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.

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.

AI/ML Overview

This document is not about an AI/ML powered medical device, but rather a traditional medical device (laser fibers). Therefore, the requested information regarding acceptance criteria and study details for an AI/ML powered device does not apply directly.

However, I can extract the information pertinent to the described device, the SureFlex Lithotripsy Laser Fibers, from the provided 510(k) summary.

Acceptance Criteria and Study for SureFlex Lithotripsy Laser Fibers (K140679)

This 510(k) pertains to a modification of an existing device (SureFlex Lithotripsy Laser Fibers, K050108), specifically a change in the resin for the fluoroacrylate resin material and a labeling update for the maximum power of the 200 um fiber. As such, the testing focuses on demonstrating that the modified device remains equivalent to the predicate and meets its intended product specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance
Product Specifications	Met
Performance Requirements	Met
Shelf Life	Successfully completed
Biocompatibility	Successfully completed
Performance Testing (Bench): Active Bending Test	Successfully completed

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Bench testing was performed to support this submission." It does not specify a distinct "test set" in the context of clinical data, as no clinical testing was performed. The non-clinical testing appears to have used samples of the device itself. The document does not provide details on the number of samples used for each bench test.

Data Provenance: Non-clinical bench testing. No country of origin for data or retrospective/prospective nature is applicable as no human data was used.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as no clinical data or expert-adjudicated ground truth was used. The evaluation was based on non-clinical, objective bench testing.

4. Adjudication Method for the Test Set

This is not applicable as no clinical data requiring expert adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. The device is a physical laser fiber, not an AI/ML algorithm requiring human reader performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone algorithmic study was conducted. This device is not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through product specifications and performance requirements as demonstrated by non-clinical bench testing.

8. Sample Size for the Training Set

This is not applicable. The device is a physical product and does not involve AI/ML models that require training sets.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set for a physical device.

Summary

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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

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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

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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'

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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:

Page 1 of 3

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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

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)

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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)

Regulation Number and Section

§ 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.