(37 days)
Not Found
No
The summary describes a light therapy system with laser diodes and a control unit, focusing on its physical characteristics and performance studies related to safety and functionality. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, which is a therapeutic purpose.
No
The device is described as a pain therapy system intended for temporary relief of minor pain, not for diagnosing conditions.
No
The device description explicitly states it is a "hand-held, non-invasive, pain therapy system" utilizing "non-heating lamps consisting of four laser diodes in one applicator head" and a "basic hand-held, battery operated control unit and a permanently attached applicator head." This clearly describes a physical hardware device, not software only.
Based on the provided information, the Excalibur IV Light Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin." This is a therapeutic use applied directly to the patient's body, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a "hand-held, non-invasive, pain therapy system" that uses light therapy. This aligns with a physical therapy or pain management device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, processing, or analyzing biological specimens (like blood, urine, tissue, etc.). There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
- Regulatory Classification: The device is described as an "infrared as described under the provisions of 21 CFR §890.5500". This CFR section pertains to Infrared lamps, which are classified under the Physical Medicine device panel, not the Clinical Chemistry, Hematology, Immunology, Microbiology, or Pathology panels where IVDs are typically found.
In summary, the Excalibur IV Light Therapy System is a therapeutic device used for pain relief through light therapy, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Excalibur IV Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for: -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin.
Product codes (comma separated list FDA assigned to the subject device)
NHN
Device Description
The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four laser diodes in one applicator head. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) approved. The system consists of a basic hand-held, battery operated control unit and a permanently attacher applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with al performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration. The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergen beam and is classified as a Class IIIa laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and shoulder
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)
The testing of the Excalibur IV Light Therapy System includes functional performance, electrica safety, and component specification. This includes four-staged manufacturing esticularly, esticulu verification.
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
JUL 2 7 2005
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, specifically 'K051631'. The characters are written in a bold, slightly irregular font, giving them a distinct and somewhat informal appearance. The numbers are clearly distinguishable, and the overall impression is that of a label or identifier. The image is simple, focusing solely on the legibility and presentation of the alphanumeric sequence.
1 of 3
510(k) Summary
(as required per 21CFR; §807.92)
Excalibur IV Light Therapy System
| I. Applicant | Stargate International, Inc. |
|---|---|
| 10235 South Progress Way #7 | |
| Parker, CO 80134 | |
| Phone: 303-840-8206 | |
| Fax: 303-840-8320 |
| II. Contact Name: | Robert H. Walker; CEO
rwalker@stargateinternational.com |
| ------------------- | ------------------------------------------------------------ |
|---|
III. Device Name
| Proprietary Name | Excalibur IV Light Therapy System |
|---|---|
| Common/Usual Name(s) | Low Level Laser Therapy (LLLT) |
| Therapeutic Light System | |
| Classification Name | Infrared Lamp; (21CFR; §890.5500) |
| Product Code | NHN |
IV. Predicate Device/Substantial Equivalency
The Excalibur IV Light Therapy System is substantially equivalent to other pulsed low level therapeutic lasers and light therapy systems currently in commercial distribution. The Excalibur IV Light Therapy System has the same intended use and similar technological characteristics to predicate devices. It combines the clinically accepted therapeutic uses of previously FDA 510(k) approved light theracy. systems currently in commercial distribution into one compact and cost-effective system.
The technological equivalence to the predicate devices is substantiated by the wavelength and power output generated by the one Excalibur IV System applicator head permanently attached to the basic unit. The Excalibur IV System will provide the same treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate devices.
1
K051631 2 of 3
The predicate device the Excalibur IV System establishes equivalence to is the following:
| Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Quantum System .................................. | K032816 | Stargate International |
V. Intended Use of the Device
The Excalibur IV Light Therapy System is a non-heating lamp, infrared as described under th provisions of 21 CFR §890.5500 and is clinically indicated for:
- -- Adjunctive use in providing temporary relief of minor chronic neck and shoulder pair of musculoskeletal origin.
