(68 days)
Not Found
No
The device description focuses on the material, shape, and mechanical properties of a spinal cage implant. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests evaluating structural integrity.
Yes
The device is intended for use in patients with degenerative disc disease to provide support and correction during lumbar interbody fusion surgeries, which is a therapeutic intervention.
No
The device is a PEEK lumbar cage designed for interbody fusion surgeries, providing support and correction. Its function is to facilitate fusion and provide mechanical support, not to diagnose conditions.
No
The device description clearly states the device is manufactured from a biocompatible polymer (PEEK) and includes radiopaque tantalum marker pins. It is a physical implant (lumbar cage) used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used with bone graft for spinal fusion in patients with degenerative disc disease. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a physical implant made of PEEK material, designed to be inserted between vertebrae. This is a medical device used in surgery, not a diagnostic tool that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information about a patient's condition based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The Gemini Medical Cage System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Gemini Medical Cage System is manufactured from a biocompatible polymer (Polyetheretherketone (PEEK)) material embedded with radiopaque tantalum marker pins, which allow the surgeon to radiographically determine the position of the implant, both intraoperatively and postoperatively. The System consists of PEEK lumbar cages of various shape and size, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries.They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The top surface of the cages have anatomical design, parallel design and wedge-shaped design respectively to adapt various vertebrae anatomical scenarios. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages are sterile provided and for single use.
There are six models to accommodate different types of superior and inferior end plates depending on their technical design and shape, LF-I, LF-II, LF-III, LF-IV, LF-V and LF-VI.
LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II has flat top and bottom tooth surface, LF-III and LF-V have flat or wedge-shaped surface.
LF-III, LF-IV and LF-V cages have a convex angle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar or lumbosacral vertebral bodies, L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Performance-bench test including:
Static Axial Compression Testing per ASTM F2077
Dynamic Axial Compression Testing per ASTM F2077
Static Compression Shear Testing per ASTM F2077
Dynamic Compression Shear Testing per ASTM F2077
Subsidence Test per ASTM F2267
The non-clinical data demonstrates the Gemini Medical Cage System is substantially equivalent to the 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.
K073291, K101923, K100089, K072791, K132897
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 logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2024
ZheJiang Decans Medical Devices Co., Ltd. % Xiaoqing Xue Registration Engineer Sinow Medical AS Vestre Fantoftåsen 44 Bergen, 5072 Norway
Re: K242267
Trade/Device Name: Gemini Medical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 1, 2024 Received: August 1, 2024
Dear Xiaoqing Xue:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Brent Showalter -S
Brent Showalter, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K242267
Device Name Gemini Medical Cage System
Indications for Use (Describe)
The Gemini Medical Cage System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental 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) |
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4
510(K) Summary
| Preparation Date: | Sep. 25, 2024 | ||
|---|---|---|---|
| Submitter | ZheJiang Decans Medical Devices Co., Ltd. | ||
| No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing | |||
| City, Zhejiang Province, 314031,P.R. China | |||
| Haifeng Liu, Registration Manager | |||
| Contact | ZheJiang Decans Medical Devices Co., Ltd. | ||
| No.2836 Xincheng Avenue, Gaozhao Street, Xiuzhou District, Jiaxing | |||
| City, Zhejiang Province, 314031,P.R. China | |||
| Postcode: 314031 | |||
| Email: hfliu@decansmd.com | |||
| Phone:+86 15210058659 | |||
| Designated | |||
| Submission | |||
| Correspondent | Company: Sinow Medical AS | ||
| Address: Vestre Fantoftåsen 44, 5072, Bergen, Norway | |||
| Contact Person: Xiaoqing Xue | |||
| Telephone: +86 15161196032 | |||
| Email: xue@bergemed.com | |||
