(291 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a spinal implant and associated instruments. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are based on non-clinical testing against standards and comparison to a predicate device, not on the performance of an AI/ML model.
Yes
The device is a spinal system indicated for interbody fusion in patients with degenerative disc disease, which is a condition that causes pain and degeneration of the disc. The device is used to treat this condition by providing support and correction during lumbar interbody fusion surgeries, which is a therapeutic intervention.
No
The Milestone™ Spinal System is an implantable device used for interbody fusion in patients with degenerative disc disease. It is a therapy device, not a diagnostic one. While it mentions "radiographic studies" to confirm disc degeneration, the device itself does not perform any diagnostic function.
No
The device description explicitly states it consists of physical lumbar cages made of PEEK material and includes various device-specific instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Milestone Spinal System Function: The Milestone Spinal System is a surgical implant (lumbar cage) used for interbody fusion in the spine. It is a physical device implanted into the body to provide structural support and facilitate bone growth.
- Intended Use: The intended use clearly states it's for "interbody fusion with autogenous bone graft in patients with degenerative disc disease." This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description details a physical implant made of PEEK material with specific design features for surgical implantation.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information based on such analysis. The "radiographic studies" mentioned are used to confirm the diagnosis of DDD and guide the surgical procedure, not as input for the device itself to perform a diagnostic function.
In summary, the Milestone Spinal System is a surgical implant used for treatment, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two 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 hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
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)
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 complies with the following standards:
- 1SO11137-2:2012, Sterilization of healthcare products-Radiation-Part 2: Establishing the sterilization dose:
- USP Bacterial Endotoxin Limit;
- ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F 2077-03 Test Methods For Intervertebral Body Fusion Devices
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
§ 888.3080 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
K133053 Page 1 of 4
JUL 1 5 2014
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________
-
7.1 Date of Submission
07/14/2014 -
7.2 Sponsor Identification
Weigao Orthopaedic Device Co., Ltd.
No 26 Xiangjiang Road, Tourist Resorts Weihai, Shandong, 264203, China
Establishment Registration Number: 3006639944
Contact Person: Han Wang Position: Quality & Technique Manager Tel: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com
7.3 Designated Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
1
7.4 Identification of Proposed Device
Trade Name: Milestone™ Spinal System Common Name: Intervertebral Body Fusion Device
Regulatory Information: Classification Name: Intervertebral body fusion device Classification: II; Product Code: MAX: Regulation Number: 21 CFR 888.3080; Review Panel: Orthopedic;
Intended Use Statement:
The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
7.5 Device Description
The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two 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 hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.
7.6 Identification of Predicate Device
510(k) Number: K073291 Product Name: CAPSTONE® Spinal System Manufacturer: Medtronic Sofamor Danek USA, Inc.
2
7.7 Non-Clinical Test Conclusion
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 complies with the following standards:
- 公 1SO11137-2:2012, Sterilization of healthcare products-Radiation-Part 2: Establishing the sterilization dose:
- ア USP Bacterial Endotoxin Limit;
- ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials; ア
- 公 ASTM F 2077-03 Test Methods For Intervertebral Body Fusion Devices
- 7.8 Clinical Test Conclusion
No clinical study is included in this submission.
- 7.9 Substantially Equivalent (SE) Comparison
| Item | Proposed Device(s) | Predicate Device(s) |
|---|---|---|
| Product Code | MAX | MAX |
| Regulation Number | 21 CFR 888.3038 | 21 CFR 888.3038 |
| Intended Use | The Milestone™ Spinal System is | The CAPSTONE® Spinal System is |
| indicated for interbody fusion with | indicated for with autogenous bone | |
| autogenous bone graft in patients | graft in patients with degenerative | |
| with degenerative disc disease | disc disease (DDD) at one or two | |
| (DDD) at one or two levels from | contiguous levels from L2 to S1. | |
| L2 to S1. These DDD patients may | These DDD patients may also have up | |
| also have up to Grade I | to Grade I Spondylolisthesis or | |
| Spondylolisthesis or retrolisthesis | retrolisthesis at the involved level. | |
| at the involved level. These patients | DDD is defined as discogenic back | |
| should be skeletally mature and | pain with degeneration of the disc | |
| have had six months of | confirmed by history and radiographic | |
| non-operative treatment. These | studies. These patients should be | |
| implants may be implanted via an | skeletally mature and have had six | |
| open or a minimally invasive | months of non-operative treatment. | |
| posterior approach. Alternatively, | These implants may be implanted via | |
| these implants may also be | an open or a minimally invasive | |
| implanted via transforaminal | posterior approach. Alternatively, | |
| approach. These implants are to be | these implants may also be implanted | |
| used with autogenous bone graft. | via an anterior and/or | |
| transformational approach. These |
Table 6-1 Comparison of Technology Characteristics
3
3
K133053 Page 4 of 4
4 .
| | | DDD is defined as discogenic back
pain with degeneration of the disc
confirmed by history and
radiographic studies. | implants are intended to be used with
supplement fixation instrumentation,
which has been cleared by the FDA
for use in lumbar spine. |
|--------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | | These devices are intended to be
used with supplemental fixation
instrumentation, which has been
cleared by the FDA for use in the
lumbar spine. | |
| Sterile | | Radiation Sterilized | Radiation Sterilized |
| Single Use | | Yes | Yes |
| Shelf Life | | 4 years | 4 years |
| Performance | | Comply with ASTM F2077-03 | Comply with ASTM F2077-03 |
| Features | | a convex, bullet nose design | a convex, bullet nose design |
| | | angular teeth | angular teeth |
| | | hollow geometry | hollow geometry |
| Patient
contact
material | Cage | INVIBIO PEEK-OPTIMA LTI | PEEK |
| | Instrument | 630 Stainless Steel | 630 Stainless Steel |
| | radiographic | tantalum | tantalum |
| | maker | | |
| Physical | Height | 8mm, 10mm, 12mm, 14mm | 8mm, 10mm, 12mm, 14mm |
| specification | Length | 22mm, 26mm, 32mm, 36mm | 22mm, 26mm, 32mm, 36mm |
7.10 Substantially Equivalent (SE) Conclusion
Based on the comparison above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2014
Weigao Orthopaedic Device Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120. CHINA
Re: K133053
Trade/Device Name: Milestone Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 13, 2014 Received: June 16, 2014
Dear Ms. Hong:
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 (reporting of medical
5
Page 2 - Ms. Diana Hong
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
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) K133053
Device Name Milestone Spinal System
Indications for Use (Describe)
The Milestone Spinal System is interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via transforaminal approach. These implants are to be used with autogenous bone graft.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FDA USE ONLY - CARRET PLATE 11:48:00:00
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Anton E. Dmitriev. PhD
Division of Orthopedic Devices
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