(36 days)
The Osseoflex® SB is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s). An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.
The provided text describes the acceptance criteria and the results of a study for the Osseoflex SB device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Profile and Tamp (Catheter) Working Length (TM-003) | Balloon profile ≤ 2.79 mm (0.109 in) Balloon catheter working length > 16.5 cm | The device meets or exceeds all performance requirements (implying the reported performance met these criteria, though specific values are not provided). |
| Balloon Compliance (TM-004) | Balloon working length (L) ≤ 24 mm Balloon diameter (D) ≤ 19 mm | The device meets or exceeds all performance requirements. |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. | The device meets or exceeds all performance requirements. |
| Bond Tensile Strengths (TM-007) | Bond tensile strength ≥ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters) requirements. This tensile force may be applied to the device during use when the balloon is deflated and retracted back through the access cannula. | The device meets or exceeds all performance requirements. |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability. | The device meets or exceeds all performance requirements. |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles. | The device meets or exceeds all performance requirements. |
| Balloon Inflation, Deflation Time (TM-010) | Deflation times to be < 5 seconds with 90/90% confidence/reliability. | The device meets or exceeds all performance requirements. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each non-clinical test. The tests are non-clinical, implying they were conducted in a laboratory setting, not on human subjects. Therefore, there is no country of origin or retrospective/prospective data as it relates to patient data. The provenance is internal laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The tests are non-clinical engineering and performance characteristic tests of a medical device, not clinical studies requiring expert ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as no expert adjudication was involved in these non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. The studies described are non-clinical performance evaluations of a medical device, not AI-assisted diagnostic studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical instrument (inflatable bone tamp), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for these non-clinical tests is based on established engineering and material science principles, international standards (e.g., ISO 10555 for bond tensile strength), and device design specifications. The acceptance criteria themselves serve as the 'ground truth' for performance evaluation.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical device performance study, not an AI model training study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. For the non-clinical tests, the "ground truth" (acceptance criteria) was established based on engineering requirements and relevant industry standards.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2014
Osseon LLC Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407
Re: K141930
Trade/Device Name: Osseoflex SB Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: July 30, 2014 Received: July 31, 2014
Dear Mr. Burger:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141930
Device Name Osseoflex SB
Indications for Use (Describe)
The Osseoflex® SB is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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1.0 510(K) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92 prepared on July 15th, 2014 and last modified on August 19th, 2014.
510(k) Owner
Osseon LLC 2330 Circadian Way Santa Rosa, CA 95407 Phone: 707-636-5940 Fax: 707-636-5941
Official Contact Keith Burger Director of Research and Development
Device Information
| Trade or ProprietaryName: | Osseoflex® SB |
|---|---|
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | Primary: ArthroscopeSecondary: Cement, Bone Vertebroplasty |
| Classification Panel: | Orthopedic |
| Regulation: | Class II per 21CFR §888.1100;Class II per 21CFR §888.3027 |
| Product Code(s): | HRX; NDN |
| Legally marketeddevice(s) to whichequivalence isclaimed: | Osseoflex SB Inflatable Bone Tamp K122533Osseoflex SB, 2ml K140937 |
| Reason for 510(k): | New Device |
| Device Description: | The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloonserves to create a cavity in the vertebral body, thereby reducing the fracturewhile still allowing for cement interdigitation. The balloon catheter is thefunctional part of the device that creates a cavity and reduces the fracture. Theballoon catheter provides a conduit through which the physician can inflatethe balloon at the distal end of the catheter. After the bone is disrupted,PMMA is injected through an Osseoflex® needle to fill the previously createdvoid(s). |
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An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device. The articulating or steering feature of the device assists the clinician in directing the device to the pre-existing channel. The Osseoflex® SB knob can be turned clockwise to aid in directing the distal portion of the device. Turning the knob counter-clockwise will relax the device and allow the device to be returned to its start position. The device should be manipulated only while under fluoroscopic observation with radiographic equipment that provides high quality images.
Intended Use: The Osseoflex® SB is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
| Summary of Technological Characteristics of the Additional Size | ||||
|---|---|---|---|---|
| Compared to the Current Size (Predicate) | ||||
| Characteristic | Line Extension | Line Extension | Current Size (Predicate) | Current Size (Predicate) |
| Trade Name, Model | Osseoflex SB,OF-0224 | Osseoflex SB,OF-0222 | Osseoflex SB,OF-0005 | Osseoflex SB,OF-8222 |
| Cannula size | 10G | 8G | ||
| Max inflation volume | 4ml | 2ml | 4ml | 2ml |
| Balloon Inflation Medium | 60% Contrast | |||
| Balloon Material | Polyurethane | |||
| Balloon Diameter at nominal volume | 18 mm | 14 mm | 14 mm | 14 mm |
| Balloon Length at nominal volume | 21 mm | 14 mm | 19 mm | 17 mm |
| Balloon Shape | Cylindrical | Spherical | Cylindrical | Spherical |
| Max inflation pressure | 400 psi (27 ATM) |
| Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence | |
|---|---|
| Performance Test Summary | |
| Test Performed | Acceptance Criteria |
| Balloon Profile and Tamp(Catheter) Working Length (TM-003) | Balloon profile $≤$ 2.79 mm (0.109 in) Balloon catheter working length > 16.5 cm |
| Balloon Compliance (TM-004): | Balloon working length (L) $≤$ 24 mm Balloon diameter (D) $≤$ 19 mm |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. |
| Bond Tensile Strengths (TM-007) | Bond tensile strength $≥$ 15 N (3.37 lbf). The tensile force |
Osseon LLC Osseoflex SB, 10ga Special 510(k)
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| specification was adopted directly from ISO 10555 (Single UseIntravascular Catheters) requirements. This tensile force maybeapplied to the device during use when the balloon is deflated andretracted back through the access cannula. | |
|---|---|
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximumrecommended volume with 95% confidence and 90% reliability. |
| Balloon Fatigue, Unconstrained(TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds /deflate; without leaks for 20 cycles. |
| Balloon Inflation, Deflation Time(TM-010) | Deflation times to be < 5 seconds with 90/90% confidence/reliability. |
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A – No clinical test were conducted for this submission
Conclusions Drawn from Non-Clinical and Clinical Data
The results of the non-clinical tests show that the Osseoflex SB, 10 gauge meets or exceed all performance requirements, and are substantially equivalent to the predicate device.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”