(86 days)
Not Found
No
The 510(k) summary describes laser surgery fibers, which are passive devices for delivering laser energy. There is no mention of AI, ML, image processing, or any computational analysis of data for diagnosis, treatment planning, or device control. The performance studies are focused on the physical properties and sterility of the fibers.
No
The device is a laser delivery system used in various surgical applications, not a therapeutic device itself. Its purpose is to deliver energy for procedures like incision, excision, or coagulation which are therapeutic actions, but it is a tool for therapy rather than a therapy in itself.
Denied
The provided text explicitly states the device's intended use is for surgical applications like incision, excision, vaporization, and coagulation of soft tissue, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly states that the device is a physical fiber intended to deliver laser energy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- BeaMed Laser Surgery Fibers Function: The description clearly states that these fibers are used to deliver laser energy directly to soft tissue within the body for surgical procedures (incision, excision, vaporization, etc.). This is an in vivo application, not an in vitro one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a patient's health based on laboratory results.
The device is a surgical tool used for therapeutic and procedural purposes, not for diagnostic testing of samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, external tumors and lesions, internal organs, tumors or lesions, greater saphenous vein
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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).
2
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
3
Indications for Use
Submission Number (if known)
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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4
BeaMed Laser Surgery Fibers - 510(k) Summary
| Submitter: | BT BeaMedical Technologies Ltd. (BeaMed)
7 HaEshel St.
Caesarea 3088900
Israel |
|---------------------------|-----------------------------------------------------------------------------------------|
| Contact person: | Gil Shapira, CEO |
| Phone: | +972 4 6779919 |
| Fax : | + 972 4 8591505 |
| e-Mail: | shapirag@beam-med.com |
| Type of 510(k) | Traditional |
| Date
Prepared: | September 5, 2023 |
| Device Trade
Name: | BeaMed Laser Surgery Fibers |
| Common
Name: | Fiber optic laser delivery system |
| Classification
Name: | General and Plastic Surgery |
| Device product
code: | GEX |
| Device
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
5
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 | |
| BeaMed Laser Surgery Fibers | Predicate Device | |
| Adler MicroMed Laser | ||
| Surgery Fibers | ||
| 510(k) | Pending | K152417 |
| 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, | ||
| 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. | 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.
The Adler MicroMed 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
(continuation on next page) |
| Specification | Subject Device
BeaMed Laser Surgery Fibers | Predicate Device
Adler MicroMed Laser
Surgery Fibers |
| Indications for
Use
(continuation
from previous
page) | | 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. |
| Fiber core
material | Silica quartz glass | Silica quartz glass |
| Fiber cladding
material | silica quartz glass cladding and/or
Hardclad
(depending on type of fiber) | silica quartz glass cladding
and/or Hardclad
(depending on type of fiber) |
| Buffer | silicone buffer (depending on type of
fiber) | silicone buffer (depending on
type of fiber) |
| Jacket material | silicone / ETFE /polymide /nylon /
acrylate / PVDF/ PU may be used in
the jacket depending on type of
fiber.
Color additives (see Biocompatibility
tests) may be included according to
fibers models and variants. | silicone / ETFE /polymide
/nylon / acrylate / PVDF/ PU
may be used in the jacket
depending on type of fiber.
Color additives (see
Biocompatibility tests) may be
included according to fibers
models and variants. |
| 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 |
| 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) |
| Maximal laser
power | Suitable for laser power up to 100W | Suitable for laser power up to
100W |
| Shelf life | 5 years | 5 years |
| Numerical
aperture range | 0.37 (for quartz/ hardclad fibers),
0.22 (for quartz/quartz) | 0.37 (for quartz/hardclad
fibers), 0.22 (for quartz/quartz) |
| Core diameter
range | 200 µm to 1000 μm | 200 µm to 1000 μm |
| Outer diameter
range | 240 µm to 1800 µm typically | 240 µm to 1800 µm typically |
| 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 |
| Fiber tip outer
diameter range | 1.0mm to 1.8mm | 1.0mm to 1.8mm |
| Wavelength
range | 450nm to 2100 nm | 450nm to 2100 nm |
| Specification | Subject Device | Predicate Device |
| | BeaMed Laser Surgery
Fibers | Adler MicroMed Laser
Surgery Fibers |
| Length range | 6.5 feet (2 meters) to 9.9
feet (3 meters) | 6.5 feet (2 meters) to 9.9
feet (3 meters) |
| 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
fibe axis and radial emission
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
6
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)
7
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.