(90 days)
CeramOptec Inc.'s Ceralas Diode Laser System (Model D50)
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No
The summary describes a laser system controlled by a microprocessor, which is standard for many medical devices and does not indicate the presence of AI or ML. There are no mentions of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for various surgical procedures, including incision, excision, vaporization, hemostasis, and coagulation of soft tissues, which are all therapeutic interventions.
No
The device is described as a laser system intended for surgical procedures such as incision, excision, vaporization, hemostasis, and coagulation of soft tissues, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as gallium aluminum arsenide semiconductor diodes, thermoelectric coolers, fiber optic cables, and handpiece accessories, indicating it is a physical medical device, not software-only.
Based on the provided information, the Ceralas Diode Laser System (Ceralas D15) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for surgical procedures on soft tissues within the body (incision, excision, vaporization, hemostasis, and coagulation). This is a therapeutic and surgical application, not an in vitro diagnostic test performed on samples outside the body.
- Device Description: The description details a laser system designed to deliver energy to tissue, not to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
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. The Ceralas D15 performs surgical interventions directly on the patient.
N/A
Intended Use / Indications for Use
The Ceralas Diode Laser System ("Ceralas D15") is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat ("ENT")), including the specific ENT procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions.
Product codes
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Device Description
The Ceralas D15 utilizes gallium aluminum arsenide semiconductor diodes to generate near-infrared laser radiation. The laser is air cooled with thermoelectric coolers. The exposure mode for the laser is 0 -15 watts, either in a continuous or pulsed delivery mode. The Ceralas D15, like the Ceralas D50 is microprocessor controlled.
The delivery systems for the Ceralas D15 consist of fiber optic cables which are fitted with an SMA-905 connector at the proximal end. The distal ends are available in a variety of configurations, including cleaved/flat or sculpted/shaped (conical, round, and chisel). The fiber optic cables are composed of a quartz fiber core with a coaxially mounted protective sheath. The cables are available with or without handpiece accessories.
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
soft tissues, general surgery, urology, gynecology, neurosurgery, gastroenterology, plastic surgery, dermatology (vascular lesions), otolaryngology (i.e., ear, nose, and throat ("ENT")), tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, oral cavity lesions.
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)
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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.
CeramOptec Inc.'s Ceralas Diode Laser System (Model D50)
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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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
964497
FEB - 6 1997
510(k) SUMMARY FOR CERAMOPTEC'S CERALAS DIODE LASER SYSTEMS (MODEL D15)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 13th Street, N.W. Washington, D.C. 20004-1109 (202) 637-5794 Phone: (202) 637-5910 Facsimile:
as Regulatory Counsel to CeramOptec, Inc.
Contact Person: same as above
November 5, 1996 Date Prepared:
Name of Device and Name/Address of Sponsor
Ceralas Diode Laser Systems (Model D15)
CeramOptec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Classification Name
Surgical Laser
Predicate Device
CeramOptec Inc.'s Ceralas Diode Laser System (Model D50)
Intended Use
The Ceralas Diode Laser System ("Ceralas D15") is intended to be used for incision, excision, vaporization, hemostasis, and coagulation of soft tissues in open and closed (endoscopic) procedures. The Ceralas D15 is indicated for use in general surgery, urology, gynecology, neurosurgery (hemostasis), gastroenterology, plastic surgery, dermatology (vascular lesions), and otolaryngology (i.e., ear, nose, and throat ("ENT")), including the specific ENT
1
procedures of tonsillectomy, hemiglossectomy, vocal cord polypectomy, tracheal stenosis, polypectomy, thyroidectomy, neck dissection, and oral cavity lesions.
Technological Characteristics and Substantial Equivalence
The Ceralas D15 utilizes gallium aluminum arsenide semiconductor diodes to generate near-infrared laser radiation. The laser is air cooled with thermoelectric coolers. The exposure mode for the laser is 0 -15 watts, either in a continuous or pulsed delivery mode. The Ceralas D15, like the Ceralas D50 is microprocessor controlled.
The delivery systems for the Ceralas D15 consist of fiber optic cables which are fitted with an SMA-905 connector at the proximal end. The distal ends are available in a variety of configurations, including cleaved/flat or sculpted/shaped (conical, round, and chisel). The fiber optic cables are composed of a quartz fiber core with a coaxially mounted protective sheath. The cables are available with or without handpiece accessories.
The Ceralas D15 has the same intended use, principles of operation, and technological characteristics as the previously cleared predicate laser svstem. The Ceralas D15 and the Ceralas D50 both employ a semiconductor diode to generate the treatment beam. The Ceralas D15 and D50 are both solid state lasers that emit a beam in the near-infrared region of the electromagnetic spectrum. The wavelength for the Ceralas D15 and D50 is 980 ± 30 nm. Both lasers offer a continuous and pulsed exposure operating mode. They also both use the same laser diode aiming beam with a 670 nm wavelength with an adjustable power output maximum of 4 mW. The only difference between the Ceralas D15 and D50 is the power output; the Ceralas D15 provide 0-15 watts whereas the D50 provides 0-50 watts. This modification does not raise new issues of safety or effectiveness because the cleared laser's power output range encompasses the Ceralas D15's 0-15 power output range.