(64 days)
No
The device description focuses on mechanical components and manual manipulation under fluoroscopic guidance. There is no mention of AI/ML terms, image processing for automated analysis, or data sets for training/testing algorithms.
Yes
The device is described as being used for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine" using balloon kyphoplasty and PMMA cement injection, which are therapeutic interventions.
No
The device description indicates that the Osseoflex® SB is an interventional device used to create a cavity in vertebral bodies for fracture reduction and cement injection, which are therapeutic actions. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly outlines 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Osseoflex® SB Function: The Osseoflex® SB is a surgical device used within the body during a procedure (kyphoplasty) to create a cavity and reduce fractures in the spine. It is a tool used for treatment, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for "reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine," which is a surgical intervention.
- Device Description: The description details its mechanical function in creating a cavity and facilitating cement injection, not any form of diagnostic testing.
- Input Imaging Modality: It uses fluoroscopic observation, which is a real-time imaging technique used during surgical procedures, not for analyzing samples.
Therefore, the Osseoflex® SB falls under the category of a surgical or interventional device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX, NDN
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)
Performance Test Summary – Osseoflex SB
Characteristic: Inflation Pressure; Standard/Test/FDA Guidance: Constrained Burst Test; Results Summary: The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment
Characteristic: Inflation Volume; Standard/Test/FDA Guidance: Unconstrained Burst Test; Results Summary: The balloon catheter exceeded the requirements for the minimum burst volume in an unconstrained environment
Characteristic: Balloon Double Wall Thickness; Standard/Test/FDA Guidance: Calibrated Measurement; Results Summary: The double wall thickness of the balloon was substantially equivalent to that of the predicate devices
Summary of Clinical Tests Conducted for Determination of Substantial Equivalence
N/A – No clinical test were conducted for this submission
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.
Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251
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.
CareFusion Inflatable Bone Tamp, K103064, K093463, K090211
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
§ 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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OCT 2 3 2012
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
510(k) Owner
Osseon® Therapeutics, Inc. 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, Procode HRX |
| Class II per 21CFR §888.3027. Procode NDN | |
| Product Code(s) | OF-0005 |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed | Kyphon Inflatable Bone Tamp, K041454, K032212, K010246, K981251 |
| CareFusion Inflatable Bone Tamp, K103064, K093463, K090211 | |
| 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). |
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 |
1
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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 Device Compared to the Predicate Devices | |||
|---|---|---|---|
| Characteristic | New Device | Predicate Device | |
| Trade Name | Osseoflex SB | Kyphon IBT (K041454, | |
| K032212, K010246, | |||
| K981251) | Carefusion | ||
| AVAmax Vertebral | |||
| Balloon (K103064, | |||
| K093463, K090211) | |||
| Cannula size | 8G | 8G | 8G |
| Balloon Inflation | |||
| Medium | 60% Contrast | 60% Contrast | 60% Contrast |
| Balloon Material | Polyurethane | Polyurethane | Polyurethane |
| Balloon Size | 15mm | 10, 15, and 20mm | 10, 15, and 20mm |
| 15mm Balloon Diameter | |||
| at nominal volume (2ml) | 10.2mm | 8.5mm | 11.8mm |
| 15mm 'Balloon Length | |||
| at nominal volume (2ml) | 13.7mm | 14.6mm | 14.9mm |
| Balloon Shape | Cylindrical | Variable | Cylindrical |
| Max inflation pressure | 400 psi (27 ATM) | 400 psi (27 ATM) | 400 psi (27 ATM) |
| Max inflation volume | 4ml | 4ml | 4ml |
Summary of Non-Clinical Tests Conducted for Determination of Substantial Equivalence Toct Summa Douts C
| Performance Test Summary – Osseoflex SB | ||
|---|---|---|
| Characteristic | Standard/ Test/ | |
| FDA Guidance | Results Summary | |
| Inflation Pressure | Constrained Burst | |
| Test | The balloon catheter exceeded the requirements for | |
| the minimum burst pressure in a constrained | ||
| environment | ||
| Inflation Volume | Unconstrained | |
| Burst Test | The balloon catheter exceeded the requirements for | |
| the minimum burst volume in an unconstrained | ||
| environment | ||
| Balloon Double | ||
| Wall Thickness | Calibrated | |
| Measurement | The double wall thickness of the balloon was | |
| substantially equivalent to that of the predicate devices | ||
| 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 meet or exceed all performance | ||
| requirements and are substantially equivalent to the predicate devices |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Osseon® Therapeutics, Incorporated % Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407
Re: K122533
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: October 5, 2012 Received: October 11, 2012
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
OCT
23 2012
3
Page 2 -- Mr. Keith Burger
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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
David Krone
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATION FOR USE STATEMENT 12.0
K122533 510 (k) Number:
Osseoflex® SB Device Name:
Indication For 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. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Om Division of Surgical, Ofthopedic, and Restorative Devices
510(k) Number K122533
Osseon Therapeutics Incorporated Osseoflex® SB Steerable Bone Tamp 510(k) — K122533