(202 days)
Not Found
No
The description focuses on mechanical and optical components for visualization, tumescence infusion, and tissue resection/aspiration. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for the resection and ablation of varicose veins, which is a therapeutic intervention. It also facilitates visualization and infusion of tumescent solution during a medical procedure, contributing to the therapy.
No
The device is used for resection and ablation of varicose veins, providing visualization and infusion during the procedure, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical hardware components (Illuminator Handpiece, Disposable Illuminator, Resector Handpiece, Resector Disposable) that perform the primary functions of the device (illumination, tumescence infusion, morcellation, aspiration). While there is mention of "Resector Software Integration Validation," this indicates software is part of the system, but not that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ambulatory phlebectomy procedures for the resection and ablation of varicose veins." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a surgical tool used to visualize, resect, and aspirate varicose veins. It involves physical intervention within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
The device is a surgical instrument used for treatment, not for diagnosing a condition by analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.
Product codes
DWQ
Device Description
The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.
The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator. The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins. The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.
The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities. The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.
The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following tests have been completed to evaluate the performance of the subject device compared with the predicate device:
- Illuminator Design Validation . Shaft ø (in) Length: Shaft (in) Length: IV Spike to Pump (in) Length: Pump Tube (in) Length: Pump to Hub (in) Flow Rate (ml/min) Light Output (lumens) Leak Testing Sheath Length (in) Usability Through Sheath Sheath Maintains Microbial Barrier Tensile Strength: Hub to Shaft (Ibf) Torque Strength: Disposable (in-lb) Tensile Strength: Disposable to HP (1bf) Tensile Strength: Tubing to Hub (1bf) Tensile Strength: IV Spike to Tubing (lbf) Tensile Strength: Pump tube to Connectors Kink Test: Infusion Tubing
- . Illuminator Validation System Basic Function Low Battery Functionality Fault Insertion and Power Supply Fuse testing
- Resector System Validation ● Voltage Regulation Motor RPM Home Position and Home Position Drift Communications and Diagnostic Logging Embedded Processor Hardware Basic Function Jam Clear Battery Critical Function Embedded processor/Software load
- Resector Software Integration Validation ● Integration Test- timer functionality Integration Test- low battery functionality Integration Test- low level hardware configuration of the micro-controller hardware Integration Test- motor state machine running Integration Test- functionality of the oscillation feature and software Integration Test- fault states related to the "anti-stall routine Integration Test- high motor current fault by simulating excessive motor current Integration Test- the motor time save and retrieve function Integration Test- the Real Time Clock (RTC) against the system clock Integration Test- battery critical lockout feature.
- Resector Design Validation Shaft Diameter 4.5mm Shaft Diameter 5.5mm Shaft Length 4.5mm Shaft Length 5.5mm Aspiration Tube Length Aspiration Tube tensile strength to Connector Kink Testing & Leak Testing Bond Tubing to Back Lid Aspiration Flow Rate Comparison 4.5 Aspiration Flow Rate Comparison 5.5 Motor Functionality Data Sterile Sheath: Adequate length Sterile Sheath: Microbial Barrier Testing Sterile Sheath: Maintains Contamination Barrier Disposable Hub to Main Shaft: Tensile Strength 4.5mm
- Disposable Hub to Main Shaft: Tensile Strength 5.5mm Disposable Hub to Shaft assembly: Torque Strength Driven Gear to the resector inner shaft Tensile Strength 4.5mm Driven Gear to the resector inner shaft Tensile Strength 5.5mm Driven Gear to the resector inner shaft Torque Strength Bonded joint between proximal hub and the backlid Disposable Assembly to Handpiece: Tensile Strength Distal Hub Pinned to proximal resector
- Microbial Sheath Barrier Design Validation ● Sheath Bubble Leak Test
- PhasTIPP Illuminator Injection Line Design Validation Pressurized Leak Testing
- PhasTIPP Illuminator Injection Line Shelf Life Validation (2 years Accelerated aging) ● Pressurized Leak Testing Flow Rate Measurement Luer Fitting Tensile Strength test Overall Length
- PhasTIPP Performance Testing ● System performance testing in 3D in-vitro bench test
- PhasTIPP Illuminator Heat Evaluation ● Evaluation of heat produced by PhasTIPP Illuminator
- PhasTIPP Testing to IEC 60601 Medical Electrical Equipment . Radiated Emissions Electro-Static Discharge Radiated Field Immunity Power Frequency Magnetic Field
The verification activities conducted on the subject device indicate that the subject device meets the product performance specifications and the modifications do not raise any additional safety issues.
