(104 days)
No
The device description and performance studies focus on the mechanical properties and structural integrity of the interbody fusion device, with no mention of AI or ML capabilities.
Yes
The device is implanted to treat degenerative disc disease and facilitate fusion, indicating a therapeutic purpose.
No
Explanation: The device, DISCOVERY, is described as a cervical interbody fusion device intended for surgical implantation to facilitate fusion in patients with degenerative disc disease. Its description focuses on its physical characteristics as an implant, not on diagnosing medical conditions or processing medical images for diagnostic purposes.
No
The device description clearly states it is a physical implant manufactured from PEEK and includes tantalum markers. It also describes mechanical testing performed on the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- DISCOVERY Device Function: The DISCOVERY device is an implantable medical device designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "anterior cervical interbody fusion procedures" and is "to be implanted via an open, anterior approach." This describes a surgical procedure, not an in vitro diagnostic test.
- Device Description: The description details the physical characteristics of the implant (material, shape, features) and its purpose in promoting bone integration. It does not mention any components or functions related to analyzing biological specimens.
Therefore, based on the provided information, the DISCOVERY device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Product codes
ODP
Device Description
The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
Indicated Patient Age Range
skeletally mature patients
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 following mechanical testing was performed per ASTM F2077 and F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the DISCOVER Y is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 888.3080 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.
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KIII 484
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510(k) Summary
SEP 1 2 2011
Summary of 510(k) Safety and Effectiveness
| Submitted By: | Intuitive Spine, LLC
16450-3 S. Tamiami Trail #112
Fort Myers, Florida 33908 |
|---------------------------------|------------------------------------------------------------------------------------|
| Date: | July 27, 2011 |
| Contact Person: | Jennifer Palinchik
Development and Regulatory Consultant |
| Contact Telephone: | (440) 933-8850 |
| Device Trade Name: | DISCOVERY |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, |
| Cervical Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Regulation Number: | 888.3080 |
| Product Code: | ODP |
| Predicate Device: | LDR Spine Cervical Interbody Fusion System (K091088) |
Device Description:
The DISCOVERY is a cervical interbertebral body fusion device consisting of teeth on the inferior and superior surfaces to prevent back out and migration. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various heights accommodate variability among patients and is manufactured from PEEK Optima® LT1 per ASTM F2026 and includes tantalum markers per ASTM F560.
Indications for Use:
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Substantial Equivalence Information:
The design features, material, and indications for use of the DISCOVERY device are substantially equivalent to the predicate device listed above. The safety and effectiveness is
1
adequately supported by the substantial equivalence, material information, and analysis data provided within this Premarket Notification.
Summary of Non-Clinical Test:
The following mechanical testing was performed per ASTM F2077 and F2267 to demonstrate substantial equivalence of the subject device to the predicate device: Static Compression, Dynamic Compression, Static Torsion, Dynamic Torsion, Subsidence, and Expulsion. The device functioned as intended and the performance results show that the DISCOVER Y is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intuitive Spine, LLC % Thogus Products Company / RP+M Ms. Jennifer Palinchik 33490 Pin Oak Parkway Avon Lake, Ohio 44012
SEP 1 2 2011
Re: K111484
Trade/Device Name: DISCOVERY Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 27, 2011 Received: September 27, 2011
Dear Ms. Palinchik:
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 ffor 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
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Page 2 - Ms. Jennifer Palinchik
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 device-related adverse evenis) (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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/wcm115809.html 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Erie O. Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K111484 510(k) Number (if known):
Device Name: DISCOVERY
Indications for Use:
The DISCOVERY is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion and is to be implanted via an open, anterior approach.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Difision of Surgical, Orthopedic, and Restorative Devices
510(k) Number_KIII 1484