(271 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a laser fiber, with no mention of AI or ML capabilities.
Yes
The device is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue, which are all therapeutic actions.
No
The device description and intended use clearly state that the DuraLaze™ HoLEP Laser Fiber is for surgical procedures (enucleate, vaporize, maintain hemostasis, and excise prostate tissue) and energy delivery, not for diagnosing conditions.
No
The device description clearly outlines physical components like a fiber optic cable, jacket, connector, and sheath, and the performance studies focus on physical characteristics and interactions.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH)." This describes a surgical procedure performed directly on the patient's tissue in vivo.
- Device Description: The description details a laser fiber designed to deliver laser energy for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on biological samples. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The DuraLaze™ HoLEP Laser Fiber is a straight fire fiber optic laser energy delivery device. The laser fiber contains a 550µm silica core jacketed with ethylene tetrafluoroethylene (ETFE) and a standard SMA-905 laser connector with a strain relief. The distal 10 cm of the ETFE jacket is pre-stripped and coated during the manufacture of the laser fiber to minimize the potential of laser fiber damage caused by jacket stripping during surgical use and for the convenience of the operating room staff. The pre-stripped distal tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate 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)
MedKey has conducted performance testing with samples aged at T=0 and T=1 year accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the safety and effectiveness of the proposed device:
- Fiber Energy Transmission
- Fiber & Stability Sheath Interactions
- Fiber Dimensions
- Fiber Bend Radius
- Distal Fiber Coated OD
- Fiber Stability Sheath Dimensions and Functionality
- Fiber Connector Strength
- Connector Tensile
- Aiming Beam
- Packaging integrity Testing per ISO 11607-1:2006
- Biological evaluation of medical devices per ISO10993-1:2009
- ETO Sterilization validation per ISO 11135-1:2007
The testing and assessments performed on the subject device meet all specified criteria. The results of the performance testing demonstrate that the DuraLaze™ HoLEP Laser Fiber is substantially equivalent to the predicate device.
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
MedKey, LLC Babacar Diouf Catheter Research, Inc. 5610 W. 82nd Street Indianapolis, IN 46278
Re: K153124
Trade/Device Name: DuraLaze HoLEP Laser Fiber 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: June 22, 2016 Received: June 23, 2016
Dear Babacar Diouf:
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
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Christopher J. Ronk -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153124
Device Name DuraLaze™ HoLEP Laser Fiber
Indications for Use (Describe)
The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
| Applicant/Sponsor: | MedKey, LLC.
2620 N. Walnut Street, Suite 1205
Bloomington, Indiana 47404 |
|--------------------|-----------------------------------------------------------------------------------------|
| Contact Person: | Babacar Diouf
VP of RA and QS
CRI
317-872-0074 x3512
bdiouf@cri-devices.com |
| Date Prepared: | April 4th, 2016 |
Device Name:
| Proprietary Name: | DuraLaze™ HoLEP Laser Fiber |
|---|---|
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General and Plastic Surgery |
| Product Code: | GEX |
| Classification Regulation: | 21 CFR 878.4810. Class II |
Predicate Device (Legally Marketed Devices to Which Substantial Equivalence Is Claimed):
| Proprietary Name: | Lumenis VersaPulse PowerSuite | ||
|---|---|---|---|
| Classification Name: | Powered Laser Surgical Instrument (and Accessories) | ||
| Review Panel: | General and Plastic Surgery and Dermatology | ||
| Product Code: | GEX | ||
| Classification Regulation: | 21 CFR 878.4810. Class II | ||
| Premarket Notification: | K011703 |
Secondary Predicate (Used to Substantiate Technological Characteristics' Equivalency):
| Proprietary Name: | AccuMax™ |
|---|---|
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General and Plastic Surgery and Dermatology |
| Product Code: | GEX |
| Classification Regulation: | 21 CFR 878.4810. Class II |
| Premarket Notification: | K093691 |
Device Description:
The DuraLaze™ HoLEP Laser Fiber is a straight fire fiber optic laser energy delivery device. The laser fiber contains a 550µm silica core jacketed with ethylene tetrafluoroethylene (ETFE) and a standard SMA-905 laser connector with a strain relief. The distal 10 cm of the ETFE jacket is pre-stripped and coated during the manufacture of the laser fiber to minimize the potential of laser fiber damage caused by jacket stripping during surgical use and for the convenience of the operating room staff. The pre-stripped distal
4
tip comes with a printed axial line that improves the surgeon's visibility by increasing the contrast between the fiber tip and the surrounding tissue. The DuraLaze™ HoLEP Laser Fiber is contained within a 9 French, polyurethane stability sheath that holds and secures the laser fiber during surgical use. The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use. It is specifically designed for use with Ho:YAG laser systems, with regulatory clearance for surgical use and compatible with a standard SMA-905 connector.
