Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for cutting and aspirating tissue and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is intended for the excision of polyps, which is a therapeutic intervention to remove diseased tissue.

Diagnostic

No.
The device's intended use is for the excision (cutting and aspirating) of polyps, which is a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held cutting device" and mentions "Bench Top Performance Testing" and "Cadaver Predicate Comparison testing" involving physical resection and aspiration, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "excision of polyps in the nasal passageways and in sinuses." This is a surgical procedure performed directly on the patient's body.
Device Description: The device is described as a "hand-held cutting device" intended for "cutting and aspirating polyp tissue." This is a surgical instrument.
Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on specimens.

The information provided clearly describes a surgical device used for tissue removal within the body, not a diagnostic test performed on a sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

ERL

Device Description

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 and device cleaner.

The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nose (including sinuses)

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)

Bench-top Performance Testing
Study Type: In-vitro bench study
Sample Size: Not specified
Key Results: Non-inferiority was demonstrated based on resection rates in two sample tissue models. Data collected on clogging trended in favor of the PolypVac Microdebrider, where the device clogged less frequently than the Xomed XPS 3000 blades. The results demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate in terms of aspiration rates in simulated polyp tissue models representing the spectrum of human polypoid tissue.

Cadaver Predicate Comparison Testing
Study Type: Cadaver study
Sample Size: Three (3) independent board-certified ENT surgeons
Key Results: Non-inferiority was demonstrated based on the degree of complete polyp removal (as measured by grams of unresected tissue). Post-resection images of the attachment site were graded by a blinded reviewer and found to be similar for the PolypVac Microdebrider (average: 1.08) and Xomed XPS 3000 (average: 1.00). The results demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate when used to navigate to and resect worst-case polyps during simulated polypectomy procedures in a cadaver model.

Other in-vitro bench studies conducted:

Dimensional Verification Testing
Tensile Testing
Flow Rate Testing
Device Durability
Shaft Malieability and Durability
Leakage & Syringe Compatibility
Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation)
Sterilization Validation
Packaging Validation
Shelf Life

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041413

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Laurimed LLC

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name, Address, Phone and Fax Number of Applicant

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

B. Contact Person

Nancy Lincé, RAC Regulatory Affairs Consultant Lincé Consulting Phone: (650) 759-6186 nlince@linceconsulting.com

Alternate Contact: Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 ddegregorio@linceconsulting.com

C. Date Prepared

September 27, 2013

Device Name D.

Trade Name:	Laurimed PolypVac Microdebrider
Common Name:	Microdebrider
Classification Name:	Ear, nose, and throat electric or pneumatic drill

E. Device Classification

Classification:	21 CFR §874.4250
Product Code:	ERL
Device Class:	Class II

1

F. Predicate Devices

The Laurimed PolypVac Microdebrider is substantially equivalent to the Medtronic Xomed, Inc., XPS 3000 System (K041413).

G. Device Description

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 and device cleaner.

The PolypVac Microdebrider is supplied sterile and is single-use and disposable.

H. Intended Use

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

1. Technological Comparison

The Laurimed PolypVac Microdebrider has similar features as compared to the predicate devices in the table below.

