K Number
K072289
Device Name
SPINEFRONTIER DORADO VBR
Date Cleared
2007-11-01

(77 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Device Description
The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. The system is comprised of devices of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist implant pullout.
More Information

P960025, P950002

Not Found

No
The summary describes a physical implant (intervertebral body cage) and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.

Yes
The device is described as an intervertebral body cage for patients with degenerative disc disease, intended to treat a pathological condition and restore function.

No

The device description indicates it is an intervertebral body cage, which is an implant used for spinal fusion, not for diagnosing conditions.

No

The device description clearly states it is a spinal intervertebral body cage, which is a physical implant, not software. The performance studies also describe mechanical testing of the physical device.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The description clearly states the DORADO™ Intervertebral Body Cage is a physical implant intended for surgical placement in the spine. It is used with bone graft and supplemental fixation systems.
  • Intended Use: The intended use describes a surgical procedure to treat degenerative disc disease by fusing vertebrae, not a diagnostic test performed on a sample.

The information provided describes a surgical implant, not a diagnostic device.

N/A

Intended Use / Indications for Use

The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

Product codes

MAX

Device Description

The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. The system is comprised of devices of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist implant pullout.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spinal levels from L2-S1

Indicated Patient Age Range

Skeletally mature

Intended User / Care Setting

Not Found

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)

The testing method for the DORADO™ Intervertebral Body Cage followed ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices," ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression," and ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Methods for Intervertebral Body Fusion Devices." Draft #2 - August 29, 2000.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

P960025, P950002

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

0

072289

NOV -- 1 2007

5.0 510(k) Summary

1. Sponsor

SpineFrontier, Inc. 100 Cummings Center Suite 240C Beverly, MA 01915

Primary Contact:Mr. Thomas A. Carlson
Telephone:1-978-232-3990

October 16, 2007 Date Prepared:

2. Device Name:

Proprietary Name:DORADO™ Intervertebral Body Cage
Common/Usual Name:Intervertebral Fusion Device With Bone Graft,
Lumbar
Classification Name:Intervertebral Fusion Device With Bone Graft,
Lumbar
(21 CFR 888.3080), Class II, Product Code
MAX

3. Predicate Device(s)

P960025 - Saber Lumbar I/F Cage and Jaguar Lumbar I/F Cage P950002 - BAK Interbody Fusion System with Instrumentation

4. Device Description

The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. The system is comprised of devices of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist implant pullout.

5. Intended Use

The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I

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K072289
Page 2 of 2

spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

6. Technological Characteristics and Substantial Equivalent

The SpineFrontier DORADO™ Intervertebral Body Cage and its predicate device have the same indications for use and operating principles.

Representative samples of the device were tested according to ASTM standards to demonstrate comparable functional and performance characteristics to the predicate device. The 17mmx25mm device was selected for testing to support the addition of the 17mm device. Although the DORADO™ cage (Peek Optima®-LT1 ®) and predicate (CFR-Peek Optima®) materials vary slightly in content, the results of the ASTM mechanical testing demonstrate substantial equivalence.

7. Performance Testing

The testing method for the DORADO™ Intervertebral Body Cage followed ASTM F2077-03, "Test Methods for Intervertebral Body Fusion Devices," ASTM F2267-04, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression," and ASTM Draft Standard F-04.25.02.02, "Static Push-out Test Methods for Intervertebral Body Fusion Devices." Draft #2 - August 29, 2000.

2

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail feathers. The eagle is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2007

SpineFrontier, Incorporated c/o Mr. Tom Carlson Chief Operating Officer 100 Cummings Center, Suite 240C Beverly, MA 01915

Re: K072289

Trade/Device Name: Dorado™ Intervertebral Body Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 16, 2007 Received: October 17, 2007

Dear Mr. Carlson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

3

Page 2 - Mr. Tom Carlson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark A. Mellauson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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K072289
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Indications for Use Statement 4.0

510(k) Number (if Known): _____ K072289

Indications for Use:

The DORADO™ Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Over-The-Counter Use: Prescription Use: _X AND/OR (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C)

Mark A. Melkerson

(Divasion Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K072289