The BeaMed Laser Surgery Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue, it is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

The BeaMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

Device Description

The BeaMed Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the BeaMed Laser Surgery Fibers. It details the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

Based on the provided text, the device in question (BeaMed Laser Surgery Fibers) is a physical medical device, not an AI/software-based medical device. Therefore, the requested information regarding acceptance criteria, ground truth, sample sizes for training and testing, expert adjudication, and MRMC studies, which are typical for AI/ML medical devices, is largely not applicable to this submission.

The "studies" mentioned in this document are primarily bench testing to demonstrate the physical and performance characteristics of the laser fibers, and to show that they are substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text in the context of your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one would for an AI/ML model's diagnostic accuracy. Instead, it relies on demonstrating that the BeaMed Laser Surgery Fibers meet the same specifications and performance characteristics as the predicate device (Adler MicroMed Laser Surgery Fibers, K152417). The acceptance criteria are implicitly that the subject device performs equivalently to the predicate across various physical and functional parameters.

Bench Test Summary (Implicit Acceptance Criteria and Performance):

Test/Specification	Implicit Acceptance Criteria	Reported Device Performance (as demonstrated by testing)
Indications for Use	Same as predicate device	The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. Wavelength range of 450 nm to 2100 nm, contact/non-contact mode, multiple surgical specialties, SMA 905 connector. (Identical to predicate)
Fiber core material	Silica quartz glass	Silica quartz glass (Identical to predicate)
Fiber cladding material	Silica quartz glass cladding and/or Hardclad	Silica quartz glass cladding and/or Hardclad (Identical to predicate)
Buffer	Silicone buffer	Silicone buffer (Identical to predicate)
Jacket material	Silicone / ETFE / polymide / nylon / acrylate / PVDF/ PU; Color additives possible	Silicone / ETFE / polymide / nylon / acrylate / PVDF/ PU; Color additives possible (Identical to predicate)
Maximal temperature	176°F (80°C) for nylon jacket, 302°F (150°C) for ETFE jacket	176°F (80°C) for nylon jacket, 302°F (150°C) for ETFE jacket (Identical to predicate)
Minimal bend radius	51 x core diameter (short term) 121 x core diameter (long term)	51 x core diameter (short term) 121 x core diameter (long term) (Identical to predicate)
Maximal laser power	Suitable for laser power up to 100W	Suitable for laser power up to 100W (Identical to predicate)
Shelf life	5 years	5 years (Identical to predicate)
Numerical aperture range	0.37 (quartz/hardclad), 0.22 (quartz/quartz)	0.37 (for quartz/ hardclad fibers), 0.22 (for quartz/quartz) (Identical to predicate)
Core diameter range	200 µm to 1000 μm	200 µm to 1000 μm (Identical to predicate)
Outer diameter range	240 µm to 1800 µm typically	240 µm to 1800 µm typically (Identical to predicate)
Distal fiber tip types	Flat, conical, ball, spherical or bended bare fibers, round or conical caps	Flat, conical, ball, spherical or bended bare fibers, round or conical caps (Identical to predicate)
Fiber tip outer diameter range	1.0mm to 1.8mm	1.0mm to 1.8mm (Identical to predicate)
Wavelength range	450nm to 2100 nm	450nm to 2100 nm (Identical to predicate)
Length range	6.5 feet (2 meters) to 9.9 feet (3 meters)	6.5 feet (2 meters) to 9.9 feet (3 meters) (Identical to predicate)
Emission angle range	Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360°	Straight, forward directed cone or 60° cone angle from fiber axis, diffuse emission, and radial 360° (Slight difference noted in description between subject and predicate - predicate says "fibe axis and radial emission of 360°" while subject says "fiber axis, diffuse emission, and radial 360°". The FDA found this difference acceptable for substantial equivalence).
Single/multiple use	Single use	Single use (Identical to predicate)
Sterility	Sterile by EO	Sterile by EO (Identical to predicate)
Packaging	Sterile, double pouched	Sterile, double pouched (Identical to predicate)
Proximal end	SMA 905 connector	SMA 905 connector (Identical to predicate)
Bench Tests	Meet established standards for each test	Transmission validation of fibers; Packaging seal strength; Dye penetration test; Packaging microbial barrier; Sterilization re-validation; Bioburden tests; Shelf-life validation; EO residuals report; Sterility Assurance Level (SAL); Biocompatibility tests. All these tests were performed and presumably met the required standards to demonstrate safety and effectiveness equivalent to the predicate.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set: For the bench testing, the "sample size" would refer to the number of fibers or samples of materials tested for each specific bench test (e.g., how many fibers were tested for transmission validation, how many packages for seal strength). This specific number is not provided in the summary.
Data Provenance: Not specified, but generally, bench testing data would be generated within the manufacturer's facility or a contracted testing lab. No patient data or geographical provenance is mentioned, as this is a physical device submission relying on bench tests. The testing would be "prospective" in the sense that the tests are conducted intentionally to demonstrate performance for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. For a physical device like a laser fiber, "ground truth" isn't established by medical experts in the diagnostic sense (e.g., radiologists interpreting images). The "truth" is based on objective physical measurements and engineering specifications, and compliance with recognized standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus ground truth in subjective medical interpretation, typically for AI/ML diagnostic devices. This device relies on objective engineering and performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human "readers" interpreting medical cases. No MRMC study was performed or is relevant to this device's substantial equivalence determination.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on:

