The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures: ethmoidectomy, maxillary antrostomy, polypectomy, turbinectomy / turbinate reduction, sphenoidotomy, and frontal recess dissection.

Device Description

The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of endoscopic sinus procedures. The system consists of a hand-held cutting device, tissue filter, and stylet. The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

AI/ML Overview

This document describes a 510(k) premarket notification for the PolypVac Microdebrider. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically the PolypVac Microdebrider (K161101) and the Medtronic Xomed XPS 3000 (K041413).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical "acceptance criteria" in the format of a table with thresholds and corresponding performance values for the new PolypVac Microdebrider. Instead, it relies on demonstrating that the device functions as intended, meets design specifications, and is substantially equivalent to predicate devices based on various non-clinical tests.

The "Testing Type" and "Results Supporting Substantial Equivalence" columns in Table 2 serve as a proxy for acceptance criteria and reported performance:

Testing Type	Test Description	Reported Device Performance and Support for Substantial Equivalence
Bench Testing	- Durability/Functionality Testing – Motor and Shaft- Dimensional Testing- Pull Force Testing - Bond Strength- Predicate Comparison - Resection Rate	"The subject PolypVac Microdebrider passed all functional testing and met all product specification requirements, thereby demonstrating equivalence to the predicate PolypVac device and suitability to the expanded indications for use." The comparison of technological characteristics in Table 1 (pages 4-5) implicitly provides performance comparisons (e.g., "Same" for mechanism of action, compatibility, human factors, materials/biocompatibility, and sterility; "Blades of similar diameter are offered" for design features like blade diameter). In particular, the "Predicate Comparison - Resection Rate" implies that the new device's resection rate performance was comparable to the predicate.
Validation Testing	"Cadaver Simulated Use Testing"	"Simulated use testing was completed successfully, no adverse events were observed. This testing demonstrates that the subject PolypVac Microdebrider is capable of safely performing the following procedures: turbinate reduction / turbinectomy, uncinectomy / maxillary antrostomy, ethmoidectomy, frontal recess dissection, and sphenoidotomy."

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

Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the bench testing or the cadaver simulated use testing. For the cadaver study, it implies a sufficient number of cadavers/procedures were used to successfully complete the testing without adverse events across a range of procedures.
Data Provenance: Not explicitly stated, but the testing would typically be conducted at the manufacturer's R&D facilities or a contract research organization. Given it's a premarket notification to the US FDA, the data is intended for the US market. The testing is non-clinical bench and cadaver testing, not human subject data. It's prospective in the sense that the studies were designed and conducted specifically for this submission.

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

There is no mention of experts establishing a "ground truth" for the non-clinical bench or cadaver testing in the same way as, for example, a clinical study interpreting images. The "ground truth" for these tests would be the established engineering specifications and the successful completion of the simulated surgical procedures.

In the cadaver study, the success was based on the device's capability of safely performing the procedures and the absence of adverse events, which would be assessed by the surgical operators (likely qualified surgeons or trained personnel) conducting the simulations. However, the exact number and qualifications of these individuals are not provided.

4. Adjudication Method for the Test Set

Not applicable in the context of this non-clinical testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., imaging reads). Here, the tests evaluate mechanical performance, functionality, and simulated surgical outcomes, which would be objectively assessed against design specifications and technical success criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was performed nor necessary in support of this premarket notification." Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. The PolypVac Microdebrider is a mechanical surgical device, not an AI algorithm. Its performance is inherent to its design and function, not based on an algorithm that operates independently or with human input.

7. The Type of Ground Truth Used

For the non-clinical testing:

Bench Testing: The "ground truth" is defined by the device's technical specifications and engineering requirements (e.g., specified dimensions, bond strengths, motor functionality, resection rates comparable to predicate devices).
Cadaver Simulated Use Testing: The "ground truth" is the successful and safe execution of the listed surgical procedures on cadaveric tissue, with the absence of adverse events. This implies functional performance equivalent to established surgical practice.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not an AI or machine learning system that requires a "training set."

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

Not applicable, as no training set was used or required.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2017

Laurimed LLC Mr. Brian DuBois General Manger 500 Arguello St., Suite 100 Redwood City, CA 94063

Re: K163247

Trade/Device Name: PolypVac Microdebrider Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL Dated: February 8, 2017 Received: February 9, 2017

Dear Mr. DuBois:

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, 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 (reporting of medical devicerelated 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" (21 CFR 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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K163247

Device Name

PolypVac Microdebrider

Indications for Use (Describe)

The PolypVac Microdebrider is a shaver system intended for the resection of soft tissue and thin bone as part of the following endoscopic sinus procedures; ethmoidectorny, polypectorny, polypectorny, turbinate reduction, sphenoidotomy, and frontal recess dissection.

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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510(k) Summary – K163247

General Information [807.92(a)(1)] l.

