The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece 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.

Device Description

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains the identical same components and design as the device cleared under K946336, K923953 and K943445 for Biolitec Inc. There are no differences in technology and as such does not raise any new questions on safety or efficacy. Additional flat/ bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u are included for clearance in this submission.

AI/ML Overview

The provided text is a 510(k) summary for the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece. This document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria for a new, independent device evaluation.

Therefore, many of the requested sections about acceptance criteria, detailed study parameters, and ground truth establishment are not applicable or not present in this type of submission.

Here's a breakdown based on the provided text, indicating where information is present or absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: No specific quantifiable acceptance criteria are provided in the document.
Reported Device Performance: The document states: "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."

Therefore, a table cannot be created as the submission explicitly states no new performance testing was conducted.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable, as no new performance testing was conducted or submitted.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.

4. Adjudication Method for the Test Set

Not applicable, as no new performance testing requiring adjudication was conducted or submitted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Was an MRMC study done?: No.
Effect size of improvement with AI vs. without AI assistance: Not applicable, as this is a physical medical device (fiber optic delivery system), not an AI/software device, and no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable, as this is a physical medical device, not an algorithm, and no standalone performance study was conducted.

7. The Type of Ground Truth Used

Not applicable, as no new performance testing requiring ground truth establishment was conducted or submitted.

8. The Sample Size for the Training Set

Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set was used.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is a physical medical device, not a machine learning algorithm, and therefore no training set with ground truth was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria

The submission does not describe a study to prove the device meets acceptance criteria in the traditional sense of novel performance testing. Instead, the basis for approval is Substantial Equivalence (SE) to legally marketed predicate devices.

The key points of the argument for SE are:

Predicate Devices: MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece (K946336, K923953, and K943445).
Technological Characteristics: The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. contains "the identical same components and design" as the predicate device(s). The only difference mentioned is the inclusion of "Additional flat/bare (no tips) fiber optic sizes of 230µ, 365µ, 400µ and 550u for clearance."
Safety and Efficacy: The submission explicitly states, "There are no differences in technology and as such does not raise any new questions on safety or efficacy."
Intended Use: The intended use is identical: "to vaporize, coagulate, incise and excise tissue for any application for which the lasers are cleared."
Performance Data: The submission states, "Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission."

In essence, the "study" that proves the device meets (implicitly understood) acceptance criteria is the accumulated evidence and historical performance data of the predicate device, combined with the argument that the new device is technologically identical and shares the same intended use. The FDA agreed with this assessment by issuing a substantial equivalence determination.

Summary

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K 113709 113

510(k) Summary MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece

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 Fiber Optic Delivery System with Additional Tips & Handpiece Biolitec Medical Devices, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028

Classification Name

ਾਂ
ਪ੍ਰ

Surgical laser accessory

Predicate Devices

MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece, (K946336, K923953 and K943445)

Intended Use/Indication for Use

Technological Characteristics

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113 709 2/2

Performance Data

ﺔ ﺍﻟﻤ

Since the performance of the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is well established and documented on soft tissue no performance testing is being specifically included in this submission.

Substantial Equivalence

The MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece is as safe and effective for these Indications for Use as the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece. Thus, the MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece for Biolitec Medical Devices, Inc. is substantially equivalent to its predicate device.

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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 stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biolitec Medical Devices, Incorporated % Harry Hayes, Ph.D. Regulatory Consultant 515 Shaker Road East Longmeadow, Massachusetts 01028

JAN 2 0 2012

Re: K113709

· Trade/Device Name: MegaBeam Fiber Optic Delivery System with Additional Tips and Handpiece 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 16, 2011 Received: December 19, 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 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 – Harry Haves, Ph.D.

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 (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 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,

erson

Mark N. Melkerson 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):_____________________________________________________________________________________________________________________________________________________

Device Name: MegaBeam Fiber Optic Delivery System with Additional Tips & Handpiece.

The MegaBeam Fiber Optic Delivery System with Indications for Use: Additional Tips & Handpiece 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)

Nail R.P. Oden for mxm

(Division Sign-(Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number. K113709.

Prescription Use __ (Per 21 C.F.R. 801.109) OR

Over The Counter Use_ (Optional Format 1-2-96)

Regulation Number and Section

§ 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.