(30 days)
No
The device description focuses on the physical components of a laser fiber and an RFID tag for data storage, with no mention of AI or ML capabilities for data analysis, decision-making, or control.
Yes
The device is described as assisting in "vaporization, ablation, hemostasis, coagulation, excision, incision of soft tissue, and lithotripsy of urinary calculi," which are all therapeutic medical procedures.
No
The device is described as a laser fiber intended for transmitting laser energy for surgical applications such as vaporization, ablation, and lithotripsy, not for diagnostic purposes.
No
The device description explicitly details physical components like fiber optic cables, connectors, and an RFID tag, indicating it is a hardware device for transmitting laser energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to transmit laser energy to urological anatomy for surgical procedures like vaporization, ablation, lithotripsy, etc. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details a fiber optic laser energy delivery device. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of Diagnostic Language: The document does not use any language typically associated with IVDs, such as "diagnosis," "detection," "measurement," "analysis of samples," or "in vitro."
- Performance Studies: The performance studies described are bench evaluations focused on the device's ability to transmit laser energy and its safety and effectiveness for surgical use. There are no studies related to diagnostic accuracy or performance with biological samples.
In summary, the Flexiva Pulse and Flexiva Pulse TracTip laser fibers are surgical devices used to deliver laser energy for therapeutic purposes within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho: YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
Product codes
GEX
Device Description
The Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. The Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242um, 365um, 550um and 910um size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242um size).
These fibers may be used in a variety of laser-based surgical cases. For the Flexiva Pulse ID and the Flexiva Pulse ID TracTip laser fibers, an RFID (radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological anatomy, urinary calculi
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)
Boston Scientific has conducted performance testing with samples aged at T=0 and T= 3 year accelerated aging in support of the proposed laser device. IEC 60601-1:2005 was considered when testing connector temperature. The Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID, and Flexiva Pulse ID TracTip laser fibers conform to Section 11.1.1, Maximum temperature during Normal Use. All other sections of IEC 60601-1 Clause 11 are not applicable, as the fiber functions only as an accessory to the Medical Electrical Equipment (laser).
The following testing was completed to evaluate the effects of the design changes.
- Fiber Jacket Outer Diameter
- No Damage to Scope Liner (Ball-Tip)
- Ball Tip Fracture Resistance
- Distal Tip Length
- Fiber Length
- Bent Transmission
- Fiber Stiffness
- Fiber Power Rating and Power Output Efficiency of Fiber
- Fiber Connector Temperature and Durability
- Fiber Aiming Beam Visualization
- Laser Compatibility
- RFID Recognition
- Scope Adaptor Compatibility
- Tensile Strength of fiber to connector housing
- Fiber Hub to Connector Housing Torque
- Pouch Seal Integrity
- Pouch Seal Strength
- Biocompatibility
The results of the performance testing demonstrate that the Flexiva Pulse Laser Fiber, Flexiva PulseTracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are considered safe and effective for their intended use.
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 28, 2021
Boston Scientific % Dave Yungvirt, CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K210925
Trade/Device Name: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip 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: II Product Code: GEX Dated: March 24, 2021
Dear Dave Yungvirt:
Received: March 29, 2021
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. 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 located 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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). 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-device-advice-comprehensive-regulatoryassistance/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.
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210925
Device Name
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fiber
Indications for Use (Describe)
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho: YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
| 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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510(k) Summary for the Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber
Date Prepared A.
April 26, 2021
B. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752
Contact C.
