(350 days)
The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.
The provided text is a 510(k) summary for the HC Spinal System, a medical device. It does not describe a study involving an AI algorithm or human-in-the-loop performance. Instead, it details the non-clinical testing performed on a physical spinal implant system to demonstrate its substantial equivalence to a predicate device.
Therefore, most of the requested information regarding AI performance, sample sizes for test/training sets in an AI context, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document.
Here's the relevant information that can be extracted:
1. A table of acceptance criteria and the reported device performance
The document states that a series of non-clinical tests were performed. The "reported device performance" is a general statement that the device met the requirements. Specific numerical acceptance criteria and performance values are not provided in this summary.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meeting requirements of pre-defined acceptance criteria (implied by test standards) | All test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses. |
| Compliance with ASTM F1717 for Performance | Complied with ASTM F1717 |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample sizes for test set: Not specified in the document. The tests performed are engineering/materials tests on physical devices, not clinical studies with human participants.
- Data provenance: Taiwan (R.O.C.) (where the submitter is located), for the device manufacturing/testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device (spinal implant) is established through engineering and material testing standards (e.g., ASTM F1717). No human expert consensus for a "test set" in the context of interpretation of medical data is described.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document does not describe an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" or standard for evaluation is based on pre-defined acceptance criteria derived from established engineering and material testing standards, such as ASTM F1717 for mechanical performance, and general biological safety standards for cytotoxicity, irritation, etc. These are objective measures rather than expert consensus on medical image interpretation or pathology.
8. The sample size for the training set
Not applicable. There is no AI algorithm, so no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm, so no training set or associated ground truth establishment.
Summary of the study that proves the device meets the acceptance criteria:
The study described is a series of non-clinical tests performed on the HC Spinal System. These tests are outlined in Section 8 ("Non-clinical Testing") and include:
- Shelf Life Test
- In vitro Cytotoxicity Test
- Intracutaneous Irritation Study
- Skin Sensitization Study
- Pyrogen Test
- Acute Intravenous Systemic Toxicity Study
- Acute Intraperitoneal Systemic Toxicity Study
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Chromosomal Aberration Test
- Rodent Micronucleus Test
- Bone Implantation Study
- Subchronic Intravenous Systemic Toxicity Study
- Static and Dynamic axial Compress Bending Testing
- Static Torsional Test
The document states that "All the test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses." Specifically, for performance, it notes compliance with ASTM F1717. The purpose of these tests was to demonstrate the safety and performance of the device and to establish substantial equivalence to the predicate device (Xia® 4.5 Spinal System) under 510(k) regulations. No clinical test data was used to support this decision.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human face or profile, composed of three curved lines that suggest the nose, mouth, and chin.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2016
Hung Chun Bio-S Company, Limited % Mr. Michael Lee Acmebiotechs Consulting Incorporation 38F-7, No. 368, Sec. 1, Wenhua Road, Banqiao District New Taipei City 22041 TAIWAN (R.O.C.)
Re: K151362
Trade/Device Name: HC Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: April 15, 2015 Received: April 20, 2016
Dear Mr. Lee:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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/Resourcesfor You/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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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) K151362
Device Name HC Spinal System
Indications for Use (Describe)
The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| 1 Type of Submission: | Traditional |
|---|---|
| 2 Date of Summary: | April 15, 2016 |
| 3 Submitter: | Hung Chun Bio-S Co., Ltd. |
| Address: | No.12, Luke 1 st Rd., Luzhu Dist. |
| Kaohsiung City 821, Taiwan (R.O.C.) | |
| Phone: | +886-7-695-5369 |
| Fax: | +886-7-695-5379 |
| Contact: | Hsin Tai Hu (tai@hc-bios.com) |
4 Identification of the Device:
| Proprietary/Trade name: | HC Spinal System |
|---|---|
| Device Classification: | II |
| Panel: | Orthopedic |
| Regulation Number: | 888.3070 |
| Product Code: | MNH, MNI |
| Classification Name: | Pedicle screw spinal system |
5 Identification of the Predicate Device:
| Predicate Device Name: | Xia® 4.5 Spinal System |
|---|---|
| Manufacturer: | Stryker Spine |
| Regulation number: | 888.3070, 888.3050, 888.3060 |
| Product Code: | MNH, MNI, KWP, KWQ |
| 510(k) Number: | K050461 |
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6 Intended Use and Indications for Use of the subject device
The HC Spinal System is intended for posterior noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients for the following indications: severe spondylolisthesis (i.e., Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
7 Device Description
The HC Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients as an adjunct to fusion. The HC Spinal System consists of monoaxial and polyaxial pedicle screws, set screw and rods. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.
