SLEEP-IN BONE SCREW SYSTEM

K972023 · Influence, Inc. · LRK · Aug 25, 1997 · Dental

Device Facts

• Record ID: K972023
• Device Name: SLEEP-IN BONE SCREW SYSTEM
• Applicant: Influence, Inc.
• Product Code: LRK · Dental
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sleep-In™ Bone Screw System is intended for anterior advancement and suspension of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

Device Story

System consists of titanium bone screw with polypropylene suture, battery-operated inserter, and suture passer. Used by clinicians to perform tongue base suspension procedure. Screw is anchored into bone; suture is passed through floor of tongue to advance/suspend tongue base anteriorly. Procedure aims to reposition tongue to treat OSA and snoring. Benefits include mechanical stabilization of tongue base to reduce airway obstruction.

Clinical Evidence

Initial clinical experience demonstrated potential for treating OSA and/or snoring. Performance characteristics validated through in vitro and in vivo studies.

Technological Characteristics

Titanium alloy 6AL-4V Eli (ASTM F136-84). Components: sharp-tipped bone screw, polypropylene monofilament no. 1 suture, battery-operated single-use inserter, suture passer. Mechanical suspension principle.

Indications for Use

Indicated for patients with obstructive sleep apnea (OSA) and/or snoring requiring anterior advancement and suspension of the tongue base.

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

• In-Fast™ Bone Screw System (K970292)
• Mitek GII Anchor (K920213)
• PM Positioner™ (K953293 & K955503)
• Snor-X Mouthguard (K954324)
• Protecta-Pass™ Suture Passer (K932925)

Submission Summary (Full Text)

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9 72023

16 25

#### 510(k) Summary

# Influence, Inc.'s Sleep-In™ Bone Screw System

#### Company Name:

Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111

## Submitter's Name and Contact Person:

Peter Bick, M.D., President and CEO Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, California 94111 Telephone: [phone] Fax: [phone]

#### Date Prepared:

May 29, 1997

#### Trade/Proprietary Name:

Sleep-In™ Bone Screw System

#### Classification Name:

The Sleep-In™ Bone Screw System has not yet been classified.

#### Predicate Devices:

Sleep-In™ Bone Screw and Sleep-In™ Bone Inserter:

- · In-Fast™ Bone Screw System (K970292)
- · Mitek GII Anchor (K920213)
- · PM Positioner™ (K953293 & K955503)
- · Snor-X Mouthguard (K954324)

#### Sleep-In™ Suture Passer:

- · Protecta-Pass™ Suture Passer (K932925)

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### Performance Standards:

No performance standards applicable to the bone screw systems have been established by the FDA. However, the titanium alloy 6AL-4V Eli alloy used to manufacture the Sleep-In™ Bone Screw meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84).

#### Intended Use:

The Sleep-In™ Bone Screw System is intended for anterior advancement and suspension of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

#### System Description:

The Sleep-In™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The Sleep-In™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base.

The Sleep-In™ Bone Screw Inserter is a disposable, battery operated, single use device. The Sleep-In™ Suture Passer is designed to assist in passing the suture through the floor of the tongue during the Sleep-In™ procedure.

#### Technological Characteristics and Substantial Equivalence:

The performance characteristics of the Sleep-In™ Bone Screw System has been tested and approved through a series of in vitro and in vivo studies.

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Furthermore, initial clinical experience with the Sleep-In™ Bone Screw System has demonstrated its potential for treating patients suffering from OSA and/or snoring.

The Sleep-In™ Bone Screw System, like its predicate devices the In-Fast™ Bone Screw System and the Mitek GII Anchor, is based on suspending soft tissue to fixed bone by means of sutures attached to bone screw.

In respect to the procedure, the Sleep-In™ System procedure is based upon well accepted and commonly used procedures like Hyoid Bone Suspension, Chin Osteotomy and Mandibular Advancement for the treatment of OSA and/or snoring.

The Sleep-In™ Bone Screw System is substantially equivalent to PM Positioner™ and the Snor-X Mouthguard with respect to the intended use for the treatment of OSA and/or snoring by means of repositioning of the tongue.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around it. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 26 2009

David Guzek Sr. Regulatory Specialist Medtronic ENT Medtronic USA, Inc. 6743 Southpoint Dr., N. Jacksonville, FL 32216-0980

Re: K972023 K981677

Dear Mr. Guzek:

We have reviewed your letters, received January 8, 2009, stating that the rights to the above referenced premarket notification (510(k)) have been transfer of 510(k) rights alone does not require submission of a new 510(k) under 21 CFR 807.81(a)(3). Consequently, we cannot change the name of the original 510(k) submitter in our database. Please note, as per 21 CFR 807.85(b), a firm may not both manufacture and distribute a device under their own name without having their own 510(k).

We suggest that information showing the transfer of the 510(k) and its current ownership should be maintained in the company's files for review by an FDA investigator. You may contact the Center for Devices and Radiological Health's Office of Compliance at [phone] if you have any questions on what information we expect to be maintained in your files.

"Please note, under 21 CFR 807.81(a)(2) a firm may not both retain and transfer 510(k) marketing rights to another person, e.g., a contract manufacturer, because each person who manufactures and distributes a device must have their own 510(k), if the device is not exempt from the premarket notification requirement. Likewise, distributors need 510(k) clearances before marketing devices when they alter them by doing more than putting their name on the device, because such actions would disqualify them from the 510(k) distributor exemption under 21 CFR 807.85(b)."

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If you have any other questions regarding this letter, please contact the 510(k) Staff at [phone].

Sincerely yours,

Juli Stuart

Julie "Brandi" Stuart Consumer Safety Officer Premarket Notification Section Program Operations Staff Office of Device Evaluation Center for Devices and Radiological Health

cc: Influence, Inc. 601 Montgomery Street, Suite 845 San Francisco, CA 94111

Influence, Inc. c/o Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004-1109

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## INDICATIONS FOR USE

| 510(k) Number (if known): | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Sleep-In™ Bone Screw System |
| Indications for Use: | The Sleep-In™ Bone Screw System is<br>intended for anterior advancement of the<br>tongue base by means of a bone screw<br>threaded with suture. It is indicated for<br>the treatment of obstructive sleep apnea<br>(OSA) and/or snoring. |

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

Concurrence of CI)RH, Office of Device Evaluation (ODE) (Division Sign-off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number *K972063*

Prescription Use V (Per 21 CFR 801. 109)

OR

Susa Sumr

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number న్న

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