(528 days)
Cool Laser Optics Device and numerous Cold Packs
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No
The device description details a purely mechanical and electronic system for delivering a cooling spray, with no mention of AI, ML, or any form of data processing or learning.
No
The device minimizes thermal injury and reduces pain, which are supportive functions for laser therapy rather than directly treating a medical condition itself.
No
The device is described as minimizing thermal injury and reducing pain during laser therapy, not for diagnosing conditions. It is a cooling device for therapeutic procedures.
No
The device description explicitly lists hardware components: a source of refrigerant fluid, a solenoid delivery valve, and electronic timing circuitry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to minimize thermal injury and reduce pain during laser therapy. This is a therapeutic and protective function applied to the patient's skin, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device cools the skin externally. It does not analyze any biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Candela's Dynamic Cooling Device has undergone and passed testing during its development designed to assess the performance of components and finished devices, including dimensional testing, functional properties, function according to its intended use, ease of use and durability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Cool Laser Optics Device and numerous Cold Packs
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.
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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).
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§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
0
AUG 1 5 1996
K95/033
CANDELA DYNAMIC COOLING DEVICE 510(k) SUMMARY
GENERAL INFORMATION
| Classification: | Laser Surgical Instrument Accessory for use in General and
Plastic Surgery and in Dermatology |
|-------------------|--------------------------------------------------------------------------------------------------|
| Common Name: | Skin refrigerant |
| Predicate Device: | Cool Laser Optics Device and numerous Cold Packs |
DESCRIPTION
Candela's Dynamic Cooling Device consists of 1) a source of skin refrigerant fluid (CFC R-12), 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with an SPTL laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of CFC R-12 just prior to the delivery of a laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. Thermal injury to non-vascular structures is minimized and pain associated with the laser treatment is reduced.
INTENDED USE STATEMENT
The intended use of the Candela Dynamic Cooling Device is to minimize thermal injury to non-vascular skin structures during laser therapy of benign cutaneous vascular lesions, and to reduce pain associated with laser treatment.
TESTING
Candela's Dynamic Cooling Device has undergone and passed testing during its development designed to assess the performance of components and finished devices, including dimensional testing, functional properties, function according to its intended use, ease of use and durability.
PRODUCT DEVELOPMENT REVIEW
Design reviews conducted during development of this device verify the appropriateness of materials and design selection.
SUMMARY OF SUBSTANTIAL EQUIVALENCE
Candela's Dynamic Cooling Device is substantially equivalent to the Cool Laser Optics device and to numerous legally marketed Cold Packs on the basis of similarities in operating principles, intended use and functional performance.