(214 days)
P980048
Not Found
No
The summary describes a passive intervertebral spacer made of inert materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes.
The device is indicated for intervertebral body fusion in patients with degenerative disc disease, which involves treating a medical condition for health restoration.
No
Explanation: This device is described as an intervertebral body fusion spacer, which is an implantable device used to facilitate fusion and maintain spacing, not to diagnose a condition. The "Indications for Use" section describes the patient population the device is intended for, but does not state that the device itself performs any diagnostic function.
No
The device description explicitly states the device is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy, indicating it is a physical implant, not software.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Eclipse Vertebral Spacer System-Cervical is an implantable device designed to be surgically placed in the cervical spine to maintain spacing and facilitate bone fusion. It is a physical device used within the body, not a test performed on samples from the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2 to 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)
Mechanical Test Data:
The following testing was performed on this device:
- Axial Compression Static & Dynamic per ASTM F 2077 .
- Compression-Shear Static & Dynamic per ASTM F 2077 .
- Torsion Static & Dynamic per ASTM F 2077 .
- Subsidence per ASTM F 2267 ●
- Expulsion per ASTM Draft F04.25.02.02 ●
Conclusion: ASTM Standards F2077, F2667 and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use
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.
P980048, LDR Spine Cervical Interbody Fusion System, ROI-C, SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage
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
§ 888.3080 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
Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JAN - 7 2011
Submitter Information
| Submitter's Name: | Apollo Spine |
|---|---|
| Address: | 3700 Campus Dr. Suite 105 |
| Newport Beach, CA 92660 | |
| Telephone: | 949-645-1615 |
| Fax: | 949-757-0460 |
| Contact Person: | Christine Santagate, STD Medical |
| Telephone : | 781-828-4400 |
| Fax : | 781-344-5895 |
| Date Prepared: | June 4, 2010 |
| Device Trade Name: | Eclipse Vertebral Spacer-Cervical |
| Common/Usual Name: | Intervertebral body fusion device |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code(s): | ODP |
Predicate Device(s):
- Eate Device(s).
BAK/Cervical (BAK/C®), P980048, Zimmer Spine, Approved 4/20/01 ● - LDR Spine Cervical Interbody Fusion System, ROI-C, Approved 4/15/09 .
- SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage, Approved . 10/30/09
Substantial Equivalence:
The Eclipse Vertebral Spacer-Cervical was shown to be substantially equivalent to The Lonpo Vertobial Space. Sen the same indications for use, design, function, and materials used.
. ・
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101588
Page 2 of 2
Apollo Spine . Premarket Notification 510(k) Eclipse Vertebral Spacer June 4, 2010
JAN - 7 2011
Device Description:
The Eclipse Vertebral Spacer-Cervical acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Eclipse Vertebral Spacer is manufactured from PEEK, unalloyed titanium, and Ti6Al4V titanium alloy. "
Indications:
When used as an Intervertebral Body Fusion System:
The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.
Mechanical Test Data:
The following testing was performed on this device:
- Axial Compression Static & Dynamic per ASTM F 2077 .
- Compression-Shear Static & Dynamic per ASTM F 2077 .
- Torsion Static & Dynamic per ASTM F 2077 .
- Subsidence per ASTM F 2267 ●
- Expulsion per ASTM Draft F04.25.02.02 ●
Conclusion:
ASTM Standards F2077, F2667 and Draft F04.25.02.02 (Expulsion Testing) were adhered to and all applicable requirements were met. Test results demonstrate that the Eclipse Spacer is substantially equivalent to publically available data for the predicate devices and therefore demonstrate its suitability for its intended use
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three heads, depicted in a flowing, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Apollo Spine % STD Medical, Inc. Ms. Christine Santagate 3700 Campus Drive, Suite 105 Newport Beach, CA 92660
SEP 12 2311
Re: K101588
Trade/Device Name: Eclipse Vertebral Spacer System-Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 20, 2010 Received: December 29, 2010
Dear Ms. Santagate:
This letter corrects our substantially equivalent letter of January 7, 2011.
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 (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 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
3
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A Milheim
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Apollo Spine Premarket Notification 510(k) Eclipse Vertebral Spacer - Cervical June 4, 2010
Page 1//
JAN - 7 2911
Indications for Use Statement
510(k) Number (if known):
101588
Device Name: Eclipse Vertebral Spacer System
Indications for Use:
The Eclipse Vertebral Spacer System-Cervical is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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) Division of Surgical, Orthopedic, and Restorative Devices
KIO1588 510(k) Number_