Name, Address, Phone and Fax	Contact Person
Number of Applicant	Alex Gordon
Laurimed LLC	Director of Operations
500 Arguello Street, Suite 100	Laurimed LLC
Redwood City, CA 94063	500 Arguello Street, Suite 100
Phone: (650) 587-5296	Redwood City, CA 94063
Fax:(650) 587-3823	Phone: (650) 587-5230
	Fax: (650) 587-3823

Date Prepared

February 8, 2017

II. Device Information [§807.92(a)(2)]

Trade Name: PolypVac Microdebrider Common Name: Microdebrider Classification Name: Ear, nose, and throat electric or pneumatic drill Classification: 21 CFR §874.4250 Product Code: ERL Device Class: Class II

lll. Predicate Device [§807.92(a)(3)]

The subject PolypVac Microdebrider is substantially equivalent to the primary predicate, the PolypVac Microdebrider (K161101), and the secondary predicate, the Medtronic Xomed XPS 3000 (K041413).

IV. Device Description [§807.92(a)(4)]

V. Indications for Use [§807.92(a)(5)]

VI. Comparison of Technological Characteristics with the Predicate Device [§807.92(a)((6)]

The technological characteristics and principles of operation of the subject PolypVac Microdebrider are substantially equivalent to the PolypVac Microdebrider primary predicate device (K161101) and the Medtronic Xomed XPS 3000 secondary predicate device (K041413).

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Model Name	PolypVac Microdebrider(Primary Predicate)	Xomed XPS 3000(Secondary Predicate)	PolypVac Microdebrider	Rationale for Substantial
Device Trade Name	PolypVac Microdebrider	XPS 3000 System	PolypVac Microdebrider	Equivalence
510(k) Number	K161101	K041413	K163247
Product Code	ERL	ERL	ERL	Same.
Intended Use	Intended for the resection ofsoft tissue during sinonasalpolypectomy.	Intended for the incision and removal ofsoft and hard tissue or bone in generalotorhinolaryngology, head and neck, andotoneurological surgery.	Intended for the resection of softtissue and thin bone inendoscopic sinus procedures.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 are intended for the resectionof soft tissue and thin bone duringotorhinolaryngology procedures.
Indications forUse	Indicated for the excision ofpolyps in the nasalpassageways and in sinusesfor which access has beenpreviously established.	The XPS 3000 is intended for the incisionand removal of soft and hard tissue or bonein general otorhinolaryngology, head andneck, and otoneurological surgery.(non-applicable sections removed)Sinus indications include: Septoplasty,removal of septal spurs, POLYPECTOMY,ANTROSTOMY, ETHMOIDECTOMY /sphenoethmoidectomy, frontal sinustrephination and irrigation, frontal sinus drillout, endoscopic DCR, trans-spheniodalprocedures, maxillary sinus POLYPECTOMY,circumferential MAXILLARY ANTROSTOMY,choanal atresia, SPHENOIDOTOMY, andmedial, lateral, and posterior FRONTALSINUSOTOMY. (non-applicable sections removed)	The PolypVac Microdebrider is ashaver system intended for theresection of soft tissue and thinbone as part of the followingendoscopic sinus procedures:ethmoidectomy, maxillaryantrostomy, polypectomy,turbinectomy / turbinatereduction, sphenoidotomy, andfrontal recess dissection.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 are indicted for:$\Sigma$ Ethmoidectomy$\Sigma$ Maxillary Antrostomy$\Sigma$ Polypectomy$\Sigma$ Turbinectomy / TurbinateReduction$\Sigma$ Sphenoidotomy$\Sigma$ Frontal recess dissection
Contraindications	None	None	None	Same.
TargetPopulation	Patients with accessiblesinonasal polyps	Patients in otorhinolaryngology, head andneck, otoneurology, lipoplasty, andorthopedic procedures.	Patients in otorhinolaryngologyprocedures.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 serve patients who wouldbenefit from otorhinolaryngologyprocedures.
Anatomic Sites	Nose (including accessiblesinuses)	Nasal passageways, sinuses, nasopharynx,larynx, ear, head and neck, and variousanatomic locations associated withlipoplasty and/or orthopedic procedures.	Nasal passageways and sinuses.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 are intended for use in thenasal passageways and sinuses.
Model Name	PolypVac Microdebrider(Primary Predicate)	Xomed XPS 3000(Secondary Predicate)	PolypVac Microdebrider	Rationale for SubstantialEquivalence
Device Trade Name	PolypVac Microdebrider	XPS 3000 System	PolypVac Microdebrider
510(k) Number	K161101	K041413	K163247
Target Tissue	Sinonasal Polyps	Various soft and hard tissues encounteredduring otology, otorhinolaryngology, headand neck, lipoplasty, and orthopedicprocedures.	Various soft and hard tissuesencountered duringotorhinolaryngology procedures.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 are intended for the resectionof various soft and hard tissuesencountered duringotorhinolaryngology procedures.
Method ofIntroduction	Manual placement undervisual guidance.	Manual placement under visual guidance.	Manual placement under visualguidance.	Same.
Mechanism ofAction	Suction from user-suppliedvacuum pump draws tissueinto side-facing cuttingwindow, tissue excised byoscillating cutter.	Suction from user-supplied vacuum pumpdraws tissue into side-facing cuttingwindow, tissue excised by oscillating cutter.	Suction from user-suppliedvacuum pump draws tissue intoside-facing cutting window, tissueexcised by oscillating cutter.	Same.
Compatibility	User-supplied endoscope,vacuum pump, and sterileirrigant syringe / bag.	User-supplied endoscope, vacuum pump,and sterile irrigant bag.	User-supplied endoscope,vacuum pump, and sterile irrigantsyringe / bag.	Same.
Design Features	Blade Diameter:3.3 mm and 4.0 mm	Blade Diameter:3.5 mm and 4.0 mm(RAD 12 & 40 Blades)	Blade Diameter:3.3 mm and 4.0 mm	Blades of similar diameter areoffered.
	Distal Tip:Blunt distal tip with side-facing cutting window.	Distal Tip:Blunt distal tip with side-facing cuttingwindow.	Distal Tip:Blunt distal tip with side-facingcutting window.	Same.
	Internal Irrigation:Irrigant routed within theshaver blade to the cuttingwindow, where it issuctioned through thedevice, facilitatingevacuation of excised tissue.	Internal Irrigation:Irrigant routed within the shaver blade tothe cutting window, where it is suctionedthrough the device, facilitating evacuation ofexcised tissue.	Internal Irrigation:Irrigant routed within the shaverblade to the cutting window,where it is suctioned through thedevice, facilitating evacuation ofexcised tissue.	Same.
Model Name	PolypVac Microdebrider(Primary Predicate)	Xomed XPS 3000(Secondary Predicate)	PolypVac Microdebrider	Rationale for SubstantialEquivalence
Device Trade Name	PolypVac Microdebrider	XPS 3000 System	PolypVac Microdebrider
510(k) Number	K161101	K041413	K163247
Human Factors	Handle fits in the surgeon'shand. Shaver blade extendsforward while vacuum andirrigant connections extendbackwards.Trigger location on side ofhandle activates and haltsthe motion of the tissuecutter.	Handle fits in the surgeon's hand. Shaverblade extends forward while vacuum andirrigant connections extend backwards.Foot pedal activates and halts the motion ofthe tissue cutter.	Handle fits in the surgeon's hand.Shaver blade extends forwardwhile vacuum and irrigantconnections extend backwards.Trigger location on side of handleactivates and halts the motion ofthe tissue cutter.	Same.Both the subject PolypVacMicrodebrider and the Xomed XPS3000 have controls that must bepressed in order to activateoscillation of the tissue cutter.
Materials /Biocompatibility	Biocompatible for itsintended use. All contactmaterials have beenevaluated per ISO 10993.	Biocompatible for its intended use.Specific materials not known.	Biocompatible for its intendeduse. All contact materials havebeen evaluated per ISO 10993.	Both the subject PolypVacMicrodebrider and the Xomed XPS3000 are biocompatible for theirintended use.
Sterility	E-beam radiation (SAL $10^{-6}$ ).	Ethylene Oxide (single-use shaver blades).	E-beam radiation (SAL $10^{-6}$ ).	Both the subject PolypVacMicrodebrider and the shaver bladesfor the Xomed XPS 3000 are suppliedsterile.