Manufacturer	Medtronic Xomed, Inc.	Laurimed LLC
Model Name	XPS 3000 System
(with RAD12 & RAD40 shaver blades)	PolypVac Microdebrider
510(k) Number	K041413	TBD
Indications for Use	Intended for the incision and removal of
soft and hard tissue or bone in general
otorhinolaryngology, head and neck, and
otoneurological surgery.
Sinus Indications include septoplasty,
removal of septal spurs, polypectomy,
antrostromy.
ethmoidectomy/specnoethmoidectorny,
frontal sinus trephination and irrigation,
frontal sinus drill out, endoscopic DCR,
trans-spheniodal procedures, maxillary
sinus polypectomy, circumferential
maxillary antrostomy, choanal atresia,
sphenoidotomy, and medial, lateral, and
posterior frontal sinusotomy	Indicated for the excision of polyps in the
nasal passageways and in sinuses for
which access has been previously
established.
Product Code	ERL	Same
Manufacturer	Medtronic Xomed, Inc.	Laurimed LLC
Model Name	XPS 3000 System
(with RAD12 & RAD40 shaver blades).	PolypVac Microdebrider
510(k) Number	K041413	TBD
Mechanics of
Action	Cutting elements moving inside an open
window with suction	Same
Anatomical sites	Head, neck, ear, nose (including the
sinuses), and throat	Nose (including sinuses)
Design Features	3.5 mm Shaver Blade
Rounded tip
Side-facing cutting window with
serrated edges
Fixed curves
Rotatable
Hand-piece
Houses electrical motor
Foot-switch activated
Proximal end attaches to user-
supplied vacuum and irrigant
sources
Console
Electrical power source	3.5 mm Shaver Blade
Rounded tip
Side-facing cutting window with
serrated edge

                                          |  |

2

.

·

3

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

J. Summary of Non-Clinical Data

The Laurimed PolypVac Microdebrider performance characteristics were evaluated in the following in-vitro bench studies:

. Dimensional Verification Testing
. Tensile Testing
. Flow Rate Testing
. Device Durability
. Shaft Malieability and Durability
. Bench Top Performance*
. Leakage & Syringe Compatibility
. Cadaver Predicate Comparison **
. Biocompatibility Testing
- o Cytotoxicity
- o Sensitization
- o Irritation
. Sterilization Validation
. Packaging Validation
Shelf Life .

*Bench-top Performance Testing

Bench Top Performance Testing using the PolypVac Microdebrider and the Xomed XPS 3000 with RAD40 blades was completed to compare the aspiration rate performance of the subject and predicate device using simulated polyp tissue models. Non-inferiority was demonstrated based on resection rates in two sample tissue models. Data collected on clogging trended in favor of the PolypVac Microdebrider, where the device clogged less frequently than the Xomed XPS 3000 blades. Therefore, the results of this testing demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate in terms of aspiration rates in simulated polyp tissue models representing the spectrum of human polypoid tissue.

**Cadaver Predicate Comparison Testing

Cadaver Predicate Comparison testing using the PolypVac Microdebrider and the Xomed XPS 3000 with RAD12 and RAD40 blades was completed to compare the performance when used by three (3) independent board-certified ENT surgeons to excise simulated attached sinonasal polyps from worst-case accessible locations in a cadaver model. Non-inferiority was demonstrated based on the degree of complete polyp removal (as measured by grams of unresected tissue). Post-resection images of the attachment site were graded by a blinded reviewer and found to be similar for the PolypVac Microdebrider (average: 1.08) and Xomed XPS 3000 (average: 1.00). Therefore, the results of this testing demonstrate that the PolypVac Microdebrider is substantially equivalent to the Xomed predicate when used to navigate to and resect worst-case polyps during simulated polypectomy procedures in a cadaver model.

4

Results of the non-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the Laurimed PolypVac Microdebrider meet the established specifications necessary for consistent performance during its intended use. This testing demonstrates the Laurimed PolypVac Microdebrider is safe and is substantially equivalent to the named predicate.

K. Summary of Data

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, including comparative 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 non-clinical performance testing 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.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized emblem with three curved lines resembling a person with outstretched arms. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.

December 23, 2013

Public Health Service

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

Laurimed, LLC % Ms. Nancy Lincé, RAC Lincé Consulting 8 Crow Canyon Court, Suite 205 San Ramon, CA 94583

Re: K133133

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 Received: September 27, 2013 Dated: September 30, 2013

Dear Ms. Lincé:

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.

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.

6

Page 2 - Ms. Nancy Lincé

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Tina Kiang -S 2013.12.23 15:54:36 -05'00' 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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| Laurimed LLC | Traditional 510(k) Notification
PolypVac Microdebrider |

--------------	-----------------------------------------------------------

Indications for Use Statement

510(k) Number (If known):	K133133
Device Name:	PolypVac Microdebrider

Indications for Use:

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

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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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