Indications for use:
The DuraLaze™ HoLEP Laser Fiber is intended for use in laser enabled endoscopic surgery to enucleate, vaporize, maintain hemostasis, and excise prostate tissue associated with benign prostatic hyperplasia (BPH). The DuraLaze™ HoLEP Laser Fiber is supplied ETO sterilized and is intended for single use only. It is specifically designed for use with Ho:YAG laser systems, with requlatory clearance for surgical use and compatible with a standard SMA-905 connector.
Technological Characteristics:
The DuraLaze™ HoLEP Laser Fiber is substantially equivalent in technological characteristics and fundamental design to its predicates. The materials and dimensions of the subject device and its predicates are comparable with the exception of the fiber's stripped distal tip. The DuraLaze™ HoLEP Fiber distal tip is pre-stripped 10.0 cm to minimize potential of laser fiber damage caused by stripping the jacket during surgery, whereas the predicate device(s) fiber distal tip is pre-stripped 0.4 cm, which requires additional stripping during use. The subject device distal tip is also printed with an axial line that improves the surgeon's visibility.
| Technological Characteristics | Primary Predicate Device
Name: Lumenis VersaPulse
PowerSuite | Secondary Predicate Device
Name:
AccuMax™ | Proposed Device
Name: DuraLaze™ HoLEP Laser
Fiber |
|-----------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------|
| Energy Specifications | | | |
| Energy type | Ho:YAG / ND:YAG laser energy | Ho:YAG laser energy | Ho:YAG laser energy |
| Max. Input Wattage | 100 Watts - 550µm core fiber | 100 Watts - 550µm core fiber | 100 Watts - 550µm core fiber |
| Dimensional Specifications | | | |
| Laser Fiber: | | | |
| Core Size | 550µm | 550µm | 550µm |
| Outside Diameter | 780 µm | 750 µm | 750 µm |
| Working Length | 2.5 m | 2.6 m | 2.6 m |
| Distal tip:ETFE jacket stripped length | 0.4 cm | 0.4 cm | 10.0 cm |
| Sheath: | | | |
| Sheath | Provided Separately | Provided Separately | Fiber is placed in sheath |
| Sheath OD | 7 French | 7 French | 9 French |
| Sheath length | N/A | N/A | 36 cm |
| Sheath Tip ID | N/A | N/A | 0.030 in |
| Materials (Individual components) | | | |
| Fiber Core | Silica | Silica | Silica |
| Fiber Jacket | Tetrafluoroethylene (ETFE) | Tetrafluoroethylene (ETFE) | Tetrafluoroethylene (ETFE) |
| Coating - Distal Fiber Tip | N/A | N/A | Acrylate coating: 10cm |
| Strain Relief - Laser Fiber to SMA-905
Connector | Unknown Polymer | Sanoprene | Sanoprene |
| Sheath | Provided Separately | Provided Separately | Polyurethane tubing |
| Tuohy Borst Adapter for sheath | N/A | N/A | Fluoropolymer seal & Polycarbonate
housing |
| Laser Fiber Connector | SMA-905 Connector | SMA-905 Connector | SMA-905 Connector |
| Tip Marking | Not included | Not included | Marabou Ink, Axial 10cm distal line |
| Packaging Pouch | Tyvek Pouch | Tyvek Pouch | Tyvek Pouch |
Reference the table below for details.
5
Substantial Equivalence:
A direct comparison of key characteristics demonstrates that the DuraLaze™ HoLEP Laser Fiber is substantially equivalent to its predicates in terms of intended use, technological characteristics, and performance characteristics.
Non-Clinical Testing / Performance Testing (Bench Evaluation):
MedKey has conducted performance testing with samples aged at T=0 and T=1 year accelerated aging in support of the proposed laser device. The following testing was completed to evaluate the safety and effectiveness of the proposed device:
- Fiber Enerqy Transmission .
- Fiber & Stability Sheath Interactions ●
- . Fiber Dimensions
- . Fiber Bend Radius
- Distal Fiber Coated OD
- Fiber Stability Sheath Dimensions and Functionality
- . Fiber Connector Strength
- . Connector Tensile
- Aiming Beam ●
- . Packaging integrity Testing per ISO 11607-1:2006
- Biological evaluation of medical devices per ISO10993-1:2009 ●
- . ETO Sterilization validation per ISO 11135-1:2007
Conclusion:
The testing and assessments performed on the subject device meet all specified criteria. The results of the performance testing demonstrate that the DuraLaze™ HoLEP Laser Fiber is substantially equivalent to the predicate device.