Table 1: Summary of Technological Characteristics

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VII. Performance Data [§807.92(b)]

Results of non-clinical testing demonstrate that the subject PolypVac Microdebrider is safe and effective for its intended use and substantially equivalent to the predicates.

Summary of Nonclinical Testing [§807.92(b)(1)]

Non-clinical testing was conducted to verify / validate the performance of the device and ensure the subject PolypVac Microdebrider functions as intended and meets design specifications. The results demonstrate that the subject PolypVac Microdebrider is substantially equivalent to the predicate device for its intended use and does not raise new issues of safety or effectiveness. Note that the changes presented in this submission have no effect on previously performed packaging validation and biocompatibility validation testing.

Testing Type	Test Description	Results Supporting SubstantialEquivalence
Bench Testing	Durability/Functionality Testing– Motor and ShaftDimensional TestingPull Force Testing - BondStrengthPredicate Comparison -Resection Rate	The subject PolypVacMicrodebrider passed allfunctional testing and met allproduct specificationrequirements, therebydemonstrating equivalence tothe predicate PolypVac deviceand suitability to the expandedindications for use.
Validation Testing	Cadaver Simulated Use Testing	Simulated use testing wascompleted successfully, noadverse events were observed.This testing demonstrates thatthe subject PolypVacMicrodebrider is capable ofsafely performing the followingprocedures: turbinate reduction/ turbinectomy, uncinectomy /maxillary antrostomy,ethmoidectomy, frontal recessdissection, and sphenoidotomy.

	Table 2. Performance Testing and Substantial Equivalence Support
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Summary of Clinical Data [§807.92(b)(2)]

No clinical testing was performed nor necessary in support of this premarket notification.

VIII. Conclusion [§807.92(b)(3)]

The subject PolypVac Microdebrider has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to verify / validate the performance of the device and ensure the subject PolypVac Microdebrider functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the subject PolypVac Microdebrider is substantially equivalent to the primary predicate, the PolypVac Microdebrider (K161101), and the secondary predicate, the Medtronic Xomed XPS 3000 (K041413), for the updated indication described in this submission.

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.