As with the predicate device, pain therapy treatment can be prescribed for pain associated with with the clinical presentation specified above by having the beams pulsed or continuous with time consid erations. The Excalibur IV Light Therapy System's variables conform to the performance specification of the clinical parameters used by the predicate devices in frequency, wavelength, time, and power outpul
VI. Description of the Device
The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four laser diodes in one applicator head. It combines the clini cally accepted therapeutic treatment of numerous predicate light therapy systems currently in commercia distribution and 510(k) approved.
The system consists of a basic hand-held, battery operated control unit and a permanently attacher applicator head. The laser operates at a measured wavelength of 635nm (±1%) and complies with al performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International Inc. is a registered laser manufacturer with the Food and Drug Administration.
The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergen beam and is classified as a Class IIIa laser.
VII. Summary of Technical Characteristics of the Device To Referenced Predicate Devices
The Excalibur IV Light Therapy System and the aforementioned predicate devices use Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output to emit visible photonic energy to human tissue. The technology is dependent on the laws of physics in that the variables are free wency wavelength, power output, and time.
The performance parameters and intended use of the Excalibur IV Light Therapy System are identical to all predicate devices.
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VIII. System Testing
The testing of the Excalibur IV Light Therapy System includes functional performance, electrica safety, and component specification. This includes four-staged manufacturing esticularly, esticulu verification.
There is no software incorporated into the operation of the Excalibur IV Light Therapy System.
The Excalibur IV Light Therapy System is manufactured, performs, is labeled, and is tested to comply with the following standards:
- FCC Standard 47CFR Part 15B .
- All Electrical Components Utilized Are UL® Approved .
- . Class IIIa Laser - 21CFR Part 1040.
IX. Conclusions
In accordance with testing and comparison to the predicate devices, and pursuant to 21CFR; §890.500, the Excalibur IV Light Therapy System has the same intended use, with similar functional and performance characteristics.
The device meets or exceeds the design, testing, and labeling standards required by law. The Excalibur IV Light Therapy System is manufactured and performs as intended and does not raise any new regulatory, safety, and/or clinical efficacy issues.
3
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is circular in shape and features an abstract image of an eagle in the center. The eagle is composed of three curved lines that suggest the shape of the bird's head, body, and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 2005
Mr. Robert H. Walker Chief Executive Officer Stargate International, Inc. 10235 South Progress Way, #7 Parker, Colorado 80134
Re: K051631
Trade/Device Name: Excalibur IV Light Therapy System Regulation Number: 21 CFR 890.5500 Regulation Name: Lamp, non-heating for adjunctive use in pain therapy Regulatory Class: II Product Code: NHN Dated: June 15, 2005 Received: June 20, 2005
Dear Mr. Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations to toges and the Medical Device Amendments, or to conninered province to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug. de vices martie 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 r ou may, merers, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device to such additional controls. Existing major regulations affecting your device can may oc subject to sublications, 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 1 toase be determination that your device complies with other requirements of the Act that 1127 has made a and regulations administered by other Federal agencies. You must or any I each statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fat 607); adoming (21 CFR Part 820); and if applicable, the electronic form in the quant) 35 real provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert H. Walker
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins lotter will and my your e FDA finding of substantial equivalence of your device to a legally premarked predicated 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), please If you acono of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.himl.
Sincerely yours,
Stypk Curles
Mark N. Mellecker
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
| 510(k) Number (if known): | K05/63 |
|---|---|
| --------------------------- | -------- |
Device Name: Excalibur IV Light Therapy System
The Excalibur IV Light Therapy System is a non-heating lamp, infrared as Indications For Use: described under the provisions of 21 CFR §890.5500 and is indicated for:
Adjunctive use in providing temporary relief of minor chroni‹ neck and shoulder pain of musculoskeletal origin.
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 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 General, Restorative and No rological Devices
510(k) Number K051631
Page 10 - Excalibur IV 510(k) dated June 15, 2005