The Laurimed PolypVac Microdebrider is intended for cutting and aspirating polyp tissue during sinus and nasal 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

The provided document is a 510(k) Pre-market Notification for a medical device called the "PolypVac Microdebrider." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive efficacy studies with explicit acceptance criteria related to a specific disease or condition.

Therefore, the document does not contain information about explicit acceptance criteria for disease diagnosis or treatment effectiveness based on a study of the device's performance against ground truth (e.g., sensitivity, specificity, AUC, or other accuracy metrics). Instead, the acceptance criteria are related to the functional performance and safety of the device, and the "study" is a series of non-clinical bench tests comparing it to a predicate device.

Here's the information as requested, adapted to the content provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Related to Functional Performance/Safety)	Reported Device Performance and Assessment
Functional Testing: Device must meet all product specification requirements and function as intended.	The modified PolypVac Microdebrider passed all functional testing and met all product specification requirements, demonstrating equivalent performance to that of the predicate device (K133133).
Resection Rate: (Implied: similar or equivalent to predicate device)	Specific rates are not provided, but the device passed functional testing, implying its resection rate is considered adequate and equivalent to the predicate.
Simulated Use Testing: (Implied: safe and effective under simulated use conditions)	The device passed simulated use testing, demonstrating equivalent performance to the predicate.
Biocompatibility: All contact materials must be evaluated per ISO 10993 and found biocompatible.	The modified PolypVac Microdebrider and the predicate device are biocompatible in accordance with ISO 10993. This was assessed through Cytotoxicity, Sensitization, and Irritation tests.
Irrigation: The modified device must meet all fluid flow requirements.	The modified device meets all fluid flow requirements.
Packaging: Package must meet ASTM F1980-07 and D4169-14, ensuring sterility and protection.	The modified packaging configuration has passed all packaging validation tests, showing that it equivalently protects the device and maintains sterility.
Sterilization: Must achieve a Sterility Assurance Level (SAL) of 10-6.	E-beam radiation with SAL 10-6 (Same as predicate).
Technological Characteristics: Changes do not affect the principles of operation or performance, and no additional risks/hazards identified.	User interface modifications (shape optimization, 360° blade rotation, optimized trigger) and physical/dimensional changes (blade diameter, metal tip, vacuum connection, separate filter) were concluded not to affect the principles of operation or performance and introduced no additional risks or hazards.

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

Sample Size for Test Set: Not explicitly stated in numerical terms (e.g., number of devices tested or number of trials). The "Test Set" here refers to the units of the PolypVac Microdebrider that underwent non-clinical bench testing.
Data Provenance: The testing was non-clinical, bench testing. The country of origin for the data generation is not specified, but the applicant, Laurimed LLC, is based in Redwood City, CA, USA. The data is prospective in the sense that new testing was conducted on the modified device.

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

This device is a surgical instrument. The "ground truth" for its performance is assessed through engineering and biocompatibility testing against predefined specifications and industry standards (ISO, ASTM).
Experts: Not applicable in the context of clinical "ground truth" (e.g., disease diagnosis). The tests were conducted by personnel with expertise in engineering, materials science, and sterilization validation. Specific numbers and qualifications of these individuals are not provided in this regulatory document.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing consensus on clinical ground truth (e.g., image interpretation). For bench testing, the results are typically objectively measured against specifications.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed or necessary in support of this premarket notification." This type of study is not relevant for a surgical microdebrider seeking 510(k) clearance based on substantial equivalence to a predicate device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical surgical instrument, not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of AI is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility, ASTM for packaging), and comparison to the established performance characteristics of the predicate device. This includes functional performance (e.g., resection, fluid flow), material biocompatibility, and packaging integrity.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. The design and validation are based on engineering principles and comparison to an existing device, not on statistical learning from a dataset.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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

June 22, 2016

Laurimed LLC Mr. Brian R. Dubois Vice President of Engineering 500 Arguello St., Suite 100 Redwood City, CA 94063

Re: K161101

Trade/Device Name: Polypvac Microdebrider (3.3mm And 4.0mm) 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: May 19, 2016 Received: May 23, 2016

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) к 161101

Device Name

PolypVac Microdebrider

Indications for Use (Describe)

Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

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

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

Name, Address, Phone and Fax Number of Applicant

Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: (650) 587-5296 Fax: (650) 587-3823

Contact Person

Alex Gordon Engineering and Manufacturing Manager Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: (650) 587-5296 Fax: (650) 587-3823

Date Prepared

April 18, 2016

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

Trade Name: Laurimed 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 Laurimed PolypVac Microdebrider is substantially equivalent to the Laurimed PolypVac Microdebrider (K133133)

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

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

Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

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

The technological characteristics and principals of operation of the Laurimed PolypVac Microdebrider are substantially equivalent to the Laurimed PolypVac predicate device (K133133).

