(29 days)
The Eclipse-C Vertebral Spacer System 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-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.
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.
The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device.
The provided text describes a 510(k) submission for the Apollo Spine Eclipse Vertebral Spacer-Cervical, aiming to add an additional footprint size to an already cleared device. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria based on human or AI performance.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance criteria table and reported device performance.
- Sample size for the test set and data provenance.
- Number of experts and their qualifications used to establish ground truth for the test set.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size for AI assistance.
- Standalone (algorithm only) performance study details.
- Type of ground truth used for performance evaluation.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation from the document:
The submission explicitly states its purpose: "The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device." It then compares the subject device to the predicate device (K101588) and concludes: "The dimensional differences between the subject device and the predicate are not considered significant because the new size does introduce a new worst case condition...and therefore does not raise new questions regarding safety and effectiveness of the device."
Regarding performance, the document says: "In consideration of design control activities including risk analysis the non-clinical performance testing performed on the Eclipse Vertebral Spacer Cervical (K101588) including static compression, static torsion, subsidence, and expulsion are applicable in the characterization of the new size because the new size does not introduce a new worst case condition..., therefore additional mechanical testing on the new size is not warranted."
Finally, it summarizes: "Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate device."
This indicates that the submission relies on the existing safety and effectiveness data of the predicate device and argues that the minor dimensional change does not warrant new performance studies or acceptance criteria beyond established engineering and design principles for substantial equivalence. The document does not describe any studies involving human readers, AI, or clinical outcomes that would require acceptance criteria in the context of diagnostic or prognostic performance.
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FEB 1 6 2012
201614
SPECIAL 510(K) SUMMARY
Submitter Information
| Submitter's Name: | Apollo Spine |
|---|---|
| Address: | 3700 Campus Dr. Suite 105Newport Beach, CA 92660 |
| Telephone: | 949-645-1615 |
| Fax: | 949-757-0474 |
| Contact Person: | Michele Lucey |
| Telephone : | 603-748-1374 |
| Date Prepared: | 15 Feb 2012 |
|---|---|
| Device Trade Name: | Eclipse Vertebral Spacer-Cervical |
| Common/Usual Name: | Spinal Intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3080, 888.3060 |
| Class: | II |
| Product Code: | ODP |
Intended Use:
When used as an Intervertebral Body Fusion System:
The Eclipse-C Vertebral Spacer System 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-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.
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.
The purpose of this submission is to add an additional footprint in the same heights and lordotic angles as the predicate device.
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Comparison to Predicate Device(s):
The indication for use and material composition of The Eclipse Vertebral Spacer-Cervical are the same as the currently cleared predicate device, The Eclipse Vertebral Spacer System (K101588). The only difference is the addition of a foot print size with a resulting increase in the graft chamber area:
| Predicate Eclipse Vertebral-Spacer(K101588) | The Eclipse Vertebral- Spacer (SubjectDevice) |
|---|---|
| 11 x 14 mm depth x width | 11 x 14 mm depth x width |
| 14 x 16 mm depth x width (new) |
The dimensional differences between the subject device and the predicate are not considered significant because the new size does introduce a new worst case condition (e.g. introduction of a new region with decreased cross sectional area compared to the predicate) and therefore does not raise new questions regarding safety and effectiveness of the device.
Performance Standards:
In consideration of design control activities including risk analysis the non-clinical performance testing performed on the Eclipse Vertebral Spacer Cervical (K101588) including static compression, static torsion, subsidence, and expulsion are applicable in the characterization of the new size because the new size does not introduce a new worst case condition (e.g. introduction of a new region with decreased cross sectional area compared to the predicate), therefore additional mechanical testing on the new size is not warranted.
Performance and SE Determination:
Based on the supporting documentation within this premarket notification, the subject device demonstrates substantial equivalence to the listed predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Apollo Spine % Lakeshore Medical Device Consulting, LLC Ms. Michele Lucey 128 Blye Hill Landing Newbury, New Hampshire 03255
FEB 1 6 2012
Re: K120143
Trade/Device Name: Eclipse Vertebral Spacer System - Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: January 17, 2012 Received: January 18, 2012
Dear Ms. Lucey:
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 or any I vith all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Jane Weber
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
y yours,
Malle
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 Inc. Eclipse Vertebral Spacer System - Cervical Special Premarket Notification 510(k)
17 Jan 2012
Indications for Use Statement
12120143 510(k) Number:
Device Name: Eclipse Vertebral Spacer System - Cervical
Indications for Use:
The Eclipse-C Vertebral Spacer Sy stem is indicated for in tervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) o f the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degene ration of the dis c confirmed by history and as pain of ansolgens These pa tients should have com pleted six weeks of non-operative treatment. The Eclips e-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.
X Prescription Use (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
K120143 510(k) Number.
§ 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.