(81 days)
No
The document describes a mechanical spinal rod and its intended use, with no mention of software, algorithms, or any AI/ML related terms.
Yes.
The Easy Rod is part of the ISOLA Spine System, which is used for spinal stabilization and correction of deformities and other spinal conditions, functioning as an adjunct to spinal bone grafting processes.
No
The device description indicates it is a stainless steel rod used for spinal stabilization as an adjunct to spinal bone grafting processes, not for diagnostic purposes.
No
The device description clearly states it is a "stainless steel Easy Rod" and describes its physical dimensions and material, indicating it is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal stabilization and fusion. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a stainless steel rod, a physical implant.
- Performance Studies: The performance studies mentioned are static and fatigue testing, which are relevant to the structural integrity of an implant, not diagnostic accuracy.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
Therefore, the Easy Rod is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Easy Rod is a variation of the Vincer ISOLA rod of the ISOLA Spine System. This rod offers the suggeon casier contourability and casior in-site bending compared with crising V inch disneter ISOLA System consists of two subsystems: The Posterior ISOLA system and the Anarior 1501:4 System. The Easy Rod is intended to be used with the Posterior ISOLAsystem at this time.
The ISQLA implants, when used with pedicte scews, are in Grade 3 or 4 spondylolisthesis at LS-S1 utilizing and logous bone graft, having the device to the lumbar and secral spinc and intended to be removed after solid fusion is amained.
When not used with redicle screws, the ISOLA System is intended for hook, wire, and or sacrabilias screw fixation from the T1 to the ilium/secum. The non pedicle screw indications are spondylolistesis, degate (defined as discogence back pain with degencration of the disc confirmed by history and radios), deformines (scolinsis, lordosis and kyphosis), buttor, forture and previous failed surgery.
As a whole, the Posterior ISOLA spinal system is intended for T !- secral fixation. Pedicle secon fixation is from 13-S1.
The Anterior ISOLA system is intended for use in correcing schiol deformities by establishing an scially and routionally rigid firstion bridge parallel to the soinc. The Anterior system is indicated in sincations where loss of correction is expected, where scollosis cass or where pelvic obliquity is present. Spinal levels for anterior instrumentation ac from TS-L4.
Properly used, the Posterior and Anterior ISOLA Systems will provide temporary stabilization as an adjunct to spinal bone grafing processes. Specific indications are:
-
- Idiopathic scoliosis.
- Neuromuscular scoliosis kyphoscoliosis with associated paralysis or spacisticity. 2.
- Scollosis with deficient posterior elements such as that resulting from laminectomy or myelomeningoosle. 3.
- Spinal fractures (acute reduction or late deformity). ব
- 5. Degenerative disc disease (defined as discognic back pain with deperation of the discover and radiographic studies).
-
- Neoplastic discase.
- 。 Revision surgery.
The Anterior ISOLA system is also used for the correction and stabilization of schiotic curves, for the prevence of undesired scoliotic curves, and for the stabilization of weskened trunks. Indications for these include:
- Collapsing and unstable paralytic deformity. .
-
- Progressively increasing scoliosis.
-
- Decreasing cardio-respiratory function, secondary to spinst or rib deformity or collapse.
-
- Inability to maintain sitting balance, necessitating the use of the hands.
- Increasing pelvic obliquity coincident with beck pain or loss of sitting balance. રું ર
Product codes (comma separated list FDA assigned to the subject device)
MNH, KWP and KWQ
Device Description
The stainless steel Easy Rod is offered in 1/4 inch (6.35 mm) outer diameter and 18" (457 mm) in length. Generally, two rods are required in the construct and are cut to the appropriate length during the surgical procedure. The Easy Rod is a variation of rods previously cleared for the ISOLA Spinal System under K884163 and K944737.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 to the ilium/sacrum, L5-S1 vertebral joint, lumbar and sacral spine, T1-sacral, L3-S1, T5-L4, cervical, thoracic or lumbar vertebral column
Indicated Patient Age Range
Not Found
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)
Static and fatigue testing show the AcroMed Easy Rod to perform consistent with previously cleared components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K970950 1
人 - 2017
ISOLA SYSTEM Easy Rod
JUN - 3 1997
| 510(k) SUMMARY | |
|---|---|
| COMPANY: | AcroMed Corporation |
| 3303 Carnegie Avenue | |
| Cleveland, OH 44115 | |
| TRADENAME: | Isola System Component- Easy Rod |
| CLASSIFICATION: | Spondylolisthesis Spinal Fixation Device |
| Unclassified, preamendment device system | |
| Spinal Interlaminal Fixation Orthosis- Class II | |
| DESCRIPTION: | The stainless steel Easy Rod is offered in 1/4 inch (6.35 mm) outer |
| diameter and 18" (457 mm) in length. Generally, two rods are | |
| required in the construct and are cut to the appropriate length | |
| during the surgical procedure. The Easy Rod is a variation of rods | |
| previously cleared for the ISOLA Spinal System under K884163 | |
| and K944737. | |
| MATERIAL: | The AcroMed Easy Rod is manufactured from implant grade (Grade |
| 2 annealed) stainless steel conforming to ASTM F138 specifications, | |
| with a yield strength of 70-90 KSI. | |
| INDICATIONS: | The ISOLA System consists of two sub-systems: The Posterior |
| ISOLA system and the Anterior ISOLA System. | |
| The ISOLA implants, when used with pedicle screws, are intended | |
| for use in Grade 3 or 4 spondylolisthesis at L5-S1 utilizing | |
| autologous bone graft, having the device fixed or attached to the | |
| lumbar and sacral spine, and intended to be removed after solid | |
| fusion is attained. | |
| When not used with pedicle screws, the ISOLA System is intended | |
| for hook, wire, and/or sacral/iliac screw fixation from T1 to the | |
| ilium/sacrum. The non pedicle screw indications are | |
| spondylolisthesis, degenerative disc disease (defined as discogenic | |
| back pain with degeneration of the disc confirmed by history and | |
| radiographic studies), deformities (scoliosis, lordosis and kyphosis), | |
| tumor, fracture and previous failed surgery. | |
| 1 |
MAIE : € 7861 08. 8881
3
1
ISOLA SYSTEM Easy Rod 510(k) SUMMARY
INDICATIONS (Continued) :
As a whole, the Posterior ISOLA spinal system is intended for T1sacral fixation. Pedicle screw fixation is from L3-S1.
