(25 days)
The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.
The MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K952772 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy.
This 510(k) summary states that the MegaBeam Endo-ENT Probe is substantially equivalent to a previously cleared device (MegaBeam Endo ENT Probe, K952772). Therefore, it relies on the predicate device's established performance without new studies.
Here's a breakdown of the requested information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "as safe... as the MegaBeam Endo-ENT Probe predicate device." |
| Effectiveness | "as effective ... as the MegaBeam Endo-ENT Probe predicate device." |
| Technological Characteristics | "contains the identical same components and design as the device cleared under K952772...no differences in technology." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing was conducted for this submission (K113858). The device is asserted to be identical to its predicate (K952772).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new performance testing was conducted for this submission.
4. Adjudication Method for the Test Set
Not applicable. No new performance testing was conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC study was not done for this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical probe, not an algorithm.
7. The Type of Ground Truth Used
Not applicable for this submission as no new performance data was generated. The "ground truth" for demonstrating equivalence relies on the predicate device's historical clearance and established safe and effective use.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a physical medical probe, not an AI/ML algorithm that requires training.
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K113858 1/2
JAN 2 4 2012
510(k) Summary MegaBeam® Endo-ENT Probe
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
Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant Date prepared: December 20, 2011
Name of Device and Name/Address of Sponsor
MegaBeam Endo ENT. Probe Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name Surgical laser accessory
Facsimile: (413) 525-0611
Predicate Devices
MegaBeam Endo ENT Probe, (K952772).
Intended Use/Indication for Use
The MegaBeam Endo-ENT Probe is a fiber optic delivery system intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.
Technological Characteristics
The MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K952772 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 MegaBeam Endo·ENT Probe is well established and documented no performance testing is being specifically included in this submission.
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ
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K113858 2/2
Substantial Equivalence
バー
The MegaBeam Endo-ENT Probe is as safe and effective for these Indications for Use as the MegaBeam Endo-ENT Probe predicate device. Thus, the MegaBeam Endo ENT Probe for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.
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Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JAN 2 4 2012
Biolitec Medical Devices, Inc. % Harry Hayes, Ph.D. 515 Shaker Road East Longmeadow, Massachusetts 01028
Re: K113858
Trade/Device Name: MegaBeam Endo-ENT Probe Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: December 29, 2011 Received: December 30, 2011
Dear Dr. 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
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Page 2 – Harry Haves, Ph.D.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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 vours.
Mark N. Melkerson //5/-Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):_ ヒリスタメダ
Device Name:
MegaBeam Endo-ENT Probe.
Indications for Use:
The MegaBeam Endo-ENT Probe is intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue. It is indicated for ENT surgery for use with compatible lasers cleared for use in the desired application.
(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 C.F.R. 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
ન્ત્ર
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510(k) Number K113858
GBDA/ BioMD-ENT-122911-10
Page 44
§ 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.