(62 days)
Not Found
No
The summary describes a mechanical instrument (pin press) used for implant assembly and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device, a pedicle screw fixation system, is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of instabilities or deformities, which directly addresses a medical condition.
No
The device is described as a pedicle screw fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly details a physical instrument ("Zimmer DTO Pin press") used to compress a cord within an implant, indicating it is a hardware device, not software.
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 system used for spinal fixation and stabilization. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details a tool used to assemble a component of the spinal implant system. This is also related to the surgical procedure, not a diagnostic test.
- No Mention of Diagnostic Testing: There is no mention of analyzing samples (blood, tissue, etc.) or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device does not fit that description.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:
- Who are receiving fusions with autogenous graft only;
- Who are having the device fixed or attached to the lumbar or sacral spine;
- Who are having the device removed after the development of a solid fusion mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rod-cord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Product codes (comma separated list FDA assigned to the subject device)
NOP
Device Description
The Zimmer DTO Pin press has been designed to be part of the Zimmer DTO Instruments. The Zimmer DTO Implant is provided partially assembled, in that the cord is placed in the connecting part and fixed with a needle during the manufacturing process; the mechanical integrity of the cord/rod connection is achieved immediately prior to implantation by fully inserting a pin to compress the cord with an intra-operative instrument, this step is performed with the Zimmer DTO Pin press.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
It has been determined that the proposed Zimmer DTO Pin Press is substantially equivalent the predicate Zimmer DTO Hand Press. Based on the results following tests:
- Durability and fatigue .
- Interconnection strength .
- Pull-out strength .
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.
Zimmer DTO Hand-Press, K071879
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.
0
AUG 1 8 2010
510(k) Summary
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name:
Reference:
Predicate Device:
Performance Testing:
Device Description:
Indications:
Zimmer GmbH Sulzerallee 8, P.O. Box 8404 Winterthur. Switzerland
Tim Crabtree Senior Regulatory Affairs Specialist Telephone: 952.857.5631
June 14, 2010
Zimmer® DTO® Pin Press
Spinal System Instruments
Pedicle screw spinal system
21 CFR 888.3070
Zimmer DTO Hand-Press, K071879
It has been determined that the proposed Zimmer DTO Pin Press is substantially equivalent the predicate Zimmer DTO Hand Press. Based on the results following tests:
- Durability and fatigue .
- Interconnection strength .
- Pull-out strength .
The Zimmer DTO Pin press has been designed to be part of the Zimmer DTO Instruments. The Zimmer DTO Implant is provided partially assembled, in that the cord is placed in the connecting part and fixed with a needle during the manufacturing process; the mechanical integrity of the cord/rod connection is achieved immediately prior to implantation by fully inserting a pin to compress the cord with an intra-operative instrument, this step is performed with the Zimmer DTO Pin press.
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesvs Spinal System is intended to provide immobilization and
1
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: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:
- . Who are receiving fusions with autogenous graft only;
- . Who are having the device fixed or attached to the lumbar or sacral spine;
- . Who are having the device removed after the development of a solid fusion mass.
When the Dynesys Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rodcord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Substantial Equivalence:
Based on testing it has been determined that the Zimmer DTQ Pin press is substantially equivalent to the predicate Zimmer DTO Hand-press. The proposed Pin Press has the same intended use, materials, and technology as the Zimmer DTO Hand Press.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a wavy line at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Spine, Inc. % Mr. Tim Crabtree Senior Regulatory Affairs Specialist 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
AUG 1 8 2010
Re: K101704
Trade/Device Name: Zimmer® DTO® Pin Press Instrument Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: NOP Dated: July 19, 2010 Received: July 20, 2010
Dear Mr. Crabtree:
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.
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
3
Page 2 - Mr. Tim Crabtree
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Soubace Buelur
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
SECTION V: Indications for Use Statement
510(k) Number (if known): K101704
Device Name: Zimmer DTO System/Pin Press
Indications for Use:
When used as a pedicle screw fixation system in skeletally mature patients, the Dynesys Spinal System is intended to provide 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: degenerative spondylolisthesis with objective evidence of neurologic impairment and failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the Dynesys system is indicated for use in patients:
- Who are receiving fusions with autogenous graft only;
- Who are having the device fixed or attached to the lumbar or sacral spine; .
- Who are having the device removed after the development of a solid fusion . mass.
When the Dynesvs Spinal System and the OPTIMA ZS Spinal System are used on contiguous levels, they must be used with the Zimmer DTO Implant, rod-cord combination implant, and the U & I Corporation OPTIMA ZS Transition Screw. The indications for use for each level is as specified for each system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K101704 Zimmer DTO Pin P
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