(87 days)
Not Found
No
The document describes a physical intervertebral fusion device and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "intervertebral body fusion device" indicated for anterior cervical interbody fusion procedures to treat cervical degenerative disc disease, which involves addressing a medical condition (neck pain of discogenic origin with disc degeneration) and aiming to restore function (fusion of vertebrae).
No
The device described is an intervertebral body fusion device, which is an implant used in surgical procedures to promote spinal fusion. It is a therapeutic device, not a diagnostic one. The "radiographic studies" mentioned refer to confirmation of a pre-existing condition, not an function performed by the device itself.
No
The device description clearly states that the devices are physical implants made from PEEK and tantalum, and include titanium screws, plates, and set screws. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an "intervertebral fusion device" intended to be surgically implanted into the cervical spine to promote fusion. It acts as a spacer and holds bone graft.
- No Mention of Specimen Analysis: There is no indication that this device analyzes any biological specimens from the patient. Its function is mechanical and structural within the body.
Therefore, the Vu c.POD, Complete Cervical, and Zuma-C Systems are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
ODP, OVE
Device Description
The SeaSpine Vu c-POD, Complete Cervical, and Zuma-C Systems are intervertebral fusion devices intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. All three system spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers. The Complete Cervical spacers also include titanium alloy and screws (ASTM F136), while Zuma-C includes titanium screws, as well as plates and set screws (ASTM F136).
Each system spacer is generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The systems are implanted via an anterior approach.
The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
C2-C3
C7-T1
C3-C7
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)
Non-Clinical Testing:
There are no changes to the design, materials, specifications or manufacture of the implants, therefore no mechanical testing was performed for the Vu c Pod and Complete Cervical systems.
Engineering analysis verified that the device modifications in the Zuma-C did not create any new worst cases with respect to mechanical performance. Conclusions from previously performed mechancial testing per ASTM F2077 and F2267 remain valid.
Clinical Testing:
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
K171046, K111675, K101363, K050058, K032064, K102323, K092521
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
December 21, 2017
SeaSpine Orthopedics Corporation Gina Flores Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K172926
Trade/Device Name: SeaSpine Vu cPOD, Zuma-C, Complete Cervical Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, OVE Dated: September 22, 2017 Received: September 25, 2017
Dear Gina Flores:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name SeaSpine Vu c.POD
Indications for Use (Describe)
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Vu c.POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/ or corticocancellous bone and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c•POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart 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.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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name SeaSpine Zuma-C
Indications for Use (Describe)
Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart 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.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."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name SeaSpine Complete Cervical
Indications for Use (Describe)
The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Complete Cervical implants are to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant.
X Prescription Use (Part 21 CFR 801 Subpart 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.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."
5
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA | ||
| Phone number: | (760) 216-5136 | ||
| Fax number: | (760) 683-6874 | ||
| Contact person: | Gina Flores, Sr. Regulatory Specialist | ||
| Email address: | gina.flores@seaspine.com | ||
| Date Prepared: | September 22, 2017 | ||
| Device Name | |||
| Trade Name: | SeaSpine Vu c.POD, Complete Cervical, and Zuma-C | ||
| Common Name: | Intervertebral Fusion device with bone graft, cervical | ||
| Classification Name: | Intervertebral fusion device with integrated fixation, cervical | ||
| (21 CFR 888.3080) | |||
| Class: | II | ||
| Product Code: | ODP OVE |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K171046 | ODP | Cambria System | SeaSpine Orthopedics Corporation |
| Additional PREDICATE Devices | |||
| K111675,K101363, | |||
| K050058, K032064 | ODP | Vu c-POD | SeaSpine Orthopedics Corporation |
| (originally manufactured by Integra | |||
| LifeSciences, now SeaSpine | |||
| Orthopedics Corporation) | |||
| K102323 | ODP | Complete Cervical | SeaSpine Orthopedics Corporation |
| (originally manufactured by Theken, | |||
| LLC, now SeaSpine Orthopedics | |||
| Corporation) | |||
| K092521 | ODP | Zuma-C | SeaSpine Orthopedics Corporation |
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Device Description
The SeaSpine Vu c-POD, Complete Cervical, and Zuma-C Systems are intervertebral fusion devices intended to act as a disc spacer and hold bone graft to promote fusion in the cervical spine. All three system spacers are manufactured from PEEK (ASTM F2026), with tantalum (ASTM F560) radiographic markers. The Complete Cervical spacers also include titanium alloy and screws (ASTM F136), while Zuma-C includes titanium screws, as well as plates and set screws (ASTM F136).
Each system spacer is generally box-shaped with a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The systems are implanted via an anterior approach.
The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for use
Vu c·POD:
The Vu coPOD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Vu c•POD implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu coPOD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems.
Complete Cervical:
The Complete Cervical Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The Complete Cervical implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had six (6) weeks of non-operative treatment. The cervical device is to be used with two titanium alloy screws which accompany the implant.
Zuma-C:
Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by
7
history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.
Summary of Technological Characteristics
The SeaSpine Vu c-POD, Complete Cervical, and Zuma-C Systems and the predicate devices have the same operational principle; they act as a disc spacer and hold bone graft to promote fusion in the cervical spine. The SeaSpine Vu c POD, Complete Cervical, and Zuma-C Systems are substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
Non-Clinical Testing
There are no changes to the design, materials, specifications or manufacture of the implants, therefore no mechanical testing was performed for the Vu c Pod and Complete Cervical systems.
Engineering analysis verified that the device modifications in the Zuma-C did not create any new worst cases with respect to mechanical performance. Conclusions from previously performed mechancial testing per ASTM F2077 and F2267 remain valid.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Vu c.POD. Complete Cervical, and Zuma-C Systems are substantially equivalent to the cited legally marketed predicate devices