(27 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is described as a "Spinal System" intended for posterior, non-cervical fixation as an adjunct to fusion for a variety of conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, and curvatures. These uses directly involve treating or alleviating a disease, injury, or medical condition, which aligns with the definition of a therapeutic device.
No
Explanation: The document describes a spinal fixation system (CD Horizon™ Spinal System) intended for surgical use (e.g., fusion, fixation) to treat various spinal conditions. Its purpose is to physically stabilize the spine, not to diagnose medical conditions or generate diagnostic information.
No
The device description is not provided, but the intended use and performance studies clearly indicate this is a spinal implant system, which is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for spinal fixation. This is a therapeutic device used in vivo (within the body) during surgery.
- Device Description (though not found): The description of the intended use and the testing performed (mechanical testing like compression, torsion, and fatigue) are consistent with a physical implant, not a diagnostic test performed on biological samples in vitro (outside the body).
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
Therefore, the CD Horizon™ Spinal System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, KWQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical spine (T1-S1), lumbosacral spine (L2 – S1)
Indicated Patient Age Range
skeletally mature patients, pediatric 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)
Testing and/or Rationales were completed for the following:
ASTM F1717: Static Compression, Static Torsion, Compression Fatigue
ASTM F1798: Axial Grip, Axial Torsion, Flexion Extension Static, Flexion Extension Fatigue
ASTM F2503: MRI Compatibility Evaluation
For the tested subject devices, the pre-determined acceptance criteria was met for all tests. For subject devices that are rationalized, all existing predicate data previously provided in the predicate 510(k)s is still applicable.
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.
K090390, K210637, K211958, K221244, K233951
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Sofamor Danek USA, Inc. Wafa Mustafa Sr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K243007
Trade/Device Name: CD Horizon™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: September 26, 2024 Received: September 26, 2024
Dear Wafa Mustafa:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
October 23, 2024
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Digitally signed Bightan) Signed
by Eileen Cadel
-S Eileen Cadel -S 2024.10.23
Cadel -S 2024.10.23
15:48:03 -04-25:48:03 -04'00' for
5:48:03 -04'00' for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
CD Horizon™ Spinal System
Indications for Use (Describe)
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion. With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions:
spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use. The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™indications of use.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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Page 2 of 2
5
510(k) Summary
MEDTRONIC CD HORIZON™ Spinal System
September 26, 2024
| I. Submitter | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Wafa Mustafa | |
| Contact Person | Sr. Regulatory Affairs Specialist |
| Email: wafa.mustafa@medtronic.com | |
| II. Name of Device | CD Horizon™ Spinal System |
| Common Name | Pedicle Screw System |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Classification | Class II |
| Product Codes | NKB, KWP, and KWQ (888.3070, 888.3060, 888.3050) |
| III. Predicate Devices | Primary Predicate: |
- CD HORIZON® Spinal System (K090390, S.E. 05/15/2009)
Additional Predicates: - CD Horizon™ Spinal System (K210637, S.E. 4/30/2021)
- CD Horizon™ Spinal System (K211958, S.E. 07/21/2021)
- CD Horizon™ Spinal System (K221244, S.E. 05/25/2022)
- CD Horizon™ Spinal System (K233951, S.E. 03/27/2024)
The predicates have not been subject to a design related recall. |
6
7
| V. Indications for Use | CD Horizon™ Spinal System |
|---|---|
| The CD Horizon™ Spinal System with or without Sextant™ | |
| instrumentation is intended for posterior, non-cervical fixation as | |
| an adjunct to fusion for the following indications: degenerative disc | |
| disease (DDD - 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, or lordosis), | |
| tumor, pseudarthrosis, and/or failed previous fusion. | |
| Except for hooks, when used as an anterolateral thoracic/lumbar | |
| system, CD Horizon™ Spinal System titanium, cobalt chrome, and | |
| stainless steel implants may also be used for the same indications | |
| as an adjunct to fusion. | |
| With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods | |
| and associated components may be used for the aforementioned | |
| indications in skeletally mature patients as an adjunct to fusion. The | |
| 3.5mm rods may be used for the specific pediatric indications noted | |
| below. | |
| When used for posterior non-cervical pedicle screw fixation in | |
| pediatric patients, CD Horizon™ Spinal System titanium, cobalt | |
| chrome, and stainless steel implants are indicated as an adjunct to | |
| fusion to treat progressive spinal deformities (i.e. scoliosis, | |
| kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular | |
| scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ | |
| Spinal System is intended to treat pediatric patients diagnosed with | |
| the following conditions: spondylolisthesis/ spondylolysis, fracture | |
| caused by tumor and/or trauma, pseudarthrosis, and/or failed | |
| previous fusion. These devices are to be used with autograft and/or | |
| allograft. Pediatric pedicle screw fixation is limited to a posterior | |
| approach. | |
| The CD Horizon™ PEEK rods are intended to provide posterior | |
| supplemental fixation when used with an interbody fusion cage for | |
| patients diagnosed with DDD. These DDD patients may also have | |
| up to Grade 1 spondylolisthesis or retrolisthesis at the involved | |
| level. This device is intended for 1-2 level use in the lumbosacral | |
| spine (L2 – S1) in skeletally mature patients. The device is intended | |
| for use with an interbody fusion cage at the instrumented level and | |
| is not intended for stand-alone use. | |
| The CD Horizon™ Spire™ plate is a posterior, single-level, non- | |
| pedicle supplemental fixation device intended for use in the non- |
8
| | cervical spine (T1-S1) as an adjunct to fusion in skeletally mature
patients. It is intended for plate fixation/attachment to spinous
processes for the purpose of achieving supplemental fixation in the
following conditions: DDD (as previously defined),
spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD HorizonTM Spinal
System rods may be connected to the VertexTM Reconstruction
System with the VertexTM rod connector. Refer to the VertexTM
Reconstruction System package insert for a list of the VertexTM
indications of use. |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| VI. Comparison of
Technological
Characteristics with
the Predicate Devices | The subject devices have the same intended use, indications for use,
materials, similar overall design, fundamental technology,
sterilization, and surgical technique as the following CD HorizonTM
Spinal System predicates: |
| | K090390, S.E. 05/15/2009 K210637, S.E. 4/30/2021 K211958, S.E. 07/21/202 K221244, S.E. 05/25/2022 K233951, S.E. 03/27/2024 |
| VII. Performance Data | The subject and predicate implants have the same function and
fundamental scientific technology. |
| | In accordance with the Guidance for Industry and FDA Staff –
Spinal System 510(k)'s, Medtronic has evaluated the subject
devices to demonstrate substantial equivalence to the predicate
devices.
The subject devices have been tested or rationalized based on if
Medtronic believes that testing is not warranted for the subject |
9
| | devices as they do not present a new worst case when compared to
the predicates. |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Testing and/or Rationales were completed for the following: |
| | ASTM F1717: Static Compression, Static Torsion,
Compression Fatigue ASTM F1798: Axial Grip, Axial Torsion, Flexion
Extension Static, Flexion Extension Fatigue ASTM F2503: MRI Compatibility Evaluation |
| | For the tested subject devices, the pre-determined acceptance
criteria was met for all tests. For subject devices that are
rationalized, all existing predicate data previously provided in the
predicate 510(k)s is still applicable. |
| | Therefore, Medtronic believes the design verification testing
demonstrated that the subject devices are substantially equivalent
to the predicate devices. |
| VIII. Conclusion | Based on the supporting evidence provided in this premarket
notification, Medtronic believes the subject devices are
substantially equivalent to the predicate devices. |