(23 days)
The Cl1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
Here's a breakdown of the acceptance criteria and the study information for the CL1000 IR Laser System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration. (Implied: device should provide topical heating for therapeutic purposes) | The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. It delivers infrared energy (implied to cause topical heating). The device was determined substantially equivalent to predicate devices that also utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures. |
| The CL1000 IR Laser System should have the same intended uses as the predicate devices. | The CL1000 IR Laser System was found to have "the same intended uses" as the predicate devices. |
| The CL1000 IR Laser System should have similar functional and performance characteristics to the predicate devices. | The CL1000 IR Laser System was found to have "similar functional and performance characteristics" to the predicate devices. |
| The device must meet functional performance and electrical safety testing in accordance with all applicable standards for this type of medical device. | "Testing of the CL1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device." (Note: The specific results of these tests are not provided, only the intent to perform them). |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not describe a clinical study with a test set of data. The filing is a 510(k) premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than de novo clinical trial data for effectiveness.
The "testing" mentioned refers to functional and electrical safety testing of the device itself, not a study involving human subjects or data comparison against a ground truth for classification/diagnosis.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):
Not applicable, as a clinical study with a test set and associated ground truth established by experts is not described in the provided text.
4. Adjudication Method (Test Set):
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study is not described in the provided text. This type of study is more common for diagnostic or AI-assisted interpretation devices to quantify the improvement in human reader performance. The CL1000 IR Laser System is a therapeutic device intended for topical heating.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The CL1000 IR Laser System is a physical therapeutic device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms is not relevant here. The device's "performance" would be related to its ability to emit infrared energy and generate heat, as described under functional testing.
7. Type of Ground Truth Used:
Not applicable, as there is no mention of a study involving ground truth in the context of diagnostic accuracy or output classification. The "ground truth" implicitly referred to is the generally accepted therapeutic heat performance specifications and the intended physiological effects (elevating tissue temperature, temporary pain relief, etc.) which are established medical understanding rather than specific data labels for a study.
8. Sample Size for the Training Set:
Not applicable. The CL1000 IR Laser System is a hardware device, and the filing process described does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
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DEC 9 2005
510k Notification CL1000 IR Laser System November 15, 2005
APPENDIX B
K05320/
510(k) PREMARKET NOTIFICATION SUMMARY
(per 21 CFR 807.92)
CL1000 IR Laser System
I. Applicant:
Curae Lase Inc. 2315 Hwy 701 South Loris, SC 29569 843 - 455-7020
Date Prepared:
November 15, 2005
II. Device Name
Proprietary Name: Common / Usual Name: Classification Name: Product Code:
CL1000 IR Laser System Infrared Lamp Infrared Lamp (21 CFR 890.5500) ILY
III. Intended Use of the Device
The CL1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
IV. Predicate Devices
Predicate devices to the CL1000 IR Laser System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process.
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V. Description of the Device
The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
VI. Summary of the technical characteristics of the CL1000 IR Laser System to the referenced predicate devices
The CL1000 IR Laser System and the aforementioned predicate devices are infrared lamps as defined in 21 CFR 890.5500. These devices utilize infrared and visible laser diodes to generate topical heating for the purpose of elevating tissue temperatures for temporary relief of muscle and joint pain.
VII. Testing
Testing of the CL1000 IR Laser System will include functional performance testing and electrical safety testing in accordance with all applicable standards for this type medical device.
VIII. Conclusions
Pursuant to the testing and comparison to the predicate devices, the CL1000 IR Laser System has the same intended uses, with similar functional and performance characteristics. The System is designed to comply with the generally accepted therapeutic heat performance specifications by producing a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles an eagle or bird in flight, composed of three curved lines. The text is arranged around the top and left side of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 9 2005
Curae'Lase Inc. C/O M. Joyce Heinrich Regulatory Consultant Texas Applied Biomedical Services 12101- A Cullen Blvd. Houston, Texas 77047-2951
Re: K053201
Trade/Device Name: CL1000 IR Laser System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamps Regulatory Class: Class II Product Code: ILY Dated: November 15, 2005 Received: November 23, 2005
Dear Ms. Heinrich:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. H. Joyce Heinrich
CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0120. 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 Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Notification CL1000 IR Laser System November 15, 2005
APPENDIX C
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Pending KOS 3201
Device Name:
Curae Lase Inc. CL1000 IR Laser System
Indications for Use:
The Cl1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Prescription Use: X X (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 (ODDE)
Z
(Division Sign. Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS3201
N/A