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
§ 870.4885 External vein stripper.
(a)
Identification. An external vein stripper is an extravascular device used to remove a section of a vein.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2022
LeMaitre Vascular Inc. Anurag Gadgil Sr. Regulatory Affairs Specialist 63 Second Ave Burlington, Massachusetts 01803
Re: K212894
Trade/Device Name: PhasTIPP Regulation Number: 21 CFR 870.4885 Regulation Name: External Vein Stripper Regulatory Class: Class II Product Code: DWQ Dated: February 9, 2022 Received: February 14, 2022
Dear Anurag Gadgil:
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.
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
1
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 (OS) 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 mediation-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,
Carmen Johnson, PhD for Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212894
Device Name PhasTIPP System
Indications for Use (Describe)
The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.
| 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
SECTION 5 510(K) SUMMARY
Submitter's information
| Name: | LeMaitre Vascular, Inc. |
|---|---|
| Address: | 63 Second Avenue |
| Burlington, MA,01803. USA | |
| Phone: | 781-362-5412 |
| Contact Person: | Anurag Gadgil |
| Date of preparation: | March 30, 2022 |
| Device Name: | PhasTIPP System |
| Trade Name: | PhasTIPP |
| Common/ Classification Name: | External Vein Stripper |
| Classification Panel: | 21CFR §870.4885 |
| Class: | II (2) |
| Product Code: | DWQ |
| Cardiovascular: | Cardiovascular |
Subject Device Description:
The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.
The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator.
The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a
4
K212894
cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins.
The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.
The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities.
The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.
The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.
Intended Use:
The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.
Predicate Device:
| 510(k): | K032387 |
|---|---|
| Device Name: | Trivex System |
| SE Date: | 10/29/2003 |
| Regulation Number: | 21CFR §870.4885 |
| Device Class Name: | External Vein Stripper |
| Device Class: | II |
| Product Code: | DWQ |
Summary of Technological Characteristics Comparison with Predicate:
5
| Characteristic | Predicate Device: Trivex | Subject Device: PhasTIPP |
|---|---|---|
| Design - Patient | ||
| Interacting | ||
| Components | The distal ends of the devices that | |
| interact with the patient include | ||
| the Illuminator distal shaft | ||
| (produces light and infuses) and | ||
| the Resector distal shaft (rotates, | ||
| cuts, and provides suction). | The distal ends of the devices that | |
| interact with the patient include the | ||
| Illuminator distal shaft (produces light | ||
| and infuses) and the Resector distal | ||
| shaft (rotates, cuts, and provides | ||
| suction). | ||
| Design – User | ||
| Interacting | ||
| Components | The proximal ends of the devices | |
| that the user interacts with include | ||
| the control box with | ||
| buttons/settings, the Resector | ||
| MDU with an additional button, | ||
| and the Illuminator (no controls). | The proximal ends of the devices that | |
| the user interacts with include the | ||
| Resector Handpiece with two buttons | ||
| and the Illuminator with one button. | ||
| Materials | Primarily stainless steel shafts, | |
| PEEK MDU handle, silicone and | ||
| PVC tubing, and ABS. | Primarily stainless steel shafts, PEEK | |
| MDU handle, silicone and PVC | ||
| tubing, and ABS. | ||
| Energy Source | 110V wall outlet | Resector: 4.1V Tadiran battery |
| Illuminator: CR123 battery | ||
| Sterilization | Disposables: ETO | |
| Reusables: Steam (on-site) | Disposables: ETO | |
| Reusables: None (ETO sterilized | ||
| microbial barrier covers handpieces) |
Summary of Product Testing:
