BeaMed Laser Surgery Fibers

K232769 · Bt Beamedical Tachnoogies Ltd. (Beamed) · GEX · Dec 6, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K232769
• Device Name: BeaMed Laser Surgery Fibers
• Applicant: Bt Beamedical Tachnoogies Ltd. (Beamed)
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 6, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

BeaMed Laser Surgery Fibers are sterile, single-use fiber optic delivery systems; transmit laser energy from external laser source to soft tissue; used in contact or non-contact modes; compatible with lasers (450-2100 nm) via SMA 905 connector; includes aiming beam for target visibility. Operated by physicians in clinical settings (OR, endoscopy suites); delivers energy for incision, excision, vaporization, ablation, hemostasis, or coagulation. Benefits include precise tissue interaction during surgical procedures. No software or active electronic components.

Clinical Evidence

No clinical or animal studies were performed. Evidence consists of bench testing: transmission validation, packaging seal strength, dye penetration, microbial barrier, sterilization re-validation, bioburden, shelf-life validation, EO residuals, and biocompatibility testing.

Technological Characteristics

Fiber optic delivery system; silica quartz glass core; silica quartz/Hardclad cladding; silicone buffer; jacket materials include silicone, ETFE, polyimide, nylon, acrylate, PVDF, or PU. SMA 905 proximal connector; distal tips include flat, conical, ball, spherical, or bended bare fibers/caps. Wavelength range 450-2100 nm; max power 100W. Sterile by ethylene oxide (EO).

Indications for Use

Indicated for patients requiring soft tissue incision, excision, vaporization, ablation, hemostasis, or coagulation in general, endoscopic, urological, gastroenterological, gynecological, dermatological, vascular, neurosurgical, plastic, or ENT surgery. Also indicated for endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux and laser-assisted lipolysis.

Regulatory Classification

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.

Predicate Devices

• Adler MicroMed Laser Surgery Fibres (K152417)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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)<br>7 HaEshel St.<br>Caesarea 3088900<br>Israel |
|---------------------------|-----------------------------------------------------------------------------------------|
| Contact person: | Gil Shapira, CEO |
| Phone: | [phone] |
| Fax : | + 972 4 8591505 |
| e-Mail: | [e-mail] |
| Type of 510(k) | Traditional |
| Date<br>Prepared: | September 5, 2023 |
| Device Trade<br>Name: | BeaMed Laser Surgery Fibers |
| Common<br>Name: | Fiber optic laser delivery system |
| Classification<br>Name: | General and Plastic Surgery |
| Device product<br>code: | GEX |
| Device<br>Classification: | 21 CFR 878.4810 |
| Predicate: | Adler MicroMed Laser Surgery Fibres (K152417) |

## 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.

## 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.

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.

