(68 days)
The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis)
In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors. The titanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided.
This 510(k) premarket notification for the Altiva HydraLok™ System does not contain specific acceptance criteria or details of a comprehensive study proving the device meets acceptance criteria related to its performance characteristics (e.g., strength, durability, biomechanical stability).
The document states, "Performance data were submitted to characterize the HydraLok System." However, the actual performance data, acceptance criteria for that data, and the study design are not provided within this summary.
Based on the provided information, I cannot complete the requested tables and descriptions because the document primarily serves as a regulatory submission summary rather than a detailed performance study report.
Here's what can be inferred from the document regarding the type of data submitted, but not the specifics:
1. Table of Acceptance Criteria and Reported Device Performance
- Not available from the provided text. The document only states that "Performance data were submitted to characterize the HydraLok System." No specific criteria or reported performance values are given.
2. Sample size used for the test set and the data provenance
- Not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This specific type of "ground truth" establishment is typically relevant for AI/diagnostic devices, not for a spinal fixation system, unless the performance data involved human assessment of biomechanical outcomes, which is not indicated here.
4. Adjudication method
- Not applicable. See point 3.
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 is a mechanical device, not an AI or diagnostic tool where human reader performance would be enhanced by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used
- Not applicable. For a mechanical device, performance is typically evaluated against engineering specifications, material properties, and biomechanical testing standards, rather than "ground truth" derived from expert consensus, pathology, or outcomes data in the way AI/diagnostic devices are.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of available information:
The document is a 510(k) summary for a medical device called the "HydraLok™ System," a pedicle screw spinal fixation system. It outlines the company, contact, date, trade name, common name, classification, device description, intended use, and predicate device information. It explicitly states that "Performance data were submitted to characterize the HydraLok System," which is a mandatory part of a 510(k) submission to demonstrate substantial equivalence to a predicate device. However, the details of that performance data, including specific acceptance criteria, test results, study methodology, sample sizes, and how ground truth was established, are not contained within this summary document.
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K05/216 1/2
PREMARKET NOTIFICATION 510(K) SUMMARY
JUL 1 9 2005
| Company: | Director RA/QAAltiva Corporation9800 Suite 1, Southern Pines BlvdCharlotte, NC 28273Telephone: 704/409-1754Fax: 704/409-1771 |
|---|---|
| Company Contact: | John Kapitan |
| Date: | May 10, 2005 |
| Trade Name: | HydraLok™ System |
| Common NameClassification:FDA Product Code : | Pedicle Screw Spinal Fixation SystemOrthopedics, 888.3070, Class IIMNI, MNH |
| Device Description: | The HydraLok System is a top-loading spinal fixationsystem including screws, rods, and connectors. Thetitanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided. |
| Intended Use: | The HydraLok System is intended to provideimmobilization and stabilization of spinal segments asan adjunct to fusion in the treatment of the followingacute and chronic instabilities or deformities of thethoracic, lumbar and sacral spine includingdegenerative spondylolisthesis with objective evidenceof neurological impairment, fracture, dislocation,scoliosis, kyphosis, spinal tumor and failed previousfusion (pseudoarthrosis) |
| In addition, when used as a pedicle screw fixationsystem, the HydraLok System is intended for skeletallymature patients with severe spondylolisthesis (Grades 3and 4) of the L5-S1 vertebra, who are receiving fusionby autogenous bone graft only having the deviceattached to the lumbar and sacral spine (L3 and below),who are having the device removed after thedevelopment of a solid fusion. | |
| Predicate Device: | Predicate device information is included. |
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KOS/216 2/2
Performance Data:
Performance data were submitted to characterize the HydraLok System.
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
Mr. John Kapitan Director RA/QA Altiva Corporation 9800-I Southern Pine Boulevard Charlotte, North Carolina 28273
Re: K051216
Trade/Device Name: Altiva HydraLokTM System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNH, MNI Dated: May 10, 2005 Received: May 12, 2005
Dear Mr. Kapitan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(s) pressed is substantially equivalent (for the indications felerenced above and nave decembergally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars and the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not requent of the general controls provisions of the Act. The You may, merciole, manol the Act include requirements for annual registration, listing of general controls provisions of the Free 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 If your device is classified (300 a0070) als. Existing major regulations affecting your device can may be subject to such additions, 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 I least be advised that I DT is lessants of the complies with other requirements of the Act that I Dri has intado a actuations administered by other Federal agencies. You must of any I cuttar statures and regaranents, including, but not limited to: registration and listing (21 Compry with an the Aot 8 requirements, 11); good manufacturing practice requirements as set CFR Part 807), adomig (21 OFF Part 820); and if applicable, the electronic forth in the quality bystelly (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. John Kapitan
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your antial equivalence of your device to a legally premarket notheation. The PDA miding of bactification 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 If you desire specific advice for your acon 276-0120. Also, please note the regulation entitled, comact the Office of Compuners as (2 + + n = (21CFR Part 807.97). You may obtain "Misbranding by reference to premanteenoulties. Souther the Act from the Division of Small other geteral information on your responsible and its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Prosistanter Prosis.org/vcdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Altiva HydraLok™ System
Indications for Use: · ·- · · · ·
نخست تي تي تي تي
The HydraLok System is intended to provide immobilization and stabilization The Hydracok System is intended to free treatment of the following
of spinal segments as an adjunct to fusion in the treasing lymber ond socra of spinal segments as an adjunct to racion in the thoracic, lumbar and sacral spine:
degenerative spondylolisthesis with objective evidence of neurological . impairment,
- fracture, .
- dislocation, .
- scoliosis, .
- kyphosis, .
- spinal tumor and .
- failed previous fusion (pseudoarthrosis) .
In addition, when used as a pedicle screw fixation system, with acquere System is intended for skeletally mature patients with severe System - is - intended - for - Skolotally - marketra, who are receiving spondylolistiesis (Craces o ana f) or life drive the device attached to the fusion by adtogenous bone grait only having the device removed after the development of a solid fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ or Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
iriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K051216
§ 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.