(472 days)
Not Found
No
The device description and intended use focus on mechanical components and surgical procedures, with no mention of AI or ML capabilities. The performance studies reference previous 510(k) submissions for similar mechanical devices.
Yes
The device is intended for the treatment of obstructive sleep apnea and/or snoring, which are medical conditions, and it achieves this by fixating soft tissue to bone using a bone screw, thereby providing a therapeutic effect.
No
Explanation: The device is described as a surgical system for treating obstructive sleep apnea and snoring by fixating soft tissue. Its components and intended use involve physical procedures (implantation, passing suture), not the collection, analysis, or interpretation of data to determine a medical condition or disease.
No
The device description clearly outlines physical components including a bone screw, inserter, and suture passer, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Repose™ Bone Screw System Function: The Repose™ Bone Screw System is a surgical implant and instrument system used within the body to physically suspend the tongue base or perform a hyoid procedure. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for "anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone" and "performance of a hyoid procedure." These are surgical interventions, not diagnostic tests.
- Device Description: The description details surgical components like bone screws, inserters, and suture passers, which are used in surgical procedures.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the Repose™ Bone Screw System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 procedure. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue base, mandible bone, hyoid bone
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)
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.
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
AUG-17-99 14:57 From:HOGAN & HARTSON 7W 109
【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【】【
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: 415-546-7700 Fax: 415-546-7744
or
Jonathan S. Kahan, Esq Hogan and Hartson, L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004 Telephone: 202-637-5794 Fax: 202-637-5910
Date Prepared:
May 11, 1998
Trade/Proprietary Name:
Repose™ Bone Screw System
Classification Name:
The Repose Bone Screw System has not yet been classified.
1
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.
2
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
3
accepted practice of Hyoid Bone Suspension by means of tongue base advancement via the hyoid bone which is attached to the tongue base musculature.
4
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
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 (240) 276-0100 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)."
5
Page 2 -
If you have any other questions regarding this letter, please contact the 510(k) Staff at (240) 276-4040.
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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Page 1 of 1
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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