(64 days)
Not Found
No
The device description and performance studies focus on mechanical cutting and aspiration, with no mention of AI/ML terms or functionalities.
Yes.
The device is used for the excision of polyps in the nasal passageways and sinuses, which is a therapeutic intervention.
No
The device description clearly states its intended use is 'for cutting and aspirating polyp tissue during sinus and nasal procedures,' which is an interventional/surgical function, not a diagnostic one.
No
The device description explicitly states it consists of a hand-held cutting device, tissue filter, and stylet, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Laurimed PolypVac Microdebrider is a surgical instrument used for the physical excision (cutting and aspirating) of tissue (polyps) directly from the nasal passageways and sinuses. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "Indicated for the excision of polyps," which is a surgical procedure, not a diagnostic test.
- Device Description: The description details a "hand-held cutting device" and its function in "cutting and aspirating polyp tissue," further confirming its surgical nature.
The device is used to remove tissue, not to analyze it for diagnostic purposes.
N/A
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, tissue filter, and stylet. 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 accessible 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 Testing:
- Functionality Testing: The modified PolypVac Microdebrider passed all functional testing and met all product specification requirements demonstrating equivalent performance to that of the predicate device.
- Resection Rate
- Simulated Use Testing
Biocompatibility Testing:
- Cytotoxicity: The modified PolypVac Microdebrider and the predicate device are biocompatible in accordance with ISO 10993.
- Sensitization
- Irritation
Shelf-life, Packaging, and Sterilization Validation testing were also conducted.
No clinical testing was performed.
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.
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
§ 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.
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 (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)]
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
Substantial
Equivalence |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K133133 | TBD | N/A (Same). |
| Product Code | ERL | ERL | N/A (Same). |
| Indications for Use | Indicated for the excision of
polyps in the nasal
passageways and in sinuses
for which access has been
previously established. | Indicated for the excision of
polyps in the nasal
passageways and in sinuses
for which access has been
previously established. | N/A (Same). |
| Contraindications | None | None | N/A (Same). |
| Anatomical Sites | Nose (including accessible
sinuses) | Nose (including accessible
sinuses) | N/A (Same). |
| Target Tissue | Sinonasal Polyps | Sinonasal Polyps | N/A (Same). |
| Equipment /
Materials Required | User-supplied endoscope (≤5
mm diameter), vacuum pump,
and sterile irrigant syringe /
bag. | User-supplied endoscope (≤5
mm diameter), vacuum pump,
and sterile irrigant syringe /
bag. | N/A (Same). |
| Method of
Introduction | Manual placement under
visual guidance. | Manual placement under
visual guidance. | N/A (Same). |
| Mechanism of
Action | Suction from user-supplied
vacuum pump draws polyp
tissue into side-facing cutting
window, tissue excised by
reciprocating cutter. | Suction from user-supplied
vacuum pump draws polyp
tissue into side-facing cutting
window, tissue excised by
reciprocating cutter. | N/A (Same). |
| Model Name | PolypVac Microdebrider | PolypVac Microdebrider | Rationale for
Substantial
Equivalence |
| 510(k) Number | K133133 | TBD | |
| User Interface | The handle body fits in the
palm of the surgeon's hand
and the shaver blade extends
approximately perpendicular
to the handle body. | Same.
The handle shape has been
optimized to reduce size and
improve ergonomics. | The modifications to the
User Interface do not
affect the principles of
operation or the
performance of the
device and no additional
risks or hazards have
been identified with these
changes. |
| | Rotatable shaver blade
(+/- 90°). | Rotatable shaver blade (360°)
with knob. | |
| | Trigger located on side of
handle activates and halts
reciprocating motion of cutter. | Same.
The trigger shape has been
optimized. | |
| | Connection for vacuum
(nipple) located at base of
handpiece. | Connection for vacuum located
at back of barrel. | |
| | PVC Tubing with a luer
connects to the base of the
handpiece. | Smaller diameter tubing with a
luer connects at the back of the
barrel. | |
| | Filter integrated into
handpiece. | Filter is separate from
handpiece. | |
| Physical /
Dimensional
Characteristics | Blade diameter: 3.5 mm. | Blade diameter: 3.3 mm &
4.0 mm. | The devices utilize the
same technology and |
| | Rounded atraumatic plastic
tip. | Rounded atraumatic metal tip. | principles of operation
and the rounded tips are
equivalent. No additional
risks or hazards have
been identified with
these changes. |
| Irrigation | Irrigant is routed to the distal
tip through a lumen in the
shaver blade's plastic sheath. | Irrigant is routed to the distal
tip within the shaver blade
(between the evacuation tube
and the stainless steel tube). | The modified device
meets all fluid flow
requirements. |
| Materials | All contact materials have
been evaluated per ISO
10993. | All contact materials have
been evaluated per ISO
10993. | Finish product was tested
and is biocompatible in
accordance with ISO
10993. |
| Packaging | Package meets ASTM
F1980-07 and D4169-14. | Package meets ASTM
F1980-07 and D4169-14. | The modified packaging
configuration has passed
all packaging validation
tests, showing that it
equivalently protects the
device and maintains
sterility. |
| Sterilization | E-beam radiation with
SAL 10-6 | E-beam radiation with
SAL 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 Supporting
Substantial Equivalence |
|--------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bench Testing | Functionality Testing | The modified PolypVac
Microdebrider passed all
functional testing and met all
product specification
requirements demonstrating
equivalent performance to that
of the predicate device. |
| | Resection Rate | |
| | Simulated Use Testing | |
| Biocompatibility Testing | Cytotoxicity | The modified PolypVac
Microdebrider and the
predicate device are
biocompatible in accordance
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.