(84 days)
Indicated for the excision of polyps in the nasal passageways and in sinuses for which access has has been previously established.
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.
The provided text describes the Laurimed PolypVac Microdebrider and its substantial equivalence to a predicate device. However, it does not present acceptance criteria in a quantitative table or the specific details of a study designed to prove the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, etc. for a diagnostic or AI-driven medical device.
The studies mentioned are non-clinical (bench-top and cadaver) and aim to demonstrate substantial equivalence to a predicate device, focusing on mechanical performance and safety, rather than diagnostic accuracy.
Here's an analysis of the information provided based on your request, highlighting the absence of certain details relevant to evaluating an AI/diagnostic device:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given text in the format of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) and corresponding reported performance.
The non-clinical studies aimed to demonstrate "non-inferiority" in specific mechanical and functional aspects compared to the predicate device. If we interpret "acceptance criteria" loosely as the demonstration of non-inferiority in these performance characteristics, then we can summarize the findings as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-inferiority in resection rates (Bench-top Performance) | Demonstrated non-inferiority based on resection rates in two sample simulated polyp tissue models. The device "trended in favor of the PolypVac Microdebrider" for clogging (clogged less frequently than the predicate). |
| Non-inferiority in complete polyp removal (Cadaver Comparison) | Demonstrated non-inferiority based on the degree of complete polyp removal (measured by grams of unresected tissue). Post-resection images were graded similarly for both devices (PolypVac: 1.08 average; Predicate: 1.00 average, by a blinded reviewer). The text implies 1.08 and 1.00 are scores for the "degree of complete polyp removal." |
| Meeting established specifications for materials, manufacturing, design, and consistent performance (Overall Non-Clinical Data) | Results of non-clinical testing demonstrate that the materials chosen, manufacturing process, and design meet established specifications necessary for consistent performance and that the device is substantially equivalent to the named predicate in terms of safety and effectiveness. |
2. Sample size used for the test set and the data provenance
- Bench-top Performance Testing: "two sample tissue models" were used. The number of tests or runs performed on these models is not specified. Data provenance is implied to be laboratory-generated.
- Cadaver Predicate Comparison Testing: A "cadaver model" was used. The number of polyps excised or the number of simulated polypectomy procedures is not specified. Data provenance is implied to be laboratory-generated using a cadaver.
- Type of Study: Both are non-clinical, in-vitro (bench-top) or ex-vivo (cadaver) studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Bench-top Performance Testing: No explicit "experts" were used to establish ground truth in the sense of clinical interpretation. The evaluation was based on measurable resection rates.
- Cadaver Predicate Comparison Testing:
- Operators: Three (3) independent board-certified ENT surgeons performed the excisions.
- Reviewer for Post-resection images: A "blinded reviewer" graded the post-resection images. Qualifications beyond "blinded reviewer" are not specified (e.g., specialty, years of experience).
4. Adjudication method for the test set
- Bench-top Performance Testing: Not applicable. Performance was measured quantitatively (resection rates, clogging frequency).
- Cadaver Predicate Comparison Testing: One "blinded reviewer" graded post-resection images. This is a single-reviewer assessment, not a consensus-based adjudication method like 2+1 or 3+1.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, which is not what the Laurimed PolypVac Microdebrider is. The study involved human operators (surgeons) using the device, but it wasn't an evaluation of AI assistance to human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this device is a surgical instrument, not an algorithm. Therefore, this concept is not applicable. The device relies on human operation.
7. The type of ground truth used
- Bench-top Performance Testing: The "ground truth" was the physical measurement of resected simulated polyp tissue and observation of clogging.
- Cadaver Predicate Comparison Testing: The "ground truth" was based on:
- "grams of unresected tissue" (objective measurement after surgeon's attempt).
- Grades from a "blinded reviewer" on post-resection images (subjective assessment, but based on physical evidence).
8. The sample size for the training set
- Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning model. There is no concept of a "training set" for its development as described in the provided text.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
In summary: The provided 510(k) summary focuses on demonstrating the substantial equivalence of a traditional medical device (a microdebrider) through non-clinical performance and safety testing. It does not provide the kind of acceptance criteria or study design details typically associated with AI-powered diagnostic devices, which involve performance metrics like sensitivity, specificity, and human reader studies. The "acceptance criteria" here are implicitly achieving non-inferiority to a predicate device in functional and mechanical performance.
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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 |
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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 ofsoft and hard tissue or bone in generalotorhinolaryngology, head and neck, andotoneurological 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, maxillarysinus polypectomy, circumferentialmaxillary antrostomy, choanal atresia,sphenoidotomy, and medial, lateral, andposterior frontal sinusotomy | Indicated for the excision of polyps in thenasal passageways and in sinuses forwhich access has been previouslyestablished. | |
| 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 ofAction | Cutting elements moving inside an openwindow with suction | Same | |
| Anatomical sites | Head, neck, ear, nose (including thesinuses), and throat | Nose (including sinuses) | |
| Design Features | 3.5 mm Shaver BladeRounded tipSide-facing cutting window withserrated edgesFixed curvesRotatableHand-pieceHouses electrical motorFoot-switch activatedProximal end attaches to user-supplied vacuum and irrigantsourcesConsoleElectrical power source | 3.5 mm Shaver BladeRounded tipSide-facing cutting window withserrated edge | |
| Mechanism ofAction | User-supplied vacuum pump draws polyptissue into side-facing cutting window,tissue incised by blade | User-supplied vacuum pump draws polyptissue into side-facing cutting window,tissue incised by blade | |
| Components | Hand-pieceRemovable Distal Shaft with CuttingElementDevice CleanerConsole & Footswitch | Hand-piece with Integrated Distal Shaftwith Cutting ElementDevice Cleaner | |
| Safety Features | Blunt Tip, Side-Cutting Window, Activationswitch | Same, with the addition of a low-speedmotor | |
| Sterile Packaging | Tyvek/Mylar Pouch for sterile / disposabledistal shafts | Same | |
| SterilizationMethodExternal DeviceCompatibility | Ethylene Oxide (EtO) for sterile /disposable distal shaftsEndoscopeVacuum pumpSterile Irrigant bagCollection Canister | E-beam radiationEndoscopeVacuum pumpSterile Irrigant syringe or bag | |
| Biocompatible forIntended Use | Yes | Same | |
| Blade / windowmaterial | Stainless Steel | Same | |
| Shaft OuterDiameter | 3.5 mm (RAD 12 & 40 blades) | 3.5 mm | |
| Shaft Length | 11 cm (RAD 12 & 40 blades) | 12 cm | |
| Angle of Distal TipUser Interface | 12° - 40° (RAD 12 & 40 blades)Activation switch (footswitch) | 0° - 45°Activation switch (hand-piece trigger) | |
| Human Factors | User holds the hand-piece to insert andposition device at intended surgical site | Same | |
| Contraindications | None | Same | |
| Method ofIntroduction | Manual placement under endoscopicguidance | Same | |
| Function. | Device is positioned at intended site andswitch activated to begin resection. | Same |
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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.
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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.
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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.
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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) NotificationPolypVac 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.
| Prescription Use | X | Or(per 21 CFR 801.109) | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---------------------------- | ---------------------- |
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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§ 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.