(344 days)
Not Found
No
The summary describes a physical implant and delivery tool for stiffening the soft palate, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat snoring by stiffening soft palate tissue, which is a therapeutic intervention, and the predicate device is labeled as an "Anti-Snoring Device."
No
The device is described as a treatment for snoring by stiffening soft palate tissue, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of an implant and a delivery tool, which are physical components, not software.
Based on the provided information, 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 Pillar Palatal Implant System is a physical implant designed to be surgically placed in the soft palate tissue. Its function is to mechanically stiffen the tissue to reduce snoring. It does not analyze or test any biological samples.
- Intended Use: The intended use is to reduce snoring by stiffening the soft palate, not to diagnose or monitor a condition through the analysis of biological samples.
Therefore, the Pillar Palatal Implant System falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Pillar System is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals
Indications for use of the System include: symptomatic, habitual, and social snoring due to palatal flutter.
The Pillar Palatal Implant System is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Pillar Palatal Implant System is intended as a treatment option for snoring. The Pillar Palatal Implant System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring.
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is The implant to a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft Palate
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)
Not Found
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
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
0
K11b623
FEB 1 0 2012
Section 5.0 510(k) Summary & ech .; 20 .;
A. 510(k) Owner
Medtronic Xomed, Inc 6743 Southpoint Drive North Jacksonville, FL 32216 USA Tel: 904-296-9600 Fax: 904-296-2386 Registration Number: 1045254
Rozanne Paciej Senior Regulatory Affairs Specialist 904-332-8233 (phone) 904-296-2386 (fax) rozanne.paciej@medtronic.com
C. Date Submission Prepared
Pillar Palatal Implant System
March 3, 2011
D. Proprietary Name
B. Contact Information
E. Device Name
Trade Name: Common/Usual Name: Classification Name:
Pillar Palatal Implant System Anti-Snoring Device LRK- Device, Anti-Snoring 21 CFR 872.5570, Class II
Pillar Palatal Implant System
Anti-Snoring Device
F. Predicate Devices:
Trade Name: Common/Usual Name: Classification Name:
Premarket Notification:
LRK- Device, Anti-Snoring 21 CFR 872.5570, Class II K011723
G. Purpose of Submission:
Updating the labeling to the currently cleared Pillar Palatal Implant System.
H. Device Description
The Pillar Palatal Implant System is intended as a treatment option for snoring. The Pillar Palatal Implant System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring.
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is The implant to a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable.
1
I. Intended Use/Indications for Use
Indications for Use:
The Pillar System is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals
Intended Use
Indications for use of the System include: symptomatic, habitual, and social snoring due to palatal flutter.
J. Substantial Equivalence
The Pillar Palatal Implant System is identical in intended use, indications for use, design, intended I he 1 mail 1 and target population to the previously cleared Pillar Palatal Implant System (Anti-Snoring Device).
| Pillar Palatal Implant System | Pillar Palatal Implant System (Anti-Snoring Device) | |
|---|---|---|
| 510(k) Number | TBD | K011723 |
| Substantial Equivalence Date | TBD | December 18, 2002 |
| Regulation Number | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Product Code/Classification | LRK; Class II | LRK; Class II |
| Intended Use/Indications for Use | Intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals | Intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals |
| Device Description | Intended as a treatment option for snoring. The System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring. |
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of | Intended as a treatment option for snoring. The System consists of an implant and a delivery tool. The implants are designed to stiffen the tissue of the soft palate reducing the dynamic flutter which causes snoring.
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant |
2
| | the implant submucosally in
the soft palate. The implant
is designed to be permanent
while the delivery tool is
disposable. | submucosally in the soft
palate. The implant is
designed to be permanent
while the delivery tool is
disposable. |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Anatomical Site | Soft Palate | Soft Palate |
| Target Population | Patients seeking treatment
for snoring | Patients seeking treatment for
snoring |
J. Conclusion
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Albreviated Othizing 1 Drs 3 Caracteristics demonstrates that the proposed Pillar Palatal Implant System is substantially equivalent to the predicate device since it is identical in intended miplant Bysten is basignian your ded anatomical site, and target population. The Pillar Palatal abo, indreations for as effective, and performs as well as the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Rozanne Paciej Senior Regulatory Affairs Specialist Medtronic Xomed, Inc. 6743 Southpoint Drive, North Jacksonville, Florida 32216
FEB 1 0 2012
Re: K110623 Trade/Device Name: Pillar Palatal Implant System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: February 1, 2012 Received: February 2, 2012
Dear Ms. Paciej
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.
4
Page 2 - Ms. Paciej
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4.0 Indications for Use Statement - 1.0
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Pillar Palatal Implant System
Indications for Use:
The Pillar Palatal Implant System is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Quores
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Clouices Division Control, Dental Devices
510(k) Number: K110623
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