(136 days)
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No
The summary describes a physical implant (cage) for spinal fusion and mentions only mechanical performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant intended to treat degenerative disc disease by facilitating interbody fusion, which clearly aligns with the definition of a therapeutic device.
No
The device description indicates it is a surgical implant (cage system) used for support during interbody fusion surgeries, not for diagnosing conditions.
No
The device description explicitly states the device consists of physical components (cages, marker pins) made of PEEK and Ti-6Al-4V, which are hardware materials. The performance studies also focus on mechanical testing of these physical components.
No, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant (a cage system) used to support the spine during fusion surgery. It is physically implanted into the patient's body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is structural support and facilitating bone fusion.
Therefore, based on the provided information, the Double Medical Cage System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage with autogenous bone graft (i.e. autograft).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
L2 to L5 (vertebral bodies)
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the proposed device conforms to ASTM F2077 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression, including:
- Static axial compression test
- Static compression shear test
- Dynamic axial compression test
- Dynamic compression shear test
- Subsidence Test
No clinical performance data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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Image /page/0/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Double Medical Technology Inc. Ms. Yan Zuo Regulatory Specialist No. 18 Shanbianhong East Road, Haicang District Xiamen, 361026 CHINA
February 1, 2018
Re: K172828
Trade/Device Name: Double Medical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 10, 2018 Received: January 12, 2018
Dear Ms. Zuo:
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);
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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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Indications for Use
510(k) Number (if known) K172828
Device Name Double Medical Cage System
Indications for Use (Describe)
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage with autogenous bone graft (i.e. autograft).
| 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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510(k) Summary
Submitter
Double Medical Technology Inc. No. 18, Shanbianhong East Road, Haicang District, Xiamen, 361026, P. R. China
Tel: 86-592-6885068 Fax: 86-592-6087671 Email: intl ra@double-medical.com; zuoyan@double-medical.com
Contact Person: Yan Zuo Date Prepared: Jan. 10th, 2018
Device
Trade /Proprietary Name: Double Medical Cage System Common or Usual Name: Double Medical Cage System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulatory Classification: Class II Product Code: MAX
Predicate Device
Primary predicate device:
K133053 Weigao Milestone Spinal System
Additional Predicates:
K100089 Synthes T-PAL Spacer
Device Description
Double Medical Cage System consists of cages of various lengths and heights, which can be inserted between two vertebral bodies to give support during interbody fusion surgeries. The cages consist of main bodies and marker pins. The main bodies are made of PEEK, which meets the requirements of ASTM F 2026-02 Standard Specification for
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Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications. Marker pins are made of Ti-6Al-4V following ASTM F 1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Allov for Surgical Implant Applications.
Indication for Use
Double Medical Cage System is indicated for use in patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 whose condition requires the use of interbody fusion combined with supplemental fixation. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Cage should be packed with autogenous bone graft (i.e. autograft).
Comparison with the Predicate Device
The rationale for substantial equivalence is based on consideration of the following characteristics: Regulatory Classification: Same as the predicate devices Indications for Use: Substantially equivalent (SE) to the predicate devices Materials: Substantially equivalent (SE) to the predicate devices Design Features: Substantially equivalent (SE) to the predicate devices
Non-Clinical Performance Data
Non-Clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
The test results demonstrated that the proposed device conforms to ASTM F2077 Test Methods For Intervertebral Body Fusion Devices and ASTM F2267 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression, including:
- Static axial compression test
- Static compression shear test
- Dynamic axial compression test
- Dynamic compression shear test
- Subsidence Test
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Clinical Performance Data
No clinical performance data is included in this submission.
Conclusion
The proposed device is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be Substantially Equivalent (SE) to the predicate device.