Engineering Specifications: The design specifications of the fiber (e.g., dimensions, materials).
Objective Bench Testing: Measurable physical and functional properties validated through laboratory tests (e.g., power transmission, bend radius, sterility, biocompatibility).
Comparison to Predicate Device: The performance and safety profile of the legally marketed predicate device (K152417) serves as the benchmark against which the new device demonstrates substantial equivalence. The predicate device's established safety and effectiveness are the "ground truth" for the new device's acceptable performance.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

Summary Conclusion from the Document:

The FDA determined that the BeaMed Laser Surgery Fibers are substantially equivalent to the predicate device (Adler MicroMed Laser Surgery Fibers, K152417) based on shared indications for use, technical characteristics, and performance data from internal bench testing. The submission confirms "Animal or clinical studies: None," indicating that the equivalence was demonstrated entirely through physical and performance testing against the predicate.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 6, 2023

BT BeaMedical Tachnoogies Ltd. (BeaMed) Gil Shapira CEO 7 HaEshel Street Caesarea, 3088900 Israel

Re: K232769

Trade/Device Name: BeaMed Laser Surgery Fibers 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: September 10, 2023 Received: September 11, 2023

Dear Gil Shapira:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tanisha L. Hithe Tanisha L. รั 2023.12.06 Hithe -S 22:54:02 -05'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K232789

Device Name

BeaMed Laser Surgery Fibers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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BeaMed Laser Surgery Fibers - 510(k) Summary

Submitter:	BT BeaMedical Technologies Ltd. (BeaMed)7 HaEshel St.Caesarea 3088900Israel
Contact person:	Gil Shapira, CEO
Phone:	+972 4 6779919
Fax :	+ 972 4 8591505
e-Mail:	shapirag@beam-med.com
Type of 510(k)	Traditional
DatePrepared:	September 5, 2023
Device TradeName:	BeaMed Laser Surgery Fibers
CommonName:	Fiber optic laser delivery system
ClassificationName:	General and Plastic Surgery
Device productcode:	GEX
DeviceClassification:	21 CFR 878.4810
Predicate:	Adler MicroMed Laser Surgery Fibres (K152417)

Device Description:

Indications for Use:

The Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. It is also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of

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Image /page/5/Picture/1 description: The image shows the logo for BeaMed. The logo consists of a purple circle with lines running through it, and three curved lines above it. The text "BeaMed" is written in a dark gray sans-serif font below the circle.

external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.

