(28 days)
No
The document describes a spinal fixation system composed of mechanical components (screws, rods, connectors) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies are bench tests of mechanical properties.
Yes.
The device is intended for posterior, non-cervical fixation as an adjunct to fusion for skeletally mature patients for various spinal conditions, indicating its therapeutic purpose in treating and alleviating these conditions.
No
The device description indicates it is a spinal system (screws and rods) for posterior fixation as an adjunct to fusion, which is a treatment, not a diagnostic tool.
No
The device description explicitly states that the system consists of physical components like screws and rods made from titanium or cobalt chrome alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. This is a therapeutic device used in vivo (within the body) to provide structural support.
- Device Description: The description details screws, rods, and connectors made of titanium or cobalt chrome, designed to be implanted into the spine. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an in vivo surgical implant.
N/A
Intended Use / Indications for Use
The Adena-Zina System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Adena-Zina Spinal System consists of a variety of shapes and sizes of screws and Ø5.5mm and Ø6.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, reduction screws, fixed angle reduction screws, multi-axial screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066).
The subject submission seeks to add ZINA II screws to the Adena-Zina Spinal System, along with associated class I instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non - cervical fixation; lumbar and sacral spine (levels may be from L3 to the sacrum/ilum)
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)
Bench performance testing was performed on the subject ZINA II screws including static compression bending, dynamic compression bending, and static torsion per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Performance bench testing has been performed and shows that the subject ZINA II screws perform equivalent to or better than the primary predicate device.
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.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
July 28, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Shanghai Sanyou Medical Co, LTD % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K231931
Trade/Device Name: Adena-Zina Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 30, 2023 Received: June 30, 2023
Dear Christine Scifert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image contains the name "Colin O'neill -S" in a large, clear font. The text is positioned on the left side of the image. To the right of the name, there is a faint, light blue watermark of the letters "FDA".
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Adena-Zina Spinal System
Indications for Use (Describe)
The Adena-Zina System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the Adena-Zina System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.
| 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) |
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3
510(k) Summary Adena-Zina Spinal System 30 June 2023
| Company: | Manufacturing Facility and Headquarters:
Shanghai Sanyou Medical Co, LTD
385 Huirong Road, Jiading District,
Shanghai 201815
Phone: 021-58389980 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | David Fan
VP Marketing
david.fan@sanyou-medical.com
Phone: +86 21 58389980
Fax: +86 21 59990826 |
| Official Correspondent: | Christine Scifert - MRC Global, LLC
Christine.Scifert@askmrcglobal.com
901-831-8053 |
| Secondary Correspondent: | Jen McBride - MRC Global, LLC
Jen.McBride@askmrcglobal.com
901-831-8053 |
| Trade Name: | Adena-Zina Spinal System |
| Common Name: | Thoracolumbosacral pedicle screw system |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3070 (Thoracolumbosacral pedicle screw system) |
| Panel: | Orthopedic |
| Product Code: | NKB |
Device Description:
The Adena-Zina Spinal System consists of a variety of shapes and sizes of screws and Ø5.5mm and Ø6.35mm rods that can be rigidly locked in a variety of configurations, with each construct being tailormade for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy or cobalt chrome alloy. Components of the system include the originally cleared (K152781) straight and pre-bent rods, reduction screws, fixed angle reduction screws, multi-axial screws, multi-axial reduction screws, T-links, domino connectors, sacro-illiac connectors, as well as the Duetto dual headed screws and connectors, along with associated set screws (K212066).
4
The subject submission seeks to add ZINA II screws to the Adena-Zina Spinal System, along with associated class I instruments.
Indications for Use:
The Adena-Zina Spinal System is intended for posterior, non - cervical fixation as an adjunct to fusion for skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. In addition, when used as a pedicle screw fixation system, the Adena-Zina Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Substantial Equivalence:
The subject Adena-Zina System is substantially equivalent to the following predicate devices:
Primary Predicate:
- Shanghai Sanyou Adena-Zina System K152781 ●
Secondary Predicates:
- Medtronic CD Horizon Fenestrated Screw Set- K152604; K193011
There are insignificant differences between the subject ZINA II screws and the predicate devices. The Indications for Use and Materials for predicate devices are all inclusive of the subject device, with the subject device materials and indications being identical to the primary predicate Adena-Zina System (K152781). The device design is similar to the secondary predicate Medtronic CD Horizon Fenestrated Screw Set (K152604). Performance bench testing has been performed and shows that the subject ZINA II screws perform equivalent to or better than the primary predicate device. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Bench performance testing was performed on the subject ZINA II screws including static compression bending, dynamic compression bending, and static torsion per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
Conclusion:
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.