Model Name	PolypVac Microdebrider	PolypVac Microdebrider	Rationale forSubstantialEquivalence
510(k) Number	K133133	TBD	N/A (Same).
Product Code	ERL	ERL	N/A (Same).
Indications for Use	Indicated for the excision ofpolyps in the nasalpassageways and in sinusesfor which access has beenpreviously established.	Indicated for the excision ofpolyps in the nasalpassageways and in sinusesfor which access has beenpreviously established.	N/A (Same).
Contraindications	None	None	N/A (Same).
Anatomical Sites	Nose (including accessiblesinuses)	Nose (including accessiblesinuses)	N/A (Same).
Target Tissue	Sinonasal Polyps	Sinonasal Polyps	N/A (Same).
Equipment /Materials Required	User-supplied endoscope (≤5mm diameter), vacuum pump,and sterile irrigant syringe /bag.	User-supplied endoscope (≤5mm diameter), vacuum pump,and sterile irrigant syringe /bag.	N/A (Same).
Method ofIntroduction	Manual placement undervisual guidance.	Manual placement undervisual guidance.	N/A (Same).
Mechanism ofAction	Suction from user-suppliedvacuum pump draws polyptissue into side-facing cuttingwindow, tissue excised byreciprocating cutter.	Suction from user-suppliedvacuum pump draws polyptissue into side-facing cuttingwindow, tissue excised byreciprocating cutter.	N/A (Same).
Model Name	PolypVac Microdebrider	PolypVac Microdebrider	Rationale forSubstantialEquivalence
510(k) Number	K133133	TBD
User Interface	The handle body fits in thepalm of the surgeon's handand the shaver blade extendsapproximately perpendicularto the handle body.	Same.The handle shape has beenoptimized to reduce size andimprove ergonomics.	The modifications to theUser Interface do notaffect the principles ofoperation or theperformance of thedevice and no additionalrisks or hazards havebeen identified with thesechanges.
	Rotatable shaver blade(+/- 90°).	Rotatable shaver blade (360°)with knob.
	Trigger located on side ofhandle activates and haltsreciprocating motion of cutter.	Same.The trigger shape has beenoptimized.
	Connection for vacuum(nipple) located at base ofhandpiece.	Connection for vacuum locatedat back of barrel.
	PVC Tubing with a luerconnects to the base of thehandpiece.	Smaller diameter tubing with aluer connects at the back of thebarrel.
	Filter integrated intohandpiece.	Filter is separate fromhandpiece.
Physical /DimensionalCharacteristics	Blade diameter: 3.5 mm.	Blade diameter: 3.3 mm &4.0 mm.	The devices utilize thesame technology and
	Rounded atraumatic plastictip.	Rounded atraumatic metal tip.	principles of operationand the rounded tips areequivalent. No additionalrisks or hazards havebeen identified withthese changes.
Irrigation	Irrigant is routed to the distaltip through a lumen in theshaver blade's plastic sheath.	Irrigant is routed to the distaltip within the shaver blade(between the evacuation tubeand the stainless steel tube).	The modified devicemeets all fluid flowrequirements.
Materials	All contact materials havebeen evaluated per ISO10993.	All contact materials havebeen evaluated per ISO10993.	Finish product was testedand is biocompatible inaccordance with ISO10993.
Packaging	Package meets ASTMF1980-07 and D4169-14.	Package meets ASTMF1980-07 and D4169-14.	The modified packagingconfiguration has passedall packaging validationtests, showing that itequivalently protects thedevice and maintainssterility.
Sterilization	E-beam radiation withSAL 10-6	E-beam radiation withSAL 10-6.	N/A (Same).

Table 1 Summary of Technological Characteristics

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VII. Performance Data [§807.92(b)]

Results of non-clinical testing demonstrated that the Laurimed PolypVac Microdebrider is safe and effective for its intended use and substantially equivalent to the predicate.

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

The Laurimed 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 validate the performance of the device and ensure the Laurimed PolypVac Microdebrider functions as intended and meets design specifications. The comparison and nonclinical results demonstrate that the Laurimed PolypVac Microdebrider is substantially equivalent to the predicate device for its intended use and does not raise new issues of safety or effectiveness.

Testing Type	Test Description	Results SupportingSubstantial Equivalence
Bench Testing	Functionality Testing	The modified PolypVacMicrodebrider passed allfunctional testing and met allproduct specificationrequirements demonstratingequivalent performance to thatof the predicate device.
	Resection Rate
	Simulated Use Testing
Biocompatibility Testing	Cytotoxicity	The modified PolypVacMicrodebrider and thepredicate device arebiocompatible in accordancewith ISO 10993.
	Sensitization
	Irritation

Table 2. Performance Testing and Substantial Equivalence Support

In addition to the performance testing listed in Table 2, Laurimed conducted Shelf-life, Packaging, and Sterilization Validation testing on the Polypvac Microdebrider.

Summary of Clinical Data [§807.92(b)(2)]

No clinical testing was performed or necessary in support of this premarket notification.

VIII. Conclusion [§807.92(b)(3)]

The Laurimed PolypVac Microdebrider does not raise any new issues of safety or effectiveness, as both the modified and the predicate devices have the same intended use, and utilize similar performance specifications and comparable technological features to achieve the same mechanism of action: therefore, the Laurimed PolypVac Microdebrider is substantially equivalent to the predicate devices.

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.