The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The Anterior system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present. Spinal levels for anterior instrumentation are from TS-L4.
The Easy Rod is intended to be used with the Posterior ISOLA system at this time.
PERFORMANCE DATA: _
SUBSTANTIAL EQUIVALENCE:
Static and fatigue testing show the AcroMed Easy Rod to perform consistent with previously cleared components.
The AcroMed Easy Rod is equivalent to AcroMed's 1/2 inch diameter ISOLA rod as cleared under K944737 and to the Harrington System, manufactured by Zimmer beginning in the 1960's.
4
£970950 =2 of 2
MAI 8 : 6 7681 .08 . V 881
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and healing. The caduceus is depicted with a staff entwined by two snakes and topped with a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Ms. Mary Lewis Product Approval Partner AcroMed Corporation 3303 Carnegie Avenue Cleveland, Ohio 44115
K970950 Re: AcroMed Easy Rod to be used with the ISOLA Spine System Requlatory Class: II Product Codes: MNH, KWP and KWQ Dated: March 12, 1997 Received: March 14, 1997
Dear Ms. Lewis:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act) . . found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against
3
Page 2 - Ms. Mary Lewis
misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as-described-above, would-cause-the-device-ro-w system to be adulterated under 501(f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1 . label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) havinq severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device 2. system for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device e system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- The screws of this device system are not intended ● for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
4
Page 3 - Ms. Mary Lewis
- Benefit of spinal fusions utilizing any pedicle . screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this . device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended 3. uses other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above .
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major
第一次第四次学生 第一
5
Page 4 - Ms. Mary Lewis
FIFTER
regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General -(GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
6
Page 5 - Ms. Mary Lewis
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Number (if known):
Device Name:
Indications for Use:
The Easy Rod is a variation of the Vincer ISOLA rod of the ISOLA Spine System. This rod offers the suggeon casier contourability and casior in-site bending compared with crising V inch disneter ISOLA System consists of two subsystems: The Posterior ISOLA system and the Anarior 1501:4 System. The Easy Rod is intended to be used with the Posterior ISOLAsystem at this time.
The ISQLA implants, when used with pedicte scews, are in Grade 3 or 4 spondylolisthesis at LS-S1 utilizing and logous bone graft, having the device to the lumbar and secral spinc and intended to be removed after solid fusion is amained.
When not used with redicle screws, the ISOLA System is intended for hook, wire, and or sacrabilias screw fixation from the T1 to the ilium/secum. The non pedicle screw indications are spondylolistesis, degate (defined as discogence back pain with degencration of the disc confirmed by history and radios), deformines (scolinsis, lordosis and kyphosis), buttor, forture and previous failed surgery.
As a whole, the Posterior ISOLA spinal system is intended for T !- secral fixation. Pedicle secon fixation is from 13-S1.
The Anterior ISOLA system is intended for use in correcing schiol deformities by establishing an scially and routionally rigid firstion bridge parallel to the soinc. The Anterior system is indicated in sincations where loss of correction is expected, where scollosis cass or where pelvic obliquity is present. Spinal levels for anterior instrumentation ac from TS-L4.
Properly used, the Posterior and Anterior ISOLA Systems will provide temporary stabilization as an adjunct to spinal bone grafing processes. Specific indications are:
-
- Idiopathic scoliosis.
- Neuromuscular scoliosis kyphoscoliosis with associated paralysis or spacisticity. 2.
- Scollosis with deficient posterior elements such as that resulting from laminectomy or myelomeningoosle. 3.
- Spinal fractures (acute reduction or late deformity). ব
- 5. Degenerative disc disease (defined as discognic back pain with deperation of the discover and radiographic studies).
-
- Neoplastic discase.
- 。 Revision surgery.
The Anterior ISOLA system is also used for the correction and stabilization of schiotic curves, for the prevence of undesired scoliotic curves, and for the stabilization of weskened trunks. Indications for these include:
- Collapsing and unstable paralytic deformity. .
-
- Progressively increasing scoliosis.
-
- Decreasing cardio-respiratory function, secondary to spinst or rib deformity or collapse.
-
- Inability to maintain sitting balance, necessitating the use of the hands.
- Increasing pelvic obliquity coincident with beck pain or loss of sitting balance. રું ર
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (Ol
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K470950
Prescription Use (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Optional Format 1-2-96)
AM 5:30 30. 1997