(89 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the physical components and intended use as an accessory to a laser system, with no mention of intelligent processing or algorithms.
Yes
The device is intended for use as an accessory to surgical laser systems to "vaporize, coagulate, incise and excise tissue," which are therapeutic actions.
No
The device is described as an accessory to surgical laser systems used for tissue vaporization, coagulation, incision, and excision, which are therapeutic and not diagnostic functions.
No
The device description explicitly states it contains "components and design," indicating it is a physical 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 states the device is for "vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description focuses on the physical components and design of a fiber optic delivery system used in conjunction with a surgical laser.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Mentioning reagents, assays, or laboratory procedures
The device is an accessory to a surgical laser system, used for direct tissue manipulation during surgery. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
Product codes
GEX
Device Description
The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue
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)
Since the performance of the MagaBeam Reusable Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MegaBeam Reusable Fiber Optic Delivery System, (K980838)
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
MAR. 1 3 2012
510(k) Summarv MegaBeam Reusable Fiber Optic Deliverv System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow. Massachusetts 01028 Phone: (413) 525-0600 Facsimile: (413) 525-0611
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: December 14, 2011
Name of Device and Name/Address of Sponsor
MegaBeam Reusable Fiber Optic Delivery System Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name
Surgical laser accessory
Predicate Devices
MegaBeam Reusable Fiber Optic Delivery System, (K980838)
Intended Use/Indication for Use
TheMegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
Technological Characteristics
The MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K980838 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
Performance Data
Since the performance of the MagaBeam Reusable Fiber Optic Delivery System is well established and documented on soft tissue no performance testing is being specifically included in this submission.
1
Substantial Equivalence
The MegaBeam Reusable Fiber Optic Delivery System is as safe and effective for these Indications for Use as the Biolitec Inc MegaBeam Reusable Fiber Optic Delivery System. Thus, the MegaBeam Reusable Fiber Optic Delivery System for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolitec Medical Devices, Inc. % Mr. Harry Hayes 515 Shaker Road East Longmeadow, Massachusetts 01028
MAR 1 3 2012
Re: K113688 Trade/Device Name: MegaBeam Reusable Fiber Optic Delivery System 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: December 14, 2011 Received: December 15, 2011
Dear Mr. Hayes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Harry Hayes
CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melasky
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: MegaBeam Reusable Fiber Optic Delivery System
Indications for Use:
The MegaBeam Reusable Fiber Optic Delivery System is intended for use as an accessory to any surgical laser system to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Snyder for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 113688
Prescription Use _V (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)