The following tests have been completed to evaluate the performance of the subject device compared with the predicate device:
- Illuminator Design Validation . Shaft ø (in) Length: Shaft (in) Length: IV Spike to Pump (in) Length: Pump Tube (in) Length: Pump to Hub (in) Flow Rate (ml/min) Light Output (lumens) Leak Testing Sheath Length (in) Usability Through Sheath Sheath Maintains Microbial Barrier Tensile Strength: Hub to Shaft (Ibf) Torque Strength: Disposable (in-lb) Tensile Strength: Disposable to HP (1bf) Tensile Strength: Tubing to Hub (1bf) Tensile Strength: IV Spike to Tubing (lbf) Tensile Strength: Pump tube to Connectors Kink Test: Infusion Tubing
6
- . Illuminator Validation System Basic Function Low Battery Functionality Fault Insertion and Power Supply Fuse testing
- Resector System Validation ●
Voltage Regulation Motor RPM Home Position and Home Position Drift Communications and Diagnostic Logging Embedded Processor Hardware Basic Function Jam Clear Battery Critical Function Embedded processor/Software load
- Resector Software Integration Validation ● Integration Test- timer functionality Integration Test- low battery functionality Integration Test- low level hardware configuration of the micro-controller hardware Integration Test- motor state machine running Integration Test- functionality of the oscillation feature and software Integration Test- fault states related to the "anti-stall routine Integration Test- high motor current fault by simulating excessive motor current Integration Test- the motor time save and retrieve function Integration Test- the Real Time Clock (RTC) against the system clock Integration Test- battery critical lockout feature.
- Resector Design Validation Shaft Diameter 4.5mm Shaft Diameter 5.5mm Shaft Length 4.5mm Shaft Length 5.5mm Aspiration Tube Length Aspiration Tube tensile strength to Connector Kink Testing & Leak Testing Bond Tubing to Back Lid Aspiration Flow Rate Comparison 4.5 Aspiration Flow Rate Comparison 5.5 Motor Functionality Data Sterile Sheath: Adequate length Sterile Sheath: Microbial Barrier Testing Sterile Sheath: Maintains Contamination Barrier Disposable Hub to Main Shaft: Tensile Strength 4.5mm
7
K212894
Disposable Hub to Main Shaft: Tensile Strength 5.5mm Disposable Hub to Shaft assembly: Torque Strength Driven Gear to the resector inner shaft Tensile Strength 4.5mm Driven Gear to the resector inner shaft Tensile Strength 5.5mm Driven Gear to the resector inner shaft Torque Strength Bonded joint between proximal hub and the backlid Disposable Assembly to Handpiece: Tensile Strength Distal Hub Pinned to proximal resector
- Microbial Sheath Barrier Design Validation ● Sheath Bubble Leak Test
- PhasTIPP Illuminator Injection Line Design Validation Pressurized Leak Testing
- PhasTIPP Illuminator Injection Line Shelf Life Validation (2 years Accelerated aging) ● Pressurized Leak Testing Flow Rate Measurement Luer Fitting Tensile Strength test Overall Length
- PhasTIPP Performance Testing ● System performance testing in 3D in-vitro bench test
- PhasTIPP Illuminator Heat Evaluation ● Evaluation of heat produced by PhasTIPP Illuminator
- PhasTIPP Testing to IEC 60601 Medical Electrical Equipment . Radiated Emissions Electro-Static Discharge Radiated Field Immunity Power Frequency Magnetic Field
The verification activities conducted on the subject device indicate that the subject device meets the product performance specifications and the modifications do not raise any additional safety issues.
Sterilization:
The PhasTIPP Illuminator and Resector disposable assemblies are provided sterile and sterilization method is EtO gas. The sterilization validation followed the guidelines in the Product Adoption and Process Equivalence for Ethylene Oxide Sterilization AAMI TIR28:2016. The sterilization process has been validated per EN ISO 11135-1:2014.
8
K212894
LeMaitre Vascular has performed biocompatibility assessment per ISO 10993-1:2018 and FDA Guidance Use of International Standard ISO 10993-1 "Biological evaluation of medical device-Part 1." The Phas TIPP Illuminator and the Resector are categorized as External Communicating Device, Contact Circulating Blood, for limited use (