(64 days)
The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.
In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery.
The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.
This document is a 510(k) Premarket Notification for the DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II) device. It is a medical device submission, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way a diagnostic AI/ML device submission would.
Therefore, the requested information elements related to AI/ML device performance, ground truth, expert adjudication, sample sizes for training/test sets, and MRMC studies are not applicable to this document. This submission relates to a physical orthopedic implant, not a diagnostic algorithm.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance:
Since this is a submission for a physical implant demonstrating substantial equivalence, "acceptance criteria" are not defined as specific performance metrics like sensitivity/specificity for an AI/ML diagnostic. Instead, the submission relies on comparison to predicate devices and mechanical testing standards.
| Acceptance Criteria (Implied by equivalence) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence: Same intended use, design (fundamental scientific technology). | The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. Design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. Accommodates a wide variety of anatomical deformities. |
| Material Equivalence: Similar materials. | All VEPTR/VEPTR II components are manufactured from titanium alloy, Ti-6Al-7Nb (ASTM F1295), with the exception of S-Hooks, S-Rods (CP Ti Grade 4, ASTM F67), and 2mm rods (CP Ti Grade 1, ASTM F67). |
| Performance Equivalence (Mechanical): Meets relevant mechanical testing standards. | Non-clinical testing included static compressive bending and dynamic compressive bending according to ASTM 1717. Results demonstrate the VEPTR device performs in a manner substantially equivalent to the predicate device. |
| Safety & Effectiveness Equivalence (Clinical): Clinical data demonstrates comparable safety and effectiveness for stated indications. | The results of the HDE (H030009) post-market follow-up demonstrate the device can be used safely with probable benefit for the indications stated. Clinical data demonstrated a substantially equivalent safety and effectiveness profile as cited predicate growing spine systems (K133904 and K141509). |
| Sterility & Biocompatibility: Comparable to predicate. | Stated as a basis for substantial equivalence, implying they meet relevant standards. Specific data not detailed in this summary. |
2. Sample sized used for the test set and the data provenance:
- Test Set (for clinical evaluation of safety and effectiveness): The submission references the results of the HDE (H030009) post-market follow-up. The specific sample size for this HDE is not provided in this document summary.
- Data Provenance: The HDE (H030009) is a Humanitarian Device Exemption, typically involving devices for rare conditions. This indicates a clinical study with human subjects, likely multi-center, but the specific country of origin and retrospective/prospective nature are not detailed in this summary. HDEs are inherently prospective post-market follow-ups to gather data on probable benefit and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. This is not an AI/ML device where "ground truth" is established by experts for diagnostic performance. Clinical outcomes and safety were evaluated in the HDE study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device with a human-labeled test set requiring adjudication. Clinical trial data typically has pre-defined endpoints and evaluation criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical orthopedic implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The closest equivalent to "ground truth" here would be clinical outcomes data from the HDE post-market follow-up, which would involve patient data reflecting safety and probable benefit in treating Thoracic Insufficiency Syndrome.
8. The sample size for the training set:
Not applicable. This is a physical orthopedic implant, not an AI/ML model.
9. How the ground truth for the training set was established:
Not applicable. This is a physical orthopedic implant, not an AI/ML model.
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July 29, 2022
Depuy Synthes Spine, Inc. Catherine Kilshaw Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K142587
Trade/Device Name: DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II) Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: MDI
Dear Catherine Kilshaw:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 18, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov.
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
DePuy Synthes Spine Ms. Catherine Kilshaw Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K142587
Trade/Device Name: DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II)
Regulatory Class: Unclassified Product Code: MDI Dated: September 12, 2014 Received: September 15, 2014
Dear Ms. Kilshaw:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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Page 2 - Ms. Catherine Kilshaw
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 yours,
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) K142587
Device Name
DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib (VEPTR/VEPTR II)
Indications for Use (Describe)
The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.
| 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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510(k) Summary
Date Prepared: October 24, 2014
| Submitter: | DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767 |
|---|---|
| Contact Person: | Catherine KilshawSr. Regulatory Affairs AssociateTelephone: (508) 880-8412Fax: (508) 828-3797 |
| Trade Name: | DePuy Synthes Spine Vertical Expandable Prosthetic Titanium Rib(VEPTR/VEPTR II) |
| Device Class: | II |
| Product Code: | MDI |
| Common Name: | Prosthesis, Rib Replacement |
| Classification Name: | Unclassified |
| Regulation Number: | Pre-Amendment Unclassified |
| Primary Predicate Device: | Medtronic CD HORIZON® Growth Rod Conversion Set (K133904) |
| Additional Predicate Devices: | Medos Sarl ISOLA® and EXPEDIUM® Growing Spine Systems (K141509) |
| Reference Devices: | Harrington Spinal Rod System (Pre-Amendment), Vertical ExpandableProsthetic Titanium Rib VEPTR and VEPTR II (H030009) |
| Device Description: | In children with or at risk of developing Thoracic Insufficiency Syndrome, thenatural course of lung development is arrested due to constriction by thethorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correctthoracic deformities to allow the chest and lungs to grow.The VEPTR devices are attached perpendicularly to the subject's natural ribs andlumbar vertebra or pelvis. This mechanically stabilizes the chest wall andenlarges the thorax to improve respiration and lung growth. Once theVEPTR/VEPTR II device is in place, its design allows for expansion, anatomicdistraction, and replacement of component parts through less invasive surgery. |
| The VEPTR/VEPTR II devices allow assembly in a number of differentconfigurations. All of these configurations are required to accommodate thewide variety of anatomical deformities encountered by the clinician in treatingpatients with or at risk of developing Thoracic Insufficiency Syndrome. | |
| Indications: | The VEPTR/VEPTR II device is indicated for skeletally immature patients withsevere, progressive spinal deformities and/or three dimensional deformity ofthe thorax associated with or at risk of thoracic Insufficiency Syndrome(TIS). TIS is defined as the inability of the thorax to support normal respirationor lung growth. This would include patients with progressive congenital,neuromuscular, idiopathic, or syndromic scoliosis. |
| Materials: | All VEPTR/VEPTR II components are manufactured from titanium alloy, Ti-6Al-7Nb (ASTM F1295), with the exception of the sacral S-Hook, S-Rod, and 2mmrod. The S-Hooks and S-Rods are manufactured from commercially puretitanium, CP Ti Grade 4 (ASTM F67). The 2mm rods are manufactured fromcommercially pure titanium, CP Ti Grade 1 (ASTM F67). |
| Comparison toPredicate Devices: | The substantial equivalence of the subject device to the predicates identifiedabove is based upon the similarity of intended use, design (fundamentalscientific technology) materials, performance, sterility and biocompatibility. |
| Non-clinical TestSummary: | Non-clinical testing on the VEPTR/VEPTR II devices included mechanical testing,static compressive bending and dynamic compressive bending according to themethods outlined in ASTM 1717. Results of these tests demonstrate that theVEPTR device performs in a manner substantially equivalent to the predicatedevice. |
| Clinical TestSummary: | The results of the HDE (H030009) post-market follow-up demonstrate that thedevice can be used safely with probable benefit for the indications stated. Inaddition, the clinical data presented demonstrated a substantially equivalentsafety and effectiveness profile as the cited predicate growing spine systems(K133904 and K1411509) for the indications presented. |
| Conclusion: | Based upon the side-by-side predicate comparison, clinical performance datafor the intended use, and pre-clinical testing, the proposed device issubstantially equivalent to the predicate device |
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§ 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.