(206 days)
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Not Found
No
The provided 510(k) summary does not mention AI, ML, or any related terms, and the device description focuses on laser technology for soft tissue procedures.
Yes
The device is indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue, which are procedures performed to treat medical conditions.
No
Explanation: The device is indicated for incision/excision, ablation, and coagulation of soft tissue in surgical procedures, not for identifying or diagnosing diseases or conditions.
No
The device description explicitly states "Protégé and Protégé LP Er: YAG Laser Systems and Accessories," indicating a hardware-based laser system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical laser system used for incision, excision, ablation, and coagulation of soft tissue during surgical procedures. This is a direct treatment or intervention on the patient's body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The device is described as a "Laser System," which is consistent with a surgical tool, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health status based on laboratory results.
Therefore, the Protégé and Protégé LP Er: YAG Laser Systems are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dentistry
Soft tissue (incision, excision, ablation and coagulation)
Dermatology and Plastic Surgery
Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery
GI, GU, GYN and Pulmonary Surgery
- Orthopedic Surgery
- Thoracic Surgery
- Ophthalmology
- Podiatry
- General Surgery
Product codes
GEX
Device Description
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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 tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands; Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy); Ear Nose & Throat (ENT), Head and Neck
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 1997
Marilyn M. Chou, Ph.D. Executive Vice President Xintec Corporation 900 Alice Street Oakland, California 94607
Re: K971912
Trade Name: Protégé and Protégé LP Er: YAG Laser Systems and Accessories Regulatory Class: II Product Code: GEX Dated: August 1, 1997 Received: August 5, 1997
Dear Dr. Chou:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Marilyn M. Chou, Ph.D.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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.. L
510(k) Number: #K971912
Device Name: Protégé (tm) Er: Y AG Laser Systems and Accessories
Indications For:Use:
The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dentistry
Soft tissue (incision, excision, ablation and coagulation)
Dermatology and Plastic Surgery
Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery
GI, GU, GYN and Pulmonary Surgery
- Orthopedic Surgery
- Thoracic Surgery
- Ophthalmology
- Podiatry
- General Surgery
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-Off) (Division of General Restorative Device 510(k) Number
Prescription Use
(21 CFR 801.109)
OR
Over-The-Counter Use