(82 days)
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system.
The purpose of this submission is to: expand the use of the system to include the use of screws in the posterior cervical spine, add line extension components and modify an existing component.
This document is a 510(k) premarket notification for a medical device called the "Streamline OCT Occipito-Cervico-Thoracic System." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices. The information provided is about the device itself and its regulatory clearance process, rather than a study proving performance against specific acceptance criteria for AI or diagnostic performance metrics.
Therefore, many of the requested sections about acceptance criteria and study details for an AI-powered diagnostic device cannot be extracted from this document.
However, I can extract information related to the non-clinical testing performed for this physical medical device.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of precise acceptance criteria with numerical thresholds for performance (e.g., tensile strength > X, fatigue life > Y), nor does it report specific measured values for device performance against such criteria. Instead, it generally states that engineering analysis and re-creation testing demonstrated improvements and confirmed that the physical components met regulatory expectations.
| Acceptance Criteria Category | Reported Device Performance (General Statement from Document) |
|---|---|
| Mechanical Performance (General) | Engineering analysis confirmed that subject components do not introduce new worst-case components or impact previously completed construct testing. |
| Mechanical Performance (Modifications) | Re-creation testing was completed to demonstrate the modifications improve performance. |
| Compliance with Standards | Previously completed mechanical testing (ASTM F1717 and ASTM F2706) demonstrate that the subject and predicate systems are substantially equivalent. |
| Safety & Effectiveness | No new risks to safety or effectiveness were raised by the published literature search or non-clinical testing. |
2. Sample size used for the test set and the data provenance
For the non-clinical mechanical testing, the document does not specify the sample size used for each test (e.g., number of constructs tested for fatigue or static loading). It simply refers to "engineering analysis" and "re-creation testing."
The term "data provenance" (e.g., country of origin, retrospective/prospective) is not applicable here as the testing is physical mechanical testing on device components, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the non-clinical mechanical testing of this physical medical device. "Ground truth" in this context would typically refer to clinical diagnoses or outcomes, which are not part of the described engineering or mechanical testing.
4. Adjudication method for the test set
This question is not applicable to the non-clinical mechanical testing of this physical medical device. Adjudication methods like "2+1" or "3+1" are used in clinical studies to resolve discrepancies in expert interpretations of medical data, which is not what was performed for this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data, often with AI assistance, to assess improvements in reader performance. This document is about a spinal implant system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This is also not applicable to a physical spinal implant system.
7. The type of ground truth used
For the non-clinical mechanical testing described, the "ground truth" would be established by the physical properties and behavior of the materials and constructs under specific, controlled loading conditions, as defined by engineering standards (e.g., ASTM F1717, ASTM F2706). It is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set
This concept is not applicable as this document is not describing an AI/machine learning device that requires a training set. The "training set" refers to data used to train an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2016
Pioneer Surgical Technology, Incorporated (DBA RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K161498
Trade/Device Name: Streamline OCT Occipito-Cervico-Thoracic System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: May 31, 2016 Received: June 1, 2016
Dear Ms. Pleaugh:
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 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,
Vincent J. Devlin -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)
K161498
Device Name
Streamline OCT Occipito-Cervico-Thoracic System
Indications for Use (Describe)
The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion when using autograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/ or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.
The system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Streamline OCT System may be connected to the Quantum Spinal Fixation System, Streamline MIS Spinal Fixation System or Streamline TL Spinal System using connectors and/or transition rods.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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Prepared: August 17, 2016
| Company: | Pioneer Surgical Technology, Inc.(DBA RTI Surgical, Inc.)375 River Park CircleMarquette, MI 49855 USAPhone: (906) 226-9909Fax: (906) 225-5868 |
|---|---|
| Contact: | Sarah Pleaugh, Regulatory Affairs Specialist |
| Trade name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Device name: | Streamline OCT Occipito-Cervico-Thoracic System |
| Classification: | Unclassified; Pre-amendment device(Product Code NKG, KWP) |
| Panel: | Panel Code 87 |
| Primary Predicate: | Medtronic VERTEX Reconstruction System (K143471) |
| Additional Predicates: | Streamline OCT Spinal System (K150254)DePuy Mountaineer OCT Spinal System (K151885) |
| Description: | The Streamline OCT System consists of a variety of rods, hooks, polyaxial screws, high-angle screws, locking caps, occipital plates, occipital screws, and connecting components used to build an occipito-cervico-thoracic spinal construct. System components are manufactured from ASTM F136 medical grade titanium alloy and ASTM F1537 medical grade cobalt chromium molybdenum alloy. Medical grade titanium alloy and medical grade cobalt chromium molybdenum alloy may be used together. The system should be implanted using only the surgical instruments designed for the system.The purpose of this submission is to: expand the use of the system to include the use of screws in the posterior cervical spine, add line extension components and modify an existing component. |
| Indications for Use: | The Streamline OCT Occipito-Cervico-Thoracic System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion when using autograft and/or allograft for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.The system is also intended to restore the integrity of the spinal column |
| even in the absence of fusion for a limited time period in patients withadvanced stage tumors involving the cervical spine in whom lifeexpectancy is of insufficient duration to permit achievement of fusion.In order to achieve additional levels of fixation, the Streamline OCTSystem may be connected to the Quantum Spinal Fixation System,Streamline MIS Spinal Fixation System or Streamline TL Spinal Systemusing connectors and/or transition rods. | |
| Summary ofTechnologicalCharacteristics: | The subject system has a similar fundamental scientific technology asthe predicate K143471 Medtronic VERTEX Reconstruction System(primary predicate) and reference devices. The subject system utilizesequivalent surgical approaches, fundamental technology, designs,materials, sterilization and packaging as the predicate devices. |
| Discussion ofSupporting ClinicalEvidence and Non-Clinical Testing: | Engineering analysis was presented to confirm that the subject componentsdo not introduce new worst-case components or impact previouslycompleted construct testing. For device modifications, re-creation testingwas completed to demonstrate the modifications improve performance. Insupport of the indications for use change, published literature andpreviously completed mechanical testing (ASTM F1717 and ASTMF2706) demonstrate that the subject and predicate systems are substantiallyequivalent. No new risks to safety or effectiveness were raised by thepublished literature search or non-clinical testing. |
| SubstantialEquivalence andComparison toLegally MarketedDevices: | The subject system is substantially equivalent to the K143471 MedtronicVERTEX Reconstruction System (primary predicate) and K151885DePuy Mountaineer OCT Spinal System (reference device). Withrespect to the implants used to create the constructs utilized for theindications sought, the subject devices are the same or similar in designto the Streamline OCT devices most recently cleared in K150254(earlier clearances of the system are noted in this submission forreference purposes).The design features, materials, indications for use, surgical approach,and fundamental technology are substantially equivalent to predicatedevices. Previously completed mechanical testing and the clinicalevidence provided in this submission demonstrate there are no new risksto safety or efficacy raised by the subject Streamline OCT System |
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§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.