(210 days)
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No
The device description and intended use are for a mechanical spinal fixation system. There is no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The Procyon Spinal System is intended for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
The Procyon Spinal System is described as a "fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion." Its components are screws, rods, and connecting components, which are used to treat instabilities or deformities. This indicates a therapeutic or supportive role rather than a diagnostic one.
No
The device description explicitly states that the Procyon Spinal System consists of physical components (polyaxial screws, rods, and connecting components) fabricated from titanium alloy. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Procyon Spinal System Function: The provided description clearly states that the Procyon Spinal System is a "pedicle screw fixation system" intended for "immobilization and stabilization of spinal segments as an adjunct to fusion." This is a surgical implant used directly within the body to provide structural support.
- Lack of Specimen Analysis: The description does not mention any interaction with or analysis of human specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the intended use and device description, the Procyon Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in the non-cervical spine of skeletally mature patients, the Procyon Spinal System is intended for 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: 1) degenerative spondylolisthesis with objective evidence of neurological impairment, 2) fracture, 3) dislocation, 4) scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is intended for skeletally mature patients: 1) having severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, 2) who are receiving fusion by autogenous bone graft only; 3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and 4) who are having the device removed after the development of a solid fusion mass.
Product codes
MNI: 888. 3070, MNH: 888.3070
Device Description
The Procyon Spinal System consists of polyaxial screws, rods, and connecting components. The components are fabricated from titanium alloy (ASTM F-136).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-cervical spine, thoracic, lumbar and sacral spine, L5-S1 vertebra, L3 and below
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were submitted to characterize the Procyon Spinal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
0
Procyon Spinal System
510(k) Application
JUN 0 3 2004
PREMARKET NOTIFICATION 510(K) SUMMARY B.
| Company: | NAS Medical Technologies, Inc.
9191 Towne Centre Dr., Suite 395
San Diego, CA 92122
Phone: (858) 452-5589
Fax: (858) 777-5790 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Makoto Nonaka, M.D., Ph.D. |
| Proposed Proprietary
Trade Name: | Procyon Spinal System |
| Classification Name: | Spondylolisthesis spinal fixation device system
Pedicle screw system |
| FDA Product Code
Classification: | MNI: 888. 3070, MNH: 888.3070 |
| Device Description: | The Procyon Spinal System consists of polyaxial screws,
rods, and connecting components. The components are
fabricated from titanium alloy (ASTM F-136). |
| Intended Use: | When used as a pedicle screw fixation system in the non-
cervical spine of skeletally mature patients, the Procyon
Spinal System is intended for 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: 1)
degenerative spondylolisthesis with objective evidence of
neurological impairment, 2) fracture, 3) dislocation, 4)
scoliosis, 5) kyphosis, 6) spinal tumor and 7) failed previous
fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the
Procyon Spinal System is intended for skeletally mature
patients: 1) having severe spondylolisthesis (Grades 3 and 4)
of the L5-S1 vertebra, 2) who are receiving fusion by
autogenous bone graft only; 3) who are having the device
fixed or attached to the lumbar and sacral spine (L3 and
below); and 4) who are having the device removed after the
development of a solid fusion mass. |
| | Predicate Devices: |
| Performance Data: | Performance data were submitted to characterize the Procyon
Spinal System. |
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Makoto Nonaka, M.D., Ph.D. NAS Medical Technologies, Inc. 9191 Towne Centre Drive, Suite 395 San Diego, California 92122
K033512 Re: Trade Name: Procyon Spinal System Regulation Number: 21 CFR 888.3070 (b) (1) Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH Dated: March 22, 2004 Received: March 23, 2004
Dear Dr. Nonaka:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o relay he 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 conninered prior to May 20, 1978, the ecoordance with the provisions of the Federal Food, DINA de nees that have been receasoned in assee approval of a premarket approval application (PMA). and Cosmetic Tor (1101) that do not require to the general controls provisions of the Act. The r ou may, mercerere, manel the Act include requirements for annual registration, listing of general controls provising 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 If your device is oneshined (see are roy als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of t may or subject to back addess the sublations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Dr. Mako Nonaka, M.D., Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualic of a substantal equirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a delefinination that your cerred by other Federal agencies. You must or any Federal Statutes and regulations administered of not limited to: registration and listing (21 l comply with all the Act 3 requirements, moradice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sectroni CFR Part 807), labeling (21 CFR Part 800), good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000, 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections 50 - 5 vice as described in your Section 510(k)
This letter will allow you to begin marketing your device of car device to legg I his letter will anow you to begin mankemig your avong equivalence of your device to a legally premarket nother in the PDA midning of backanding of 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 do rice at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misoranding by reference to premainter nevilivans ander the Act from the Division of Small other general Information on your responsible and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free number on the b Manufacturers, International and Coness http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Miriam C. Provost
for 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
3
Procyon Spinal System 510(k) Application
TAB 5. Labeling
A. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Procyon Spinal System
Indications for Use:
INTER used as a pedicle screw fixation system in the non-cervical spine of skeletally malure
s and as a provinced for a first and intended for mmobilization of spinal When used as a pedicle screw is intended for immobilization and stabilization of spinal
patients, the Procyon Spinal System is intreasonal of the following instabilities patients, the Procyon System is intended of the following acute and chronic instabilities.
segments as an adjunct to fusion in the treatment of the following acute and segments as an adjunct to fusion in the treatment of the following to the spondylolisthesis with
or deformities of the thoracic, lumbar and sacral spiric: 1) degenerative spo or deformities of the thoracio, lumbar and sacal spine. 1) degation, 4) scoliosis, 5)
objective evidence of neurological impairment, 2) fracture, 3) dislocationsis), objective evidence of neurological "Impanies")
kypohsis, 6) spinal tumor and 7) failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw fixation system, the Procyon Spinal System is
t Intended for skeletally mature patients: 1) having severe spondyblisthssis (Grades 3 and 4) of intended for skeletally mature patients: 1) having severe speners bone graft only; 3) who are
the L 5-S1 v ertebra, 2 ) w ho are receiving fusion by autogenous bone graft onl the L 5-S1 v ertebra, 2 ) who are receiving rushor and sacral some (L3 and below); and 4) who
having the device fixed or attached to the nament of a colid fusion nas having the device fixed of attached to the taken.
are having the device removed after the development of a solid fusion mass.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use __ or Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Division Sign-Off) Division of General, Restorative, and Neurological Devices K633512 510(k) Number.