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.

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.

AI/ML Overview

This document describes the PhasTIPP System, an external vein stripper. The FDA's 510(k) summary provides details about the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format alongside "reported device performance" in the way one might expect for a clinical study with primary endpoints. Instead, it lists various design validation, system validation, and performance tests that were completed to demonstrate the device meets product performance specifications and for substantial equivalence.

For the purpose of this request, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" as the overall statement that the device meets these specifications.

Acceptance Criteria (Inferred from Tests)	Reported Device Performance (Summary)
Illuminator Design Validation:	The Illuminator's design, including shaft dimensions, flow rate, light output, leak testing, sheath integrity and usability, and tensile/torque strengths of components, met specifications.
Shaft diameter, length, IV spike to pump, pump tube, pump to hub lengths	Met specifications
Flow Rate (ml/min)	Met specifications
Light Output (lumens)	Met specifications
Leak Testing	Passed
Sheath Length (in)	Met specifications
Usability Through Sheath	Confirmed
Sheath Maintains Microbial Barrier	Confirmed
Tensile Strength: Hub to Shaft (lbf), Disposable (lbf), Pump tube to Connectors, IV Spike to Tubing (lbf)	Met specifications
Torque Strength: Disposable (in-lb)	Met specifications
Kink Test: Infusion Tubing	Passed
Illuminator System Validation:	The Illuminator's system functions, including basic operation and low battery performance, were verified.
Basic Function	Verified
Low Battery Functionality	Verified
Fault Insertion and Power Supply Fuse testing	Verified
Resector System Validation:	The Resector's system functions, including voltage regulation, motor RPM, home position, communications, diagnostics, embedded processor, and battery critical function, were verified.
Voltage Regulation	Verified
Motor RPM	Verified
Home Position and Home Position Drift	Verified
Communications and Diagnostic Logging	Verified
Embedded Processor Hardware Basic Function	Verified
Jam Clear	Verified
Battery Critical Function	Verified
Embedded processor/Software load	Verified
Resector Software Integration Validation:	The Resector's software integration for timer, low battery, hardware configuration, motor state machine, oscillation, anti-stall, high current fault, motor time save/retrieve, and RTC were validated.
Timer functionality	Validated
Low battery functionality	Validated
Low level hardware configuration of the micro-controller hardware	Validated
Motor state machine running	Validated
Functionality of the oscillation feature and software	Validated
Fault states related to the "anti-stall routine	Validated
High motor current fault by simulating excessive motor current	Validated
Motor time save and retrieve function	Validated
Real Time Clock (RTC) against the system clock	Validated
Battery critical lockout feature	Validated
Resector Design Validation:	The Resector's design, including shaft diameters and lengths, aspiration tube characteristics, sterile sheath integrity, and tensile/torque strengths of components, met specifications.
Shaft Diameter (4.5mm & 5.5mm)	Met specifications
Shaft Length (4.5mm & 5.5mm)	Met specifications
Aspiration Tube Length	Met specifications
Aspiration Tube tensile strength to Connector	Met specifications
Kink Testing & Leak Testing	Passed
Bond Tubing to Back Lid	Met specifications
Aspiration Flow Rate Comparison (4.5 & 5.5)	Met specifications
Motor Functionality Data	Met specifications
Sterile Sheath: Adequate length, Microbial Barrier Testing, Maintains Contamination Barrier	Confirmed
Tensile Strength: Disposable Hub to Main Shaft (4.5mm & 5.5mm), Driven Gear to the resector inner shaft (4.5mm & 5.5mm), Disposable Assembly to Handpiece	Met specifications
Torque Strength: Disposable Hub to Shaft assembly, Driven Gear to the resector inner shaft	Met specifications
Bonded joint between proximal hub and the backlid	Met specifications
Distal Hub Pinned to proximal resector	Met specifications
Microbial Sheath Barrier Design Validation:	The sheath's bubble leak test confirmed its barrier integrity.
Sheath Bubble Leak Test	Passed
PhasTIPP Illuminator Injection Line Design Validation:	The injection line's pressurized leak testing met specifications.
Pressurized Leak Testing	Passed
PhasTIPP Illuminator Injection Line Shelf Life Validation (2 years Accelerated aging):	The injection line maintained performance after accelerated aging.
Pressurized Leak Testing	Passed
Flow Rate Measurement	Met specifications
Luer Fitting Tensile Strength test	Met specifications
Overall Length	Met specifications
PhasTIPP Performance Testing:	System performance was confirmed in a 3D in-vitro bench test.
System performance in 3D in-vitro bench test	Confirmed
PhasTIPP Illuminator Heat Evaluation:	The heat produced by the Illuminator was evaluated.
Evaluation of heat produced by PhasTIPP Illuminator	Evaluated (implies within acceptable limits for a medical device)
PhasTIPP Testing to IEC 60601 Medical Electrical Equipment:	The device met relevant IEC 60601 standards for electromagnetic compatibility.
Radiated Emissions	Compliant
Electro-Static Discharge	Compliant
Radiated Field Immunity	Compliant
Power Frequency Magnetic Field	Compliant
Biocompatibility (ISO 10993-1:2018):	The device was found to be biocompatible for its intended use.
External Communicating Device, Contact Circulating Blood, limited use (<24h)	Demonstrated biocompatible
Sterilization (EtO gas):	The sterilization process was validated according to industry standards.
Per EN ISO 11135-1:2014 and AAMI TIR28:2016	Validated