| Comparison between subject and predicate devices | | |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specification | Subject Device<br>BeaMed Laser Surgery Fibers | Predicate Device<br>Adler MicroMed Laser<br>Surgery Fibers |
| 510(k) | Pending | K152417 |
| Indications for<br>Use | The Fibers are indicated for use in<br>general surgical applications for<br>incision, excision, vaporization,<br>ablation, hemostasis or coagulation of<br>soft tissue. It is also indicated for use<br>in open or closed endoscopic<br>applications where incision,<br>excision,tissue dissection, excision of<br>external tumors and lesions, complete<br>or partial resection of internal organs,<br>tumors or lesions, tissue vaporization,<br>hemostasis and or coagulation may be<br>indicated.<br><br>The BeaMed Laser Surgery Fibers<br>have a wavelength range of 450 nm to<br>2100 nm, can be used in contact and<br>non-contact mode and are indicated<br>for use in general surgery, urology,<br>gastroenterology, gynecology,<br>dermatology, vascular surgery,<br>neurosurgery, plastic surgery, ENT<br>and endovenous occlusion of the<br>greater saphenous vein in the patient<br>with superficial vein reflux and laser<br>assisted lipolysis with a cleared<br>compatible laser marketed for the<br>mentioned intended uses and using an<br>SMA 905 connector. | The Fibers are indicated for use<br>in general surgical applications<br>for incision, excision,<br>vaporization, ablation,<br>hemostasis or coagulation of<br>soft tissue. It is also indicated<br>for use in open or closed<br>endoscopic applications where<br>incision, excision,tissue<br>dissection, excision of external<br>tumors and lesions, complete or<br>partial resection of internal<br>organs, tumors or lesions, tissue<br>vaporization, hemostasis and or<br>coagulation may be indicated.<br><br>The Adler MicroMed Laser<br>Surgery Fibers have a<br>wavelength range of 450 nm to<br>2100 nm, can be used in contact<br>and non-contact mode and are<br>indicated for use in general<br>surgery, urology,<br>gastroenterology, gynecology,<br>dermatology, vascular surgery,<br>neurosurgery, plastic surgery,<br>ENT and endovenous occlusion<br>of the greater saphenous vein<br>(continuation on next page) |
| Specification | Subject Device<br>BeaMed Laser Surgery Fibers | Predicate Device<br>Adler MicroMed Laser<br>Surgery Fibers |
| Indications for<br>Use<br>(continuation<br>from previous<br>page) | | in the patient with superficial<br>vein reflux and laser assisted<br>lipolysis with a cleared<br>compatible laser marketed for<br>the mentioned intended uses and<br>using an SMA 905 connector. |
| Fiber core<br>material | Silica quartz glass | Silica quartz glass |
| Fiber cladding<br>material | silica quartz glass cladding and/or<br>Hardclad<br>(depending on type of fiber) | silica quartz glass cladding<br>and/or Hardclad<br>(depending on type of fiber) |
| Buffer | silicone buffer (depending on type of<br>fiber) | silicone buffer (depending on<br>type of fiber) |
| Jacket material | silicone / ETFE /polymide /nylon /<br>acrylate / PVDF/ PU may be used in<br>the jacket depending on type of<br>fiber.<br>Color additives (see Biocompatibility<br>tests) may be included according to<br>fibers models and variants. | silicone / ETFE /polymide<br>/nylon / acrylate / PVDF/ PU<br>may be used in the jacket<br>depending on type of fiber.<br>Color additives (see<br>Biocompatibility tests) may be<br>included according to fibers<br>models and variants. |
| Maximal<br>temperature | 176°F (80°C) for nylon jacket, 302°F<br>(150°C) for ETFE jacket | 176°F (80°C) for nylon jacket,<br>302°F (150°C ) for ETFE jacket |
| Minimal bend<br>radius | 51 x core diameter (short term) 121 x<br>core diameter (long term) | 51 x core diameter (short term)<br>121 x core diameter (long term) |
| Maximal laser<br>power | Suitable for laser power up to 100W | Suitable for laser power up to<br>100W |
| Shelf life | 5 years | 5 years |
| Numerical<br>aperture range | 0.37 (for quartz/ hardclad fibers),<br>0.22 (for quartz/quartz) | 0.37 (for quartz/hardclad<br>fibers), 0.22 (for quartz/quartz) |
| Core diameter<br>range | 200 µm to 1000 μm | 200 µm to 1000 μm |
| Outer diameter<br>range | 240 µm to 1800 µm typically | 240 µm to 1800 µm typically |
| Distal fiber tip<br>types | Flat, conical, ball, spherical or bended<br>bare fibers, round or conical caps | Flat, conical, ball, spherical or<br>bended bare fibers, round or<br>conical caps |
| Fiber tip outer<br>diameter range | 1.0mm to 1.8mm | 1.0mm to 1.8mm |
| Wavelength<br>range | 450nm to 2100 nm | 450nm to 2100 nm |
| Specification | Subject Device | Predicate Device |
| | BeaMed Laser Surgery<br>Fibers | Adler MicroMed Laser<br>Surgery Fibers |
| Length range | 6.5 feet (2 meters) to 9.9<br>feet (3 meters) | 6.5 feet (2 meters) to 9.9<br>feet (3 meters) |
| Emission angle range | Straight, forward directed<br>cone or 60° cone angle from<br>fiber axis, diffuse emission,<br>and radial 360° | Straight, forward directed<br>cone or 60° cone angle from<br>fibe axis and radial emission<br>of 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