(108 days)
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The HILT Family Laser provides 1,064 nm wavelength. Laser emission activation is by used selectable controller. Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
The Hilt Family Laser: HILT I, HILT III is a Nd:YAG laser, Intrared Lamp system for heat therapy. The three possible treatment configurations are initalou Eamp Hilt II, non-contact; Hilt III, both contact and non-contact. The noncontact hand piece utilizes a spacer between the output window and the skin of the patient.
The provided document is a 510(k) summary for the El En HILT Family Laser, cleared by the FDA in 2005. It does not contain information about acceptance criteria or a study proving the device meets said criteria as it is a premarket notification for a predicate device, focusing on substantial equivalence rather than performance studies with specific metrics.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in this document.
Here's a breakdown of what can be extracted and what is explicitly stated as not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (Specific performance metrics and thresholds are not mentioned in this 510(k) summary. The basis for approval is substantial equivalence to a predicate device, not fulfillment of specific quantitative performance criteria.) | (No specific performance data, such as accuracy, sensitivity, or specificity, is reported. The device is equated to its predicate based on indications for use, principle of operation, and similar specifications.) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable (No clinical performance data or test set mentioned for the 510(k) submission).
- Data provenance: Not applicable (No clinical performance data or test set mentioned). The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable (No test set or ground truth established for performance evaluation).
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable (No test set mentioned).
5. 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:
- MRMC study: No. This device is a laser for topical heating, not an AI-assisted diagnostic tool for human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone study: No. This is not an algorithmic device. The document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
7. The type of ground truth used:
- Type of ground truth: Not applicable (No performance study with ground truth data was submitted or required for this 510(k) clearance, as it relied on substantial equivalence to a predicate device).
8. The sample size for the training set:
- Sample size for training set: Not applicable (No training set for an algorithm is relevant for this device).
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable.
Summary from the Document:
The basis for the FDA's approval of the El En HILT Family Laser (HILT I, HILT II, HILT III) was "Predicate Device" equivalence, specifically to the MLT-1000 IR Laser System. The 510(k) summary explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
The conclusion states: "The HILT Family Laser is a safe and effective device for the indications specified." This conclusion is drawn from its substantial equivalence to the predicate device, meaning it has the same indications for use, principle of operation, and similar performance specifications. No independent studies showcasing new performance data or meeting specific acceptance criteria were provided or required for this type of clearance.
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SEP 2 6 2005
510(K) Summary
| SEP 26 2005 | K051537p. 1 of 1 | |
|---|---|---|
| Submitter: | 510(K) SummaryEl EnVia Baldanzese, 17-50041 | |
| Contact:Date Summary Prepared:Device Trade Name: | Calenzano (Florence), ItalyAndrea TozziDirector, Quality AssuranceJune 9, 2005HILT Family Laser | |
| Common Name: | Nd:YAG laser | |
| Classification Name: | Infrared Lamp21 CFR 890.5500 | |
| Equivalent Device: | MLT-1000 IR Laser System | |
| Device Description: | The HILT Family Laser provides 1,064 nm wavelength. Laseremission activation is by used selectable controller. Electricalrequirement is 230 VAC, 15A, 50-60 Hz, single phase. | |
| Intended Use: | The HILT Family Laser is intended to provide topical heating for thepurpose of elevating tissue temperature for temporary relief of muscleand joint pain and stiffness, arthritis pain, or muscle spasm, thetemporary increase in local blood circulation and/or promoting | |
| Comparison: | relaxation of muscle.The HILT Family Laser has the same indications for use, the sameprinciple of operation, and similar performance specifications as thepredicate devices. | |
| Nonclinical Performance Data: | none | |
| Clinical Performance Data: | none | |
| Conclusion:Additional Information: | The HILT Family Laser is a safe and effective device for theindications specified.none |
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Name of Manufacturer: El En SpA (Italy), represented by Cynosure, Inc.
Laser Model Name and Number: HILT Family Laser: HILT I, HILT II, HILT III; Nd: YAG laser, Infrared Lamp System.
Laser Type: (Circle all that apply) Luser Type: \ < Short CO2, Copper-Vapor, Diode, Dye, Nd: YAG, Erbium, Hol: YAG, Krypton, Ruby, KTP/532, Excimer, HENE, Accessory, Other _______________________________________________________________________________________________________________________________
Indications in this application: To provide topical heating for the purpose of elevating thateauous in this upplicamporary relief of muscle & joint pain & stiffness, arthritis pain or muscle spasm; the temporary increase in local blood circulation &/or promoting relaxation of muscle.
FDA Document Control Number: K051537/S001
FDA Product Code: 90 ILY
Reviewer Computer Initials: ABC
Date of Clearance Letter: 9/16/05
Basis of Approval: (Circle all that apply) Predicate Device (PD) Clinical Data (CD), Animal Data (AD), Specifications (SPECS), Bench Test Data (BTD), Historical Information (HI), Other __________________________________________________________________________________________________________________________
Description of Laser: The Hilt Family Laser: HILT I, HILT III is a Nd:YAG laser, Intrared Lamp system for heat therapy. The three possible treatment configurations are initalou Eamp Hilt II, non-contact; Hilt III, both contact and non-contact. The noncontact hand piece utilizes a spacer between the output window and the skin of the patient.
Operation Modes: (Circle all that apply) CW, Pulsed O-Switched, Mode Locked, Contact, Free Beam, Other ________________________________________________________________________________________________________________
CW, Pulsed, Q-Switched, Mode Locked, Contact, Free Beam, Other:__
Wavelength in Nanometers: 1064 nm
Power/Energy Range (Watts): 10 Maximum
Pulse Width: Hilt I, 60-150 μs; Hilt II, 80-120 μs; Hilt III, 60-100 μs
Repetition Rate: Hilt I, 10-30 Hz; Hilt II, 10-40 Hz; Hilt III, 10-30 Hz
Delivery System: Contact and Non-contact hand pieces connected to the system via a 600 µm diameter fiber optic cable.
Comments:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Public Health Service
SEP 26 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Sr. Vice President Medical Technology Cynosure, Inc. 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K051537
Trade/Device Name: El En HILT Family Laser (HILT I, HILT II, HILT III) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: II Product Code: ILY Dated: August 19, 2005 Received: August 22, 2005
Dear Mr. Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becament to (2) 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 encrobare) to regary the Medical Device Amendments, or to conninered province with the provisions with the provisions of the Federal Food. Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Cosmetic recry that ac nevice, subject to the general controls provisions of the Act. The r ou may, dicrerero, market alle a Act include requirements for annual registration, listing of general controls provisions of the tice, 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 is elabilitional controls. Existing major regulations affecting your device can may be subject to back acated 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 i lease oc advisou that i Dr o lessian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I outhal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N Fart 007); idocinig (2 (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.
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Page 2- Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manies.org your device of your device to a legally prematice notification: "The PDF intelling sification 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 desire specific advice for your as (240) 276-0115. Also, please note the regulation entitled, Comation of Critics of Course to premarket notification" (21CFR Part 807.97). You may obtain Misoranding of reference to premaintentibilities under the Act from the Division of Small other general information on your respenses Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchholz
for
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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K051537 510(k) Number (if known):
Device Name: __ El En HILT Family Laser (HILT I, HILT II, HILT III)
Indications For Use:
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Prescriptive Use X OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 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)
Barbara BonettD for MKM
Division of General, Restorative. and Neurological Devices
510(k) Number K051537
§ 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.