(265 days)
No
The summary describes a bone cement and fenestrated screw system for spinal stabilization, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is used to restore the integrity of the spinal column, which is a therapeutic action.
No
The device, a spinal cement and fenestrated screw system, is used to restore the integrity of the spinal column, which is a therapeutic rather than a diagnostic function.
No
The device description clearly details physical components: spinal cement (PMMA) and fenestrated screws. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that the device is a spinal cement and screw system used to restore the integrity of the spinal column in patients with advanced stage tumors. This is a surgical implant and a material used in a surgical procedure, not a test performed on a sample outside the body.
- Lack of Mention of Samples or Testing: The text does not mention any collection of biological samples, laboratory testing, or diagnostic procedures.
Therefore, this device falls under the category of a surgical implant/device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CONFIDENCE™ High Viscosity Spinal Cement
When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
VIPER® and EXPEDIUM® Fenestrated Screw Systems
When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes (comma separated list FDA assigned to the subject device)
PML, MNI
Device Description
-
- The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 testing and clinical data were submitted to characterize the subject components in this notification. The data provided supports the substantial equivalence of the subject devices.
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.
Medtronic KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, K152604
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.
EXPEDIUM Verse Spine System, K142185, EXPEDIUM and VIPER Cortical Fix Screws, K110216, CONFIDENCE High Viscosity Spinal Cement, K112907, K060300
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 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 circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2016
Medos International Sárl % Jeffrey Shiffman, J.D., M.S. Senior Regulatory Affairs Specialist DePuy Spine, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K160879
Trade/Device Name: CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, MNI Dated: November 17, 2016 Received: November 18, 2016
Dear Mr. Shiffman:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
Mark N. Melkerson -S
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
510(k) Number (if known) K160879
Device Name CONFIDENCE™ High Viscosity Spinal Cement
Indications for Use (Describe)
When the CONFIDENCE 114 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K160879
Device Name
VIPER® and EXPEDIUM® Fenestrated Screw Systems
Indications for Use (Describe)
When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE™ High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| A. | Submitter Information | ||
|---|---|---|---|
| Manufacturer: | Medos International Sárl | ||
| Chemin-Blanc 38 | |||
| 2400 Le Locle, Switzerland | |||
| Submitter: | DePuy Spine, Inc. | ||
| 325 Paramount Drive | |||
| Raynham, MA 02767 | |||
| Contact Person: | Jeffrey Shiffman, J.D., M.S. | ||
| 325 Paramount Drive | |||
| Raynham, MA 02767 | |||
| Telephone number: | 508-977-3857 | ||
| Fax number: | 508-828-3797 | ||
| Email: | jshiffma@its.jnj.com | ||
| B. | Date Prepared | December 16, 2016 | |
| C. | Device Name | ||
| Trade/Proprietary Name: | 1) CONFIDENCE™ High Viscosity Spinal | ||
| Cement |
- VIPER® and EXPEDIUM® Fenestrated Screw
Systems | |
| | Common/Usual Name: | 1) Polymethylmethacrylate (PMMA) bone cement; - Pedicle screw spinal system | |
| | Classification Name and
Product Classification Code: | 1) Bone cement, posterior screw augmentation per
21 CFR §888.3027
PML - Orthosis, Pedicle screw spinal fixation
per 21 CFR §888.3070:
MNI | |
D. Predicate Device Name
Primary: Medtronic KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set, K152604 Reference: EXPEDIUM Verse Spine System, K142185 EXPEDIUM and VIPER Cortical Fix Screws, K110216 CONFIDENCE High Viscosity Spinal Cement, K112907, K060300
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E. Device Description
-
- The VIPER® and EXPEDIUM® Fenestrated Screw Systems are designed with a cortical fix screw shank that is fully cannulated with lateral fenestrations at the distal end which allow for the controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement. The design of the distally fenestrated screws provides a controlled means to deliver PMMA cement into the vertebral body. The screws are available in diameters of 4.35, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0mm and lengths of 30-80mm (in 5mm increments). Screws with lengths of 30mm have three fenestrations and screw lengths of 35mm and longer have six fenestrations. The VIPER® fenestrated screws are compatible with the VIPER System, VIPER2 and EXPEDIUM 5.5 Spine Systems (K111136) and the EXPEDIUM fenestrated screws are compatible with the EXPEDIUM VERSE® System (K142185).
F. Intended Use
-
- When CONFIDENCE 100 High Viscosity Spinal Cement is used in conjunction with the VIPER® and EXPEDIUM® Fenestrated Screw Systems, the cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE 110 High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
-
- When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the VIPER® and EXPEDIUM® Fenestrated Screw Systems are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The VIPER® and EXPEDIUM® Fenestrated Screw Systems augmented with the CONFIDENCE ! 10 High Viscosity Spinal Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
6
G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
-
- CONFIDENCE™ High Viscosity Spinal Cement is cleared via K060300 and K112907. The sterilization method for the subject cement has not changed from K060300 and K112907, and incorporates bacterial endotoxin testing applying the 20 EU/mL pyrogen limit specification utilizing the Limulus amebocyte lysate (LAL) test.
The difference between the predicate and subject cement is the delivery method of the cement. Although the cement delivery system is not changing, the additional delivery method and expanded indications enables the subject cement to be delivered through the cannulated fenestrated screw for a controlled flow of cement into the pedicle.
- CONFIDENCE™ High Viscosity Spinal Cement is cleared via K060300 and K112907. The sterilization method for the subject cement has not changed from K060300 and K112907, and incorporates bacterial endotoxin testing applying the 20 EU/mL pyrogen limit specification utilizing the Limulus amebocyte lysate (LAL) test.
CONFIDENCE™ High Viscosity Spinal Cement is similar to the Medtronic KYPHON HV-R Fenestrated Screw Cement (K152604) as both devices are viscous, polymethylmethacrylate material that hardens over time. After a screw is placed posteriorly within a prepared bone canal, the cement is delivered through the cannulated screw and out through the distal fenestrations. Both the predicate and proposed devices are intended to augment the fixation of screws in a posterior spinal system construct.
-
- The VIPER® and EXPEDIUM® Fenestrated Screw Systems are similar to Medtronic CD Horizon Fenestrated screws (K152604). The proposed screw designs are similar to the predicate with fully cannulated screw shanks with side fenestrations at the distal tip to allow cement delivery. The intended use is similar as both the predicate and proposed devices are intended to provide immobilization and stabilization of spinal segments.
H. Materials
-
- The powder component of the CONFIDENCE™ High Viscosity Spinal Cement is composed of acrylic polymer, benzoyl peroxide and barium sulphate. The liquid component of the CONFIDENCE™ High Viscosity Spinal Cement contains both methyl methacrylate monomer, hydroquinone (HQ) and N. N-Dimethyl-p-Toluidine (DMpT). The complete material composition of CONFIDENCE™ High Viscosity Spinal Cement can be found in K060300 and K112907.
-
- The VIPER® and EXPEDIUM® Fenestrated Screw Systems are manufactured from ASTM F 136 implant grade titanium alloy and ASTM F1537 cobalt chromium alloy.
I. Performance Data
Non-clinical testing and clinical data were submitted to characterize the subject components in this notification. The data provided supports the substantial equivalence of the subject devices.
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J. Conclusion
The performance testing, clinical literature, and substantial equivalence justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.