(156 days)
The AlRvance™ 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 indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AlRvance™ Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
The AlRvance™ 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 AlRvance™ bone screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base. The AlRvance™ Bone Screw Inserter is a disposable, battery operated, single use device. The AlRvance™ Suture Passer is designed to assist in passing the suture through the floor of the tongue base advancement procedure or through the neck during a hyoid suspension procedure.
This 510(k) summary (K122391) for the AIRvance™ Bone Screw System indicates that the device is substantially equivalent to a predicate device (Repose™ Bone Screw System (K981677)) and did not involve a standalone study or a comparative effectiveness study with human readers assisted by AI.
The submission states: "No additional nonclinical tests were conducted in support of this submission. The current device is identical to the predicate." and further, "Because the new device is physically identical to the predicate device, justifying no new nonclinical testing, along with the evolution of upper airway surgery and the factors reqarding the method of treatment identified in the clinical information, we conclude that this new device is safe and effective for its intended use and performs as well or better than the predicate device."
Therefore, the acceptance criteria and the study that proves the device meets the acceptance criteria are based on its substantial equivalence to the predicate device and existing literature, rather than a new standalone performance study for this specific device.
Here's an attempt to structure the information based on your request, acknowledging the limitations due to the nature of this 510(k) submission:
Acceptance Criteria and Device Performance for AIRvance™ Bone Screw System (K122391)
1. Table of Acceptance Criteria and Reported Device Performance
Given that this 510(k) relies on substantial equivalence to a predicate device and existing clinical literature for similar procedures, there are no specific quantitative acceptance criteria or reported performance metrics derived from a new study of the AIRvance™ Bone Screw System itself.
Instead, the "acceptance criteria" can be inferred as the demonstration of substantial equivalence to the predicate device (Repose™ Bone Screw System (K981677)) and the established effectiveness of the underlying surgical procedures (hyoid suspension, tongue base suspension) as supported by peer-reviewed literature.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (as per 510(k) and predicate) |
|---|---|
| Mechanical/Physical Equivalence: Device components (bone screw, inserter, suture passer) are physically identical to the predicate device. | "The AlRvance™ Bone Screw System like its predicate device, the Repose™ Bone Screw System (K981677), is based on suspending soft tissue to fixed bone by means of sutures attached to bone screw... None of the Technological Characteristics are different from those of the Predicate." and "Because the new device is physically identical to the predicate device, justifying no new nonclinical testing..." |
| Intended Use Equivalence: The indications for use are substantially similar to the predicate device. | "The AlRvance™ Bone Screw System is intended for anterior tonque base suspension... for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AlRvance™ Bone Screw System is also suitable for the performance of a hyoid suspension procedure... for the treatment of obstructive sleep apnea (OSA) and/or snoring." (These align with the general indications for devices of this type for OSA and snoring). |
| Safety and Effectiveness: The device is as safe and effective as the predicate device. | "The current device is identical to the predicate." and "...we conclude that this new device is safe and effective for its intended use and performs as well or better than the predicate device." The clinical information section provides a "summary of clinical studies involving hyoid suspension published in the peer-review literature, to show that this treatment is often used successfully to reduce hypopharyngeal airway compromise in the effective treatment of OSA and may be used in combination with other surgical procedures..." This literature review supports the procedure's effectiveness, which the device facilitates. |
| Technological Characteristics Equivalence: The technology and operating principle are the same as the predicate. | "The AlRvance™ Bone Screw System like its predicate device... is based on suspending soft tissue to fixed bone by means of sutures attached to bone screw." and "None of the Technological Characteristics are different from those of the Predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No new test set data was generated for this 510(k) submission for the AIRvance™ Bone Screw System, as its performance was established through substantial equivalence to the predicate and existing literature.
- Data Provenance: The "Clinical Information" section refers to a "summary of clinical studies involving hyoid suspension published in the peer-review literature." The specific countries of origin or whether these were retrospective/prospective studies are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No new clinical "ground truth" for a test set was established for the specific AIRvance™ Bone Screw System as part of this submission. The "clinical conclusion" is based on the general understanding of hyoid suspension procedures from published literature, implying general consensus among the medical community.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no new test set requiring adjudication in this submission for the AIRvance™ Bone Screw System.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This submission does not mention or present the results of an MRMC study.
- Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study or AI assistance component is described for this device.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Was a standalone study done? No. This submission explicitly states: "No additional nonclinical tests were conducted in support of this submission. The current device is identical to the predicate." Therefore, no standalone performance study was conducted for the AIRvance™ Bone Screw System.