Rebecca Perrine Sr. Regulatory Affairs Specialist 508-683-4604 rebecca.perrine@bsci.com
or
John Capone Regulatory Affairs Director 617-842-9632 john.capone@bsci.com
D. Proposed Device
| Trade Name(s): | Flexiva Pulse Laser Fiber
Flexiva Pulse TracTip Laser Fiber
Flexiva Pulse ID Laser Fiber
Flexiva Pulse ID TracTip Laser Fiber |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Laser Instrument, Surgical, Powered |
| Classification Number: | 21 CFR 878.4810 |
| Classification Name: | Laser Surgical Instrument for use in general and plastic
surgery and in dermatology |
| Classification: | Class II |
| Product Code: | GEX |
| Product Code Name: | Powered Laser Surgical Instrument |
| 510(k) Number: | K210925 |
4
E. Predicate Devices
| Trade Name: | Flexiva™ High Power Single Use Laser Fiber |
|---|---|
| Common/Usual Name: | Laser Instrument, Surgical, Powered |
| Classification Number: | 21 CFR 878.4810 |
| Classification Name: | Laser Surgical Instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification: | Class II |
| Product Code: | GEX |
| Product Code Name: | Powered Laser Surgical Instrument |
| Identification of | |
| Predicate Device: | Modified Straight Fire Laser Fiber, Boston Scientific, |
| K100078 | |
| Trade Name: | Flexiva™ TracTip Single Use Laser Fiber |
| Common/Usual Name: | Laser Instrument, Surgical, Powered |
| Classification Number: | 21 CFR 878.4810 |
| Classification Name: | Laser Surgical Instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification: | Class II |
| Product Code: | GEX |
| Product Code Name: | Powered Laser Surgical Instrument |
| Identification of | |
| Predicate Device: | Flexiva™ TracTip™ Single Use Laser Fiber, Boston |
F. Device Description
The Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. The Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242um, 365um, 550um and 910um size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242um size).
Scientific, K110685
These fibers may be used in a variety of laser-based surgical cases. For the Flexiva Pulse ID and the Flexiva Pulse ID TracTip laser fibers, an RFID (radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).
5
G. Intended Use/Indications for Use
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho: YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
H. Technological Characteristics Compared to Predicate
The principles of operation are identical between the predicate and subject devices. The Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID, and Flexiva Pulse ID TracTip laser fibers have the same technological characteristics and fundamentals design as the predicate devices.
The differences between the subject device and the predicates are minor. Differences include:
- Use with holmium lasers only with an increased maximum frequency ●
- Connector/hub including: manufacturing, shape and non-patient contacting . connector/hub materials
- . Primary and Secondary Coating on fiber length
The technological characteristics remain equivalent to the predicate device because the modifications that are the subject of this submission are limited to improvements to the existing design.
I. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are substantially equivalent to the predicate devices in terms of intended use, technological characteristics and performance characteristics. The Flexiva Pulse Laser Fiber, Flexiva Pulse TracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are as safe and effective as the predicate devices.
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J. Biocompatibility
Biocompatibility testing was performed to show that all patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2018 and the FDA guidance: Use of International Standard ISO 10993-1 "Biological evaluation of medical devices. Evaluation and testing within a risk management process."
The following testing was performed with passing results to support the biocompatibility of the device:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Materials Mediated Pyrogenicity ●
K. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with samples aged at T=0 and T= 3 year accelerated aging in support of the proposed laser device. IEC 60601-1:2005 was considered when testing connector temperature. The Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID, and Flexiva Pulse ID TracTip laser fibers conform to Section 11.1.1, Maximum temperature during Normal Use. All other sections of IEC 60601-1 Clause 11 are not applicable, as the fiber functions only as an accessory to the Medical Electrical Equipment (laser).
The following testing was completed to evaluate the effects of the design changes.
- Fiber Jacket Outer Diameter
- No Damage to Scope Liner (Ball-Tip) ●
- Ball Tip Fracture Resistance ●
- Distal Tip Length ●
- Fiber Length ●
- Bent Transmission ●
- Fiber Stiffness ●
- Fiber Power Rating and Power Output Efficiency of Fiber
- Fiber Connector Temperature and Durability ●
- Fiber Aiming Beam Visualization ●
- Laser Compatibility ●
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- RFID Recognition ●
- Scope Adaptor Compatibility ●
- Tensile Strength of fiber to connector housing ●
- Fiber Hub to Connector Housing Torque ●
- Pouch Seal Integrity ●
- Pouch Seal Strength ●
- Biocompatibility ●
The results of the performance testing demonstrate that the Flexiva Pulse Laser Fiber, Flexiva PulseTracTip Laser Fiber, Flexiva Pulse ID Laser Fiber, and Flexiva Pulse ID TracTip Laser Fiber are considered safe and effective for their intended use.