(34 days)
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for 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.
The U & I Spinal Hook and Rod System can be used in coniunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
The U&I America, Spinal Hook System ™ is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Spinal Hook System ™ implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The U&I America, Spinal Hook System ™ can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The U&I America, Spinal Hook System ™ design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic (spinal) location and orientation.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Spinal Hook System ™ implants.
The U&I America, Spinal Hook System™ is a spinal fixation system. Based on the provided 510(k) summary, the device's acceptance criteria and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical equivalence to predicate devices | "Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices." |
| Material conformity to industry standards | Fabricated from titanium alloy (Ti-6AL-4V ELI) that conforms to ASTM F 136. |
| Design equivalence to predicate devices | "The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices." |
| Operational principles equivalence to predicate devices | "The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." |
| Safe and effective for stated indications | "From the foregoing, we conclude that the subject U&I America, Spinal Hook System ™ device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document refers to "Bench testing as listed in Section XII". However, the specific sample size used for the test set is not explicitly stated in the provided text. The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory data (bench testing).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable or provided as the device is a physical medical device (spinal implant) and its performance is evaluated through mechanical bench testing, not through expert review of medical images or patient data.
4. Adjudication Method for the Test Set:
This information is not applicable or provided as the evaluation is based on objective bench testing against ASTM standards, not on subjective human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MrMC comparative effectiveness study was done. This type of study is typically used for AI-powered diagnostic devices where human readers' performance with and without AI assistance is compared. This document describes a physical spinal implant device tested through bench testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This information is not applicable or provided. As above, this pertains to AI/software performance, not a physical implant. The "performance" described is the mechanical integrity and material properties of the device itself.
7. Type of Ground Truth Used:
The ground truth used for the device's performance evaluation is established mechanical standards (ASTM F1717) and material specifications (ASTM F136). The performance is compared to these objective standards and to the performance of legally marketed predicate devices.
8. Sample Size for the Training Set:
This concept is not applicable to this type of medical device (physical spinal implant). Training sets are used for machine learning algorithms. The manufacturing process of a physical device does not involve a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as in point 8.
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JUN 2 4 2003
K031595 ' of 3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
Submission Information:
Classification Name:
| Contact: | Patrick MooreManager, Quality Assurance | |
|---|---|---|
| Sponsor: | U&I America6132 South 380 WestMurray, UT 84107Phone: 801.262.3100Fax: 801.262.3151 | |
| Date Prepared: | June 11, 2003 | |
| Device Identification: | ||
| Trade Name:Common Name: | U&I America, Spinal Hook System™Spinal Hook System |
Appiliance, Fixation, Spinal Interlaminal (KWP) per 21 CFR ട്ട് 888.3050
Spinal Hook System
Substantially Equivalent Predicate Legally Marketed Devices:
United States Surgical Corporation, Rogozinski Spinal System – KWP, MNH, MNI, KWQ -- (K983804) Cotrel-Dubousset (CD™) Spinal system -- MNH, MNI, KWQ, KWP -- (K001319, K955807)
The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operational principles to the above listed predicate devices.
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K031595 2 cm 3 Device Description:
The U&I America, Spinal Hook System ™ is a top-loading posterior spinal fixation system which consists of hooks, rods, set screws, connectors, and a transverse (cross) linking mechanism. The Spinal Hook System ™ implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The U&I America, Spinal Hook System ™ can be used in the posterior plane providing unilateral and bilateral modes of fixation.
The U&I America, Spinal Hook System ™ design allows adjustment in both the sagittal and coronal planes permitting hook placement according to the best possible anatomic (spinal) location and orientation.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Spinal Hook System ™ implants.
From the foregoing, we conclude that the subject U&I America, Spinal Hook System ™ device is as safe and effective as named predicates and currently marketed competitive devices for the stated indications.
Indications for Use:
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with deqeneration 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.
The U & I Spinal Hook and Rod System can be used in coniunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
Statement of Technological Comparison:
The subject spinal implant system is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles.
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Image /page/2/Figure/0 description: The image shows the alphanumeric string 'K031595' on the top line. Below that, there is a handwritten line that reads '3 c4 3'. The characters in the second line are less clear and appear to be handwritten digits with a possible letter in the middle.
Performance Data:
Bench testing as listed in Section XII which was conducted in accordance with ASTM F1717 demonstrates equivalence to the above listed predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three flowing lines representing the department's services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2003
Mr. Patrick Moore Manager, Quality Assurance U&I America 6132 South 380 West, Suite 200 Murray, Utah 84107
Re: K031595
Trade Name: U&I America, Spinal Hook System™ Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: May 16 and June 10, 2003 Received: May 21 and June 12, 2003
Dear Mr. Moore:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
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Page 2 - Mr. Patrick Moore
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
sincerely yours,
L. Mark N. Millerm
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K031595, Spinal Hook System Additional Information:
510(k) Number (if known): K031595
Device Name: U&I America, Spinal Hook System ™
Indications for Use:
The U & I Spinal Hook and Rod System intended for use as a posterior, noncervical, nonpedicle system indicated for 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.
The U & I Spinal Hook and Rod System can be used in conjunction with the OPTIMA Spinal System or the GLOBAL Spinal Fixation System.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over-the-Counter Use_ _____________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96)
Mark A. Mikkelsen
vision Sign-Off) sion of General, Restorative Neurological Devices
s. (k) Number -
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.