K172828 · Double Medical Technology, Inc. · MAX · Feb 1, 2018 · Orthopedic
Device Facts
Record ID
K172828
Device Name
Double Medical Cage System
Applicant
Double Medical Technology, Inc.
Product Code
MAX · Orthopedic
Decision Date
Feb 1, 2018
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3080
Device Class
Class 2
Attributes
Therapeutic
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).
Device Story
Double Medical Cage System comprises PEEK cages with titanium marker pins; designed for insertion between vertebral bodies to provide structural support during interbody fusion surgery. Used in clinical settings by surgeons; device must be packed with autogenous bone graft. Provides mechanical stabilization of the disc space to facilitate fusion; intended for patients with degenerative disc disease. Benefits include restoration of disc height and promotion of spinal fusion.
Clinical Evidence
No clinical data. Bench testing only.
Technological Characteristics
Intervertebral body fusion device; materials: PEEK (ASTM F2026-02) and Ti-6Al-4V (ASTM F1472-14). Mechanical design includes cages of various heights/lengths with marker pins. Testing performed per ASTM F2077 and ASTM F2267.
Indications for Use
Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels from L2 to L5 requiring interbody fusion with supplemental fixation, following six months of failed non-operative treatment.
Regulatory Classification
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.
Special Controls
*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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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) | |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">✖</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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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.
