(69 days)
K 122533
Not Found
No
The device description focuses on mechanical components and their function in a surgical procedure. There is no mention of AI, ML, image processing for analysis, or any data-driven decision-making within the device itself. The performance studies are based on mechanical properties, not algorithmic performance.
Yes.
The device is used for the reduction of fractures and/or creation of a void in cancellous bone in the spine, which directly treats a medical condition.
No
This device is intended for the reduction of fractures and creation of a void in cancellous bone (a therapeutic purpose) and does not mention any diagnostic capabilities.
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 In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "reduction of fractures and/or creation of a void in cancellous bone in the spine" and "percutaneous vertebral augmentation." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a balloon catheter used to create a cavity within the bone and facilitate cement injection. This is a physical intervention, not a test performed on a sample outside the body.
- Input Imaging Modality: The device is used with "fluoroscopic observation," which is a real-time imaging technique used during surgical procedures.
- Anatomical Site: The device is used on the "spine," a part of the human body.
- Intended User: The intended user is a "physician," indicating a medical professional performing a procedure.
In Vitro Diagnostic devices are designed to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Osseoflex® SB does not perform this function. It is a surgical tool used for a therapeutic procedure.
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 perculancous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutancous 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
manual (fluoroscopic observation with radiographic equipment)
Anatomical Site
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)
Non-Clinical Tests:
- Balloon Profile and Tamp (Catheter) Working Length (TM-003): Balloon profile ≤ 3.48 mm (0.137 in), Balloon catheter working length > 16.5 cm (length of access cannula).
- Balloon Compliance (TM-004): Balloon working length (L) is 16 mm (reference) at the maximum recommended volume 2 mL. Balloon diameter (D) is 15 mm maximum at the maximum recommended volume 2 mL.
- 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).
- Balloon Maximum Volume (TM-008): Maximum inflation volume 2 mL with 95% confidence and 90% reliability.
- Balloon Fatigue, Unconstrained (TM-009): Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles.
- Balloon Inflation, Deflation Time (TM-010): The Osseoflex SB 2ml samples deflation times to be clinically equivalent to other marketed inflatable bone tamps.
Clinical Tests: N/A – No clinical test were conducted for this submission.
Key Results: The results of the non-clinical tests show that the Osseoflex SB, 2ml meet or exceed all performance requirements, and are substantially equivalent to the predicate device.
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.
K 122533
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.
Not Found
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.”
0
Image /page/0/Picture/1 description: The image shows the word "CSSEA" in a stylized font. The letters are thick and outlined, with a horizontal line running beneath them. The letters are evenly spaced and appear to be part of a logo or brand name.
JUN 1 9 2014
Attachment 4:
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
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:
Common Name:
Osseoflex® SB
Common Name:
L. S. Ashworth
Classification Name:
Classification Panel:
Regulation:
Product Code(s)
Legally marketed device(s) to which equivalence is claimed Reason for 510(k)
Device Description
Inflatable Bone Tamp
Primary: Arthroscope Secondary: Cement, Bone Vertebroplasty
Orthopedic
Class II per 21CFR §888.1100 Class II per 21CFR §888.3027
HRX; NDN
Osseoflex SB Inflatable Bone Tamp K 122533
New Device
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
Osseon LLC Osseoflex SB, 2ml Special 510(k)
1
Image /page/1/Picture/1 description: The image shows the word "CSSA01" in a stylized font. The letters are outlined in black and have a three-dimensional appearance. The word is underlined with a black line. There is a registered trademark symbol to the right of the number 1.
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 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 | Additional Size | Current Size (Predicate) |
| Trade Name, Model | Osseoflex SB, | |
| OF-8222 | Osseoflex SB, | |
| OF-0005 | ||
| Cannula size | 8G | 8G |
| Balloon Inflation Medium | 60% Contrast | 60% Contrast |
| Balloon Material | Polyurethane | Polyurethane |
| Balloon Diameter at nominal volume | 15 mm max | 15 mm max |
| Balloon Length at nominal volume | 16 mm | 15 mm |
| Balloon Shape | Spherical | Cylindrical |
| Max inflation pressure | 400 psi (27 ATM) | 400 psi (27 ATM) |
Osseon LLC Osseoflex SB, 2ml
Special 510(k)
Intended Use
2
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| Company of Children And List and A A Marcel Company of Children Company of Children | Angel Build Build Build Build Build Build Artistics | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|---|
| September 1998 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 199 | ||
| Max inflation volume | Zmi | 4m |
| 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- |
-
| Balloon profile $\le$ 3.48 mm (0.137 in) Balloon catheter working length > 16.5 cm (length of access cannula) | |
| Balloon Compliance
(TM-004): | Balloon working length (L) is 16 mm (reference) at the maximum recommended volume 2 mL. Balloon diameter (D) is 15 mm maximum at the maximum recommended volume 2 mL. The 15 mm diameter maximum specification is to ensure that the diameter of the balloon will not grow large enough to possibly go through the end plates of the vertebrae. | |
| | 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 $\ge$ 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 2 mL with 95% confidence and 90% reliability. |
| | Balloon Fatigue,
Unconstrained (TM-
009) | Inflate to maximum recommended volume of 2 mL, hold for 30 seconds / deflate; without leaks for 20 cycles. |
| Balloon Inflation,
Deflation Time (TM-
010) | The Osseoflex SB 2ml samples deflation times to be clinically equivalent to other marketed inflatable bone tamps. | |
| 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, 2ml meet or exceed all performance requirements, and are substantially equivalent to the predicate device. | | |
. ,
:
.
,
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
Osseon LLC % Mr. Keith Burger Director of Research and Development 2330 Circadian Way Santa Rosa, California 95407
Re: K140937
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: May 30, 2014 Received: June 2, 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 that I Dr. I has I 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); Jabeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
4
Page 2 - Mr. Keith Burger
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 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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017
See PRA Statemant below.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510(k) Number (if known) K140937
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 perculancous vertebral augmentation. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutancous 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)
Laurence D. Coyne -A
(Division Sign-OST) Division of Orthopedic Devices SID(k) Number: K 140937
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