(78 days)
Sharplan CO2 Lasers, ScalpelTEC, Inc. Myringotomy Safety Scalpel
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No
The document describes a surgical CO2 laser and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device is a surgical laser intended for soft tissue incision, specifically Myringotomy/Tympanostomy, which are therapeutic procedures.
No.
The device is a surgical laser intended for soft tissue incision, not for diagnosing conditions.
No
The device description explicitly states it is a surgical laser that emits a treatment laser beam and an aiming beam, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "surgical laser" that "emit[s] a treatment laser beam." This is a therapeutic device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
This device is clearly a surgical tool used for a specific medical procedure.
N/A
Intended Use / Indications for Use
CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication
Product codes
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Device Description
The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.
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
Clinical results from 80 patients, which were obtained at 2 sites, were presented as part of this 510(k) submission, along with historical data, in order to demonstrate the safety and effectiveness of the device.
Key Metrics
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Predicate Device(s)
the Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image shows the text 'NOV - 5 1996'. The text is in bold and appears to be part of a document or label. The date is likely a reference to when the document was created or when the label was printed. The image is simple and straightforward, with the text being the main focus.
Image /page/0/Picture/1 description: The image shows the logo for Sharplan Lasers, Inc. The logo consists of a stylized circle with a pie chart-like design on the left, followed by the word "SHARPLAN" in large, bold, sans-serif font. Below "SHARPLAN" is the text "LASERS, INC." in a smaller, sans-serif font. The entire logo is in black against a white background.
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510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication
In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Sharplan CO2 Laser Systems for Laser Assisted Myringotomy/ Tympanostomy Indication is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel .
- 1 . Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 George J. Hattub, Director of Regulatory Affairs/Quality Assurance August 16, 1996
- Model: Sharplan Models 20c, 30c, and 40c CO2 Lasers 2 .
- Predicate Devices: The Sharplan CO2 Lasers which are intended for use in ENT and 3 . the ScalpelTEC, Inc. Myringotomy Safety Scalpel.
- The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers 4 . Description: are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 um up to 40 watts and a 3 mWatt HeNe aiming beam.
- The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to 5 . the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.
Clinical results from 80 patients, which were obtained at 2 sites, were presented as part of this 510(k) submission, along with historical data, in order to demonstrate the safety and effectiveness of the device.
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510(k) Summary of Safety and Effectiveness Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication (continued)
- From a design and clinical perspective, the predicate and candidate laser devices, are of the same technology (they are identical), and have the same intended use. The other predicate device, which is a surgical scalpel, has the same intended use as the candidate device. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this expanded indication should not raises any concerns regarding the safety or effectiveness of the Sharplan Lasers, Inc. CO2 Laser Systems for a Laser Assisted Myringotomy/Tympanostomy Indication
- Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.