(41 days)
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No
The summary describes a laser fiber delivery system and does not mention any AI or ML components or functionalities.
Yes
Explanation: The device is described as having various surgical uses like ablation, coagulation, incision, excision, and vaporization, which are therapeutic actions.
No
The "Intended Use / Indications for Use" states the device is for surgical uses such as ablation, coagulation, incision, excision, and vaporization, which are therapeutic procedures, not diagnostic ones.
No
The device is described as "Holmium Bare Fibers," which are physical components used in laser surgery, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed on the body (ablation, coagulation, incision, excision, vaporization) using a laser delivery system. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device's function is to deliver laser energy for surgical intervention directly on the patient.
N/A
Intended Use / Indications for Use
The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
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
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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)
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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.
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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
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three overlapping profiles forming the body and wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy L. Arnold President Laser Peripherals, Inc. . . . . . . . . . . . 5484 Feltl Road Minnetonka, Minnesota 55343
JUL 29 1997
Re: K972272
Trade Name: Laser Peripherals Holmium Bare Fibers Regulatory Class: II Product Code: GEX Dated: June 16, 1997 Received: June 18, 1997
Dear Ms. Arnold:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 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. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission 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.
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Page 2 - Ms. Nancy L. Arnold
This letter will allow you to begin marketing your device as described in your 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 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 device, 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.
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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INDICATIONS FOR USE K972272
The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
eefer
(Division Sign-Off)
Division of General Restorative Devices K472272
510(k) Number.
Prescription Use
(Per 21 CFR 801.109)