(122 days)
No
The device description focuses on the physical components and function of a laser fiber for energy delivery, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a delivery system for laser energy used in surgical procedures for ablation, incision, excision, vaporization, and coagulation of tissues, as well as fragmentation of calculi, which are all therapeutic actions.
No
The device description indicates that the EndoBeam™ Holmium Laser Fibers are "free-beam delivery devices that transmit laser energy" for surgical uses like "ablation, incision, excision, vaporization, and coagulation," and "fragmentation of calculi." This describes a therapeutic, not a diagnostic, function.
No
The device description clearly details physical components like fibers, connectors, and sheaths, indicating it is a hardware device for delivering laser energy.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the EndoBeam™ Holmium Laser Fibers are used to deliver laser energy directly to tissue or calculi within the body for surgical procedures (ablation, incision, excision, vaporization, coagulation, fragmentation). This is an in vivo application, meaning it's used within a living organism.
- Lack of Mention of Samples: There is no mention of the device being used to test samples taken from the body.
Therefore, the EndoBeam™ Holmium Laser Fibers are a surgical device used for direct intervention within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.
The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.
Product codes
GEX
Device Description
The EndoBeam™ Holmium Laser Fibers are free-beam delivery devices that transmit laser energy in a forward direction. The devices are either 2.5 meters (8.2 ft.) or 3.0 meters (9.8 ft) in length and are terminated with a laser specific connector on the proximal end. These delivery systems are capable of delivering Ho:YAG (2140nm) and Nd:YAG (1064nm). The devices are either single use or reusable and are supplied Ethylene Oxide (EtO) sterilized.
The Bard Holmium series of laser fibers are fiber optic laser energy delivery devices consisting of an SMA 905 connector, strain relief, and a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The fibers are further equipped with a polished, flat output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.
The line of reusable laser fibers will feature a protective sheath outside of the jacketed fiber and extending from the strain relief to the midpoint of the fiber length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and cartilaginous tissue
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)
Nonclinical functional performance testing was conducted and included visual, functional and tensile strength testing carried out per internal test methods and per IEC 61754-22 - IEC Standard for Fiber Optic Connectors. Nonclinical biocompatibility testing in accordance with ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" was conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K972272, K011207, K050108, K011703
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Section 4: 510(k) Summary 510/k) Premarket Notification: EndoBeam™ Holmium Laser Fibers, Page 1 of 2
JUL 2 7 2012
Bard Medical Division C.R. Bard Inc. 8195 Industrial Blvd. Covington, GA 30014
RAIRD | MEDICAL
510(k) Summary Section 4:
The following information is provided as required by 21 CFR §807.92 for the EndoBeam™ Holmium Laser Fiber 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
| BARD Medical Division |
|---|
| C. R. BARD, Inc. |
| 8195 Industrial Blvd. |
| Covington, GA 30014 |
Contact:
Sponsor:
Terri Morris Regulatory Affairs Specialist Bard Medical Division C. R. Bard, Inc. Ph: 770-784-6994 Fax: 770-385-4706 E-mail: terri.morris@crbard.com
Date Prepared:
February 29, 2012
Subject Device:
Trade Name: EndoBeam™ Holmium Laser Fibers Common/Usual Name: Holmium Laser Fiber Classification Name: Powered Laser Surgical Instrument Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX
Predicate Device(s): The EndoBeam™ Holmium Laser Fiber is substantially equivalent with respect to the following predicate devices:
| Product | Company | 510(k) Number |
|---|---|---|
| Laser Peripherals Holmium Bare Fibers | Laser Peripherals LLC | K972272 |
| Laser Peripherals Reusable Holmium | ||
| Fiber | Laser Peripherals LLC | K011207 |
| SureFlex™ Laser Fiber | InnovaQuartz (a subsidiary of | |
| American Medical Systems) | K050108 | |
| SlimLineEZ™ Fiber Delivery Device | Lumenis | K011703 |
1
Section 4: 510(k) Summary
510(k) Premarket Notification: EndoBeam™ Holmium Laser Fibers, Page 2 of 2
Device Description: The EndoBeam™ Holmium Laser Fibers are free-beam delivery devices that transmit laser energy in a forward direction. The devices are either 2.5 meters (8.2 ft.) or 3.0 meters (9.8 ft) in length and are terminated with a laser specific connector on the proximal end. These delivery systems are capable of delivering Ho:YAG (2140nm) and Nd:YAG (1064nm). The devices are either single use or reusable and are supplied Ethylene Oxide (EtO) sterilized.
The Bard Holmium series of laser fibers are fiber optic laser energy delivery devices consisting of an SMA 905 connector, strain relief, and a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The fibers are further equipped with a polished, flat output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.
The line of reusable laser fibers will feature a protective sheath outside of the jacketed fiber and extending from the strain relief to the midpoint of the fiber length.
Intended Use: The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation, and fragmentation of calculi.
The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.
Technological Characteristics: The EndoBeam™ Holmium Laser Fibers have the same technological characteristics as the predicate devices. The fiber core and cladding for the subject device are made from silica which is the same material used in all the predicate devices. Additionally, as with the predicate devices, the fiber coating of the subject device is constructed from hard-fluoropolymer and the fiber jacket is Ethylene Tetrafluoroethylene (ETFE). Various core diameter sizes (200, 272, 365, 365 reduced buffer, 550 and 1000 micron) are offered.
Performance Data: Nonclinical functional performance testing was conducted and included visual, functional and tensile strength testing carried out per internal test methods and per IEC 61754-22 - IEC Standard for Fiber Optic Connectors. Nonclinical biocompatibility testing in accordance with ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and FDA Bluebook Memorandum G95-1, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing" was conducted.
Substantial Equivalence: The EndoBeam™ Holmium Laser Fibers have the same intended use as the predicate devices. Nonclinical test data demonstrate that the device is safe and effective and is substantially equivalent to the legally marketed predicate devices.
CONFIDENTIAL
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2012
C.R. Bard, Incorporated % Ms. Terri Morris Regulatory Affairs Specialist, Bard Medical Division 8195 Industrial Boulevard Covington, Georgia 30209
Re: K120926
Trade/Device Name: EndoBeam™ Holmium Laser 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: July 20, 2012 Received: July 23, 2012
Dear Ms. Morris:
We have reviewed vour 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
3
Page 2- Ms. Terri Morris
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 yours.
Erinal Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
cations
510(k) Number:
Device Name:
Indications for Use:
K120926
EndoBeam™ Holmium Laser Fibers
The EndoBeam™ Holmium Laser Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, incision, excision, vaporization, and coagulation of soft and cartilaginous tissue and in surgical procedures involving vaporization, ablation and fragmentation of calculi.
The delivery system may be used in surgical specialty or procedures for which compatible Holmium and Nd:YAG lasers have received regulatory clearance. Refer to the applicable laser system user manual for complete information regarding applications, contraindications, precautions and warnings when using this fiber.
Prescription Use: 风
or
Over the Counter Use
Part 21 CFR 801 Subpart D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R.P. Ogale for mkm
(Division Sign. DM)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120926
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