| Subject Device | Trade name | Gemini Medical Cage System | |
| Regulatory Class | II | ||
| Regulation Number | 21 CFR 888.3080 | ||
| Classification Name | Intervertebral body fusion device | ||
| Product Codes | MAX | ||
| Common name for | |||
| product codes | Intervertebral fusion device with bone graft, | ||
| lumbar | |||
| Primary Predicate | |||
| Device | Manufacturer | Medtronic Sofamor Danek USA. Inc. | |
| Trade name | CAPSTONE SPINAL SYSTEM | ||
| 510(K) number | K073291 | ||
| Regulatory Class | II | ||
| Regulation Number | 21 CFR 888.3080 | ||
| Classification Name | Intervertebral body fusion device | ||
| Product Codes | MAX | ||
| Additional Predicate | |||
| Devices | Manufacturer | DePuy Synthes | |
| Trade name /510(K) | |||
| number | K101923, CONCORDE CURVE SYSTEM | ||
| K100089, SYNTHES T-PAL SPACER | |||
| K072791, SYNTHES ORACLE PLATE | |||
| Regulatory Class | II | ||
| Regulation Number | 21 CFR 888.3080 | ||
| Product Codes | MAX | ||
| Classification Name | Intervertebral body fusion device | ||
| Additional Predicate | |||
| Device | Manufacturer | Medtronic Sofamor Danek USA. Inc. | |
| Trade name | CLYDESDALE SPINAL SYSTEM | ||
| 510(K) number | K132897 | ||
| Regulatory Class | II | ||
| Regulation Number | 21 CFR 888.3080 | ||
| Product Codes | MAX | ||
| Classification Name | Intervertebral body fusion device | ||
| Indications for use | The Gemini Medical Cage System is indicated for use with autogenous | ||
| bone graft in patients with degenerative disc disease (DDD) at one or | |||
| two contiguous levels from L2 to S1. These DDD patients may also | |||
| have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved | |||
| levels. These patients should be skeletally mature and have had six | |||
| months of non-operative treatment. These devices are intended to be | |||
| used with supplemental fixation. | |||
| Device Description | Gemini Medical Cage System is manufactured from a biocompatible | ||
| polymer (Polyetheretherketone (PEEK)) material embedded with | |||
| radiopaque tantalum marker pins, which allow the surgeon to | |||
| radiographically determine the position of the implant, both | |||
| intraoperatively and postoperatively. The System consists of PEEK | |||
| lumbar cages of various shape and size, which can be inserted between | |||
| two lumbar or lumbosacral vertebral bodies to give support and | |||
| correction during lumbar interbody fusion surgeries.They are designed | |||
| with angular teeth to allow the implant to grip the superior and inferior | |||
| end plates. The top surface of the cages have anatomical design, parallel | |||
| design and wedge-shaped design respectively to adapt various vertebrae | |||
| anatomical scenarios. The hollow geometry of the implants allows them | |||
| to be packed with autogenous bone graft in lumbar interbody fusion | |||
| procedures. The cages are sterile provided and for single use. | |||
| There are six models to accommodate different types of superior and | |||
| inferior end plates depending on their technical design and shape, LF-I, | |||
| LF-II, LF-III, LF-IV, LF-V and LF-VI. | |||
| LF-I, LF-IV and LF-VI have curved top and bottom tooth surface, LF-II | |||
| has flat top and bottom tooth surface, LF-III and LF-V have flat or | |||
| wedge-shaped surface. | |||
| LF-III, LF-IV and LF-V cages have a convex angle. | |||
| Summary of | |||
| indication for use | |||
| and technological | |||
| characteristics | The Gemini Medical Cage System is substantially equivalent to the | ||
| predicate devices when evaluating indication for use and technological | |||
| characteristics. | |||
| The subject device has the identical indication for use as the predicate | |||
| device. The subject device and predicate devices are substantially | |||
| equivalent, differences do not raise new questions of safety and | |||
| effectiveness. | |||
| Non-clinical test | Performance-bench test including: | ||
| Static Axial Compression Testing per ASTM F2077 | |||
| Dynamic Axial Compression Testing per ASTM F2077 | |||
| Static Compression Shear Testing per ASTM F2077 | |||
| Dynamic Compression Shear Testing per ASTM F2077 | |||
| Subsidence Test per ASTM F2267 | |||
| Substantial | |||
| Equivalence | The Gemini Medical Cage System is substantially equivalent to the | ||
| predicate devices when evaluating indication for use and technological |
5
6
| | characteristics with only minor differences. These differences do not
raise new questions of safety and effectiveness. |
|------------|---------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The non-clinical data demonstrates the Gemini Medical Cage System is |
| | substantially equivalent to the predicate device. |