that may be used with any of three controllers, the differences being a two, a three or a four port configuration. Any pad, alone, or in any combination with any other pad, may be used with any of these three controllers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
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
JAN 2 1 2011
Image /page/0/Picture/1 description: The image is a logo for a company called "BioRemedi Therapeutic Systems". The logo features a stylized letter "B" with the word "REMEDI" overlaid on it in a smaller font. Below "REMEDI" is the text "THERAPEUTIC SYSTEMS". Above the text is a graphic of lines radiating upwards in a semi-circular shape, resembling the sun's rays.
Bioremedi Therapeutlc Systems, Inc � 714 Center Hill Rd, Route 7a � Copake, NY 12516
PHONE: 888 395-3040 ✈ FAX: 888 376-0113 ☎ HEALTHLIGHT.COM.AU
SECTION 5.0 SUMMARY OF SAFETY & EFFECTIVENESS
This summary of 510 (k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92.
| 5.1 | ADMINISTRATIVE INFORMATION |
|---|---|
| 5.1.1 | Sponsor Identification |
| BioRemedi Therapeutic Systems, Inc. | |
| 714 Center Hill Road | |
| Copake, NY 12516 | |
| Patrick Doyle | |
| Tel: (888) 395-3040 | |
| Fax: (888) 376-0113 | |
| Email: Patrick Doyle | |
| 5.1.2 | Establishment Registration Number: 3006276091 |
| 5.1.3 | Submission Correspondent |
| Norman F. Estrin, Ph.D. | |
| Managing Partner | |
| ESTRIN CONSULTING GROUP LLC. | |
| 9109 Copenhaver Drive | |
| Potomac, MD 20854 | |
| Tel: (301)279-2899 | |
| Fax:(301)294-0126 | |
| estrin@yourFDAconsultant.com | |
| 5.1.4 | Date Prepared: June 21, 2010 |
| 5.2 | DEVICE NAME AND CLARIFICATION |
| 5.2.1 | Proprietary (Trade) Name: HealthLightTM |
| 5.2.2 | Models: MicroController, MiniPro, ProNeuroLight, and Pro Unit |
| 5.2.3 | Common Name: LED light therapy device |
| Classification Name: Lamp. Infrared, therapeutic Heating | |
| 5.2.4 | Regulation Numbers: 21 CFR 890.5500 |
| 5.2.5 | Proposed Regulation Class: Class II |
| 5.2.6 | Device Product Code: ILY |
| 5.2.7 | Medical Specialties: Physical Medicine |
| 5.2.8 | |
| 5.3 | DEVICE DESCRIPTION |
| The BioRemedi HealthLight™ is a scalable system consisting of seven | |
| different shaped/sized pads holding LEDs that may be used with any of | |
| three controllers, the differences being a two, a three or a four port | |
| configuration. Any pad, alone, or in any combination with any other pad, | |
| may be used with any of these three controllers. | |
| 5.4 | INDICATIONS FOR USE |
| The BioRemedi HealthLight™ System is indicated for the following prescription | |
| uses | |
| Provides heat therapy, i.e., temporarily relieves minor pain, stiffness, | |
| and muscle spasm. Temporarily increases local blood circulation. | |
| It is indicated for Rx Only use. | |
| 5.5.1 | Predicate Device Name: SMI™ SpectroPad |
| 5.5.2 | Predicate Device FDA 510(k) Number: K931261 |
| 5.6 | SUBSTANTIAL EQUIVALENCE |
| The BioRemedi HealthLight™ System is substantially equivalent to the | |
| predicate device, the SMI SpectroPad, (K931261). | |
| Similarities | |
| Anodyne (formerly SMI) and HealthLight™ are pulsed infrared devices using a | |
| separate controller to power flexible pads attached by a cable. | |
| Anodyne and HealthLight™ pads contain an array of light emitting diodes. | |
| Anodyne and HealthLight™ controllers are designed to power more than one | |
| pad at a time. | |
| 000013 |
1
2
Anodyne and HealthLight™ are powered by plug packs converting mains power to 12VDC.
Differences
Anodyne (formerly SMI) is a solid-state device, HealthLight™ operates with a microprocessor.
Anodyne does not have a timer or auto shut off feature, HealthLight™ has a timer and an auto shut off feature after 30 minutes maximum.
Anodyne's design allows the controller to fail in an open or UNSAFE mode. HealthLight TM controller is designed to fail in a SAFE mode, i.e., shut off, Anodyne cables use RCA connectors that are soldered to the input iacks. HealthLight™ cables use 5 pin DIN plugs that are removable from the device as commonly the case for electronic devices.
Anodyne solders the power supply lead to the power input connector.
HealthLight™'s power supply is removable, as is commonly the case for electronic devices.
HealthLight™ differs from the predicate device in that is a prescription only device while the predicate device is indicated for OTC use.
The differences identified above do not impact adversely the Safety and Effectiveness of the HealthLight™ device.
CONCLUSION 5.7
In summary, BioRemedi has demonstrated that its BioRemedi HealthLight™ System meets its specifications, is safe and effective for its intended use, and is substantially equivalent to the referenced predicate device.
000014
3
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BioRemedi Therapeutic Systems, Inc. % Estrin Consulting Group. LLC Norman F. Estrin. Ph.D. 9109 Copenhaver Drive Potomac, Maryland 20854
JAN 2 1 201
Re: K101894
Trade/Device Name: HealthLight" MicroController, MiniPro, ProNeuroLight, and Pro Unit Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: ILY Dated: January 09, 2011 Received: January 11, 2011
· Dear Dr. Estrin:
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. 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
4
Page 2 - Norman F. Estrin, Ph.D.
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 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/CentersQffices/CDRH/Offices/ucm115809.html 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
A. B. R.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HealthLight™ MicroController, MiniPro, ProNeuroLight, and Pro Unit
Indications for Use:
HealthLight™ MicroController, MiniPro, ProNeurolLght, and Pro Unit are intended for the following indications for use:
-
Provides heat therapy, i.e., temporarily relieves minor pain, stiffness and muscle spasm.
-
Temporarily increases local blood circulation.
It is an Rx Only medical device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milrope Ogle for men
ivision Sien-U Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of .
510(k) Number
000017
(Posted November 13, 2003)