7. Type of Ground Truth Used
- Type of Ground Truth: For the purpose of establishing safety and effectiveness, the "ground truth" relied upon is the established clinical efficacy of hyoid suspension procedures as demonstrated in peer-reviewed medical literature and the documented safety and performance of the predicate device (Repose™ Bone Screw System). This is a form of expert consensus and outcomes data at the procedural level, rather than specific performance data for the new device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm requiring a training set. The substantial equivalence argument relies on the physical and technological identity to the predicate device and the clinical understanding of the surgical procedures for which it is used.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set Established: Not applicable, as there is no training set for this device.
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JAN 1 0 2013
510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Establishment Registration Number:
1045254
Address of Manufacturer:
Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 (904) 296-9600 Phone (904) 296-2386 Facsimile
Contact Person:
Douglas Johnson
December 19, 2012
(K981677)
Date:
Trade or Proprietary Name:
AlRvance™ Bone Screw System
| Product Code | • LRK |
|---|---|
| Class | • II |
| Common name(s): | • Device, Anti-Snoring |
| Classification Name(s): | • Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea. (21 CFR§ 872.5570) |
| Predicate device to the AIRvance™ | • Repose™ Bone Screw System |
Bone Screw System (K122391)
System Description:
The AlRvance™ 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 AlRvance™ bone screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base. The AlRvance™ Bone Screw Inserter is a disposable, battery operated, single use device. The AlRvance™ Suture Passer is designed to assist in passing the suture through the floor of the tongue base advancement procedure or through the neck during a hyoid suspension procedure.
Technological Characteristics:
The AlRvance™ Bone Screw System like its predicate device, the Repose™ Bone Screw System (K981677), is based on suspending soft tissue to fixed bone by means of sutures attached to bone screw. In respect to the procedures, the AlRvance™ Bone Screw System procedures are 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. None of the Technological Characteristics are different from those of the Predicate.
Indication for Use:
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The AlRvance™ Bone Screw System is intended for anterior tonque base suspension by fixation of the soft tissue of the tonque base to the mandible bone using a bone screw with pre-threaded suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. The AlRvance™ Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Non Clinical Information:
No additional nonclinical tests were conducted in support of this submission. The current device is identical to the predicate.
Clinical Information:
The clinical information consists of a summary of clinical studies involving hyoid suspension published in the peer-review literature, to show that this treatment is often used successfully to reduce hypopharyngeal airway compromise in the effective treatment of OSA and may be used in combination with other surgical procedures (e.g. nasal, tongue palatal) that address additional sites of obstruction in the airway.
Multilevel upper airway surgery has evolved over the past 20 years and includes a variety of procedures to both enlarge the lumen and reduce the collapsibility of the upper airway . during sleep. Currently, there is no readily defined standard by which to decide which combinations of procedures work best for a given patient. Factors that go into surgical decision making include physiologic variables (e.g., BMI), anatomic factors (e.g., craniofacial structure, tongue and tonsil size), sleep apnea severity, findings on upper airway fiber-optic endoscopy, and patient preference and economic/ health insurance considerations.
Because the hyoid and its attendant musculature are integral to the base of the tonque and the supraglottic airway, various surgical techniques have been used to bring the hyoid forward in order to advance the hypopharyngeal tissues and therefore expand hypopharyngeal space, specifically at the inferior base of the tongue, vallecula, and epiglottis.
Clinical Conclusion:
The use of hyoid suspension is an effective method to treat hypopharyngeal-based obstructions and can be used in combination with other procedures to effectively treat OSA with or without tongue suspension.
Conclusion:
Because the new device is physically identical to the predicate device, justifying no new nonclinical testing, along with the evolution of upper airway surgery and the factors reqarding the method of treatment identified in the clinical information, we conclude that this new device is safe and effective for its intended use and performs as well or better than the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
Mr. Douglas Johnson Principal Regulatory Affairs Specialist Medtronic Xomed, Incorporated 6743 Southpoint Drive North JACKSONVILLE FL 32216
Re: K122391
Trade/Device Name: AIRvance™ Bone Screw System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Oral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea
Regulatory Class: II Product Code: LRK Dated: January 2, 2013 Received: January 4, 2013
Dear Mr. Johnson:
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.
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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/ucm115809.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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): K122391
Device Name: AlRvance™ Bone Screw System
Indications for Use:
The AlRvance™ 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 indicated for the treatment of obstructive sleep apnea (OSA) pro an couron. The AlRvance™ Bone Screw System is also suitable for the performance of a hyoid suspension procedure which can be used in combination with other procedures for the treatment of obstructive sleep apnea (OSA). It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2013.01.1
Susan Runner DDS, MA
0 14:25:24
-05'00'
(Division Sign-Off) (Diyiston of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k12239
§ 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.”