8 Non-clinical Testing
A series of tests were performed on the proposed device, HC Spinal System.
- o Shelf Life Test
- In vitro Cytotoxicity Test
- Intracutaneous Irritation Study
- o Skin Sensitization Study
- . Pyrogen Test
- o Acute Intravenous Systemic Toxicity Study
- Acute Intraperitoneal Systemic Toxicity Study
- o Salmonella Reverse Mutation Test
- . In Vitro Mammalian Chromosomal Aberration Test
- . Rodent Micronucleus Test
- . Bone Implantation Study
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- o Subchronic Intravenous Systemic Toxicity Study
- Static and Dynamic axial Compress Bending Testing ●
- . Static Torsional Test
All the test results demonstrate that HC Spinal system meets the requirements of its pre-defined acceptance criteria and intended uses.
9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
10 Substantial Equivalence Determination
The HC Spinal system submitted in this 510(k) file is substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared Xia® 4.5 Spinal System. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
| Proposed Device | Predicate Device | |
|---|---|---|
| Item | HC Spinal System | Xia® 4.5 Spinal System (K050461) |
| Classification | Class II | Class II |
| Product Code | MNH, MNI | MNH, MNI, KWP, KWQ |
| Intended Use | The HC Spinal System is intended forposterior noncervical pedicle fixationas an adjunct to fusion in skeletallymature patients for the followingindications: severe spondylolisthesis(i.e. Grades 3 and 4 at L5-S1 ordegenerative spondylolisthesis withobjective evidence of neurologic | The XIA® 4.5 Spinal System isintended for posterior noncervicalpedicle fixation for the followingindications: severe spondylolisthesis(i.e. Grades 3 and 4 at L5-S1 ordegenerative spondylolisthesis withobjective evidence of neurologicimpairment), trauma (i.e. fracture or |
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| impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion. | dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.The XIA® 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, non-pedicle fixation 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, pseudoarthrosis and failed previous fusion. | |||
|---|---|---|---|---|
| Material | Titanium Alloy | Titanium Alloy | ||
| MaterialCompliance | ASTM F136 | ASTM F136 | ||
| Diameter (mm) | Length (mm) | Diameter (mm) | Length (mm) | |
| Ø 4.5 | 30, 35, 40, 45, 50, 55, 60 | Ø 4.0 | 20-40 | |
| MonoaxialScrews | Ø 5.0 | 30, 35, 40, 45, 50, 55, 60 | Ø 4.5 | 25-45 |
| Ø 5.5 | 30, 35, 40, 45, 50, 55, 60 | Ø 5.0 | 25-50 | |
| Ø 6.0 | 30, 35, 40, 45, 50, 55, 60 | Ø 5.5 | 30-55 | |
| Ø 6.5 | 30, 35, 40, 45, 50, 55, 60 | Ø 6.5 | 30-60 | |
| PolyaxialScrews | Diameter(mm) | Length(mm) | Diameter(mm) | Length(mm) |
| Ø 4.5 | 30, 35, 40, 45,50, 55, 60 | Ø 4.0 | 20-40 | |
| Ø 5.0 | 30, 35, 40, 45,50, 55, 60 | Ø 4.5 | 25-70 | |
| Ø 5.5 | 30, 35, 40, 45,50, 55, 60 | Ø 5.0 | 30-60 | |
| Ø 6.0 | 30, 35, 40, 45,50, 55, 60 | Ø 5.5 | 30-60 | |
| Ø 6.5 | 30, 35, 40, 45,50, 55, 60 | Ø 6.5 | 30-60 | |
| Set screw | ID(mm) | OD(mm) | ID(mm) | OD(mm) |
| 5.05 | 9.90 | 5.05 | 9.90 | |
| Rod | Diameter(mm) | Length(mm) | Diameter(mm) | Length(mm) |
| Ø 4.5 | 40, 45, 50, 60,70, 80, 90, 100 | Ø 4.5 | 30, 40, 50, 60,70, 80, 90,100, 200, 480,600 | |
| Sterilizationmethod | Non-sterile | Non-sterile | ||
| Performance | Comply with ASTM F1717 | Comply with ASTM F1717 |
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11 Similarity and differences
The differences between the proposed device and the predicate device are diameter and length of Monoaxial Screws, Polyaxial Screws and Rod. The proposed device has tested on safety and performance tests and the results were complied with the test requests. Therefore, the differences of proposed device and predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in intended use, main materials, safety and performance claims.
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5.12 Conclusion
After analyzing bench tests, device description and intended use/indications for use, it can be concluded that HC Spinal system is substantially equivalent to the predicate device.
§ 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.