(36 days)
Not Found
No
The device description focuses on mechanical components and manipulation under fluoroscopic observation. There is no mention of AI, ML, or any software-driven analysis or decision-making.
Yes
The device is intended for the reduction of fractures and/or creation of a void in cancellous bone in the spine, and is used with bone cements for percutaneous vertebral augmentation, all of which are medical treatments.
No
The device is described as being used for the reduction of fractures and creation of a void in cancellous bone in the spine, specifically during percutaneous vertebral augmentation (kyphoplasty). Its function is to create a cavity and reduce a fracture, not to diagnose a condition.
No
The device description clearly details physical components like a balloon catheter, needle, and knob, indicating it is a hardware device used in a surgical procedure.
Based on the provided information, the Osseoflex® SB is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "reduction of fractures and/or creation of a void in cancellous bone in the spine" and "use during percutaneous vertebral augmentation." This describes a surgical procedure performed on the patient's body.
- Device Description: The description details a physical device (balloon catheter, needle) used to manipulate bone and deliver bone cement within the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The Osseoflex® SB does not perform any such tests on biological samples.
The Osseoflex® SB is a surgical device used in a procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NDN, HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic observation with radiographic equipment
Anatomical Site
cancellous bone in the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence
| 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 specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters) requirements. This tensile force maybe applied to the device during use when the balloon is deflated and retracted back through the access cannula. |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended 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 |
§ 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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
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
1
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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Image /page/3/Picture/0 description: The image shows the word "osseon" in orange font. The letters are stylized with rounded edges and cut-out sections. A horizontal black line is present beneath the word, and a small registered trademark symbol is visible to the right of the last letter.
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 Proprietary
| Name: | Osseoflex® SB |
|---|---|
| Common Name: | Inflatable Bone Tamp |
| Classification Name: | Primary: Arthroscope |
| Secondary: 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 marketed | |
| device(s) to which | |
| equivalence is | |
| claimed: | Osseoflex SB Inflatable Bone Tamp K122533 |
| Osseoflex SB, 2ml K140937 | |
| Reason for 510(k): | New Device |
| Device Description: | 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). |
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Image /page/4/Picture/0 description: The image shows the word "osseon" in orange font. The letters are stylized with breaks in the lines. There is a black line underneath the word. A registered trademark symbol is to the right of the last letter.
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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Image /page/5/Picture/0 description: The image shows the word "osseon" in orange color. The letters are in a rounded sans-serif font. A registered trademark symbol is located to the bottom right of the last letter. A black line is located underneath the word.
| | specification was adopted directly from ISO 10555 (Single Use
Intravascular Catheters) requirements. This tensile force maybe
applied to the device during use when the balloon is deflated and
retracted back through the access cannula. |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Balloon Maximum Volume (TM-
008) | Maximum inflation volume to be greater than the maximum
recommended 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