(90 days)
Not Found
No
The device description focuses on the physical characteristics and intended use as an accessory to a laser system, with no mention of AI or ML capabilities.
Yes
The device is intended to "vaporize, coagulate, and incise and excise tissue" and for "lithotripsy procedures," all of which are therapeutic actions.
No
The device is described as an accessory to a Ho:YAG laser system intended to vaporize, coagulate, incise, excise tissue, and be used in lithotripsy procedures; these are therapeutic functions, not diagnostic ones.
No
The device is a physical fiber optic delivery system, which is a hardware component used with a laser system. The description focuses on physical characteristics like material composition, size, tip shapes, and reusability.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "vaporize, coagulate, and incise and excise tissue" and for "lithotripsy procedures." These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The description focuses on the physical characteristics of the fiber optic delivery system and its use with a laser system for surgical procedures. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is described as an accessory to a laser system used for surgical and lithotripsy procedures, which are performed directly on the patient's body.
N/A
Intended Use / Indications for Use
The reusable MegaBeam Fiber Optic Delivery System is intended to vaporize, coagulate, and incise and excise tissue. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with a Ho:YAG laser system. The reusable MegaBeam Fiber Optic Delivery System is an accessory to a Ho:YAG laser system.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The reusable MegaBeam Fiber Optic Delivery System has similar technological characteristics as its predicate devices. First, CeramOptec's reusable MegaBeam Fiber Optic Delivery System is intended for use with a Ho:YAG laser system. The Coherent SlimLine Delivery System also are intended for use with a Ho:YAG laser, and the company's cleared, disposable fiber optic delivery systems have been cleared for use with 1.44 YAG, Ho:YAG, KTP, Argon and Diode lasers.
Second, CeramOptec's reusable MegaBeam Fiber Optic Delivery System's fiber optical tip has a similar material composition as its predicate devices. Third, the reusable MegaBeam Fiber Optic Delivery System is available in four sizes: 200 micron, 365 micron, 550 micron and 1000 micron. The cleared Coherent SlimLine Laser Delivery System is available in the identical four sizes, and the cleared disposable MegaBeam Fiber Optic Delivery System is available in sizes ranging from 200 micron to 1200 micron.
Fourth, the reusable MegaBeam Fiber Optic Delivery System is available in the same tip shapes and handpiece configurations as the company's cleared disposable MegaBeam Fiber Optic Delivery System. Further, both the reusable MegaBeam Fiber Optic Delivery System and the predicate devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used.
Finally, as with the Coherent's SlimLine Laser Delivery System, the reusable MegaBeam Fiber Optic Delivery System can be reused once the optical fiber tip is properly cleaned, inspected, stripped, and cleaved.
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 required.
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, K943445, K951775, K960413
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
2 1998 JUN
510(k) SUMMARY
CeramOptec's MegaBeam Fiber Optic Delivery System
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 413-525-0600 Phone: 413-525-0611 Facsimile:
Carol Morello, V.M.D. Contact Person:
March 4, 1998 Date Prepared:
Name of Device and Name/Address of Sponsor
Reusable MegaBeam Fiber Optic Delivery System
Common or Usual Name
Ho:YAG Fiber Optic Delivery System
Classification Name
Accessory to Laser Surgical Instruments
Predicate Devices
CeramOptec's disposable MegaBeam Fiber Optic Delivery Systems (K923953, K943445 and K951775), and Coherent's SlimLine Fiber Optic Delivery System (K960413).
1
Intended Use
The reusable MegaBeam Fiber Optic Delivery System is intended to vaporize, coagulate, and incise and excise tissue. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with a Ho:YAG laser system. The reusable MegaBeam Fiber Optic Delivery System is an accessory to a Ho:YAG laser system.
Technological Characteristics and Substantial Equivalence
The reusable MegaBeam Fiber Optic Delivery System has similar technological characteristics as its predicate devices. First, CeramOptec's reusable MegaBeam Fiber Optic Delivery System is intended for use with a Ho:YAG laser system. The Coherent SlimLine Delivery System also are intended for use with a Ho:YAG laser, and the company's cleared, disposable fiber optic delivery systems have been cleared for use with 1.44 YAG, Ho:YAG, KTP, Argon and Diode lasers.
Second, CeramOptec's reusable MegaBeam Fiber Optic Delivery System's fiber optical tip has a similar material composition as its predicate devices. Third, the reusable MegaBeam Fiber Optic Delivery System is available in four sizes: 200 micron, 365 micron, 550 micron and 1000 micron. The cleared Coherent SlimLine Laser Delivery System is available in the identical four sizes, and the cleared disposable MegaBeam Fiber Optic Delivery System is available in sizes ranging from 200 micron to 1200 micron.
Fourth, the reusable MegaBeam Fiber Optic Delivery System is available in the same tip shapes and handpiece configurations as the company's cleared disposable MegaBeam Fiber Optic Delivery System. Further, both the reusable MegaBeam Fiber Optic Delivery System and the predicate devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used.
Finally, as with the Coherent's SlimLine Laser Delivery System, the reusable MegaBeam Fiber Optic Delivery System can be reused once the optical fiber tip is properly cleaned, inspected, stripped, and cleaved.
Performance Data
None required.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 JUN
CeramOptec, Incorporated c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 13th Street, N.W. Washington, District of Columbia 20004-1109
Re: K980838 Reusable MegaBeam Fiber Optic Delivery System Trade Name: Requlatory Class: II Product Code: GEX Dated: March 4, 1998 Received: March 4, 1998
Dear Mr. Kahan:
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 You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations 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 requirement, 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. 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.
3
Page 2 - Mr. Jonathan S. Kahan
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
4
510(k) Number (if known): K980827
Reusable MegaBeam Fiber Optic Delivery System Device Name:
Indications For Use:
The reusable MegaBeam Fiber Optic Delivery System is intended for use as an accessory to a Ho:YAG laser system to vaporize, coagulate, and incise and excise tissue, including lithrotripsy. The MegaBeam Fiber Optic Delivery System is also intended to be used in lithotripsy procedures with Ho:YAG laser systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
ence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
510(k) Numb
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)