PILLAR PALATAL IMPLANT SYSTEM

K040417 · Restore Medical, Inc. · LRK · Jul 28, 2004 · Dental

Device Facts

• Record ID: K040417
• Device Name: PILLAR PALATAL IMPLANT SYSTEM
• Applicant: Restore Medical, Inc.
• Product Code: LRK · Dental
• Decision Date: Jul 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The System is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals and reduce the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).

Device Story

Pillar Palatal Implant System treats snoring and mild-to-moderate OSA. Device consists of cylindrical braided polyester filament implants and a disposable delivery tool (handle and needle assembly). Physician places implants submucosally into soft palate. Implants stiffen palatal tissue; reduce dynamic flutter (snoring); reduce airway obstruction. Permanent implants; disposable delivery tool. Clinical results compared to predicate OSA treatments; demonstrated comparable performance.

Clinical Evidence

Clinical evaluation conducted to support expanded indication for OSA treatment. Results compared to predicate devices indicated for OSA. Data demonstrated comparable performance and safety profile.

Technological Characteristics

Implant: cylindrical braided polyester filaments. Delivery tool: handle and needle assembly. Permanent implant, disposable delivery tool. Submucosal placement in soft palate.

Indications for Use

Indicated for patients with mild to moderate Obstructive Sleep Apnea (OSA) to reduce the incidence of airway obstructions.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Pillar™ Palatal Implant System (K011723)
• Somnoplasty System (K982717)
• Sleep-In Bone Screw System (K972023)

Submission Summary (Full Text)

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## JUL 88 2004

## 510(k) Summary

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

The assigned 510(k) number is: K040417

| SUBMITTER: | Restore Medical Inc.<br>2800 Patton Road<br>St. Paul, MN 55113 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Edward W. Numainville |
| DATE PREPARED: | February 17, 2004 |
| TRADE NAME: | Pillar™ Palatal Implant System |
| COMMON NAME: | Palatal Implant System |
| CLASSIFICATION: | Unclassified |
| PRODUCT CODE: | LRK |
| DEVICE DESCRIPTION: | The Pillar™ Palatal Implant System (“System”) is intended as a treatment option for snoring and obstructive sleep apnea. 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. Additionally, the implants reduce the incidence of airway obstruction caused by the soft palate. |
| | 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 submucosally in the soft palate. The implant is designed to be permanent while the delivery tool is disposable. |
| INTENDED USE: | The System is intended for use in stiffening the soft palate tissue, which may reduce the severity of snoring in some individuals and reduce the incidence of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea). |
| EQUIVALENCE TESTING: | The System has been clinically evaluated in support of expanding the current snoring indication to include the treatment of patients with OSA. The clinical results were compared to the clinical results of other products which have an indication for the treatment of OSA. The results were comparable in terms of performance. |
| CONCLUSION: | The Pillar™ Palatal Implant System with the additional OSA indication is substantially equivalent to the current commercially available System which is indicated for snorin in terms of its design and materials and to the Influence Screw In Bone System (K972023) and the Gyrus PLC (formerly Somnus Medical Technologies) Somnoplasty System (K982717) in their indications for use in the treatment of those patients suffering from OSA.<br>Clinical data demonstrates the device performs as anticipated and raises no new questions of safety and effectiveness over the predicate devices. |

PREDICATE DEVICE(S):

Pillar™ Palatal Implant System ( a/k/a Anti-Snoring Device), manufactured by Restore Medical Inc, and cleared via 510(k) Notification K011723 on December 18, 2002 for the treatment of snoring.

Somnoplasty System, manufactured by Gyrus PLC (formerly Somnus Medical Technologies, Inc.) and cleared via 510(k) Notification K982717 on November 2, 1998 for the reduction of the incidence of airway obstructions in patients suffering from UARS (Upper Airway Resistance Syndrome) or OSAS (Obstructive Sleep Apnea Syndrome).

Sleep-In Bone Screw System, manufactured by Influence, Inc. cleared via 510(k) Notification K972023 on August 25, 1997 for the treatment of obstructive sleep apnea and/or snoring.

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Image /page/2/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Edward W. Numainville Vice President, Regulatory and Clinical Affairs Restore Medical, Incorporated 2800 Patton Road Saint Paul, Minnesota 55113

JUL 2 8 2004

Re: K040417

Ko 1011 - 11:11
Trade/Device Name: Pillar™ Palatal Implant System Regulation Number: 872.5570 Regulation Name: 172.3578
Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: June 7, 2004 Received: June 8, 2004

Dear Mr. Numainville:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section Pro(it) promains is substantially equivalent (for the referenced above and have decembined the active is smarketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed profitse Medical D indications for use stated in the enactment date of the Medical Device interstate collinered pror to thay 20, 1778, and said said and county and of a premarket Amendments, or to devices that have been roclassive a proval of a prematice the sepperal the Federal Food, Drug, and Cosmette 1 10 (10) - 10) - 10 ) - 1 the general approval application (1 Mirr). I ou . The general controls provisions of the Act include controls provisions of the rec. The gentiral of devices, good manufacturing practice, requirements prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classfired (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such adultions, Title 21, Parts 800 to 898. In
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Featurers concerning your device in the Federal Register.

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Page 2 - Mr. Numainville

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualles of a Sacounties with other requirements
mean that FDA has made a determination that your device complies with or Federal organisa mean that FDA nas made a decemmanent that your and inistered by other Federal agencies. of the Act of any rederal statutes and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, including annetice You must comply with an the Act 3 requirement 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800'; and i and listing (21 CFK Fall 807), laboring (21 CFR Pat 800); and if (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your dection 5 10(k) This letter will anow you to begin manoling your as a
premarket notification. The FDA finding of substantial equivalence of your device the state premarket notification. The PDA mining of basians of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device en our case in the regulation please contact the Other or Ochiphanes and premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of general monnation on your Fepped interpational and Consumer Assistance at its toll-free Division of Binastic of Sincer [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chin-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040417

Pillar™ Palatal Implant System Device Name:

Indications for Use: The Pillar™ Palatal Implant System is intended for the reduction of the incidence The I mai - Patatal Imprail - January - 1
of airway obstructions in patients suffering from mild to moderate OSA (Obstructive Sleep Apnea).

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punner

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Antool, Dental Devices

510(k) Number. K640417

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