(94 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a laser fiber for delivering laser energy. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The SureFlex laser fibers are delivery devices for laser energy used in surgical procedures, not therapeutic devices themselves. The therapeutic effect comes from the laser, not the fiber.
No
The device is a laser fiber intended for surgical applications involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision, and fragmentation of tissues and calculi. It is a therapy delivery device, not a diagnostic one.
No
The device description clearly states it is a "fiber optic laser delivery device" consisting of physical components like a fiber, cladding, and jacket, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a tool for surgical procedures involving the direct interaction with tissue and calculi using a laser. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a fiber optic laser delivery device, designed to transmit laser energy for surgical purposes. This aligns with a surgical instrument, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue samples, etc.) outside of the body to provide information for diagnosis, monitoring, or screening. The device is used in vivo during surgery.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparosopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, and incision of soft and cartilaginous tissue and surgical procedures involving vaporization of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAG) lasers, but may be used with any laser wavelength between 500mm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode
Specific, by Surgical Specialty (most common use first)
Urology -
Urinary Lithotripsy including but not limited to endoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.
Urological Surgery (vaporization, coagulation, hemostasis, excision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder turnors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH).
Gastroenterology -
Laser-based surgical procedures including, but not limited to open, endoscopic gastroenterological surgery for ablation, vaporization, fragmentation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.
Product codes
GEX
Device Description
The SureFlex™ Lithotripsy Laser Fiber (SureFlex fiber) is a fiber optic laser delivery device consisting of a patented, high energy termination (Black Hole™); a length of silica/silica fiber with a UV cured polymer secondary cladding and an ethylene tetrafluoro-ethylene copolymer (ETFE) jacket. The standard fiber output is a laser polished tip. SureFlex fibers are designed for use in a wide variety of surgical procedures as an integral part of a surgical laser system.
The device is identical to the currently marketed predicate device, SureFlex fiber, with the exception of the modification to the resin for the flouroacrylate resin material and a labeling update changing the listed maximum power of the 200 um fiber from 25W to 12W. There are no other changes to device design, material or Indications for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract (lower pole of the kidney to the urethra), bladder, ureteral, prostate, biliary tract.
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)
Bench testing was performed to support this submission. Results of the testing demonstrate that the SureFlex Laser Fibers meet product specification and performance requirements.
The following testing has been successfully completed:
- . Shelf Life
- Biocompatibility .
- Performance Testing (Bench): Active Bending Test ●
No clinical testing was performed to support this Traditional 510(k) Premarket Application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2014
American Medical Systems Mr. Josh Clarin Regulatory Affairs Manager 3070 Orchard Drive San Jose, California 95134
Re: K140679
Trade/Device Name: SureFlex Lithotripsy 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: June 5, 2014 Received: June 6, 2014
Dear Ms. Clarin:
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. Iisting 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2 - Mr. Josh Clarin
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/ResourcesforYou/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,
David Krause -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140679
Device Name
SureFlex Lithotripsy Laser Fibers
Indications for Use (Describe)
General
SureFlex laser fibers are intended for use in laser-based surgical applications, but not limited to endoscopic, laparosopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, and incision of soft and cartilaginous tissue and surgical procedures involving vaporization of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAG) lasers, but may be used with any laser wavelength between 500mm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode Specific, by Surgical Specialty (most common use first)
Urology -
Urinary Lithotripsy including but not limited to endoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.
Urological Surgery (vaporization, coagulation, hemostasis, excision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder turnors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH). Gastroenterology -
Laser-based surgical procedures including, but not limited to open, endoscopic gastroenterological surgery for ablation, vaporization, fragmentation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.06.19 14:58:18 -04'00'
3
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4
510(k) Summary As required by 21CFR 807.92(c)
510(k) Number: K140679
Date Prepared: Submitter Information: February 10, 2014
Submitter's Name/ Address:
Contact Person:
American Medical Systems 3070 Orchard Drive San Jose,CA 95134
Josh Clarin Regulatory Affairs Manager Tel: 952-939-7072 Fax: 952-930-5785 josh.clarin@AmericanMedicalSystems.com
Alternate Contact:
Melanie Hess Director, Regulatory Affairs Tel: 952-939-6490 Fax: 952-930-5785 Melanie. Hess@American Medical Systems.com
Device Information:
Trade Name/Proprietary Name: SureFlex™ Lithotripsy Laser Fibers Common Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Classification: 21 CFR § 878.4810 Product Code: GEX
Predicate Device:
SureFlex™ Lithotripsy Laser Fibers K050108
Device Description:
The SureFlex™ Lithotripsy Laser Fiber (SureFlex fiber) is a fiber optic laser delivery device consisting of a patented, high energy termination (Black Hole™); a length of silica/silica fiber with a UV cured polymer secondary cladding and an ethylene tetrafluoro-ethylene copolymer (ETFE) jacket. The standard fiber output is a laser polished tip. SureFlex fibers are designed for use in a wide variety of surgical procedures as an integral part of a surgical laser system.
Page 1 of 3
5
510(k) Summary As required by 21CFR 807.92(c)
The device is identical to the currently marketed predicate device, SureFlex fiber, with the exception of the modification to the resin for the flouroacrylate resin material and a labeling update changing the listed maximum power of the 200 um fiber from 25W to 12W. There are no other changes to device design, material or Indications for Use.
Indications for Use:
General
SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAG) lasers, but may be used with any laser wavelength between 500nm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode
Specific, by Surgical Specialty (most common use first)
Urology -
Urinary Lithotripsy including but not limited to endoscopic and laparoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.
Urological Surgery (vaporization, coagulation, hemostasis, excision and incision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder tumors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH).
Gastroenterology -
Laser-based surgical procedures including, but not limited to open, endoscopic and laparoscopic gastroenterological surgery for ablation, vaporization, fragmentation, coagulation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.
Page 2 of (3)
6
510(k) Summary As required by 21CFR 807.92(c)
Comparison to the Predicate Device:
The fundamental scientific technology on the SureFlex™ laser fiber is unchanged from the predicate device. The intended use and indication for use are also the same as the predicate device. In addition, the subject SureFlex laser fibers utilize the same surgical approach and targeted patient population as the predicate devices (K050108). The primary change to the device is a new resin for the flouracrylate polymer cladding material and maximum power listed in the IFU from 25W to 12W for the 200 um fiber size.
Summary of Non-Clinical Testing:
Bench testing was performed to support this submission. Results of the testing demonstrate that the SureFlex Laser Fibers meet product specification and performance requirements.
The following testing has been successfully completed:
- . Shelf Life
- Biocompatibility .
- Performance Testing (Bench): Active Bending Test ●
Clinical Testing:
No clinical testing was performed to support this Traditional 510(k) Premarket Application.
Statement of Equivalence:
The SureFlex fibers have the same indications for use and fundamental scientific technology as the predicate device, Based on this and the design and engineering data provided in the premarket notification, the SureFlex fibers have been shown to be substantially equivalent.
Page 3 of (3)