(179 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, or related concepts.
Yes
The device is indicated for "coagulation & ablation," "incision, excision, and ablation or coagulation of tissues with hemostasis," and "Endoscopic laser coagulation of tumors, fibroids and other soft tissue," which are all therapeutic actions.
No
The device is described as an "Endoscopic Laser Delivery System" used for tissue coagulation, ablation, incision, and excision, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description is not found, but the intended use clearly describes a "Laser Delivery System" with "fiberoptic delivery catheter" and "fiberoptic" components. These are hardware components, indicating it is 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 describes a system for delivering laser energy for tissue coagulation, ablation, incision, and excision during surgical procedures. This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The described device operates on the patient's body during surgery, not on specimens taken from the body. Therefore, it falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue.
The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
MAR 2 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ashvin Desai Manager, Regulatory Affairs ProSurg, Inc. 2193 Trade Zone Boulevard San Jose, California 95131
Re: K023257
Trade Name: Endoscopic Laser Delivery System - LaserTx Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: January 3, 2003 Received: January 9. 2003
Dear Mr. Desai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 forth in the quality systems (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. Desai
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
NUMBER (IF KNOWN) : K023257 510 (k) DEVICE NAME : Endoscopic Laser_delivery System-Lasertx INDICATIONS FOR USE:
Indications For Use:
Endoscopic Laser Delivery System -LaserTx
The Endoscopic Laser Delivery System -LaserTx with diffuser -tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general grological, general gynecological and general gastroenterological procedures , and Endoscopic laser coagulation of turnors , fibroids and other soft tissue.
The Endoscopic Laser Delivery System -Laser Tx with bare -tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostatis during general surgery, and general gastroenterological and urological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96)
Miriam C. Provost
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
K02325 510(k) Number __