(177 days)
No
The description focuses on the mechanical and optical components of a fiber optic delivery system and does not mention any AI or ML capabilities.
Yes
The device is a handpiece that is part of a larger system intended to vaporize, coagulate, incise, and excise tissue, which are therapeutic actions.
No
The device is described as a fiber optic delivery system handpiece intended for use with disposable fibers to vaporize, coagulate, incise, and excise tissue. These actions are therapeutic, not diagnostic.
No
The device description clearly states it is a "Reusable Fiber Optic Handpiece and Needles," which are physical hardware components used for delivering laser energy. It also mentions sterilization and attachment mechanisms, further indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "vaporize, coagulate, incise and excise tissue" using a laser system. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a fiber optic delivery system for delivering laser energy to tissue. This is consistent with surgical or therapeutic procedures, not in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to directly interact with tissue for therapeutic purposes.
N/A
Intended Use / Indications for Use
The MegaBeam Reusable Fiber Optic Handpiece and Needles are intended to be used with the company's disposable MegaBeam Fiber Optic Delivery Systems, which have already been cleared by FDA (K923953, K943445 and K946336). The MegaBeam Fiber Optic Delivery Systems, which contain disposable contact and non-contact fibers, are intended to vaporize, coagulate, incise and excise tissue and are cleared for any indication for which compatible Nd:YAG, 1.44 YAG, Ho:YAG, KTP and diode laser systems have been cleared by FDA.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The MegaBeam Reusable Fiber Optic Handpiece and Needles are designed to be used with the company's cleared disposable MegaBeam Fiber Optic Delivery Systems. The needle is available with 0°, 15°, 30° and 70° angles. They are designed to fit 400 micron, 600 micron, 800 micron and 1000 micron disposable optical fibers. The labeling includes instructions for sterilizing the devices using EtO or steam. The needle is attached to the handpiece by a threaded connector. The fiber optic is then threaded through the handpiece and needle. At the end of the procedure, the fiber optic is discarded and the handpiece and needle are reusable.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
None provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K923953, K946336, K943445, K960032
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.
Not Found
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).
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
510(k) SUMMARY
CeramOptec's MegaBeam Reusable Fiber Optic Handpiece and Needles
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Submitted by Regulatory Counsel for:
CeramOptec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 Phone: 413-525-0600 413-525-0611 Facsimile:
Carol Morello, V.M.D. Contact Person:
February 2, 1998 Date Prepared:
Name of Device and Name/Address of Sponsor
MegaBeam Reusable Fiber Optic Handpiece and Needles
Common or Usual Name
Nd:YAG Laser Fiber Optic Delivery System Handpiece; 1.44 YAG Laser Fiber Optic Delivery System Handpiece; Ho:YAG Laser Fiber Optic Delivery System Handpiece; KTP Laser Fiber Optic Delivery System Handpiece; and Diode Laser Fiber Optic Delivery System Handpiece;
Classification Name
Accessory to Laser Surgical Instruments
Predicate Devices
CeramOptec's original disposable handpieces (K923953), CeramOptec's disposable arthroscopy handpiece (K946336); CeramOptec's disposable general surgery straight handpiece and adjustable handpiece (K943445); TTI Medical's Optic Handpiece; and Coherent Medical's VersaLink reusable handpiece (K960032).
1
Intended Use
The MegaBeam Reusable Fiber Optic Handpiece and Needles are intended to be used with the company's disposable MegaBeam Fiber Optic Delivery Systems, which have already been cleared by FDA (K923953, K943445 and K946336). The MegaBeam Fiber Optic Delivery Systems, which contain disposable contact and non-contact fibers, are intended to vaporize, coagulate, incise and excise tissue and are cleared for any indication for which compatible Nd:YAG, 1.44 YAG, Ho:YAG, KTP and diode laser systems have been cleared by FDA.
Technological Characteristics and Substantial Equivalence
The company's MegaBeam Reusable Fiber Optic Handpiece and Needles have the same general intended use as the previously cleared predicate devices. The MegaBeam Reusable Fiber Optic Handpiece and Needles are designed to be used with the company's cleared disposable MegaBeam Fiber Optic Delivery Systems which are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. Similarly, the predicate devices also are components of delivery systems designed to deliver laser radiation to a specified point.
The MegaBeam Reusable Fiber Optic Handpiece and Needles have similar technological characteristics as their predicate devices. The needle is available with 0°, 15°, 30° and 70° angles. They are designed to fit 400 micron, 600 micron, 800 micron and 1000 micron disposable optical fibers. The labeling includes instructions for sterilizing the devices using EtO or steam. The needle is attached to the handpiece by a threaded connector. The fiber optic is then threaded through the handpiece and needle. At the end of the procedure, the fiber optic is discarded and the handpiece and needle are reusable.
CeramOptec's original, disposable handpieces that were cleared for use with the MegaBeam Delivery System (K923953) are compatible with Nd: YAG lasers and with 400, 600, 800 and 1000 micron fibers. In addition, the company's cleared disposable arthroscopy handpiece (K946336) is compatible with 1:44 YAG, Ho:YAG and Nd:YAG lasers and with 400 and 600 micron fibers. CeramOptec's cleared, disposable general surgery straight handpiece and adjustable handpiece (K943445) are compatible with Nd:YAG, KTP and diode lasers and with fibers ranging in size from 200-1200 microns.
Coherent's VersaLink Laser Delivery System consists of a reusable VersaLink handpiece assembly and VersaTip™ laser probe. The delivery system is compatible for use with Ho:YAG lasers (2.1 um wavelength). The reusable handpiece assembly, consisting of a handpiece, a fiber optic cable, a laser connector, and a protective cap, is shipped non-sterile. The handpiece assembly may be sterilized using either steam or EtO gas. The reusable VersaTip laser probe, which is
2
provided sterile, is available in the following configurations: 0° straight probe; 15° angled probe; 30° angled probe; and a 70° side fire probe. It must be sterilized using steam or EtO prior to reuse. The system is designed to be used with 600um fibers.
TTI Medical's Fiber Optic Handpiece is compatible with Nd:YAG and Ho:YAG lasers and is designed to be used with 600um, 800um and 1000um fibers. The reusable, malleable handpiece is supplied non-sterile and may be sterilized using EtO or steam in accordance with the manufacturer's instructions.
In sum, although there are some differences between the MegaBeam Reusable Fiber Optic Handpiece and Needles and their predicate devices, these differences are minor and raise no new questions of safety and effectiveness.
Performance Data
None provided.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jul 29 1998
Re:
CeramOptec, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004
K980389 Trade Name: MegaBeam Reusable Fiber Optic Handpiece and Needles Regulatory Class: II Product Code: GEX Dated: May 1, 1998 Received: May 1, 1998
Dear Mr. Kahan:
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 (QS) 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.
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Page 2 - Mr. Kahan
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) 594-4648. 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,
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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510(k) Number (if known): K 9803 89
MegaBeam Reusable Handpiece ಾevice Name: _
Indications For Use:
Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Staff Off) | |
|---|---|
| Division of Restorative Devices | |
| 510(k) Number | K980389 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)