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the individual engineering and performance tests listed. The data provenance is not specified beyond being "product testing" and "verification activities." These are typically conducted in-house by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to the tests described in this 510(k) summary. The listed tests are primarily engineering and performance validations, not clinical studies requiring expert interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments. This 510(k) submission focuses on device engineering and performance validation, so "adjudication method" is not applicable here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such MRMC study was mentioned. The device described is an external vein stripper, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the PhasTIPP System is a physical medical device (an external vein stripper) used in surgery, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the engineering and performance tests described, the "ground truth" or reference standard would be the established engineering specifications, industry standards (e.g., IEC 60601, ISO 10993-1, EN ISO 11135-1), and the performance of the predicate device. These are objective measures or recognized benchmarks. For example:

Mechanical properties (tensile strength, torque strength): Established material specifications and engineering design tolerances.
Flow rate, light output: Measured against design specifications.
Sterilization: Validated against sterility assurance levels defined by standards.
Biocompatibility: Assessed against cytotoxicity, sensitization, irritation tests as per ISO 10993.

8. The sample size for the training set

The concept of a "training set" is generally applicable to machine learning or AI models. This 510(k) summary does not concern an AI/ML device, so a training set as such is not relevant. The device undergoes design verification and validation testing.

9. How the ground truth for the training set was established

As there is no "training set" in the context of this device, this question is not applicable.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K212894

Device Name PhasTIPP System

Indications for Use (Describe)

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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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 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

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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.

Intended Use:

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:

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Characteristic	Predicate Device: Trivex	Subject Device: PhasTIPP
Design - PatientInteractingComponents	The distal ends of the devices thatinteract with the patient includethe Illuminator distal shaft(produces light and infuses) andthe Resector distal shaft (rotates,cuts, and provides suction).	The distal ends of the devices thatinteract with the patient include theIlluminator distal shaft (produces lightand infuses) and the Resector distalshaft (rotates, cuts, and providessuction).
Design – UserInteractingComponents	The proximal ends of the devicesthat the user interacts with includethe control box withbuttons/settings, the ResectorMDU with an additional button,and the Illuminator (no controls).	The proximal ends of the devices thatthe user interacts with include theResector Handpiece with two buttonsand the Illuminator with one button.
Materials	Primarily stainless steel shafts,PEEK MDU handle, silicone andPVC tubing, and ABS.	Primarily stainless steel shafts, PEEKMDU handle, silicone and PVCtubing, and ABS.
Energy Source	110V wall outlet	Resector: 4.1V Tadiran batteryIlluminator: CR123 battery
Sterilization	Disposables: ETOReusables: Steam (on-site)	Disposables: ETOReusables: None (ETO sterilizedmicrobial 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

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. 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

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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.

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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 (<24 h).

The biocompatibility tests demonstrated that the subject device is biocompatible.

Conclusion:

The PhasTIPP System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).