REPOSE BONE SCREW SYSTEM

K981677 · Influence, Inc. · LRK · Aug 27, 1999 · Dental

Device Facts

• Record ID: K981677
• Device Name: REPOSE BONE SCREW SYSTEM
• Applicant: Influence, Inc.
• Product Code: LRK · Dental
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid suspension procedure as an adjunct to tongue base suspension. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

Device Story

Repose™ Bone Screw System facilitates surgical suspension of tongue base soft tissue to mandible or hyoid bone. System components: titanium bone screw (ASTM F136-84) with pre-threaded polypropylene monofilament suture, battery-operated single-use bone screw inserter, and suture passer. Used by surgeons in clinical/surgical settings to treat OSA and snoring. Procedure involves anchoring tongue base musculature to bone to prevent airway collapse. Device provides mechanical fixation; surgeon manually operates inserter and passer to secure tissue. Benefits include stabilization of tongue base to reduce airway obstruction during sleep.

Clinical Evidence

Performance characteristics validated through in vitro and in vivo studies previously submitted under K972023.

Technological Characteristics

Titanium alloy 6AL-4V Eli (ASTM F136-84). System includes bone screw, battery-operated single-use inserter, and suture passer. Polypropylene monofilament suture. Mechanical fixation principle.

Indications for Use

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

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

• Sleep-In™ Bone Screw System (K972023)
• In-Fast™ Bone Screw System (K970292)
• Mitek GII Anchor (K920213)

Submission Summary (Full Text)

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AUG-17-99 14:57 From:HOGAN & HARTSON 7W 109

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Ka81677

AUG 27 1999

#### 510(k) Summary

# Influence, Inc.'s Repose™ Bone Screw System

## Company Name:

Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105

## Submitter's Name and Contact Person:

Peter Bick, M.D., President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: [phone] Fax: [phone]

or

Jonathan S. Kahan, Esq Hogan and Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004 Telephone: [phone] Fax: [phone]

#### Date Prepared:

May 11, 1998

## Trade/Proprietary Name:

Repose™ Bone Screw System

## Classification Name:

The Repose Bone Screw System has not yet been classified.

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#### Predicate Devices:

Repose™ Bone Screw System:

- · Sleep-In™ Bone Screw System (K972023)
- · In-Fast™ Bone Screw System (K970292)
- · Mitek GII Anchor (K920213)

### 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 Repose Bone Screw meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84).

#### Intended Use:

The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid procedure. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

## System Description:

The Repose™ 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 Repose™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. I suture crimped into its base.

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The Repose™ Bone Screw Inserter is a disposable, battery operated, single use device. The Repose™ Suture Passer is designed to assist in passing the suture through the floor of the tongue in a tongue base advancement procedure or through the neck during a hyoid suspension procedure.

#### Technological Characteristics and Substantial Equivalence:

The performance characteristics of the Repose™ Bone Screw System has been tested and approved through a series of in vitro and in vivo studies, previously submitted under 510(k): K972023 for Influence Inc's Sleep-In™ Bone Screw System.

The Repose™ Bone Screw System, like its predicate devices the Sleep-In™ Bone Screw System, 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 Repose™ System procedure is based upon well accepted and commonly used procedures like Hyoid Bone Suspension, Chin Osteotomy and Genioglossal Advancement for the treatment of OSA and/or snoring.

The Repose™ Bone Screw System is substantially equivalent to the Sleep In™ Bone Screw System with respect to the intended use for the treatment of OSA and/or snoring by means of repositioning of the tongue and to the commonly

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accepted practice of Hyoid Bone Suspension by means of tongue base advancement via the hyoid bone which is attached to the tongue base musculature.

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Image /page/4/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

K981677 510(k) Number (if known):

Repose™ Bone Screw System Device Name:

Indications for Use:

The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid suspension procedure as an adjunct to tongue base suspension. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

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

510(k) Number K081677

Prescription Use _

OR

Susan Paner

Division of Dental, Infection Control and General Hospital Device 510(k) Numbe

Counter Over the

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