(198 days)
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.
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.
The provided text is a 510(k) summary for the BioRemedi HealthLight™ System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving the device meets those criteria. Therefore, much of the requested information is not explicitly present.
However, based on the nature of a 510(k) submission for a Class II device, we can infer some aspects of what would typically be involved, even if the detailed study isn't described. The document primarily highlights similarities and differences between the proposed device and its predicate.
Here's an analysis of the provided information in the context of your request:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it argues for "substantial equivalence" to a predicate device, the SMI™ SpectroPad (K931261). The "reported device performance" is implicitly that it operates similarly to the predicate device in terms of providing heat therapy, temporarily relieving minor pain, stiffness, and muscle spasm, and temporarily increasing local blood circulation.
| Acceptance Criteria (Implied from Substantial Equivalence to Predicate) | Reported Device Performance (Implied) |
|---|---|
| Device provides heat therapy. | HealthLight™ System provides heat therapy. |
| Device temporarily relieves minor pain. | HealthLight™ System temporarily relieves minor pain. |
| Device temporarily relieves stiffness. | HealthLight™ System temporarily relieves stiffness. |
| Device temporarily relieves muscle spasm. | HealthLight™ System temporarily relieves muscle spasm. |
| Device temporarily increases local blood circulation. | HealthLight™ System temporarily increases local blood circulation. |
| Device safety and effectiveness for intended use. | HealthLight™ System is safe and effective for its intended use (as demonstrated by substantial equivalence to a legally marketed predicate and meeting its specifications). |
| Device operation in terms of power, pads, and array of LEDs. | HealthLight™ System operates with a separate controller to power flexible pads attached by a cable, containing an array of light-emitting diodes, and can power more than one pad at a time. |
| Device power source (12VDC). | HealthLight™ System is powered by plug packs converting mains power to 12VDC. |
| Fail-safe operation. | HealthLight™ controller is designed to fail in a SAFE mode (shut off). |
Study Details
The document emphasizes "substantial equivalence" rather than a de novo clinical study with specific performance metrics against acceptance criteria. Therefore, most of the following information is not provided or not applicable in the context of this 510(k) summary.
- Sample size used for the test set and the data provenance: Not applicable/not provided. The submission relies on demonstrating similarity to a device already on the market, not a new clinical trial generating new data. There is no "test set" in the sense of a data set used for performance evaluation of an AI algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. This type of information would be relevant for studies evaluating diagnostic accuracy, especially in AI.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
- 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: Not applicable/not provided. This is relevant for AI-assisted diagnostic tools, not for a light therapy device demonstrating substantial equivalence.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This device is a physical therapy device, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device (the SMI™ SpectroPad). The justification is that if the new device is sufficiently similar to the predicate and doesn't raise new questions of safety or effectiveness, it can be cleared. The clinical effects of the predicate device (pain relief, circulation increase) would have been established historically through clinical evidence or common medical knowledge for infrared therapy.
- The sample size for the training set: Not applicable/not provided. This device is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable/not provided.
Key Points from the Document Related to Equivalence:
- Predicate Device: SMI™ SpectroPad (K931261)
- Similarities:
- Pulsed infrared devices.
- Use a separate controller to power flexible pads attached by a cable.
- Pads contain an array of light-emitting diodes.
- Controllers designed to power more than one pad at a time.
- Powered by plug packs converting mains power to 12VDC.
- Differences (and justification why they don't impact safety/effectiveness):
- HealthLight™ operates with a microprocessor (vs. solid-state for Anodyne/SMI).
- HealthLight™ has a timer and auto shut-off after 30 minutes (Anodyne lacks this). This difference is presented as a safety improvement.
- HealthLight™ controller is designed to fail in a "SAFE mode" (shut off), whereas Anodyne's can fail in an UNSAFE mode. This is also presented as a safety improvement.
- HealthLight™ uses 5-pin DIN plugs for removable cables, and a removable power supply (vs. soldered RCA connectors and power supply lead for Anodyne). This is presented as common practice for electronic devices.
- HealthLight™ is Rx Only, while the predicate was OTC. This is a difference in classification of use but doesn't inherently imply adverse impact on safety/effectiveness when prescribed by a doctor.
The conclusion states: "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." This is the core claim for a 510(k) submission.
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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 IdentificationBioRemedi Therapeutic Systems, Inc.714 Center Hill RoadCopake, NY 12516Patrick DoyleTel: (888) 395-3040Fax: (888) 376-0113Email: Patrick Doyle patrick@globalhealthproducts.com |
| 5.1.2 | Establishment Registration Number: 3006276091 |
| 5.1.3 | Submission CorrespondentNorman F. Estrin, Ph.D.Managing PartnerESTRIN CONSULTING GROUP LLC.9109 Copenhaver DrivePotomac, MD 20854Tel: (301)279-2899Fax:(301)294-0126estrin@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 deviceClassification 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 |
| 5.2.85.3 | DEVICE DESCRIPTIONThe BioRemedi HealthLight™ is a scalable system consisting of sevendifferent shaped/sized pads holding LEDs that may be used with any ofthree controllers, the differences being a two, a three or a four portconfiguration. Any pad, alone, or in any combination with any other pad,may be used with any of these three controllers. |
| 5.4 | INDICATIONS FOR USEThe BioRemedi HealthLight™ System is indicated for the following prescriptionuses |
| 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 EQUIVALENCEThe BioRemedi HealthLight™ System is substantially equivalent to thepredicate device, the SMI SpectroPad, (K931261).Similarities |
| Anodyne (formerly SMI) and HealthLight™ are pulsed infrared devices using aseparate 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 onepad at a time. | |
| 000013 |
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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.
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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
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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
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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)
N/A