PolypVac Microdebrider (3.3mm and 4.0mm)

K161101 · Laurimed, LLC · ERL · Jun 22, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161101
• Device Name: PolypVac Microdebrider (3.3mm and 4.0mm)
• Applicant: Laurimed, LLC
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jun 22, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PolypVac Microdebrider is a sterile, single-use, disposable surgical instrument for cutting and aspirating polyp tissue during nasal and sinus procedures. System components include a hand-held cutting device, tissue filter, and stylet. Operated by a surgeon under visual guidance using a user-supplied endoscope (≤5mm diameter) and vacuum pump. Principle of operation: vacuum suction draws polyp tissue into a side-facing cutting window; a reciprocating cutter excises the tissue. The device features a rotatable shaver blade (360°) and an ergonomic handle with a trigger to activate/halt cutting. Irrigant is routed to the distal tip through the shaver blade. Output is the physical removal of sinonasal polyps, facilitating surgical clearance of nasal passageways. Benefits include effective tissue resection and improved ergonomic control for the surgeon.

Clinical Evidence

No clinical data was performed or necessary. Substantial equivalence is supported by non-clinical bench testing, including functionality, resection rate, and simulated use testing, alongside biocompatibility, shelf-life, packaging, and sterilization validation.

Technological Characteristics

Hand-held microdebrider; 3.3mm and 4.0mm blade diameters; reciprocating cutter mechanism; vacuum-powered aspiration. Materials evaluated per ISO 10993. Packaging meets ASTM F1980-07 and D4169-14. Sterilization via E-beam radiation (SAL 10^-6). Requires external vacuum pump and endoscope (≤5mm).

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• Laurimed PolypVac Microdebrider (K133133)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles or faces stacked on top of each other, with flowing lines suggesting movement or connection.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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: [phone] Fax: [phone]

# Contact Person

Alex Gordon Engineering and Manufacturing Manager Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: [phone] Fax: [phone]

### 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)

{4}------------------------------------------------

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

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.

#### 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 for<br>Substantial<br>Equivalence |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K133133 | TBD | N/A (Same). |
| Product Code | ERL | ERL | N/A (Same). |
| Indications for Use | Indicated for the excision of<br>polyps in the nasal<br>passageways and in sinuses<br>for which access has been<br>previously established. | Indicated for the excision of<br>polyps in the nasal<br>passageways and in sinuses<br>for which access has been<br>previously established. | N/A (Same). |
| Contraindications | None | None | N/A (Same). |
| Anatomical Sites | Nose (including accessible<br>sinuses) | Nose (including accessible<br>sinuses) | N/A (Same). |
| Target Tissue | Sinonasal Polyps | Sinonasal Polyps | N/A (Same). |
| Equipment /<br>Materials Required | User-supplied endoscope (≤5<br>mm diameter), vacuum pump,<br>and sterile irrigant syringe /<br>bag. | User-supplied endoscope (≤5<br>mm diameter), vacuum pump,<br>and sterile irrigant syringe /<br>bag. | N/A (Same). |
| Method of<br>Introduction | Manual placement under<br>visual guidance. | Manual placement under<br>visual guidance. | N/A (Same). |
| Mechanism of<br>Action | Suction from user-supplied<br>vacuum pump draws polyp<br>tissue into side-facing cutting<br>window, tissue excised by<br>reciprocating cutter. | Suction from user-supplied<br>vacuum pump draws polyp<br>tissue into side-facing cutting<br>window, tissue excised by<br>reciprocating cutter. | N/A (Same). |
| Model Name | PolypVac Microdebrider | PolypVac Microdebrider | Rationale for<br>Substantial<br>Equivalence |
| 510(k) Number | K133133 | TBD | |
| User Interface | The handle body fits in the<br>palm of the surgeon's hand<br>and the shaver blade extends<br>approximately perpendicular<br>to the handle body. | Same.<br>The handle shape has been<br>optimized to reduce size and<br>improve ergonomics. | The modifications to the<br>User Interface do not<br>affect the principles of<br>operation or the<br>performance of the<br>device and no additional<br>risks or hazards have<br>been identified with these<br>changes. |
| | Rotatable shaver blade<br>(+/- 90°). | Rotatable shaver blade (360°)<br>with knob. | |
| | Trigger located on side of<br>handle activates and halts<br>reciprocating motion of cutter. | Same.<br>The trigger shape has been<br>optimized. | |
| | Connection for vacuum<br>(nipple) located at base of<br>handpiece. | Connection for vacuum located<br>at back of barrel. | |
| | PVC Tubing with a luer<br>connects to the base of the<br>handpiece. | Smaller diameter tubing with a<br>luer connects at the back of the<br>barrel. | |
| | Filter integrated into<br>handpiece. | Filter is separate from<br>handpiece. | |
| Physical /<br>Dimensional<br>Characteristics | Blade diameter: 3.5 mm. | Blade diameter: 3.3 mm &<br>4.0 mm. | The devices utilize the<br>same technology and |
| | Rounded atraumatic plastic<br>tip. | Rounded atraumatic metal tip. | principles of operation<br>and the rounded tips are<br>equivalent. No additional<br>risks or hazards have<br>been identified with<br>these changes. |
| Irrigation | Irrigant is routed to the distal<br>tip through a lumen in the<br>shaver blade's plastic sheath. | Irrigant is routed to the distal<br>tip within the shaver blade<br>(between the evacuation tube<br>and the stainless steel tube). | The modified device<br>meets all fluid flow<br>requirements. |
| Materials | All contact materials have<br>been evaluated per ISO<br>10993. | All contact materials have<br>been evaluated per ISO<br>10993. | Finish product was tested<br>and is biocompatible in<br>accordance with ISO<br>10993. |
| Packaging | Package meets ASTM<br>F1980-07 and D4169-14. | Package meets ASTM<br>F1980-07 and D4169-14. | The modified packaging<br>configuration has passed<br>all packaging validation<br>tests, showing that it<br>equivalently protects the<br>device and maintains<br>sterility. |
| Sterilization | E-beam radiation with<br>SAL 10-6 | E-beam radiation with<br>SAL 10-6. | N/A (Same). |

Table 1 Summary of Technological Characteristics

{5}------------------------------------------------

{6}------------------------------------------------

#### 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 Supporting<br>Substantial Equivalence |
|--------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench Testing | Functionality Testing | The modified PolypVac<br>Microdebrider passed all<br>functional testing and met all<br>product specification<br>requirements demonstrating<br>equivalent performance to that<br>of the predicate device. |
| | Resection Rate | |
| | Simulated Use Testing | |
| Biocompatibility Testing | Cytotoxicity | The modified PolypVac<br>Microdebrider and the<br>predicate device are<br>biocompatible in accordance<br>with 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.