(90 days)
The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Falcon Spacer is intended to be used with supplemental fixation.
The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be used as an interbody fusion device in conjunction with supplemental fixation. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The Falcon Spacer implant may be used to accommodate varying anatomical requirements and is available in a range of heights, sizes and angles. The open architecture of the device is intended to be packed with autogenous bone (i.e., autograft).
The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560); The markers allow intra-operative radiographic assessment of the position of the implant.
The provided text describes the 510(k) summary for the Falcon Spacer. Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state acceptance criteria in terms of specific thresholds or pass/fail conditions for each test. Instead, it lists the types of tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Mechanical Performance | Device demonstrates equivalent (or superior) mechanical properties to predicate devices according to FDA Guidance and ASTM F-2077. | Synthes conducted the following bench testing: - Static Axial Compression - Dynamic Axial Compression - Static Compression Shear - Subsidence - Expulsion Conclusion: Falcon Spacer is substantially equivalent to predicate devices based on contained information. |
| Material Biocompatibility | Manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with tantalum radiopaque pins (ASTM F-560), generally recognized as safe and biocompatible materials for implantable devices. | Materials Used: Invibio® PEEK-Optima® LT-1 (ASTM F2026) for the spacer body, and four (4) tantalum radiopaque pins (ASTM F-560) for markers. |
| Radiopacity | Markers allow intra-operative radiographic assessment of implant position. | Radiopaque Markers: Four (4) tantalum radiopaque pins facilitate intra-operative radiographic assessment of position. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing. For such tests, the "sample size" typically refers to the number of test articles (e.g., spacers) subjected to each specific test. This specific number is not explicitly stated in the provided 510(k) summary.
Data Provenance: The data is generated from bench testing conducted by Synthes Spine. It is not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It would be an internal lab study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device underwent non-clinical bench testing, not a study requiring expert-established ground truth related to patient data or image interpretation. The "ground truth" for these tests would be the established engineering standards, test methods (e.g., ASTM F-2077), and performance characteristics of the predicate devices.
4. Adjudication method for the test set
Not applicable. As this was non-clinical bench testing, there was no "adjudication method" in the sense of reconciling divergent expert opinions on clinical findings. The results of the mechanical tests are objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Falcon Spacer is a physical medical device (interbody fusion spacer), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The Falcon Spacer is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for the non-clinical testing was based on established engineering standards, ASTM F-2077 guidance for spinal implant testing, and the known performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the Falcon Spacer performed mechanically equivalent to these predicates.
8. The sample size for the training set
Not applicable. This product is a physical medical device. It does not involve AI or machine learning, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as #8.
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510(k) Summary 7.
JAN 0 8 2013
| 510(k) Summary – Falcon Spacer | |
|---|---|
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
| 510(k) Contact: | Monika McDole-RussellRegulatory Affairs SpecialistTelephone: 610-719-5448Facsimile: 610-719-5102Email: mcdole-russell.monika@synthes.com |
| Date Prepared: | December 21, 2012 |
| Trade Name(s): | Falcon Spacer |
| Classification: | 21 CFR 888.3080 – Spinal Intervertebral Body FusionOrthopaedic and Rehabilitation Devices PanelProduct Code MAX Class II |
| Predicates: | Synthes Oracle Spacer (K072791)Synthes OPAL Spacer (K072791)Globus Medical PATRIOT TransContinental Spacer (K102313) |
| DeviceDescription(s): | The Falcon Spacer is a radiolucent, oval-shaped spacer intended to beused as an interbody fusion device in conjunction with supplementalfixation. Pyramidal teeth that assist in further stabilization of the constructare located on the inferior and superior surfaces of the spacer. The FalconSpacer implant may be used to accommodate varying anatomicalrequirements and is available in a range of heights, sizes and angles. Theopen architecture of the device is intended to be packed with autogenousbone (i.e., autograft).The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1(ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560);The markers allow intra-operative radiographic assessment of the positionof the implant. |
| Intended Use/Indications forUse: | Falcon Spacer is indicated for use in patients with degenerative discdisease (DDD) at one or two contiguous levels from L2 to S1 whosecondition requires the use of interbody fusion combined withsupplemental fixation. The interior of the Falcon Spacer should bepacked with autogenous bone graft (i.e., autograft).DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should |
| 510(k) Summary - Falcon Spacer | |
| be skeletally mature and have had six months of non-operative treatment.The Falcon Spacer is intended to be used with supplemental fixation. | |
| Comparison ofthe device topredicatedevice(s): | The Falcon Spacer is substantially equivalent to the predicate(s) in design,function, performance, material, and intended use. |
| PerformanceDate(Non-Clinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Synthes conducted the following bench testing (as recommended by FDAGuidance and in accordance with ASTM F-2077):Static Axial Compression Dynamic Axial Compression Static Compression Shear Subsidence Expulsion Based on information contained herein, Synthes has determined that theFalcon Spacer is substantially equivalent to the predicate devices. |
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:
. And the state of the same of the same
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol that resembles a person embracing or supporting another person, representing the department's mission of protecting the health of all Americans.
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
Letter dated: January 8, 2013
Synthes (USA) Products, LLC % Ms. Monika McDole-Russell Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K123180
Trade/Device Name: Falcon Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 21, 2012 Received: December 26, 2012
Dear Ms. McDole-Russell:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Monika McDole-Russell
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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 6.
® SYNTHES®
Spine
K 123180 510(k) Number(s): (if known)
Falcon Spacer Device Name:
The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The Falcon Spacer is intended to be used with supplemental fixation.
X Prescription Use (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)
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(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123180
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.