(244 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components, with no mention of AI or ML technologies.
Yes
The device is intended for "posterior non-cervical pedicle fixation... as an adjunct to fusion" for various spinal conditions, indicating its use in treating medical conditions or achieving therapeutic effects.
No
The device is a spinal fixation system designed to provide stabilization and promote bone fusion, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of physical components made from Titanium Alloy, such as screws, rods, and connectors, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Phamedica PHA S1 Spinal System is a collection of implants (screws, rods, connectors) made from titanium alloy. These are surgically implanted into the spine.
- Intended Use: The intended use is for posterior non-cervical pedicle fixation of the spine as an adjunct to fusion. This is a surgical procedure to stabilize the spine and promote bone healing.
The device is a surgical implant used in the body, not a device used to test samples from the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of 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
- Failed previous fusion in skeletally mature patients.
Product codes
NKB
Device Description
Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/Iliac Spine
Indicated Patient Age Range
skeletally mature patients
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)
The PHA S1 Spinal System has been tested in the following test modes:
- Static compression bending per ASTM F1717-15
- Static torsion per ASTM F1717-15
- Dynamic compression bending per ASTM F1717-15
The results of this non-clinical testing show that the strength of the PHA S1 Spinal System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2017
Phamedica, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K163011
Trade/Device Name: PHA S1 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: June 13, 2017 Received: June 14, 2017
Dear Mr. Maxwell:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/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,
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) K163011
Device Name
PHA S1 Spinal Fixation
Indications for Use (Describe)
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/ Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or all of 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
- · Failed previous fusion in skeletally mature patients.
| 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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5.510(K) SUMMARY
| Submitter's Name: | Phamedica, Inc. |
|---|---|
| Submitter's Address: | 15 Newtown Rd |
| Plainview NY 11803 | |
| Submitter's Telephone: | 719.291.6874 |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Consulting, LLC | |
| 719.337.7579 | |
| Date Summary was Prepared: | 29 June 2017 |
| Trade or Proprietary Name: | PHA S1 Spinal Fixation |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Orthosis, Spondylolisthesis Spinal Fixation | |
| Orthosis, Spinal Pedicle Fixation, For Degenerative Disc | |
| Disease | |
| Classification: | Class II per 21 CFR §888.3070 Device Classification |
| Product Code: | NKB |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Phamedica PHA S1 Spinal Fixation system consists of Poly Axial screws, Mono Axial Screws, Poly Axial and Mono Axial Reduction Screws, Rods, Set Screws, Transverse and Offset connectors made from Titanium Alloy Ti6AL4V which can be variously assembled for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.
INDICATIONS FOR USE
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or allograft for all of 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 ●
- Failed previous fusion in skeletally mature patients.
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The indications for use for the PHA S1 Spinal System is similar to that of the predicate devices listed in Table 5-1.
Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|----------------|---------------------------------------|--------------|-------------------|
| K000236 | Synergy VLS Open | Interpore | Primary |
| K111940 | S 100 Pedicle Screw System | Renovis | Additional |
PERFORMANCE DATA
The PHA S1 Spinal System has been tested in the following test modes:
- Static compression bending per ASTM F1717-15 ●
- Static torsion per ASTM F1717-15 .
- Dynamic compression bending per ASTM F1717-15 ●
The results of this non-clinical testing show that the strength of the PHA S1 Spinal System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the PHA S1 Spinal System is substantially equivalent to the predicate device.