Comparison between subject and predicate devices
Specification	Subject DeviceBeaMed Laser Surgery Fibers	Predicate DeviceAdler MicroMed LaserSurgery Fibers
510(k)	Pending	K152417
Indications forUse	The Fibers are indicated for use ingeneral surgical applications forincision, excision, vaporization,ablation, hemostasis or coagulation ofsoft tissue. It is also indicated for usein open or closed endoscopicapplications where incision,excision,tissue dissection, excision ofexternal tumors and lesions, completeor partial resection of internal organs,tumors or lesions, tissue vaporization,hemostasis and or coagulation may beindicated.The BeaMed Laser Surgery Fibershave a wavelength range of 450 nm to2100 nm, can be used in contact andnon-contact mode and are indicatedfor use in general surgery, urology,gastroenterology, gynecology,dermatology, vascular surgery,neurosurgery, plastic surgery, ENTand endovenous occlusion of thegreater saphenous vein in the patientwith superficial vein reflux and laserassisted lipolysis with a clearedcompatible laser marketed for thementioned intended uses and using anSMA 905 connector.	The Fibers are indicated for usein general surgical applicationsfor incision, excision,vaporization, ablation,hemostasis or coagulation ofsoft tissue. It is also indicatedfor use in open or closedendoscopic applications whereincision, excision,tissuedissection, excision of externaltumors and lesions, complete orpartial resection of internalorgans, tumors or lesions, tissuevaporization, hemostasis and orcoagulation may be indicated.The Adler MicroMed LaserSurgery Fibers have awavelength range of 450 nm to2100 nm, can be used in contactand non-contact mode and areindicated for use in generalsurgery, urology,gastroenterology, gynecology,dermatology, vascular surgery,neurosurgery, plastic surgery,ENT and endovenous occlusionof the greater saphenous vein(continuation on next page)
Specification	Subject DeviceBeaMed Laser Surgery Fibers	Predicate DeviceAdler MicroMed LaserSurgery Fibers
Indications forUse(continuationfrom previouspage)		in the patient with superficialvein reflux and laser assistedlipolysis with a clearedcompatible laser marketed forthe mentioned intended uses andusing an SMA 905 connector.
Fiber corematerial	Silica quartz glass	Silica quartz glass
Fiber claddingmaterial	silica quartz glass cladding and/orHardclad(depending on type of fiber)	silica quartz glass claddingand/or Hardclad(depending on type of fiber)
Buffer	silicone buffer (depending on type offiber)	silicone buffer (depending ontype of fiber)
Jacket material	silicone / ETFE /polymide /nylon /acrylate / PVDF/ PU may be used inthe jacket depending on type offiber.Color additives (see Biocompatibilitytests) may be included according tofibers models and variants.	silicone / ETFE /polymide/nylon / acrylate / PVDF/ PUmay be used in the jacketdepending on type of fiber.Color additives (seeBiocompatibility tests) may beincluded according to fibersmodels and variants.
Maximaltemperature	176°F (80°C) for nylon jacket, 302°F(150°C) for ETFE jacket	176°F (80°C) for nylon jacket,302°F (150°C ) for ETFE jacket
Minimal bendradius	51 x core diameter (short term) 121 xcore diameter (long term)	51 x core diameter (short term)121 x core diameter (long term)
Maximal laserpower	Suitable for laser power up to 100W	Suitable for laser power up to100W
Shelf life	5 years	5 years
Numericalaperture range	0.37 (for quartz/ hardclad fibers),0.22 (for quartz/quartz)	0.37 (for quartz/hardcladfibers), 0.22 (for quartz/quartz)
Core diameterrange	200 µm to 1000 μm	200 µm to 1000 μm
Outer diameterrange	240 µm to 1800 µm typically	240 µm to 1800 µm typically
Distal fiber tiptypes	Flat, conical, ball, spherical or bendedbare fibers, round or conical caps	Flat, conical, ball, spherical orbended bare fibers, round orconical caps
Fiber tip outerdiameter range	1.0mm to 1.8mm	1.0mm to 1.8mm
Wavelengthrange	450nm to 2100 nm	450nm to 2100 nm
Specification	Subject Device	Predicate Device
	BeaMed Laser SurgeryFibers	Adler MicroMed LaserSurgery Fibers
Length range	6.5 feet (2 meters) to 9.9feet (3 meters)	6.5 feet (2 meters) to 9.9feet (3 meters)
Emission angle range	Straight, forward directedcone or 60° cone angle fromfiber axis, diffuse emission,and radial 360°	Straight, forward directedcone or 60° cone angle fromfibe axis and radial emissionof 360°
Single/multiple use	Single use	Single use
Sterility	Sterile by EO	Sterile by EO
Packaging	Sterile, double pouched	Sterile, double pouched
Proximal end	SMA 905 connector	SMA 905 connector

Comparison between subject and predicate devices

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Image /page/6/Picture/1 description: The image shows the logo for BeaMed. The logo consists of the word "BeaMed" in a simple, sans-serif font, with the "Bea" portion in a lighter gray and the "Med" portion in a darker gray. Above and to the left of the word is a circular graphic in shades of purple, with curved lines emanating from the top, suggesting a signal or wave. The overall design is clean and modern, suggesting a company in the technology or medical field.

Comparison between subject and predicate devices (continuation)

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Image /page/7/Picture/2 description: The image shows the logo for BeaMed. The logo features the word "BeaMed" in a sans-serif font, with the "B" capitalized and the rest of the letters in lowercase. Above the word is a purple circle with curved lines emanating from the top, resembling sound waves or a network signal. The overall design is clean and modern, suggesting a company involved in technology or communication, possibly in the medical field.

Summary of performance bench testing included in the submission:

Transmission validation of fibers Packaging seal strength Dye penetration test Packaging microbial barrier Sterilization re-validation Bioburden tests Shelf-life validation EO residuals report Sterility Assurance Level (SAL) Biocompatibility tests

Substantial Equivalence summary and conclusion

Summary comparison

The BeaMed Laser Surgery Fibers and the predicate device, the Adler MicroMed Laser Surgery Fibers (K152417) share the same indications for use, technical and performance characteristics, accordingly, the safety and effectiveness of the BeaMed Laser Surgery Fibers is based upon a determination of the substantial equivalence to the predicate device.

Conclusion and substantial equivalence statement

After our analysis we have concluded that the subject device BeaMed Laser Surgery Fibers, and the predicate device the Adler MicroMed Laser Surgery Fibers, share the same technical characteristics and the same intended use.

Accordingly, we believe that the BeaMed Laser Surgery Fibers and the legally marketed predicate, the Adler MicroMed Laser Surgery Fibers (K152417), are substantially equivalent.

Animal or clinical studies: None

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.